A Phase 3 interventional study of CP-690,550 and CP-690,550 in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 176 sites in 30 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 956 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
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Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Drug: CP-690,550
Drug: CP-690,550
Drug: Disease-modifying antirheumatic drug
Oral tablets administered at a dose of 5 mg BID for 24 months
Oral tablets administered at a dose of 10 mg BID for 24 months
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Also known as: DMARD, MTX
Modified Total Sharp Score (mTSS) at Month 6
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time frame: Month 6
Change From Baseline at Month 6 in mTSS
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time frame: Month 6
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP).
Time frame: Month 6
Absolute Blood Pressure (BP) Values (mmHg)
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Change From Baseline in BP Values (mmHg)
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
mTSS Score at Baseline, Months 12 and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time frame: Baseline, Months 12 and 24
Change From Baseline in mTSS Score at Months 12 and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time frame: Months 12 and 24
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
Time frame: Months 6, 12, and 24
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Time frame: Months 6, 12, and 24
Erosion Scores
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
Time frame: Baseline, Months 6, 12, and 24
JSN Scores
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Time frame: Baseline, Months 6, 12, and 24
Change From Baseline in Erosion Scores
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Months 6, 12, and 24
Change From Baseline in JSN Scores
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Months 6, 12, and 24
Percentage of Participants Achieving an ACR70 Response
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Percentage of Participants Achieving an ACR20 Response
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants Achieving an ACR50 Response
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Tender Joints Count (TJC)
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in TJC
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Swollen Joints Count (SJC)
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SJC
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Physician Global Assessment of Arthritis
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Physician Global Assessment of Arthritis
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Patient Global Assessment of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Patient Global Assessment of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
C-Reactive Protein
CRP measured in milligrams per liter (mg/L)
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in CRP
Change from Baseline in CRP measured in mg/L.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) less than (\<)2.6 = remission.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour \[mm/hour\]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in DAS28-3(CRP)
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in DAS28-4(ESR)
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-3(CRP) ≤3.2
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-4(ESR) ≤3.2
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-3(CRP) <2.6
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-4(ESR) <2.6
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Short Form 36 (SF-36) Mental Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
SF-36 Physical Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SF-36 Mental Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SF-36 Physical Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
SF-36 Domain Scores
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in SF-36 Domain Scores
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Work Limitation Questionnaire (WLQ) Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in WLQ Scores
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
WLQ Work Loss Index Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Baseline and Months 3, 6, and 12
Change From Baseline in WLQ Work Loss Index Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Months 3, 6, 12, 15, 18, 21, and 24
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline and Months 3, 6, 12, 18, and 24
Change From Baseline in EQ-5D Health State Profile Utility Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Months 3, 6, 12, 18, and 24
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Baseline and Months 3 and 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Months 12, 18, and 24
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Baseline and Months 3 and 6
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Months 12, 18, and 24
Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Baseline and Months 3 and 6
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Months 12, 18, and 24
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Time frame: Baseline and Months 3 and 6
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Time frame: Months 12, 18, and 24
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Months 3, 6, 12, 18, and 24
Change From Baseline in Work Productivity and HCRU at Months 3 and 6
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Months 3 and 6
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Months 12, 18, and 24
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Months 3 and 6
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Months 12, 18, and 24
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Months 3 and 6
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Months 12, 18, and 24
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Months 3 and 6
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Months 12, 18, and 24
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Months 3, 6, 12, 18, and 24
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Baseline and Months 1, 2, and 3
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported
Time frame: Months 1, 2, 3, 6, 12, 18, and 24
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Months 6, 12, 18, and 24
Change From Baseline in MOS-SS at Months 1, 2, and 3
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Months 1, 2, and 3
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Months 6, 12, 18, and 24
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Time frame: Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Change From Baseline in FACIT-Fatigue Scale
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Time frame: Months 1, 2, 3, 6, 12, 18, and 24
Change From Baseline in Heart Rate
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Change From Baseline in Temperature
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
| Milestone | CP-690,550 5 mg Twice Daily (BID) | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Started | 373 | 397 | 186 |
| Completed | 266 | 286 | 106 |
| Not completed | 107 | 111 | 80 |
| Withdrew: Adverse event | 38 | 39 | 24 |
| Withdrew: Lack of efficacy | 20 | 11 | 26 |
| Withdrew: Lost to follow-up | 11 | 9 | 5 |
| Withdrew: Other | 13 | 25 | 12 |
| Withdrew: Withdrawal by subject | 23 | 27 | 13 |
| Withdrew: Death | 2 | 0 | 0 |
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
| score on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Modified Total Sharp Score (mTSS) at Month 6 | 20.50 ± 40.58 | 18.85 ± 39.21 | 17.54 ± 29.96 |
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
| score on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Change From Baseline at Month 6 in mTSS | 0.20 ± 0.09 | 0.15 ± 0.08 | 0.65 ± 0.12 |
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP).
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 | 25.41 | 37.34 | 12.09 |
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
| mmHg | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline: systolic BP | 123.37 ± 15.41 | 124.30 ± 14.79 | 123.47 ± 13.73 |
| Baseline: diastolic BP | 77.64 ± 8.97 | 77.59 ± 8.90 | 78.02 ± 8.89 |
| Month 1: systolic BP | 123.76 ± 15.28 | 124.57 ± 14.17 | 123.41 ± 14.59 |
| Month 1: diastolic BP | 77.79 ± 9.11 | 78.30 ± 8.62 | 76.09 ± 9.00 |
| Month 2: systolic BP | 123.65 ± 14.87 | 124.28 ± 13.33 | 122.59 ± 13.89 |
| Month 2: diastolic BP | 77.77 ± 9.08 | 78.68 ± 8.81 | 76.22 ± 9.82 |
| Month 3: systolic BP | 124.08 ± 14.94 | 124.24 ± 14.40 | 122.61 ± 13.18 |
| Month 3: diastolic BP | 77.80 ± 9.19 | 78.33 ± 9.54 | 76.52 ± 7.80 |
| Month 6: systolic BP | 123.71 ± 14.56 | 125.02 ± 14.37 | 122.28 ± 12.81 |
| Month 6: diastolic BP | 77.74 ± 8.70 | 78.56 ± 8.69 | 76.50 ± 8.32 |
| Month 9: systolic BP | 123.90 ± 13.98 | 123.89 ± 13.71 | 121.94 ± 13.01 |
| Month 9: diastolic BP | 78.01 ± 9.11 | 77.70 ± 8.38 | 76.34 ± 8.53 |
| Month 12: systolic BP | 125.61 ± 15.05 | 124.34 ± 13.68 | 122.22 ± 12.70 |
| Month 12: diastolic BP | 78.08 ± 9.14 | 78.08 ± 8.16 | 76.59 ± 8.12 |
| Month 15: systolic BP | 124.63 ± 14.24 | 124.28 ± 13.48 | 123.71 ± 13.46 |
| Month 15: diastolic BP | 77.98 ± 8.77 | 78.04 ± 8.42 | 76.46 ± 8.95 |
| Month 18: systolic BP | 124.48 ± 13.65 | 124.39 ± 12.75 | 121.57 ± 13.08 |
| Month 18: diastolic BP | 77.66 ± 8.90 | 78.34 ± 8.02 | 76.76 ± 8.89 |
| Month 21: systolic BP | 123.83 ± 13.53 | 124.52 ± 12.91 | 123.29 ± 11.98 |
| Month 21: diastolic BP | 77.28 ± 8.24 | 78.44 ± 7.56 | 76.45 ± 8.34 |
| Month 24: systolic BP | 124.48 ± 13.15 | 124.34 ± 12.24 | 122.47 ± 12.56 |
| Month 24: diastolic BP | 78.25 ± 8.15 | 78.07 ± 7.73 | 76.57 ± 8.46 |
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
| mmHg | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1: systolic BP | 0.44 ± 11.70 | 0.32 ± 11.03 | -0.02 ± 11.75 |
| Month 1: diastolic BP | 0.11 ± 7.35 | 0.78 ± 7.88 | -1.91 ± 7.96 |
| Month 2: systolic BP | 0.41 ± 12.74 | 0.07 ± 12.84 | -0.43 ± 10.93 |
| Month 2: diastolic BP | 0.13 ± 8.56 | 1.18 ± 8.86 | -1.63 ± 8.07 |
| Month 3: systolic BP | 0.91 ± 13.84 | -0.25 ± 12.71 | -0.48 ± 11.64 |
| Month 3: diastolic BP | 0.16 ± 8.70 | 0.70 ± 8.37 | -1.31 ± 8.08 |
| Month 6: systolic BP | 0.34 ± 12.60 | 0.36 ± 12.15 | -0.97 ± 10.45 |
| Month 6: diastolic BP | -0.04 ± 8.29 | 0.87 ± 8.34 | -1.41 ± 7.95 |
| Month 9: systolic BP | 0.35 ± 12.33 | -0.43 ± 12.52 | -1.69 ± 10.79 |
| Month 9: diastolic BP | 0.14 ± 9.12 | 0.04 ± 8.47 | -1.79 ± 8.42 |
| Month 12: systolic BP | 2.32 ± 12.94 | -0.02 ± 13.17 | -1.36 ± 11.19 |
| Month 12: diastolic BP | 0.29 ± 9.00 | 0.37 ± 8.03 | -1.41 ± 7.25 |
| Month 15: systolic BP | 0.93 ± 12.90 | -0.00 ± 13.57 | -0.16 ± 12.14 |
| Month 15: diastolic BP | -0.11 ± 8.98 | 0.41 ± 8.38 | -1.63 ± 8.78 |
| Month 18: systolic BP | 1.09 ± 12.61 | 0.23 ± 12.45 | -2.38 ± 13.23 |
| Month 18: diastolic BP | -0.30 ± 8.42 | 0.59 ± 9.09 | -1.49 ± 8.82 |
| Month 21: systolic BP | 0.49 ± 13.08 | 0.31 ± 13.68 | -0.68 ± 11.18 |
| Month 21: diastolic BP | -0.71 ± 8.94 | 0.65 ± 9.14 | -1.63 ± 8.06 |
| Month 24: systolic BP | 1.30 ± 12.73 | 0.06 ± 13.55 | -1.11 ± 12.42 |
| Month 24: diastolic BP | 0.38 ± 8.94 | 0.28 ± 9.62 | -1.50 ± 7.75 |
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
| score on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 19.05 ± 38.27 | 17.89 ± 38.49 | 16.11 ± 29.44 |
| Month 12 | 19.23 ± 38.37 | 18.08 ± 38.41 | 17.32 ± 30.27 |
| Month 24 | 19.70 ± 38.69 | 18.23 ± 38.43 | 18.26 ± 30.99 |
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
| score on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12 | 0.37 ± 0.14 | 0.17 ± 0.14 | 1.20 ± 0.20 |
| Month 24 | 0.57 ± 0.25 | 0.28 ± 0.24 | 2.11 ± 0.35 |
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 6 | 87.07 | 89.25 | 73.65 |
| Month 12 | 82.42 | 87.67 | 69.01 |
| Month 24 | 79.89 | 83.65 | 64.91 |
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 6 | 91.67 | 93.01 | 81.44 |
| Month 12 | 88.47 | 90.88 | 74.85 |
| Month 24 | 85.34 | 88.20 | 70.18 |
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 9.05 ± 19.00 | 9.06 ± 19.50 | 8.38 ± 15.24 |
| Month 6 | 9.18 ± 19.10 | 9.15 ± 19.50 | 8.78 ± 15.54 |
| Month 12 | 9.05 ± 18.97 | 9.18 ± 19.42 | 8.97 ± 15.46 |
| Month 24 | 9.21 ± 18.95 | 9.22 ± 19.36 | 9.37 ± 15.67 |
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
| score on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 10.01 ± 20.58 | 8.82 ± 19.80 | 7.72 ± 15.28 |
| Month 6 | 10.09 ± 20.62 | 8.86 ± 19.79 | 8.17 ± 15.70 |
| Month 12 | 10.18 ± 20.74 | 8.90 ± 19.77 | 8.35 ± 16.01 |
| Month 24 | 10.50 ± 21.12 | 9.01 ± 19.87 | 8.89 ± 16.76 |
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 6 | 0.14 ± 0.04 | 0.10 ± 0.04 | 0.35 ± 0.06 |
| Month 12 | 0.13 ± 0.07 | 0.12 ± 0.06 | 0.58 ± 0.09 |
| Month 24 | 0.16 ± 0.11 | 0.16 ± 0.10 | 0.98 ± 0.15 |
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 6 | 0.06 ± 0.06 | 0.05 ± 0.06 | 0.29 ± 0.09 |
| Month 12 | 0.23 ± 0.10 | 0.05 ± 0.10 | 0.60 ± 0.14 |
| Month 24 | 0.39 ± 0.18 | 0.12 ± 0.17 | 1.10 ± 0.25 |
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 5.22 | 9.23 | 0.55 |
| Month 2 | 16.16 | 23.02 | 3.30 |
| Month 3 | 19.95 | 26.60 | 5.49 |
| Month 9 | 29.23 | 37.85 | 13.19 |
| Month 12 | 28.69 | 37.85 | 15.38 |
| Month 15 | 30.05 | 37.85 | 17.03 |
| Month 18 | 32.24 | 36.57 | 15.93 |
| Month 21 | 32.24 | 36.83 | 17.58 |
| Month 24 | 34.15 | 37.60 | 15.38 |
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 49.32 | 58.27 | 21.20 |
| Month 2 | 63.59 | 71.57 | 42.39 |
| Month 3 | 69.92 | 77.92 | 51.63 |
| Month 6 | 71.27 | 76.14 | 50.54 |
| Month 9 | 72.09 | 73.60 | 55.43 |
| Month 12 | 67.75 | 71.57 | 51.09 |
| Month 15 | 68.83 | 66.24 | 47.28 |
| Month 18 | 64.23 | 65.99 | 46.74 |
| Month 21 | 65.04 | 62.18 | 45.11 |
| Month 24 | 64.23 | 64.21 | 42.39 |
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 17.98 | 27.99 | 3.80 |
| Month 2 | 32.61 | 40.10 | 11.41 |
| Month 3 | 40.11 | 50.00 | 20.11 |
| Month 6 | 46.61 | 56.35 | 26.63 |
| Month 9 | 49.86 | 56.85 | 35.33 |
| Month 12 | 49.86 | 55.58 | 33.70 |
| Month 15 | 50.68 | 54.31 | 33.15 |
| Month 18 | 47.97 | 51.78 | 30.43 |
| Month 21 | 49.05 | 50.51 | 30.43 |
| Month 24 | 49.32 | 49.24 | 28.26 |
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
| tender joints | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 25.65 ± 13.81 | 25.12 ± 13.51 | 25.41 ± 15.03 |
| Month 1 | 15.75 ± 12.98 | 13.66 ± 12.61 | 20.07 ± 14.83 |
| Month 2 | 12.12 ± 12.31 | 10.67 ± 12.31 | 16.39 ± 14.16 |
| Month 3 | 10.03 ± 11.52 | 8.61 ± 10.67 | 14.05 ± 14.13 |
| Month 6 | 8.71 ± 11.04 | 6.59 ± 10.28 | 11.99 ± 13.34 |
| Month 9 | 7.31 ± 10.45 | 6.14 ± 10.11 | 8.82 ± 11.27 |
| Month 12 | 6.60 ± 9.78 | 5.46 ± 10.16 | 9.13 ± 12.67 |
| Month 15 | 5.55 ± 9.15 | 5.17 ± 9.79 | 8.23 ± 10.50 |
| Month 18 | 5.12 ± 7.15 | 4.46 ± 7.98 | 6.97 ± 8.74 |
| Month 21 | 4.60 ± 6.87 | 4.19 ± 6.40 | 7.07 ± 9.68 |
| Month 24 | 4.50 ± 6.75 | 4.66 ± 8.52 | 6.01 ± 6.81 |
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
| tender joints | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -9.43 ± 0.54 | -11.40 ± 0.52 | -5.11 ± 0.75 |
| Month 2 | -12.95 ± 0.54 | -14.33 ± 0.52 | -8.63 ± 0.76 |
| Month 3 | -14.95 ± 0.55 | -16.34 ± 0.52 | -10.69 ± 0.77 |
| Month 6 | -16.00 ± 0.55 | -18.09 ± 0.53 | -12.38 ± 0.79 |
| Month 9 | -17.16 ± 0.56 | -18.29 ± 0.54 | -15.39 ± 0.81 |
| Month 12 | -17.85 ± 0.56 | -18.44 ± 0.54 | -14.74 ± 0.82 |
| Month 15 | -18.86 ± 0.58 | -18.57 ± 0.55 | -15.70 ± 0.83 |
| Month 18 | -19.08 ± 0.58 | -19.41 ± 0.56 | -16.41 ± 0.86 |
| Month 21 | -19.54 ± 0.59 | -19.70 ± 0.57 | -16.24 ± 0.87 |
| Month 24 | -19.64 ± 0.59 | -19.23 ± 0.57 | -17.01 ± 0.89 |
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
| swollen joints | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 16.27 ± 9.24 | 15.58 ± 8.37 | 16.76 ± 10.27 |
| Month 1 | 9.90 ± 9.60 | 8.02 ± 7.03 | 12.56 ± 9.40 |
| Month 2 | 6.84 ± 7.74 | 5.69 ± 6.29 | 9.97 ± 9.05 |
| Month 3 | 5.81 ± 8.76 | 4.32 ± 5.53 | 7.88 ± 7.98 |
| Month 6 | 4.70 ± 7.40 | 3.69 ± 6.05 | 6.30 ± 7.12 |
| Month 9 | 3.83 ± 5.67 | 3.22 ± 5.93 | 4.83 ± 6.74 |
| Month 12 | 3.30 ± 6.12 | 2.88 ± 6.77 | 5.17 ± 9.44 |
| Month 15 | 2.63 ± 6.35 | 3.00 ± 7.95 | 4.92 ± 8.21 |
| Month 18 | 2.44 ± 4.07 | 2.25 ± 5.28 | 3.91 ± 4.85 |
| Month 21 | 2.28 ± 4.12 | 2.02 ± 4.00 | 3.47 ± 4.14 |
| Month 24 | 2.00 ± 3.70 | 2.29 ± 6.44 | 3.38 ± 4.26 |
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
| swollen joints | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -5.99 ± 0.36 | -7.75 ± 0.35 | -3.55 ± 0.51 |
| Month 2 | -8.95 ± 0.37 | -10.03 ± 0.35 | -5.98 ± 0.51 |
| Month 3 | -9.97 ± 0.37 | -11.42 ± 0.35 | -7.97 ± 0.52 |
| Month 6 | -10.89 ± 0.37 | -11.97 ± 0.36 | -9.35 ± 0.53 |
| Month 9 | -11.47 ± 0.38 | -12.39 ± 0.36 | -11.00 ± 0.55 |
| Month 12 | -11.97 ± 0.38 | -12.54 ± 0.37 | -10.48 ± 0.56 |
| Month 15 | -12.55 ± 0.39 | -12.30 ± 0.38 | -10.69 ± 0.57 |
| Month 18 | -12.63 ± 0.39 | -13.10 ± 0.38 | -11.31 ± 0.59 |
| Month 21 | -12.74 ± 0.40 | -13.28 ± 0.38 | -11.89 ± 0.60 |
| Month 24 | -12.99 ± 0.40 | -13.06 ± 0.39 | -11.96 ± 0.61 |
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm=no pain and 100 mm=most severe pain.
| mm | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 59.06 ± 23.87 | 61.37 ± 23.14 | 58.77 ± 23.58 |
| Month 1 | 36.62 ± 23.72 | 32.78 ± 23.31 | 46.34 ± 24.47 |
| Month 2 | 31.97 ± 22.94 | 30.33 ± 23.66 | 39.74 ± 23.72 |
| Month 3 | 29.41 ± 21.53 | 27.07 ± 21.54 | 36.83 ± 21.99 |
| Month 6 | 27.07 ± 21.21 | 24.22 ± 21.53 | 30.94 ± 22.87 |
| Month 9 | 26.11 ± 20.35 | 23.76 ± 21.24 | 31.22 ± 22.50 |
| Month 12 | 26.09 ± 21.29 | 22.64 ± 20.15 | 29.91 ± 20.76 |
| Month 15 | 24.25 ± 20.39 | 23.72 ± 21.97 | 29.85 ± 22.94 |
| Month 18 | 23.66 ± 19.29 | 22.72 ± 21.78 | 27.81 ± 20.66 |
| Month 21 | 23.30 ± 19.86 | 22.85 ± 21.79 | 29.18 ± 21.46 |
| Month 24 | 23.03 ± 19.80 | 21.09 ± 19.32 | 27.52 ± 20.28 |
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
| mm | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -22.98 ± 1.17 | -27.26 ± 1.12 | -13.43 ± 1.62 |
| Month 2 | -27.73 ± 1.17 | -29.71 ± 1.12 | -19.90 ± 1.64 |
| Month 3 | -29.97 ± 1.18 | -32.90 ± 1.13 | -22.22 ± 1.66 |
| Month 6 | -31.94 ± 1.19 | -35.35 ± 1.15 | -27.71 ± 1.70 |
| Month 9 | -32.34 ± 1.21 | -35.26 ± 1.16 | -27.09 ± 1.75 |
| Month 12 | -32.31 ± 1.22 | -35.85 ± 1.18 | -27.76 ± 1.79 |
| Month 15 | -33.71 ± 1.25 | -34.54 ± 1.20 | -28.10 ± 1.82 |
| Month 18 | -34.26 ± 1.26 | -35.73 ± 1.22 | -29.42 ± 1.87 |
| Month 21 | -34.57 ± 1.27 | -35.66 ± 1.23 | -27.87 ± 1.90 |
| Month 24 | -34.78 ± 1.28 | -37.57 ± 1.24 | -29.51 ± 1.93 |
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
| mm | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 61.97 ± 16.45 | 60.50 ± 16.93 | 59.25 ± 17.70 |
| Month 1 | 36.70 ± 19.24 | 33.05 ± 18.32 | 45.52 ± 19.73 |
| Month 2 | 27.84 ± 18.26 | 25.80 ± 17.62 | 37.19 ± 18.61 |
| Month 3 | 25.06 ± 17.10 | 22.80 ± 16.36 | 32.07 ± 17.28 |
| Month 6 | 22.19 ± 17.31 | 18.32 ± 14.74 | 27.25 ± 16.80 |
| Month 9 | 18.68 ± 15.09 | 16.61 ± 15.01 | 23.65 ± 16.55 |
| Month 12 | 17.63 ± 15.09 | 14.19 ± 12.63 | 22.22 ± 15.30 |
| Month 15 | 16.65 ± 14.03 | 14.97 ± 13.13 | 23.29 ± 17.36 |
| Month 18 | 16.47 ± 12.70 | 14.02 ± 12.51 | 20.19 ± 14.74 |
| Month 21 | 15.73 ± 12.73 | 14.61 ± 13.39 | 20.01 ± 14.02 |
| Month 24 | 15.31 ± 14.14 | 14.42 ± 13.63 | 20.04 ± 15.54 |
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad.
| mm | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -24.89 ± 0.86 | -28.32 ± 0.82 | -15.79 ± 1.19 |
| Month 2 | -33.92 ± 0.86 | -35.49 ± 0.82 | -24.17 ± 1.20 |
| Month 3 | -36.41 ± 0.87 | -38.48 ± 0.83 | -28.62 ± 1.22 |
| Month 6 | -39.04 ± 0.88 | -42.49 ± 0.84 | -33.41 ± 1.25 |
| Month 9 | -42.09 ± 0.89 | -43.94 ± 0.85 | -36.54 ± 1.29 |
| Month 12 | -43.07 ± 0.90 | -46.02 ± 0.87 | -37.43 ± 1.32 |
| Month 15 | -43.91 ± 0.92 | -45.40 ± 0.88 | -36.17 ± 1.34 |
| Month 18 | -44.00 ± 0.93 | -46.50 ± 0.90 | -38.65 ± 1.38 |
| Month 21 | -44.76 ± 0.94 | -46.02 ± 0.90 | -38.92 ± 1.40 |
| Month 24 | -45.07 ± 0.95 | -46.30 ± 0.91 | -38.93 ± 1.42 |
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
| mm | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 60.20 ± 24.56 | 60.88 ± 22.65 | 57.71 ± 24.30 |
| Month 1 | 38.27 ± 24.83 | 32.63 ± 23.09 | 46.15 ± 22.82 |
| Month 2 | 31.91 ± 22.90 | 28.94 ± 22.63 | 41.29 ± 22.73 |
| Month 3 | 30.36 ± 21.78 | 28.60 ± 22.21 | 37.43 ± 21.20 |
| Month 6 | 28.37 ± 21.23 | 24.84 ± 21.61 | 32.12 ± 21.92 |
| Month 9 | 26.73 ± 20.38 | 24.98 ± 22.30 | 32.79 ± 22.42 |
| Month 12 | 26.72 ± 20.84 | 24.38 ± 22.34 | 32.40 ± 21.69 |
| Month 15 | 25.19 ± 20.12 | 23.79 ± 21.96 | 32.26 ± 22.79 |
| Month 18 | 24.76 ± 19.93 | 24.38 ± 22.59 | 29.31 ± 20.91 |
| Month 21 | 24.72 ± 20.93 | 23.86 ± 21.52 | 30.19 ± 21.15 |
| Month 24 | 24.42 ± 21.43 | 23.61 ± 20.86 | 28.81 ± 20.54 |
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
| mm | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -22.22 ± 1.17 | -27.87 ± 1.12 | -14.12 ± 1.62 |
| Month 2 | -28.74 ± 1.17 | -31.54 ± 1.12 | -18.86 ± 1.64 |
| Month 3 | -30.03 ± 1.18 | -31.72 ± 1.13 | -22.18 ± 1.66 |
| Month 6 | -31.65 ± 1.19 | -35.11 ± 1.15 | -27.00 ± 1.70 |
| Month 9 | -32.70 ± 1.21 | -34.48 ± 1.16 | -26.15 ± 1.76 |
| Month 12 | -32.75 ± 1.22 | -34.62 ± 1.18 | -26.07 ± 1.79 |
| Month 15 | -33.82 ± 1.25 | -34.94 ± 1.20 | -26.70 ± 1.82 |
| Month 18 | -34.18 ± 1.26 | -34.65 ± 1.22 | -28.64 ± 1.87 |
| Month 21 | -34.18 ± 1.27 | -35.26 ± 1.23 | -27.56 ± 1.90 |
| Month 24 | -34.41 ± 1.29 | -35.74 ± 1.24 | -28.81 ± 1.93 |
CRP measured in milligrams per liter (mg/L)
| mg/L | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 22.68 ± 27.09 | 20.25 ± 23.92 | 25.92 ± 30.94 |
| Month 1 | 6.62 ± 9.68 | 3.23 ± 5.35 | 17.37 ± 24.26 |
| Month 2 | 6.47 ± 15.24 | 3.48 ± 9.38 | 16.12 ± 26.55 |
| Month 3 | 6.75 ± 12.81 | 3.05 ± 5.60 | 11.90 ± 17.11 |
| Month 6 | 5.22 ± 11.56 | 3.14 ± 5.51 | 12.21 ± 19.32 |
| Month 9 | 6.01 ± 12.89 | 3.39 ± 6.32 | 8.18 ± 12.36 |
| Month 12 | 5.26 ± 9.93 | 2.72 ± 4.46 | 9.64 ± 16.36 |
| Month 15 | 5.57 ± 15.52 | 2.96 ± 4.40 | 8.61 ± 13.02 |
| Month 18 | 4.57 ± 8.71 | 3.59 ± 11.42 | 8.98 ± 11.72 |
| Month 21 | 4.89 ± 7.58 | 4.07 ± 8.12 | 9.54 ± 13.72 |
| Month 24 | 5.57 ± 11.49 | 3.71 ± 7.00 | 10.07 ± 17.04 |
Change from Baseline in CRP measured in mg/L.
| mg/L | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -15.64 ± 0.68 | -18.84 ± 0.66 | -5.55 ± 0.95 |
| Month 2 | -16.02 ± 0.69 | -18.59 ± 0.66 | -6.83 ± 0.97 |
| Month 3 | -15.69 ± 0.69 | -19.01 ± 0.66 | -9.86 ± 0.97 |
| Month 6 | -16.98 ± 0.70 | -18.76 ± 0.67 | -9.68 ± 1.00 |
| Month 9 | -16.03 ± 0.71 | -18.48 ± 0.68 | -12.75 ± 1.03 |
| Month 12 | -16.58 ± 0.72 | -19.16 ± 0.69 | -11.12 ± 1.05 |
| Month 15 | -16.10 ± 0.73 | -18.80 ± 0.70 | -12.35 ± 1.07 |
| Month 18 | -17.06 ± 0.74 | -18.17 ± 0.72 | -11.62 ± 1.10 |
| Month 21 | -16.83 ± 0.75 | -17.67 ± 0.72 | -11.07 ± 1.11 |
| Month 24 | -15.97 ± 0.75 | -17.96 ± 0.73 | -10.31 ± 1.14 |
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) less than (\<)2.6 = remission.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 5.56 ± 0.91 | 5.46 ± 0.94 | 5.62 ± 0.95 |
| Month 1 | 4.21 ± 1.08 | 3.77 ± 1.09 | 4.96 ± 1.17 |
| Month 2 | 3.67 ± 1.21 | 3.31 ± 1.18 | 4.50 ± 1.19 |
| Month 3 | 3.41 ± 1.21 | 3.05 ± 1.12 | 4.14 ± 1.27 |
| Month 6 | 3.21 ± 1.25 | 2.76 ± 1.08 | 3.85 ± 1.34 |
| Month 9 | 3.05 ± 1.22 | 2.69 ± 1.15 | 3.49 ± 1.20 |
| Month 12 | 2.92 ± 1.18 | 2.52 ± 1.07 | 3.42 ± 1.30 |
| Month 15 | 2.78 ± 1.10 | 2.50 ± 1.12 | 3.38 ± 1.27 |
| Month 18 | 2.70 ± 1.06 | 2.47 ± 0.98 | 3.32 ± 1.17 |
| Month 21 | 2.67 ± 1.10 | 2.48 ± 1.07 | 3.33 ± 1.27 |
| Month 24 | 2.65 ± 1.08 | 2.44 ± 1.03 | 3.22 ± 1.15 |
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour \[mm/hour\]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 6.62 ± 0.98 | 6.54 ± 0.96 | 6.60 ± 1.02 |
| Month 1 | 5.18 ± 1.28 | 4.70 ± 1.32 | 5.84 ± 1.24 |
| Month 2 | 4.54 ± 1.45 | 4.17 ± 1.39 | 5.35 ± 1.24 |
| Month 3 | 4.21 ± 1.45 | 3.94 ± 1.31 | 4.98 ± 1.37 |
| Month 6 | 4.05 ± 1.44 | 3.62 ± 1.31 | 4.61 ± 1.48 |
| Month 9 | 3.84 ± 1.37 | 3.53 ± 1.36 | 4.27 ± 1.36 |
| Month 12 | 3.69 ± 1.33 | 3.37 ± 1.29 | 4.23 ± 1.38 |
| Month 15 | 3.59 ± 1.23 | 3.32 ± 1.31 | 4.17 ± 1.46 |
| Month 18 | 3.51 ± 1.22 | 3.33 ± 1.18 | 4.05 ± 1.37 |
| Month 21 | 3.49 ± 1.26 | 3.33 ± 1.29 | 4.09 ± 1.39 |
| Month 24 | 3.43 ± 1.25 | 3.29 ± 1.29 | 3.99 ± 1.33 |
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -1.30 ± 0.06 | -1.71 ± 0.06 | -0.58 ± 0.08 |
| Month 2 | -1.85 ± 0.06 | -2.16 ± 0.06 | -1.02 ± 0.08 |
| Month 3 | -2.09 ± 0.06 | -2.42 ± 0.06 | -1.36 ± 0.08 |
| Month 6 | -2.27 ± 0.06 | -2.68 ± 0.06 | -1.62 ± 0.09 |
| Month 9 | -2.40 ± 0.06 | -2.72 ± 0.06 | -1.95 ± 0.09 |
| Month 12 | -2.52 ± 0.06 | -2.85 ± 0.06 | -1.99 ± 0.09 |
| Month 15 | -2.65 ± 0.06 | -2.85 ± 0.06 | -2.03 ± 0.09 |
| Month 18 | -2.72 ± 0.06 | -2.91 ± 0.06 | -2.05 ± 0.10 |
| Month 21 | -2.75 ± 0.06 | -2.89 ± 0.06 | -2.05 ± 0.10 |
| Month 24 | -2.76 ± 0.07 | -2.94 ± 0.06 | -2.12 ± 0.10 |
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -1.40 ± 0.07 | -1.83 ± 0.07 | -0.72 ± 0.10 |
| Month 2 | -2.03 ± 0.07 | -2.36 ± 0.07 | -1.17 ± 0.10 |
| Month 3 | -2.34 ± 0.07 | -2.59 ± 0.07 | -1.53 ± 0.10 |
| Month 6 | -2.47 ± 0.07 | -2.88 ± 0.07 | -1.87 ± 0.10 |
| Month 9 | -2.64 ± 0.07 | -2.93 ± 0.07 | -2.19 ± 0.10 |
| Month 12 | -2.78 ± 0.07 | -3.05 ± 0.07 | -2.20 ± 0.11 |
| Month 15 | -2.87 ± 0.07 | -3.08 ± 0.07 | -2.25 ± 0.11 |
| Month 18 | -2.92 ± 0.07 | -3.09 ± 0.07 | -2.34 ± 0.11 |
| Month 21 | -2.96 ± 0.08 | -3.10 ± 0.07 | -2.30 ± 0.11 |
| Month 24 | -2.99 ± 0.08 | -3.16 ± 0.07 | -2.40 ± 0.12 |
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 16.67 | 33.16 | 5.98 |
| Month 2 | 35.42 | 47.97 | 14.13 |
| Month 3 | 40.33 | 56.85 | 19.57 |
| Month 6 | 47.68 | 62.69 | 27.72 |
| Month 9 | 52.04 | 60.41 | 33.15 |
| Month 12 | 52.59 | 64.97 | 32.61 |
| Month 15 | 53.41 | 58.88 | 29.89 |
| Month 18 | 52.59 | 56.09 | 25.00 |
| Month 21 | 52.59 | 55.84 | 28.26 |
| Month 24 | 52.32 | 56.85 | 29.35 |
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 7.40 | 14.09 | 2.99 |
| Month 2 | 18.42 | 25.81 | 4.71 |
| Month 3 | 25.15 | 30.38 | 9.94 |
| Month 6 | 27.78 | 38.17 | 14.04 |
| Month 9 | 29.24 | 39.78 | 18.13 |
| Month 12 | 33.33 | 41.13 | 18.71 |
| Month 15 | 33.04 | 40.86 | 18.13 |
| Month 18 | 32.16 | 35.22 | 16.37 |
| Month 21 | 34.21 | 38.17 | 16.37 |
| Month 24 | 34.80 | 36.02 | 15.79 |
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 7.38 | 14.14 | 2.72 |
| Month 2 | 20.44 | 28.68 | 5.43 |
| Month 3 | 25.89 | 37.82 | 9.78 |
| Month 6 | 31.34 | 47.21 | 15.22 |
| Month 9 | 36.24 | 45.69 | 17.39 |
| Month 12 | 36.51 | 49.49 | 20.65 |
| Month 15 | 37.60 | 49.24 | 19.57 |
| Month 18 | 38.42 | 44.67 | 19.02 |
| Month 21 | 37.06 | 44.67 | 17.39 |
| Month 24 | 38.42 | 43.91 | 18.48 |
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 2.07 | 5.69 | 0.00 |
| Month 2 | 9.06 | 12.90 | 2.35 |
| Month 3 | 13.74 | 17.47 | 4.68 |
| Month 6 | 14.62 | 21.77 | 7.60 |
| Month 9 | 16.37 | 23.66 | 9.94 |
| Month 12 | 18.71 | 23.39 | 11.70 |
| Month 15 | 16.37 | 24.19 | 12.87 |
| Month 18 | 16.96 | 19.89 | 11.11 |
| Month 21 | 18.42 | 21.42 | 8.77 |
| Month 24 | 20.76 | 22.31 | 9.94 |
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 71.86 | 80.46 | 37.50 |
| Month 2 | 80.11 | 85.79 | 58.15 |
| Month 3 | 83.65 | 89.34 | 68.48 |
| Month 6 | 82.83 | 85.03 | 64.13 |
| Month 9 | 80.38 | 82.74 | 64.13 |
| Month 12 | 76.29 | 78.68 | 60.87 |
| Month 15 | 75.20 | 73.35 | 59.24 |
| Month 18 | 73.02 | 71.57 | 55.98 |
| Month 21 | 69.48 | 69.29 | 50.54 |
| Month 24 | 68.94 | 69.80 | 49.46 |
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 62.43 | 74.25 | 33.53 |
| Month 2 | 74.27 | 82.26 | 50.00 |
| Month 3 | 80.41 | 88.17 | 66.67 |
| Month 6 | 78.95 | 84.14 | 60.82 |
| Month 9 | 78.36 | 81.72 | 61.40 |
| Month 12 | 76.61 | 79.57 | 59.65 |
| Month 15 | 74.85 | 73.12 | 56.73 |
| Month 18 | 70.18 | 70.97 | 52.05 |
| Month 21 | 69.88 | 69.89 | 48.54 |
| Month 24 | 68.71 | 69.62 | 49.12 |
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Percentage of Participants With an ACR70 Response Sustained at Least 6 Months | 28.42 | 38.54 | 13.98 |
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| 2 consecutive visits | 8.6 | 6.5 | 7.5 |
| 3 consecutive visits | 8.6 | 11.1 | 14.5 |
| 4 consecutive visits | 5.6 | 6.8 | 10.2 |
| 5 consecutive visits | 7.0 | 4.3 | 5.4 |
| 6 consecutive visits | 6.7 | 6.0 | 4.8 |
| 7 consecutive visits | 6.7 | 6.8 | 5.9 |
| 8 consecutive visits | 9.4 | 4.5 | 5.4 |
| 9 consecutive visits | 9.7 | 11.6 | 9.7 |
| 10 consecutive visits | 23.6 | 30.5 | 4.8 |
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| 2 consecutive visits | 9.9 | 9.8 | 9.1 |
| 3 consecutive visits | 10.7 | 9.1 | 8.1 |
| 4 consecutive visits | 6.4 | 7.3 | 5.4 |
| 5 consecutive visits | 9.7 | 5.3 | 3.2 |
| 6 consecutive visits | 4.6 | 4.8 | 5.4 |
| 7 consecutive visits | 6.2 | 6.0 | 5.9 |
| 8 consecutive visits | 5.6 | 7.1 | 2.2 |
| 9 consecutive visits | 5.6 | 8.3 | 1.6 |
| 10 consecutive visits | 5.9 | 11.8 | 1.1 |
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| 2 consecutive visits | 10.7 | 8.8 | 5.9 |
| 3 consecutive visits | 5.9 | 7.8 | 3.8 |
| 4 consecutive visits | 5.4 | 6.0 | 4.3 |
| 5 consecutive visits | 4.3 | 5.8 | 1.6 |
| 6 consecutive visits | 3.8 | 3.3 | 1.1 |
| 7 consecutive visits | 2.9 | 4.8 | 2.7 |
| 8 consecutive visits | 2.9 | 4.0 | NA |
| 9 consecutive visits | 3.2 | 5.8 | 1.1 |
| 10 consecutive visits | 1.3 | 2.8 | 0 |
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| 2 consecutive visits | 10.2 | 10.6 | 7.0 |
| 3 consecutive visits | 8.6 | 8.6 | 7.0 |
| 4 consecutive visits | 6.4 | 7.3 | 3.8 |
| 5 consecutive visits | 5.1 | 5.5 | 4.3 |
| 6 consecutive visits | 5.4 | 4.0 | 1.1 |
| 7 consecutive visits | 4.0 | 7.3 | 1.6 |
| 8 consecutive visits | 3.2 | 6.5 | 1.1 |
| 9 consecutive visits | 4.0 | 7.6 | NA |
| 10 consecutive visits | 1.3 | 2.8 | NA |
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| 2 consecutive visits | 6.2 | 7.6 | 4.3 |
| 3 consecutive visits | 5.4 | 5.3 | 2.7 |
| 4 consecutive visits | 4.0 | 4.0 | 3.2 |
| 5 consecutive visits | NA | 1.3 | 1.6 |
| 6 consecutive visits | 2.4 | 2.0 | NA |
| 7 consecutive visits | 1.9 | 3.0 | NA |
| 8 consecutive visits | NA | 2.0 | 0 |
| 9 consecutive visits | NA | 2.5 | 1.1 |
| 10 consecutive visits | NA | NA | 0 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 1.54 ± 0.65 | 1.50 ± 0.67 | 1.52 ± 0.65 |
| Month 1 | 1.05 ± 0.67 | 0.89 ± 0.65 | 1.30 ± 0.67 |
| Month 2 | 0.89 ± 0.67 | 0.74 ± 0.62 | 1.17 ± 0.66 |
| Month 3 | 0.78 ± 0.64 | 0.67 ± 0.63 | 1.03 ± 0.63 |
| Month 6 | 0.69 ± 0.64 | 0.57 ± 0.59 | 0.92 ± 0.62 |
| Month 9 | 0.66 ± 0.62 | 0.56 ± 0.58 | 0.83 ± 0.57 |
| Month 12 | 0.64 ± 0.61 | 0.51 ± 0.56 | 0.79 ± 0.58 |
| Month 15 | 0.59 ± 0.59 | 0.51 ± 0.56 | 0.83 ± 0.64 |
| Month 18 | 0.58 ± 0.58 | 0.48 ± 0.55 | 0.74 ± 0.60 |
| Month 21 | 0.59 ± 0.58 | 0.49 ± 0.56 | 0.76 ± 0.64 |
| Month 24 | 0.58 ± 0.60 | 0.48 ± 0.56 | 0.77 ± 0.64 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -0.48 ± 0.03 | -0.62 ± 0.03 | -0.23 ± 0.04 |
| Month 2 | -0.65 ± 0.03 | -0.77 ± 0.03 | -0.35 ± 0.4 |
| Month 3 | -0.75 ± 0.03 | -0.85 ± 0.03 | -0.47 ± 0.04 |
| Month 6 | -0.83 ± 0.03 | -0.94 ± 0.03 | -0.58 ± 0.04 |
| Month 9 | -0.85 ± 0.03 | -0.95 ± 0.03 | -0.65 ± 0.04 |
| Month 12 | -0.87 ± 0.03 | -0.98 ± 0.03 | -0.68 ± 0.04 |
| Month 15 | -0.90 ± 0.03 | -0.98 ± 0.03 | -0.65 ± 0.05 |
| Month 18 | -0.90 ± 0.03 | -1.01 ± 0.03 | -0.74 ± 0.05 |
| Month 21 | -0.90 ± 0.03 | -1.00 ± 0.03 | -0.72 ± 0.05 |
| Month 24 | -0.90 ± 0.03 | -1.01 ± 0.03 | -0.70 ± 0.05 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 64.38 | 73.91 | 45.65 |
| Month 2 | 69.13 | 79.85 | 61.41 |
| Month 3 | 72.95 | 80.36 | 65.22 |
| Month 6 | 74.32 | 77.81 | 63.04 |
| Month 9 | 73.50 | 73.21 | 61.41 |
| Month 12 | 68.03 | 71.43 | 58.70 |
| Month 15 | 65.30 | 67.86 | 51.63 |
| Month 18 | 64.21 | 64.80 | 48.91 |
| Month 21 | 62.30 | 65.05 | 46.74 |
| Month 24 | 60.11 | 65.05 | 46.74 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 54.79 | 65.73 | 32.61 |
| Month 2 | 62.30 | 73.21 | 47.83 |
| Month 3 | 65.57 | 74.23 | 54.89 |
| Month 6 | 69.67 | 73.21 | 53.80 |
| Month 9 | 69.13 | 69.39 | 53.26 |
| Month 12 | 65.03 | 67.35 | 52.72 |
| Month 15 | 61.20 | 65.31 | 47.83 |
| Month 18 | 59.84 | 63.27 | 46.20 |
| Month 21 | 58.74 | 61.22 | 44.02 |
| Month 24 | 56.83 | 62.76 | 43.48 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, hygiene, common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15 or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 47.95 | 55.75 | 26.09 |
| Month 2 | 55.46 | 67.86 | 39.67 |
| Month 3 | 60.66 | 69.64 | 43.48 |
| Month 6 | 63.11 | 68.88 | 48.91 |
| Month 9 | 65.30 | 65.05 | 47.28 |
| Month 12 | 59.56 | 63.01 | 45.65 |
| Month 15 | 58.20 | 60.71 | 44.57 |
| Month 18 | 56.28 | 60.71 | 41.30 |
| Month 21 | 55.19 | 58.16 | 41.85 |
| Month 24 | 53.28 | 59.44 | 37.50 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 40.48 ± 12.00 | 40.73 ± 11.73 | 40.93 ± 11.27 |
| Month 1 | 44.90 ± 11.40 | 46.70 ± 10.78 | 43.98 ± 10.71 |
| Month 2 | 45.95 ± 12.10 | 46.09 ± 11.28 | 44.35 ± 10.48 |
| Month 3 | 46.82 ± 11.21 | 46.59 ± 11.33 | 45.27 ± 10.42 |
| Month 6 | 47.08 ± 10.97 | 47.55 ± 10.26 | 45.73 ± 12.06 |
| Month 9 | 46.91 ± 10.74 | 48.04 ± 10.42 | 46.86 ± 10.85 |
| Month 12 | 47.04 ± 10.67 | 48.05 ± 9.99 | 45.71 ± 11.01 |
| Month 15 | 47.40 ± 10.31 | 48.04 ± 10.13 | 45.03 ± 11.75 |
| Month 18 | 47.64 ± 10.32 | 48.25 ± 9.86 | 46.76 ± 11.49 |
| Month 21 | 46.93 ± 10.85 | 48.50 ± 10.04 | 46.70 ± 11.66 |
| Month 24 | 47.32 ± 10.23 | 48.96 ± 10.36 | 46.42 ± 10.62 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 32.92 ± 7.36 | 33.20 ± 7.33 | 33.58 ± 7.82 |
| Month 1 | 33.81 ± 8.47 | 40.61 ± 8.11 | 35.40 ± 8.28 |
| Month 2 | 40.98 ± 8.44 | 42.52 ± 8.38 | 37.51 ± 8.22 |
| Month 3 | 42.25 ± 8.57 | 43.35 ± 8.53 | 38.60 ± 8.01 |
| Month 6 | 42.82 ± 8.42 | 44.34 ± 8.79 | 40.37 ± 8.11 |
| Month 9 | 42.96 ± 8.69 | 44.77 ± 8.80 | 40.30 ± 7.97 |
| Month 12 | 43.65 ± 8.68 | 45.72 ± 8.43 | 41.27 ± 8.05 |
| Month 15 | 44.54 ± 8.83 | 45.62 ± 8.78 | 41.02 ± 8.27 |
| Month 18 | 44.53 ± 8.42 | 45.50 ± 8.95 | 41.15 ± 8.50 |
| Month 21 | 45.06 ± 8.36 | 45.56 ± 8.84 | 41.67 ± 8.44 |
| Month 24 | 44.95 ± 8.76 | 45.78 ± 8.50 | 41.53 ± 8.30 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 4.37 ± 0.51 | 6.14 ± 0.49 | 3.25 ± 0.70 |
| Month 2 | 5.39 ± 0.51 | 5.51 ± 0.49 | 3.41 ± 0.71 |
| Month 3 | 6.12 ± 0.51 | 5.89 ± 0.49 | 4.33 ± 0.72 |
| Month 6 | 6.36 ± 0.52 | 6.53 ± 0.50 | 4.84 ± 0.73 |
| Month 9 | 5.99 ± 0.52 | 6.83 ± 0.50 | 6.04 ± 0.75 |
| Month 12 | 6.21 ± 0.53 | 6.62 ± 0.51 | 4.72 ± 0.77 |
| Month 15 | 6.38 ± 0.54 | 6.30 ± 0.52 | 4.09 ± 0.78 |
| Month 18 | 6.51 ± 0.54 | 6.70 ± 0.52 | 5.78 ± 0.80 |
| Month 21 | 5.80 ± 0.55 | 6.94 ± 0.53 | 5.58 ± 0.81 |
| Month 24 | 6.23 ± 0.55 | 7.49 ± 0.53 | 5.54 ± 0.82 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 5.83 ± 0.43 | 7.54 ± 0.41 | 2.17 ± 0.59 |
| Month 2 | 8.04 ± 0.43 | 9.45 ± 0.41 | 4.23 ± 0.60 |
| Month 3 | 9.23 ± 0.43 | 10.32 ± 0.41 | 4.98 ± 0.60 |
| Month 6 | 9.66 ± 0.44 | 11.24 ± 0.42 | 6.55 ± 0.62 |
| Month 9 | 9.63 ± 0.44 | 11.53 ± 0.42 | 6.56 ± 0.63 |
| Month 12 | 10.30 ± 0.44 | 12.35 ± 0.43 | 7.48 ± 0.65 |
| Month 15 | 10.87 ± 0.45 | 12.06 ± 0.43 | 7.43 ± 0.65 |
| Month 18 | 10.76 ± 0.45 | 12.04 ± 0.44 | 7.47 ± 0.67 |
| Month 21 | 11.19 ± 0.46 | 12.19 ± 0.44 | 7.93 ± 0.68 |
| Month 24 | 11.03 ± 0.46 | 12.46 ± 0.44 | 7.63 ± 0.68 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline Vitality | 41.87 ± 9.90 | 41.63 ± 10.01 | 41.77 ± 9.56 |
| Month 1 Vitality | 47.94 ± 9.98 | 48.99 ± 9.55 | 44.83 ± 9.67 |
| Month 2 Vitality | 49.24 ± 10.90 | 49.68 ± 10.47 | 45.51 ± 9.53 |
| Month 3 Vitality | 50.10 ± 10.37 | 50.59 ± 10.00 | 47.06 ± 9.11 |
| Month 6 Vitality | 50.35 ± 10.09 | 50.69 ± 10.27 | 48.03 ± 9.87 |
| Month 9 Vitality | 50.52 ± 10.05 | 51.34 ± 10.17 | 48.52 ± 9.79 |
| Month 12 Vitality | 50.43 ± 10.35 | 51.96 ± 9.50 | 48.83 ± 8.94 |
| Month 15 Vitality | 51.40 ± 9.84 | 51.23 ± 9.89 | 48.21 ± 10.18 |
| Month 18 Vitality | 51.18 ± 9.48 | 51.83 ± 9.62 | 48.93 ± 10.48 |
| Month 21 Vitality | 51.29 ± 9.74 | 51.68 ± 9.86 | 49.26 ± 10.59 |
| Month 24 Vitality | 50.81 ± 9.45 | 52.00 ± 10.12 | 49.07 ± 9.94 |
| Baseline Social Functioning | 36.41 ± 11.32 | 36.66 ± 11.06 | 37.64 ± 11.32 |
| Month 1 Social Functioning | 41.33 ± 10.45 | 44.13 ± 9.85 | 40.12 ± 10.72 |
| Month 2 Social Functioning | 43.56 ± 10.89 | 43.78 ± 10.44 | 41.36 ± 10.28 |
| Month 3 Social Functioning | 44.75 ± 10.20 | 44.60 ± 10.49 | 42.52 ± 9.75 |
| Month 6 Social Functioning | 45.21 ± 9.97 | 46.18 ± 9.68 | 44.15 ± 10.42 |
| Month 9 Social Functioning | 45.37 ± 9.47 | 46.46 ± 9.50 | 45.08 ± 9.71 |
| Month 12 Social Functioning | 45.43 ± 10.00 | 46.88 ± 9.45 | 43.22 ± 9.94 |
| Month 15 Social Functioning | 46.09 ± 9.56 | 46.99 ± 9.25 | 42.96 ± 10.84 |
| Month 18 Social Functioning | 46.39 ± 9.32 | 46.82 ± 9.34 | 44.44 ± 10.94 |
| Month 21 Social Functioning | 46.22 ± 9.05 | 47.22 ± 9.61 | 44.49 ± 9.98 |
| Month 24 Social Functioning | 46.52 ± 9.11 | 47.76 ± 9.27 | 43.87 ± 10.38 |
| Basline Role Emotional | 34.01 ± 13.32 | 34.69 ± 13.06 | 34.69 ± 12.57 |
| Month 1 Role Emotional | 39.21 ± 12.35 | 41.31 ± 11.72 | 36.93 ± 12.10 |
| Month 2 Role Emotional | 40.59 ± 12.21 | 41.60 ± 11.62 | 38.30 ± 11.87 |
| Month 3 Role Emotional | 41.55 ± 11.59 | 42.18 ± 11.43 | 39.15 ± 11.72 |
| Month 6 Role Emotional | 41.95 ± 11.69 | 43.80 ± 10.75 | 40.34 ± 12.72 |
| Month 9 Role Emotional | 41.84 ± 11.82 | 44.08 ± 10.85 | 41.12 ± 11.81 |
| Month 12 Role Emotional | 42.19 ± 11.43 | 44.29 ± 10.85 | 40.90 ± 11.62 |
| Month 15 Role Emotional | 43.07 ± 10.93 | 44.72 ± 10.98 | 39.83 ± 12.09 |
| Month 18 Role Emotional | 43.36 ± 11.02 | 44.00 ± 10.91 | 42.43 ± 11.81 |
| Month 21 Role Emotional | 42.38 ± 11.44 | 44.53 ± 10.65 | 41.25 ± 12.14 |
| Month 24 Role Emotional | 43.49 ± 11.12 | 45.27 ± 11.02 | 41.14 ± 11.68 |
| Baseline Mental Health | 38.87 ± 11.88 | 39.51 ± 11.76 | 39.75 ± 11.30 |
| Month 1 Mental Health | 43.56 ± 11.28 | 45.59 ± 10.92 | 42.83 ± 10.84 |
| Month 2 Mental Health | 44.57 ± 12.34 | 45.27 ± 11.43 | 43.35 ± 10.34 |
| Month 3 Mental Health | 45.78 ± 11.73 | 45.71 ± 11.86 | 44.09 ± 10.55 |
| Month 6 Mental Health | 46.21 ± 11.29 | 46.48 ± 11.07 | 44.06 ± 11.85 |
| Month 9 Mental Health | 45.85 ± 11.12 | 47.31 ± 10.93 | 45.41 ± 11.36 |
| Month 12 Mental Health | 46.54 ± 11.33 | 47.43 ± 10.68 | 44.78 ± 11.25 |
| Month 15 Mental Health | 46.48 ± 10.87 | 47.16 ± 10.71 | 44.38 ± 11.92 |
| Month 18 Mental Health | 46.78 ± 10.82 | 48.05 ± 10.17 | 44.95 ± 12.62 |
| Month 21 Mental Health | 46.37 ± 11.64 | 48.06 ± 10.74 | 46.03 ± 12.31 |
| Month 24 Mental Health | 46.47 ± 10.53 | 48.18 ± 10.69 | 45.95 ± 10.96 |
| Baseline Physical Functioning | 30.21 ± 9.47 | 31.57 ± 9.86 | 32.04 ± 9.57 |
| Month 1 Physical Functioning | 36.41 ± 10.45 | 38.68 ± 10.31 | 32.82 ± 10.09 |
| Month 2 Physical Functioning | 38.24 ± 11.05 | 40.41 ± 10.82 | 35.29 ± 10.26 |
| Month 3 Physical Functioning | 39.91 ± 10.77 | 41.39 ± 10.84 | 36.12 ± 9.97 |
| Month 6 Physical Functioning | 40.62 ± 10.98 | 42.79 ± 10.83 | 37.61 ± 10.17 |
| Month 9 Physical Functioning | 41.05 ± 11.03 | 43.45 ± 10.23 | 38.52 ± 10.34 |
| Month 12 Physical Functioning | 41.72 ± 11.20 | 44.29 ± 10.17 | 39.66 ± 9.70 |
| Month 15 Physical Functioning | 42.67 ± 10.84 | 44.03 ± 10.58 | 38.85 ± 10.12 |
| Month 18 Physical Functioning | 43.06 ± 10.32 | 44.30 ± 10.64 | 39.01 ± 10.90 |
| Month 21 Physical Functioning | 43.01 ± 10.65 | 44.25 ± 10.31 | 39.32 ± 10.57 |
| Month 24 Physical Functioning | 43.45 ± 10.29 | 44.55 ± 10.40 | 39.85 ± 10.74 |
| Baseline Role Physical | 33.54 ± 9.64 | 34.11 ± 9.35 | 33.98 ± 9.42 |
| Month 1 Role Physical | 39.05 ± 9.74 | 41.30 ± 9.28 | 36.39 ± 9.36 |
| Month 2 Role Physical | 41.30 ± 9.85 | 42.73 ± 9.58 | 38.43 ± 9.33 |
| Month 3 Role Physical | 42.37 ± 9.83 | 43.51 ± 9.43 | 39.37 ± 9.67 |
| Month 6 Role Physical | 43.27 ± 9.42 | 44.46 ± 9.82 | 40.78 ± 9.76 |
| Month 9 Role Physical | 42.78 ± 9.60 | 45.04 ± 9.47 | 40.80 ± 9.66 |
| Month 12 Role Physical | 43.67 ± 9.36 | 45.81 ± 9.39 | 41.28 ± 9.28 |
| Month 15 Role Physical | 44.46 ± 9.41 | 45.90 ± 9.47 | 41.17 ± 9.35 |
| Month 18 Role Physical | 44.44 ± 90.4 | 45.27 ± 9.30 | 42.31 ± 10.15 |
| Month 21 Role Physical | 44.51 ± 9.18 | 45.77 ± 9.45 | 42.72 ± 9.72 |
| Month 24 Role Physical | 44.73 ± 9.34 | 46.20 ± 9.04 | 41.83 ± 10.15 |
| Baseline Bodily Pain | 33.29 ± 8.11 | 33.27 ± 7.25 | 33.80 ± 7.53 |
| Month 1 Bodily Pain | 40.54 ± 8.47 | 42.81 ± 8.57 | 37.54 ± 7.55 |
| Month 2 Bodily Pain | 42.78 ± 9.09 | 44.15 ± 9.19 | 38.93 ± 7.89 |
| Month 3 Bodily Pain | 44.14 ± 8.73 | 44.79 ± 9.35 | 40.61 ± 8.19 |
| Month 6 Bodily Pain | 44.44 ± 8.87 | 46.05 ± 9.47 | 42.36 ± 8.66 |
| Month 9 Bodily Pain | 44.37 ± 8.90 | 46.40 ± 9.58 | 42.62 ± 8.32 |
| Month 12 Bodily Pain | 45.32 ± 9.32 | 47.17 ± 9.25 | 42.47 ± 8.85 |
| Month 15 Bodily Pain | 45.97 ± 9.38 | 47.18 ± 9.34 | 42.72 ± 9.75 |
| Month 18 Bodily Pain | 45.72 ± 9.26 | 47.38 ± 9.31 | 43.35 ± 9.25 |
| Month 21 Bodily Pain | 46.42 ± 9.30 | 47.43 ± 9.34 | 43.70 ± 9.47 |
| Month 24 Bodily Pain | 46.24 ± 9.46 | 47.66 ± 9.42 | 43.37 ± 9.43 |
| Baseline General Health Perception | 38.02 ± 9.03 | 37.24 ± 8.55 | 37.63 ± 8.60 |
| Month 1 General Health Perception | 41.69 ± 9.37 | 42.40 ± 8.78 | 39.58 ± 8.69 |
| Month 2 General Health Perception | 43.11 ± 9.19 | 43.18 ± 9.19 | 40.68 ± 8.10 |
| Month 3 General Health Perception | 43.86 ± 9.43 | 43.72 ± 8.99 | 41.35 ± 8.07 |
| Month 6 General Health Perception | 44.00 ± 9.48 | 44.32 ± 9.24 | 42.53 ± 8.11 |
| Month 9 General Health Perception | 44.17 ± 9.32 | 44.53 ± 9.73 | 42.09 ± 8.51 |
| Month 12 General Health Perception | 44.24 ± 9.18 | 45.06 ± 9.35 | 42.74 ± 8.30 |
| Month 15 General Health Perception | 44.78 ± 9.23 | 45.14 ± 9.40 | 41.85 ± 8.40 |
| Month 18 General Health Perception | 44.92 ± 8.93 | 45.00 ± 9.60 | 42.15 ± 9.92 |
| Month 21 General Health Perception | 45.03 ± 9.08 | 45.02 ± 9.73 | 42.69 ± 9.06 |
| Month 24 General Health Perception | 44.75 ± 8.78 | 45.14 ± 9.41 | 42.75 ± 8.65 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 Vitality | 6.04 ± 0.49 | 7.27 ± 0.47 | 3.03 ± 0.68 |
| Month 2 Vitality | 7.36 ± 0.49 | 7.94 ± 0.47 | 3.68 ± 0.69 |
| Month 3 Vitality | 8.13 ± 0.49 | 8.79 ± 0.47 | 4.99 ± 0.69 |
| Month 6 Vitality | 8.36 ± 0.50 | 8.58 ± 0.48 | 5.89 ± 0.71 |
| Month 9 Vitality | 8.32 ± 0.50 | 9.06 ± 0.49 | 6.33 ± 0.73 |
| Month 12 Vitality | 8.30 ± 0.51 | 9.31 ± 0.49 | 6.44 ± 0.74 |
| Month 15 Vitality | 9.00 ± 0.52 | 8.33 ± 0.50 | 5.79 ± 0.75 |
| Month 18 Vitality | 8.65 ± 0.52 | 9.09 ± 0.51 | 6.46 ± 0.77 |
| Month 21 Vitality | 8.66 ± 0.53 | 8.94 ± 0.51 | 6.73 ± 0.78 |
| Month 24 Vitality | 8.19 ± 0.53 | 9.29 ± 0.51 | 6.47 ± 0.79 |
| Month 1 Social Functioning | 4.69 ± 0.50 | 7.46 ± 0.48 | 3.10 ± 0.69 |
| Month 2 Social Functioning | 6.97 ± 0.50 | 7.15 ± 0.48 | 4.18 ± 0.70 |
| Month 3 Social Functioning | 8.06 ± 0.50 | 7.90 ± 0.48 | 5.18 ± 0.71 |
| Month 6 Social Functioning | 8.35 ± 0.51 | 9.23 ± 0.49 | 6.82 ± 0.72 |
| Month 9 Social Functioning | 8.39 ± 0.51 | 9.37 ± 0.49 | 7.78 ± 0.75 |
| Month 12 Social Functioning | 8.46 ± 0.52 | 9.60 ± 0.50 | 5.83 ± 0.76 |
| Month 15 Social Functioning | 8.85 ± 0.53 | 9.49 ± 0.51 | 5.85 ± 0.77 |
| Month 18 Social Functioning | 8.99 ± 0.54 | 9.44 ± 0.52 | 7.33 ± 0.79 |
| Month 21 Social Functioning | 8.76 ± 0.54 | 9.87 ± 0.52 | 7.37 ± 0.80 |
| Month 24 Social Functioning | 9.05 ± 0.55 | 10.43 ± 0.53 | 6.85 ± 0.82 |
| Month 1 Role Emotional | 5.06 ± 0.56 | 6.88 ± 0.54 | 2.58 ± 0.77 |
| Month 2 Role Emotional | 6.39 ± 0.56 | 7.26 ± 0.54 | 3.62 ± 0.78 |
| Month 3 Role Emotional | 7.20 ± 0.56 | 7.73 ± 0.54 | 4.38 ± 0.79 |
| Month 6 Role Emotional | 7.49 ± 0.57 | 9.17 ± 0.55 | 5.58 ± 0.81 |
| Month 9 Role Emotional | 7.21 ± 0.58 | 9.35 ± 0.55 | 6.37 ± 0.83 |
| Month 12 Role Emotional | 7.63 ± 0.58 | 9.38 ± 0.56 | 5.94 ± 0.85 |
| Month 15 Role Emotional | 8.21 ± 0.59 | 9.61 ± 0.57 | 4.97 ± 0.86 |
| Month 18 Role Emotional | 8.43 ± 0.60 | 9.16 ± 0.58 | 7.53 ± 0.89 |
| Month 21 Role Emotional | 7.48 ± 0.60 | 9.70 ± 0.58 | 6.32 ± 0.90 |
| Month 24 Role Emotional | 8.61 ± 0.61 | 10.51 ± 0.59 | 6.59 ± 0.91 |
| Month 1 Mental Health | 4.57 ± 0.52 | 6.37 ± 0.50 | 3.50 ± 0.72 |
| Month 2 Mental Health | 5.53 ± 0.52 | 6.05 ± 0.50 | 3.94 ± 0.72 |
| Month 3 Mental Health | 6.59 ± 0.52 | 6.35 ± 0.50 | 4.67 ± 0.73 |
| Month 6 Mental Health | 7.05 ± 0.53 | 6.81 ± 0.51 | 4.65 ± 0.75 |
| Month 9 Mental Health | 6.46 ± 0.53 | 7.39 ± 0.51 | 6.10 ± 0.77 |
| Month 12 Mental Health | 7.27 ± 0.54 | 7.31 ± 0.52 | 5.38 ± 0.78 |
| Month 15 Mental Health | 7.01 ± 0.55 | 6.73 ± 0.53 | 5.02 ± 0.79 |
| Month 18 Mental Health | 7.21 ± 0.55 | 7.74 ± 0.54 | 5.41 ± 0.82 |
| Month 21 Mental Health | 6.78 ± 0.56 | 7.75 ± 0.54 | 6.39 ± 0.83 |
| Month 24 Mental Health | 6.88 ± 0.56 | 8.05 ± 0.54 | 6.40 ± 0.84 |
| Month 1 Physical Functioning | 5.74 ± 0.52 | 7.41 ± 0.49 | 1.34 ± 0.71 |
| Month 2 Physical Functioning | 7.59 ± 0.52 | 9.19 ± 0.50 | 3.66 ± 0.72 |
| Month 3 Physical Functioning | 9.18 ± 0.52 | 10.16 ± 0.50 | 4.30 ± 0.73 |
| Month 6 Physical Functioning | 9.70 ± 0.53 | 11.39 ± 0.50 | 5.69 ± 0.74 |
| Month 9 Physical Functioning | 9.98 ± 0.53 | 12.00 ± 0.51 | 6.32 ± 0.76 |
| Month 12 Physical Functioning | 10.68 ± 0.54 | 12.76 ± 0.52 | 7.41 ± 0.77 |
| Month 15 Physical Functioning | 11.18 ± 0.55 | 12.29 ± 0.52 | 6.89 ± 0.79 |
| Month 18 Physical Functioning | 11.50 ± 0.55 | 12.66 ± 0.53 | 7.05 ± 0.81 |
| Month 21 Physical Functioning | 11.33 ± 0.55 | 12.71 ± 0.53 | 7.35 ± 0.82 |
| Month 24 Physical Functioning | 11.66 ± 0.56 | 13.04 ± 0.54 | 7.93 ± 0.83 |
| Month 1 Role Physical | 5.52 ± 0.48 | 7.57 ± 0.46 | 2.75 ± 0.66 |
| Month 2 Role Physical | 7.81 ± 0.48 | 9.05 ± 0.46 | 4.57 ± 0.67 |
| Month 3 Role Physical | 8.77 ± 0.48 | 9.81 ± 0.46 | 5.24 ± 0.67 |
| Month 6 Role Physical | 9.55 ± 0.49 | 10.63 ± 0.47 | 6.60 ± 0.69 |
| Month 9 Role Physical | 8.88 ± 0.49 | 11.13 ± 0.47 | 6.57 ± 0.71 |
| Month 12 Role Physical | 9.79 ± 0.50 | 11.72 ± 0.48 | 7.03 ± 0.72 |
| Month 15 Role Physical | 10.27 ± 0.50 | 11.64 ± 0.49 | 7.06 ± 0.73 |
| Month 18 Role Physical | 10.10 ± 0.51 | 11.23 ± 0.49 | 8.20 ± 0.75 |
| Month 21 Role Physical | 10.11 ± 0.51 | 11.78 ± 0.49 | 8.65 ± 0.76 |
| Month 24 Role Physical | 10.31 ± 0.52 | 12.26 ± 0.50 | 7.78 ± 0.77 |
| Month 1 Bodily Pain | 7.21 ± 0.48 | 9.54 ± 0.46 | 4.10 ± 0.66 |
| Month 2 Bodily Pain | 9.45 ± 0.48 | 10.88 ± 0.46 | 5.40 ± 0.67 |
| Month 3 Bodily Pain | 10.69 ± 0.48 | 11.49 ± 0.46 | 6.81 ± 0.68 |
| Month 6 Bodily Pain | 10.90 ± 0.49 | 12.58 ± 0.47 | 8.32 ± 0.69 |
| Month 9 Bodily Pain | 10.66 ± 0.49 | 12.74 ± 0.47 | 8.77 ± 0.71 |
| Month 12 Bodily Pain | 11.64 ± 0.50 | 13.32 ± 0.48 | 8.43 ± 0.73 |
| Month 15 Bodily Pain | 12.09 ± 0.51 | 13.10 ± 0.49 | 8.72 ± 0.74 |
| Month 18 Bodily Pain | 11.75 ± 0.51 | 13.43 ± 0.50 | 9.11 ± 0.76 |
| Month 21 Bodily Pain | 12.35 ± 0.52 | 13.52 ± 0.50 | 9.39 ± 0.77 |
| Month 24 Bodily Pain | 12.16 ± 0.52 | 13.80 ± 0.50 | 9.06 ± 0.78 |
| Month 1 General Health Perception | 3.94 ± 0.41 | 5.19 ± 0.39 | 2.15 ± 0.57 |
| Month 2 General Health Perception | 5.37 ± 0.41 | 5.97 ± 0.39 | 3.27 ± 0.57 |
| Month 3 General Health Perception | 6.04 ± 0.41 | 6.44 ± 0.39 | 3.86 ± 0.58 |
| Month 6 General Health Perception | 6.14 ± 0.42 | 6.84 ± 0.40 | 4.87 ± 0.59 |
| Month 9 General Health Perception | 6.08 ± 0.42 | 6.89 ± 0.40 | 4.71 ± 0.60 |
| Month 12 General Health Perception | 6.08 ± 0.42 | 7.20 ± 0.41 | 5.33 ± 0.61 |
| Month 15 General Health Perception | 6.41 ± 0.43 | 7.04 ± 0.41 | 4.57 ± 0.62 |
| Month 18 General Health Perception | 6.50 ± 0.43 | 6.95 ± 0.42 | 4.61 ± 0.64 |
| Month 21 General Health Perception | 6.62 ± 0.44 | 7.06 ± 0.42 | 4.96 ± 0.64 |
| Month 24 General Health Perception | 6.39 ± 0.44 | 7.37 ± 0.42 | 4.75 ± 0.65 |
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline: Time Management | 46.41 ± 25.59 | 47.79 ± 28.29 | 47.26 ± 28.19 |
| Baseline: Physical Demands | 51.18 ± 23.02 | 50.99 ± 25.47 | 50.15 ± 25.54 |
| Baseline: Mental Demands | 31.29 ± 24.72 | 33.84 ± 26.72 | 28.57 ± 26.35 |
| Baseline: Output Demands | 40.77 ± 27.36 | 40.50 ± 28.07 | 38.34 ± 28.09 |
| Month 1: Time Management | 40.00 ± NA | 37.50 ± 53.03 | 40.00 ± NA |
| Month 2: Time Management | 25.00 ± 35.36 | 15.00 ± NA | 95.00 ± 8.66 |
| Month 3: Time Management | 31.47 ± 27.99 | 29.02 ± 29.19 | 34.76 ± 27.70 |
| Month 3: Physical Demands | 48.11 ± 31.33 | 45.77 ± 32.86 | 54.47 ± 28.36 |
| Month 3: Mental Demands | 23.84 ± 26.67 | 22.50 ± 27.28 | 22.66 ± 24.71 |
| Month 3: Output Demands | 26.46 ± 26.26 | 25.63 ± 28.30 | 27.77 ± 26.38 |
| Month 6: Physical Demands | 50.13 ± 31.81 | 45.76 ± 35.45 | 46.46 ± 30.78 |
| Month 6: Time Management | 29.18 ± 28.16 | 25.11 ± 28.08 | 27.87 ± 25.18 |
| Month 6: Mental Demands | 22.01 ± 24.05 | 18.00 ± 24.11 | 20.29 ± 23.90 |
| Month 6: Output Demands | 24.55 ± 24.47 | 20.31 ± 23.33 | 24.66 ± 25.38 |
| Month 9: Time Management | 70.00 ± NA | 35.00 ± 33.91 | 62.92 ± 32.12 |
| Month 12: Time Management | 30.82 ± 29.76 | 24.43 ± 28.49 | 25.86 ± 25.57 |
| Month 12: Physical Demands | 47.87 ± 33.29 | 46.42 ± 37.18 | 39.98 ± 32.42 |
| Month 12: Mental Demands | 22.99 ± 25.59 | 15.11 ± 21.94 | 17.21 ± 21.88 |
| Month 12: Output Demands | 25.65 ± 25.74 | 17.36 ± 22.98 | 21.49 ± 26.87 |
| Month 15: Time Management | 5.00 ± NA | 8.33 ± 14.43 | 75.00 ± NA |
| Month 15: Physical Demands | 8.33 ± NA | 33.33 ± 57.74 | 54.17 ± 25.34 |
| Month 15: Mental Demands | 5.56 ± NA | 0.00 ± 0.00 | 37.50 ± 53.03 |
| Month 15: Output Demands | 0.00 ± NA | 6.67 ± 11.55 | 48.33 ± 44.78 |
| Month 18: Time Management | 23.19 ± 25.28 | 22.16 ± 26.77 | 25.09 ± 28.46 |
| Month 18: Physical Demands | 50.79 ± 34.51 | 43.14 ± 37.06 | 43.93 ± 33.15 |
| Month 18: Mental Demands | 19.24 ± 23.15 | 17.51 ± 23.83 | 17.78 ± 22.99 |
| Month 18: Output Demands | 22.85 ± 24.60 | 19.83 ± 25.37 | 22.63 ± 26.31 |
| Month 21: Time Management | 67.50 ± 17.68 | 60.00 ± 35.36 | 80.00 ± NA |
| Month 21: Physical Demands | 62.50 ± 29.17 | 27.08 ± 20.62 | 62.50 ± NA |
| Month 21: Mental Demands | 29.63 ± 26.98 | 87.50 ± 17.68 | 25.00 ± NA |
| Month 21: Output Demands | 31.67 ± 27.54 | 82.50 ± 24.75 | 45.00 ± NA |
| Month 24: Time Management | 28.17 ± 29.38 | 21.06 ± 25.37 | 25.11 ± 25.07 |
| Month 24: Physical Demands | 51.10 ± 35.26 | 45.94 ± 36.65 | 43.75 ± 33.06 |
| Month 24: Mental Demands | 19.44 ± 22.70 | 17.25 ± 23.29 | 17.50 ± 24.04 |
| Month 24: Output Demands | 22.98 ± 25.23 | 19.39 ± 24.03 | 20.02 ± 23.85 |
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15 or 20 mg, Weekly |
|---|---|---|---|
| Month 3 Time Management Scale | -14.28 ± 2.11 | -16.87 ± 2.04 | -10.46 ± 2.98 |
| Month 6 Time Management Scale | -16.99 ± 2.16 | -20.12 ± 2.10 | -15.78 ± 3.10 |
| Month 12 Time Management Scale | -16.22 ± 2.23 | -20.72 ± 2.20 | -18.32 ± 3.29 |
| Month 15 Time Management Scale | -32.18 ± 21.24 | -14.92 ± 15.04 | 29.59 ± 21.29 |
| Month 18 Time Management Scale | -21.55 ± 2.33 | -22.60 ± 2.30 | -18.68 ± 3.47 |
| Month 21 Time Management Scale | 5.99 ± 14.90 | -16.26 ± 20.82 | -7.27 ± 20.89 |
| Month 24 Time Management Scale | -15.44 ± 2.37 | -22.25 ± 2.35 | -18.54 ± 3.64 |
| Month 3 Physical Demand | -6.44 ± 2.62 | -8.36 ± 2.55 | 0.13 ± 3.74 |
| Month 6 Physical Demand | -1.25 ± 2.68 | -9.48 ± 2.64 | -6.45 ± 3.88 |
| Month 12 Physical Demand | -5.36 ± 2.77 | -6.66 ± 2.76 | -14.62 ± 4.11 |
| Month 15 Physical Demand | -28.94 ± 28.32 | -12.26 ± 16.51 | -13.80 ± 16.68 |
| Month 18 Physical Demand | -2.35 ± 2.86 | -11.77 ± 2.95 | -7.77 ± 4.38 |
| Month 21 Physical Demand | 3.65 ± 16.22 | -18.17 ± 27.87 | 4.80 ± 27.94 |
| Month 24 Physical Demand | -2.71 ± 3.02 | -9.56 ± 3.03 | -8.03 ± 4.62 |
| Month 3 Mental/Interpersonal Demands | -6.81 ± 1.68 | -8.56 ± 1.64 | -5.99 ± 2.39 |
| Month 6 Mental/Interpersonal Demands | -10.03 ± 1.72 | -12.35 ± 1.69 | -9.36 ± 2.49 |
| Month 12 Mental/Interpersonal Demands | -9.35 ± 1.77 | -15.21 ± 11.76 | -11.64 ± 2.63 |
| Month 15 Mental/Interpersonal Demands | -17.52 ± 17.41 | -21.78 ± 10.18 | 15.00 ± 12.54 |
| Month 18 Mental/Interpersonal Demands | -11.09 ± 1.83 | -13.08 ± 1.86 | -11.33 ± 2.76 |
| Month 21 Mental/Interpersonal Demands | -4.00 ± 9.96 | 23.24 ± 17.09 | -29.23 ± 17.14 |
| Month 24 Mental/Interpersonal Demands | -9.34 ± 1.89 | -13.58 ± 1.90 | -13.14 ± 2.87 |
| Month 3 Output Demand | -12.69 ± 1.84 | -13.43 ± 1.82 | -8.73 ± 2.72 |
| Month 6 Output Demand | -14.78 ± 1.89 | -19.16 ± 1.89 | -14.02 ± 2.80 |
| Month 12 Output Demand | -14.83 ± 1.93 | -21.15 ± 1.96 | -15.84 ± 2.95 |
| Month 15 Output Demand | -29.63 ± 18.09 | -18.43 ± 10.61 | 17.17 ± 13.10 |
| Month 18 Output Demand | -14.17 ± 1.98 | -18.82 ± 2.06 | -14.15 ± 3.09 |
| Month 21 Output Demand | 0.32 ± 12.69 | 16.85 ± 17.72 | -20.75 ± 17.79 |
| Month 24 Output Demand | -13.60 ± 2.05 | -20.77 ± 2.08 | -16.40 ± 3.17 |
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 11.00 ± 5.93 | 11.21 ± 6.08 | 10.55 ± 6.24 |
| Month 3 | 8.05 ± 6.25 | 7.60 ± 6.43 | 8.32 ± 5.78 |
| Month 6 | 7.72 ± 5.74 | 6.49 ± 5.62 | 7.29 ± 5.69 |
| Month 12 | 7.89 ± 6.07 | 5.88 ± 5.31 | 6.47 ± 5.90 |
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15 or 20 mg, Weekly |
|---|---|---|---|
| Month 3 | -2.82 ± 0.41 | -3.21 ± 0.40 | -2.03 ± 0.59 |
| Month 6 | -3.24 ± 0.42 | -4.23 ± 0.41 | -3.18 ± 0.61 |
| Month 12 | -3.35 ± 0.44 | -4.99 ± 0.43 | -3.84 ± 0.65 |
| Month 15 | -7.10 ± 4.07 | -4.99 ± 2.39 | -0.19 ± 2.43 |
| Month 18 | -3.61 ± 0.45 | -4.90 ± 0.45 | -3.48 ± 0.68 |
| Month 21 | -1.14 ± 2.33 | 2.24 ± 3.99 | -4.92 ± 4.00 |
| Month 24 | -3.18 ± 0.46 | -4.96 ± 0.46 | -4.11 ± 0.70 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 0.39 ± 0.33 | 0.42 ± 0.31 | 0.46 ± 0.30 |
| Month 3 | 0.67 ± 0.25 | 0.69 ± 0.23 | 0.63 ± 0.23 |
| Month 6 | 0.68 ± 0.23 | 0.72 ± 0.22 | 0.63 ± 0.26 |
| Month 12 | 0.70 ± 0.25 | 0.74 ± 0.22 | 0.66 ± 0.21 |
| Month 18 | 0.73 ± 0.22 | 0.75 ± 0.23 | 0.66 ± 0.24 |
| Month 24 | 0.72 ± 0.24 | 0.76 ± 0.22 | 0.71 ± 0.19 |
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 3 | 0.26 ± 0.01 | 0.28 ± 0.01 | 0.21 ± 0.02 |
| Month 6 | 0.27 ± 0.01 | 0.30 ± 0.01 | 0.20 ± 0.02 |
| Month 12 | 0.28 ± 0.01 | 0.31 ± 0.01 | 0.23 ± 0.02 |
| Month 18 | 0.31 ± 0.01 | 0.33 ± 0.01 | 0.23 ± 0.02 |
| Month 24 | 0.30 ± 0.01 | 0.33 ± 0.01 | 0.28 ± 0.02 |
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| BL: seen any doctor | 1.12 ± 0.33 | 1.13 ± 0.33 | 1.12 ± 0.32 |
| BL: treated in ER | 1.95 ± 0.21 | 1.91 ± 0.28 | 1.91 ± 0.28 |
| BL:admitted for overnight stay | 0.24 ± 0.56 | 0.31 ± 0.83 | 0.25 ± 0.58 |
| BL: hospitalized | 1.89 ± 0.31 | 1.93 ± 0.26 | 1.88 ± 0.33 |
| BL: any outpatient surgery | 1.98 ± 0.15 | 1.96 ± 0.19 | 1.98 ± 0.15 |
| BL: non-study diagnostic tests | 1.74 ± 0.44 | 1.74 ± 0.44 | 1.69 ± 0.46 |
| BL: in a nursing home | 2.00 ± 0.00 | 1.99 ± 0.11 | 1.98 ± 0.13 |
| BL: home healthcare services | 1.99 ± 0.10 | 1.99 ± 0.11 | 1.98 ± 0.13 |
| BL: used aids/devices | 1.90 ± 0.30 | 1.91 ± 0.29 | 1.91 ± 0.29 |
| BL: non-medical practitioner | 1.97 ± 0.17 | 1.96 ± 0.20 | 1.96 ± 0.19 |
| BL: currently employed | 1.55 ± 0.50 | 1.53 ± 0.50 | 1.54 ± 0.50 |
| BL: feel well enough to work | 1.78 ± 0.42 | 1.78 ± 0.42 | 1.78 ± 0.42 |
| BL: unable to work due to RA | 1.45 ± 0.50 | 1.49 ± 0.50 | 1.42 ± 0.50 |
| BL: Lost job/retired early | 1.75 ± 0.44 | 1.81 ± 0.40 | 1.77 ± 0.43 |
| BL: work disabled due to RA | 1.55 ± 0.50 | 1.58 ± 0.50 | 1.59 ± 0.50 |
| BL: retired | 1.60 ± 0.49 | 1.61 ± 0.49 | 1.53 ± 0.50 |
| BL: sick leave due to RA | 1.74 ± 0.44 | 1.73 ± 0.45 | 1.74 ± 0.44 |
| BL: performed part time work | 1.90 ± 0.30 | 1.88 ± 0.33 | 1.83 ± 0.38 |
| BL: performed paid work | 1.61 ± 0.49 | 1.57 ± 0.50 | 1.57 ± 0.50 |
| BL: unable to do chores | 1.41 ± 0.49 | 1.40 ± 0.49 | 1.44 ± 0.50 |
| BL: chores by housekeeper | 1.91 ± 0.29 | 1.87 ± 0.33 | 1.93 ± 0.26 |
| BL: chores by family/friends | 1.48 ± 0.50 | 1.50 ± 0.50 | 1.49 ± 0.50 |
| Month 3: seen any doctor | 1.36 ± 0.48 | 1.30 ± 0.46 | 1.30 ± 0.46 |
| Month 3: treated in ER | 1.97 ± 0.18 | 1.96 ± 0.20 | 1.98 ± 0.13 |
| Month 3:admitted for overnight stay | 0.08 ± 0.29 | 0.06 ± 0.25 | 0.33 ± 0.58 |
| Month 3:hospitalization | 1.99 ± 0.11 | 1.99 ± 0.09 | 1.99 ± 0.11 |
| Month 3: outpatient surgery | 1.99 ± 0.12 | 1.98 ± 0.13 | 1.99 ± 0.11 |
| Month 3: non-study diagnostic tests | 1.90 ± 0.30 | 1.90 ± 0.31 | 1.92 ± 0.27 |
| Month 3: in nursing home | 2.00 ± 0.05 | 1.99 ± 0.09 | 2.00 ± 0.00 |
| Month 3: home healthcare services | 2.00 ± 0.05 | 1.99 ± 0.10 | 2.00 ± 0.00 |
| Month 3: required aids/devices | 1.94 ± 0.23 | 1.95 ± 0.22 | 1.92 ± 0.27 |
| Month 3: non-medical practitioner | 1.98 ± 0.14 | 1.98 ± 0.12 | 1.99 ± 0.11 |
| Month 3: currently employed | 1.51 ± 0.50 | 1.53 ± 0.50 | 1.53 ± 0.50 |
| Month 3: feel well enough to work | 1.62 ± 0.49 | 1.58 ± 0.50 | 1.67 ± 0.47 |
| Month 3: unable to work due to RA | 1.56 ± 0.50 | 1.64 ± 0.48 | 1.50 ± 0.50 |
| Month 3: lost job/retired early | 1.70 ± 0.46 | 1.79 ± 0.41 | 1.83 ± 0.38 |
| Month 3: work disabled due to RA | 1.64 ± 0.48 | 1.68 ± 0.47 | 1.67 ± 0.47 |
| Month 3: retired | 1.56 ± 0.50 | 1.59 ± 0.49 | 1.54 ± 0.50 |
| Month 3: sick leave due to RA | 1.87 ± 0.33 | 1.90 ± 0.31 | 1.85 ± 0.36 |
| Month 3: performed part-time work | 1.93 ± 0.25 | 1.95 ± 0.21 | 1.92 ± 0.27 |
| Month 3: performed paid work | 1.69 ± 0.46 | 1.72 ± 0.45 | 1.66 ± 0.47 |
| Month 3: unable to do chores | 1.69 ± 0.46 | 1.71 ± 0.45 | 1.54 ± 0.50 |
| Month 3: chores by housekeeper | 1.95 ± 0.22 | 1.92 ± 0.27 | 1.89 ± 0.31 |
| Month 3: chores by family/friends | 1.70 ± 0.46 | 1.71 ± 0.45 | 1.58 ± 0.50 |
| Month 6: seen any doctor | 1.40 ± 0.49 | 1.39 ± 0.49 | 1.35 ± 0.48 |
| Month 6: treated in ER | 1.96 ± 0.20 | 1.95 ± 0.22 | 1.98 ± 0.14 |
| Month 6:admitted for overnight stay | 0.36 ± 0.74 | 0.21 ± 0.54 | 1.33 ± 1.15 |
| Month 6: Hospitalization | 1.99 ± 0.09 | 1.98 ± 0.14 | 1.97 ± 0.16 |
| Month 6: outpatient surgery | 1.98 ± 0.13 | 1.98 ± 0.14 | 1.97 ± 0.16 |
| Month 6: non-study diagnostic test | 1.91 ± 0.29 | 1.88 ± 0.32 | 1.89 ± 0.31 |
| Month 6: in nursing home | 2.00 ± 0.05 | 2.00 ± 0.05 | 1.99 ± 0.08 |
| Month 6: home healthcare services | 1.99 ± 0.09 | 1.99 ± 0.07 | 2.00 ± 0.00 |
| Month 6: required aids/devices | 1.94 ± 0.24 | 1.96 ± 0.19 | 1.95 ± 0.22 |
| Month 6: non-medical practitioner | 1.99 ± 0.12 | 1.99 ± 0.07 | 1.97 ± 0.16 |
| Month 6: currently employed | 1.50 ± 0.50 | 1.53 ± 0.50 | 1.55 ± 0.50 |
| Month 6: feel well enough to work | 1.55 ± 0.50 | 1.57 ± 0.50 | 1.65 ± 0.48 |
| Month 6: unable to work due to RA | 1.64 ± 0.48 | 1.66 ± 0.47 | 1.52 ± 0.50 |
| Month 6: lost job/retired early | 1.74 ± 0.44 | 1.81 ± 0.40 | 1.78 ± 0.42 |
| Month 6: work disabled due to RA | 1.68 ± 0.47 | 1.70 ± 0.46 | 1.68 ± 0.47 |
| Month 6: retired | 1.55 ± 0.50 | 1.57 ± 0.50 | 1.52 ± 0.50 |
| Month 6: sick leave due to RA | 1.94 ± 0.24 | 1.94 ± 0.23 | 1.89 ± 0.31 |
| Month 6: performed part-time work | 1.97 ± 0.16 | 1.97 ± 0.17 | 1.95 ± 0.22 |
| Month 6: performed paid work | 1.77 ± 0.42 | 1.82 ± 0.38 | 1.69 ± 0.46 |
| Month 6: unable to do chores | 1.79 ± 0.41 | 1.81 ± 0.40 | 1.70 ± 0.46 |
| Month 6: chores by housekeeper | 1.96 ± 0.20 | 1.94 ± 0.24 | 1.94 ± 0.24 |
| Month 6: chores by family/friends | 1.78 ± 0.41 | 1.83 ± 0.37 | 1.71 ± 0.46 |
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: seen any doctor | 1.45 ± 0.50 | 1.44 ± 0.50 | 1.41 ± 0.49 |
| Month 12: treated in ER | 1.95 ± 0.21 | 1.98 ± 0.15 | 1.96 ± 0.19 |
| Month12:admitted for overnight stay | 0.19 ± 0.54 | 0.25 ± 0.46 | 0.20 ± 0.45 |
| Month 12: hospitalized | 1.98 ± 0.15 | 1.99 ± 0.11 | 1.99 ± 0.12 |
| Month 12:any outpatient surgery | 1.97 ± 0.17 | 1.98 ± 0.15 | 1.98 ± 0.15 |
| Month 12:non-study diagnostic tests | 1.90 ± 0.30 | 1.88 ± 0.33 | 1.92 ± 0.27 |
| Month 12: in a nursing home | 2.00 ± 0.00 | 1.99 ± 0.08 | 1.99 ± 0.09 |
| Month 12: home healthcare services | 1.99 ± 0.08 | 1.99 ± 0.08 | 2.00 ± 0.00 |
| Month 12: used aids/devices | 1.94 ± 0.24 | 1.97 ± 0.16 | 1.97 ± 0.17 |
| Month 12: non-medical practitioner | 1.99 ± 0.08 | 1.99 ± 0.11 | 2.00 ± 0.00 |
| Month 12: currently employed | 1.51 ± 0.50 | 1.53 ± 0.50 | 1.53 ± 0.50 |
| Month 12: feel well enough to work | 1.61 ± 0.49 | 1.56 ± 0.50 | 1.61 ± 0.49 |
| Month 12: unable to work due to RA | 1.64 ± 0.48 | 1.73 ± 0.44 | 1.61 ± 0.49 |
| Month 12: Lost job/retired early | 1.75 ± 0.44 | 1.81 ± 0.39 | 1.80 ± 0.40 |
| Month 12: work disabled due to RA | 1.66 ± 0.48 | 1.73 ± 0.44 | 1.73 ± 0.45 |
| Month 12: retired | 1.51 ± 0.50 | 1.52 ± 0.50 | 1.42 ± 0.50 |
| Month 12: sick leave due to RA | 1.94 ± 0.24 | 1.98 ± 0.14 | 1.93 ± 0.26 |
| Month 12: performed part time work | 1.97 ± 0.18 | 1.97 ± 0.16 | 1.97 ± 0.16 |
| Month 12: performed paid work | 1.80 ± 0.40 | 1.84 ± 0.36 | 1.72 ± 0.45 |
| Month 12: unable to do chores | 1.79 ± 0.41 | 1.83 ± 0.37 | 1.79 ± 0.41 |
| Month 12: chores by housekeeper | 1.96 ± 0.18 | 1.95 ± 0.21 | 1.96 ± 0.19 |
| Month 12: chores by family/friends | 1.83 ± 0.38 | 1.86 ± 0.35 | 1.79 ± 0.41 |
| Month 18: seen any doctor | 1.43 ± 0.50 | 1.49 ± 0.50 | 1.41 ± 0.49 |
| Month 18: treated in ER | 1.96 ± 0.18 | 1.97 ± 0.17 | 1.96 ± 0.20 |
| Month18:admitted for overnight stay | 0.60 ± 0.97 | 0.33 ± 0.71 | 0.40 ± 0.89 |
| Month 18:hospitalization | 1.99 ± 0.10 | 1.98 ± 0.14 | 1.97 ± 0.16 |
| Month 18: outpatient surgery | 1.98 ± 0.14 | 1.98 ± 0.15 | 1.97 ± 0.16 |
| Month 18:non-study diagnostic tests | 1.91 ± 0.29 | 1.91 ± 0.29 | 1.90 ± 0.31 |
| Month 18: in nursing home | 2.00 ± 0.06 | 2.00 ± 0.00 | 2.00 ± 0.00 |
| Month 18: home healthcare services | 2.00 ± 0.06 | 2.00 ± 0.00 | 2.00 ± 0.00 |
| Month 18: required aids/devices | 1.96 ± 0.20 | 1.97 ± 0.16 | 1.97 ± 0.18 |
| Month 18: non-medical practitioner | 1.99 ± 0.08 | 1.99 ± 0.12 | 1.99 ± 0.09 |
| Month 18: currently employed | 1.50 ± 0.50 | 1.51 ± 0.50 | 1.55 ± 0.50 |
| Month 18: feel well enough to work | 1.53 ± 0.50 | 1.57 ± 0.50 | 1.67 ± 0.48 |
| Month 18: unable to work due to RA | 1.73 ± 0.45 | 1.72 ± 0.45 | 1.59 ± 0.50 |
| Month 18: lost job/retired early | 1.80 ± 0.40 | 1.83 ± 0.38 | 1.80 ± 0.40 |
| Month 18: work disabled due to RA | 1.76 ± 0.43 | 1.78 ± 0.42 | 1.66 ± 0.48 |
| Month 18: retired | 1.49 ± 0.50 | 1.53 ± 0.50 | 1.48 ± 0.50 |
| Month 18: sick leave due to RA | 1.94 ± 0.23 | 1.96 ± 0.20 | 1.95 ± 0.22 |
| Month 18: performed part-time work | 1.98 ± 0.15 | 1.98 ± 0.14 | 1.98 ± 0.14 |
| Month 18: performed paid work | 1.78 ± 0.41 | 1.83 ± 0.38 | 1.79 ± 0.41 |
| Month 18: unable to do chores | 1.84 ± 0.36 | 1.84 ± 0.36 | 1.78 ± 0.42 |
| Month 18: chores by housekeeper | 1.98 ± 0.14 | 1.96 ± 0.20 | 1.95 ± 0.22 |
| Month 18: chores by family/friends | 1.86 ± 0.35 | 1.89 ± 0.32 | 1.84 ± 0.37 |
| Month 24: seen any doctor | 1.46 ± 0.50 | 1.50 ± 0.50 | 1.47 ± 0.50 |
| Month 24: treated in ER | 1.96 ± 0.19 | 1.96 ± 0.20 | 1.97 ± 0.17 |
| Month24:admitted for overnight stay | 0.20 ± 0.63 | 0.67 ± 0.98 | 0.00 ± 0.00 |
| Month 24: Hospitalization | 1.99 ± 0.11 | 1.99 ± 0.12 | 1.98 ± 0.14 |
| Month 24: outpatient surgery | 1.98 ± 0.12 | 1.98 ± 0.13 | 1.99 ± 0.10 |
| Month 24:non-study diagnostic test | 1.92 ± 0.27 | 1.89 ± 0.32 | 1.86 ± 0.35 |
| Month 24: in nursing home | 2.00 ± 0.06 | 1.99 ± 0.08 | 1.98 ± 0.14 |
| Month 24: home healthcare services | 2.00 ± 0.00 | 1.99 ± 0.10 | 1.99 ± 0.10 |
| Month 24: required aids/devices | 1.95 ± 0.22 | 1.96 ± 0.20 | 1.96 ± 0.19 |
| Month 24: non-medical practitioner | 1.99 ± 0.11 | 1.98 ± 0.13 | 2.00 ± 0.00 |
| Month 24: currently employed | 1.49 ± 0.50 | 1.54 ± 0.50 | 1.55 ± 0.50 |
| Month 24: feel well enough to work | 1.55 ± 0.50 | 1.57 ± 0.50 | 1.65 ± 0.48 |
| Month 24: unable to work due to RA | 1.70 ± 0.46 | 1.75 ± 0.43 | 1.52 ± 0.50 |
| Month 24: lost job/retired early | 1.76 ± 0.43 | 1.83 ± 0.38 | 1.81 ± 0.39 |
| Month 24: work disabled due to RA | 1.75 ± 0.43 | 1.77 ± 0.42 | 1.70 ± 0.46 |
| Month 24: retired | 1.47 ± 0.50 | 1.49 ± 0.50 | 1.52 ± 0.50 |
| Month 24: sick leave due to RA | 1.96 ± 0.20 | 1.98 ± 0.13 | 1.90 ± 0.31 |
| Month 24: performed part-time work | 1.98 ± 0.15 | 1.99 ± 0.09 | 1.95 ± 0.21 |
| Month 24: performed paid work | 1.82 ± 0.39 | 1.82 ± 0.39 | 1.75 ± 0.44 |
| Month 24: unable to do chores | 1.83 ± 0.37 | 1.86 ± 0.35 | 1.80 ± 0.40 |
| Month 24: chores by housekeeper | 1.96 ± 0.19 | 1.96 ± 0.20 | 1.97 ± 0.17 |
| Month 24: chores by family/friends | 1.87 ± 0.34 | 1.88 ± 0.33 | 1.81 ± 0.39 |
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
| events | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| BL: doctor visits | 4.81 ± 5.57 | 4.37 ± 3.86 | 4.82 ± 5.31 |
| BL: RA-related doctor visits | 1.55 ± 1.07 | 1.46 ± 0.95 | 1.56 ± 0.96 |
| BL: hospital ER visit | 2.13 ± 2.73 | 1.49 ± 0.98 | 1.38 ± 0.65 |
| BL: RA-related ER visits | 1.12 ± 0.86 | 1.00 ± 0.83 | 1.13 ± 1.02 |
| BL: hospitalization | 1.03 ± 0.16 | 1.00 ± 0.00 | 1.05 ± 0.21 |
| BL: RA-related hospitalization | 1.27 ± 0.55 | 1.24 ± 0.69 | 1.13 ± 0.55 |
| BL: outpatient surgery | 2.56 ± 3.24 | 2.13 ± 2.61 | 1.25 ± 0.50 |
| BL: RA-related outpatient surgery | 0.33 ± 0.50 | 0.80 ± 0.86 | 0.00 ± 0.00 |
| BL:non-study diagnostic tests | 2.25 ± 1.60 | 2.05 ± 1.27 | 1.75 ± 1.18 |
| BL: RA-related diagnostic tests | 1.20 ± 1.22 | 1.21 ± 1.21 | 1.09 ± 0.91 |
| BL: non-medical practitioner visits | 23.82 ± 56.10 | 10.07 ± 19.72 | 8.57 ± 11.13 |
| BL: RA-related non-medical visits | 1.00 ± 0.82 | 1.13 ± 0.81 | 1.14 ± 0.69 |
| Month 3: doctor visits | 3.45 ± 2.99 | 3.44 ± 3.12 | 3.57 ± 2.94 |
| Month 3: RA-related doctor visits | 0.99 ± 0.77 | 0.96 ± 0.62 | 1.03 ± 0.72 |
| Month 3: hospital ER visits | 1.83 ± 1.34 | 1.94 ± 2.08 | 1.00 ± 0.00 |
| Month 3: RA-related ER visits | 0.33 ± 0.65 | 0.13 ± 0.34 | 0.00 ± 0.00 |
| Month 3: hospitalization | 1.00 ± 0.00 | 1.00 ± 0.00 | 1.00 ± 0.00 |
| Month 3: RA-related hospitalization | 0.25 ± 0.50 | 0.33 ± 0.58 | 0.50 ± 0.71 |
| Month 3: outpatient surgery | 1.25 ± 0.50 | 1.00 ± 0.00 | 1.00 ± 0.00 |
| Month 3:RA-related outpatient surgery | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Month 3: non-study diagnostic tests | 1.32 ± 0.64 | 1.33 ± 0.73 | 1.57 ± 1.02 |
| Month 3: RA-related diagnostic tests | 0.18 ± 0.39 | 0.27 ± 0.50 | 0.21 ± 0.80 |
| Month 3:non-medical practitioner visits | 10.33 ± 15.13 | 4.50 ± 2.43 | 9.00 ± 7.07 |
| Month 3:RA-related non-medical visits | 0.67 ± 0.82 | 1.00 ± 0.63 | 2.00 ± 0.00 |
| Month 6: doctor visits | 2.57 ± 3.64 | 2.48 ± 2.82 | 2.12 ± 1.72 |
| Month 6: RA-related doctor visits | 0.82 ± 0.72 | 0.74 ± 0.64 | 0.74 ± 0.54 |
| Month 6: hospital ER visits | 1.36 ± 0.84 | 1.22 ± 0.73 | 5.33 ± 5.86 |
| Month 6: RA-related ER visits | 0.07 ± 0.26 | 0.26 ± 0.65 | 1.00 ± 1.00 |
| Month 6: hospitalization | 1.00 ± 0.00 | 2.29 ± 3.40 | 1.00 ± 0.00 |
| Month 6: RA-related hospitalization | 0.00 ± 0.00 | 0.14 ± 0.38 | 0.75 ± 0.96 |
| Month 6: outpatient surgery | 1.50 ± 1.22 | 1.43 ± 0.79 | 1.25 ± 0.50 |
| Month 6:RA-related outpatient surgery | 0.00 ± 0.00 | 0.14 ± 0.38 | 0.25 ± 0.50 |
| Month 6: non-study diagnostic tests | 1.73 ± 1.39 | 1.54 ± 1.00 | 1.47 ± 0.94 |
| Month 6: RA related diagnostic tests | 0.26 ± 0.63 | 0.12 ± 0.40 | 0.35 ± 0.79 |
| Month 6:non-medical practitioner visits | 10.40 ± 14.05 | 5.50 ± 6.36 | 4.75 ± 1.26 |
| Month 6:RA-related non-medical visits | 1.20 ± 1.30 | 1.50 ± 0.71 | 1.25 ± 1.26 |
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
| events | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: doctor visit | 2.19 ± 1.81 | 2.19 ± 1.72 | 2.22 ± 1.62 |
| Month 12: RA-related doctor visit | 0.77 ± 0.61 | 0.74 ± 0.70 | 0.89 ± 0.77 |
| Month 12: hospital ER visit | 1.06 ± 0.25 | 1.13 ± 0.35 | 1.00 ± 0.00 |
| Month 12: RA-related ER visit | 0.13 ± 0.50 | 0.00 ± 0.00 | 0.20 ± 0.45 |
| Month 12: hospitalization | 1.00 ± 0.00 | 1.00 ± 0.00 | 1.00 ± 0.00 |
| Month 12: RA-related hospitalization | 0.29 ± 0.49 | 0.00 ± 0.00 | 0.50 ± 0.71 |
| Month 12: outpatient surgery | 1.00 ± 0.00 | 1.50 ± 1.07 | 1.33 ± 0.58 |
| Month 12: RA-related outpatient surgery | 0.11 ± 0.33 | 0.13 ± 0.35 | 0.00 ± 0.00 |
| Month 12:non-study diagnostic tests | 1.61 ± 1.05 | 1.34 ± 0.57 | 1.18 ± 0.40 |
| Month 12: RA-related diagnostic tests | 0.13 ± 0.50 | 0.22 ± 0.57 | 0.36 ± 0.67 |
| Month 12:non-medical practitioner visits | 17.00 ± 18.38 | 13.33 ± 6.43 | — |
| Month 12:RA-related non-medical visits | 1.00 ± 1.41 | 1.33 ± 1.15 | — |
| Month 18: doctor visits | 2.17 ± 1.91 | 2.21 ± 1.83 | 2.93 ± 3.02 |
| Month 18: RA-related doctor visit | 0.78 ± 0.74 | 0.82 ± 0.66 | 0.80 ± 0.65 |
| Month 18: hospital ER visit | 1.60 ± 1.35 | 1.89 ± 1.36 | 1.40 ± 0.89 |
| Month 18: RA-related ER visit | 0.20 ± 0.63 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Month 18: hospitalization | 2.33 ± 2.31 | 1.00 ± 0.00 | 1.00 ± 0.00 |
| Month 18:RA-related hospitalization | 0.00 ± 0.00 | 0.67 ± 1.03 | 0.67 ± 1.15 |
| Month 18: outpatient surgery | 1.00 ± 0.00 | 2.14 ± 1.68 | 3.00 ± 2.65 |
| Month 18:RA-related outpatient surgery | 0.33 ± 0.82 | 0.14 ± 0.38 | 0.00 ± 0.00 |
| Month 18:non-study diagnostic tests | 1.48 ± 0.77 | 1.85 ± 1.43 | 1.50 ± 0.80 |
| Month 18:RA-related diagnostic tests | 0.08 ± 0.39 | 0.19 ± 0.49 | 0.08 ± 0.29 |
| Month 18:non-medical practitioner visits | 16.00 ± 19.80 | 18.00 ± 16.25 | 4.00 ± NA |
| Month 18:RA-related non-medical visits | 2.00 ± 0.00 | 1.50 ± 1.91 | 0.00 ± NA |
| Month 24: doctor visits | 2.27 ± 2.17 | 2.78 ± 3.80 | 2.75 ± 2.03 |
| Month 24: RA-related doctor visits | 0.83 ± 0.60 | 0.76 ± 0.71 | 0.93 ± 0.80 |
| Month 24 hospital ER visits | 1.40 ± 0.70 | 1.33 ± 0.65 | 1.00 ± 0.00 |
| Month 24: RA-related ER visits | 0.00 ± 0.00 | 0.00 ± 0.00 | 1.33 ± 1.15 |
| Month 24: hospitalization | 1.00 ± 0.00 | 1.25 ± 0.50 | 1.50 ± 0.71 |
| Month 24:RA-related hospitalization | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Month 24: outpatient surgery | 3.25 ± 4.50 | 2.00 ± 2.24 | 3.00 ± NA |
| Month 24:RA-related outpatient surgery | 0.00 ± 0.00 | 0.00 ± 0.00 | 2.00 ± NA |
| Month 24:non-study diagnostic tests | 1.50 ± 0.83 | 1.29 ± 0.53 | 1.40 ± 0.51 |
| Month 24:RA related diagnostic tests | 0.11 ± 0.32 | 0.03 ± 0.18 | 0.27 ± 0.59 |
| Month 24:non-medical practitioner visits | 20.67 ± 3.06 | 3.50 ± 1.91 | — |
| Month 24:RA-related non-medical visits | 0.67 ± 1.15 | 1.00 ± 1.15 | — |
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
| days | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| BL: hospital length of stay | 19.07 ± 10.86 | 23.76 ± 18.95 | 15.45 ± 11.61 |
| BL: days in nursing home | — | 30.60 ± 33.62 | 41.67 ± 42.00 |
| BL: days aids/devices used | 99.94 ± 107.83 | 93.06 ± 130.53 | 162.88 ± 140.39 |
| BL: RA-related aids used | 1.61 ± 1.15 | 1.75 ± 1.36 | 2.24 ± 1.95 |
| BL: days of work per week | 5.11 ± 0.98 | 4.96 ± 0.97 | 5.12 ± 0.91 |
| BL: days on sick leave due to RA | 23.52 ± 25.55 | 16.59 ± 22.38 | 27.67 ± 30.63 |
| BL: days of part-time work | 11.94 ± 20.56 | 12.12 ± 18.10 | 11.39 ± 14.06 |
| BL: paid work, bothered by RA | 35.69 ± 30.24 | 38.54 ± 47.28 | 31.68 ± 30.31 |
| BL: chores by housekeeper | 19.56 ± 27.62 | 25.46 ± 33.29 | 21.25 ± 32.37 |
| BL: chores by family | 32.35 ± 34.46 | 34.13 ± 34.19 | 34.35 ± 33.04 |
| Month 3: hospital length of stay | 14.25 ± 17.19 | 7.00 ± 7.21 | 20.00 ± 1.41 |
| Month 3: days in nursing home | 28.00 ± NA | 43.33 ± 40.43 | — |
| Month 3: days aids/devices used | 109.00 ± 116.27 | 123.85 ± 76.69 | 105.86 ± 77.06 |
| Month 3: RA-related aids used | 1.45 ± 1.23 | 1.75 ± 0.55 | 1.71 ± 0.91 |
| Month 3: days of work per week | 5.16 ± 1.06 | 4.99 ± 1.02 | 5.08 ± 0.80 |
| Month 3:days on sick leave due to RA | 20.76 ± 30.15 | 26.97 ± 34.53 | 36.61 ± 37.92 |
| Month 3: days of part time work | 14.85 ± 25.99 | 29.67 ± 38.10 | 16.17 ± 25.29 |
| Month 3: paid work, bothered by RA | 21.04 ± 26.24 | 19.48 ± 25.23 | 22.13 ± 28.03 |
| Month 3: chores by housekeeper | 22.53 ± 30.49 | 21.43 ± 28.45 | 17.33 ± 28.24 |
| Month 3: chores by family | 23.13 ± 29.61 | 21.06 ± 27.81 | 24.80 ± 28.39 |
| Month 6: hospital length of stay | 9.33 ± 5.03 | 9.00 ± 13.62 | 10.75 ± 9.00 |
| Month 6: days in nursing home | 14.00 ± NA | 90.00 ± NA | 61.00 ± NA |
| Month 6: days aids/devices used | 74.15 ± 65.25 | 159.08 ± 138.46 | 190.25 ± 93.12 |
| Month 6: RA-related aids used | 1.25 ± 0.55 | 2.00 ± 1.36 | 2.38 ± 0.74 |
| Month 6: days of work per week | 5.11 ± 0.95 | 4.93 ± 1.05 | 5.10 ± 0.99 |
| Month 6:days on sick leave due to RA | 18.00 ± 19.68 | 21.94 ± 33.32 | 40.07 ± 41.32 |
| Month 6: days of part time work | 14.13 ± 14.71 | 7.11 ± 5.49 | 11.71 ± 21.31 |
| Month 6: paid work, bothered by RA | 26.23 ± 30.00 | 16.41 ± 23.15 | 24.49 ± 28.36 |
| Month 6: chores by housekeeper | 21.57 ± 29.10 | 20.57 ± 28.22 | 13.80 ± 27.20 |
| Month 6: chores by family | 23.62 ± 29.77 | 20.05 ± 26.35 | 22.09 ± 28.50 |
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
| days | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: hospital length of stay | 10.43 ± 8.62 | 9.25 ± 3.59 | 9.00 ± 8.49 |
| Month 12: days in nursing home | — | 54.00 ± 50.91 | 20.00 ± NA |
| Month 12: days aids/devices used | 118.05 ± 99.31 | 231.00 ± 190.27 | 65.75 ± 16.50 |
| Month 12: RA-related aids used | 1.50 ± 0.83 | 1.89 ± 1.96 | 1.50 ± 0.58 |
| Month 12: days of work per week | 5.14 ± 0.98 | 4.95 ± 1.01 | 5.05 ± 0.93 |
| Month 12:days on sick leave due to RA | 17.47 ± 28.41 | 10.14 ± 9.94 | 2.75 ± 1.49 |
| Month 12: days of part-time work | 5.56 ± 6.82 | 12.17 ± 10.11 | 16.00 ± 15.56 |
| Month 12:paid work, bothered by RA | 19.31 ± 21.34 | 16.23 ± 22.36 | 21.10 ± 26.11 |
| Month 12: chores by housekeeper | 13.09 ± 25.89 | 24.36 ± 35.96 | 7.40 ± 3.58 |
| Month 12: chores by family | 22.04 ± 30.72 | 20.11 ± 27.19 | 17.74 ± 25.33 |
| Month 18: hospital length of stay | 6.67 ± 3.06 | 13.67 ± 9.42 | 33.33 ± 11.55 |
| Month 18: days in nursing home | 15.00 ± NA | — | — |
| Month 18: days aids/devices used | 126.67 ± 125.26 | 169.50 ± 157.29 | 159.50 ± 41.00 |
| Month 18: RA-related aids used | 2.25 ± 1.06 | 2.25 ± 1.67 | 2.50 ± 1.00 |
| Month 18: days of work per week | 5.13 ± 1.00 | 5.01 ± 0.99 | 5.00 ± 0.69 |
| Month 18:days on sick leave due to RA | 16.93 ± 23.97 | 6.09 ± 5.87 | 4.20 ± 1.64 |
| Month 18: days of part time work | 4.33 ± 3.01 | 6.80 ± 4.66 | 31.00 ± 41.01 |
| Month 18:paid work, bothered by RA | 16.82 ± 22.67 | 16.30 ± 22.60 | 19.35 ± 25.33 |
| Month 18: chores by housekeeper | 9.40 ± 6.99 | 21.75 ± 33.15 | 3.83 ± 2.48 |
| Month 18: chores by family | 20.49 ± 29.77 | 21.30 ± 30.38 | 27.37 ± 35.36 |
| Month 24: hospital length of stay | 5.33 ± 5.77 | 21.00 ± 10.65 | 6.00 ± 2.83 |
| Month 24: days in nursing home | 2.00 ± NA | 21.00 ± NA | 15.50 ± 7.78 |
| Month 24: days aids/devices used | 137.85 ± 150.03 | 178.20 ± 178.98 | 136.50 ± 87.00 |
| Month 24: RA-related aids used | 2.15 ± 1.52 | 1.82 ± 2.09 | 1.50 ± 1.00 |
| Month 24: days of work per week | 5.10 ± 1.02 | 5.03 ± 1.01 | 5.15 ± 0.80 |
| Month 24:days on sick leave due to RA | 19.33 ± 27.95 | 3.25 ± 2.50 | 7.25 ± 12.46 |
| Month 24: days of part time work | 6.60 ± 4.10 | 3.00 ± 2.83 | 19.00 ± 30.69 |
| Month 24: paid work, bothered by RA | 21.95 ± 27.30 | 9.17 ± 9.50 | 16.95 ± 17.31 |
| Month 24: chores by housekeeper | 6.90 ± 8.28 | 4.75 ± 2.99 | 4.00 ± 2.00 |
| Month 24: chores by family | 16.65 ± 23.82 | 12.18 ± 21.46 | 17.21 ± 26.87 |
RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
| hours per day | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| BL: home healthcare services | 1.50 ± 0.58 | 2.20 ± 1.64 | 1.00 ± 1.00 |
| BL: RA-related home HC services | 1.00 ± 0.82 | 0.83 ± 0.75 | 1.33 ± 0.58 |
| BL: work done | 8.53 ± 5.33 | 8.25 ± 4.02 | 7.68 ± 1.81 |
| BL: missed work due to RA | 4.36 ± 4.98 | 5.62 ± 13.58 | 6.21 ± 8.96 |
| BL: chores by housekeeper | 4.85 ± 2.31 | 6.46 ± 9.83 | 4.75 ± 2.45 |
| BL: chores by family | 4.26 ± 4.56 | 3.92 ± 4.23 | 4.08 ± 4.01 |
| Month 3: home healthcare services | 0.00 ± NA | 1.25 ± 0.50 | — |
| Month 3:RA-related home HC services | 0.00 ± NA | 0.25 ± 0.50 | — |
| Month 3: work done | 8.53 ± 4.70 | 8.55 ± 5.23 | 8.33 ± 3.71 |
| Month 3: missed work due to RA | 4.11 ± 2.51 | 8.86 ± 15.72 | 5.58 ± 7.95 |
| Month 3: chores by housekeeper | 4.50 ± 2.43 | 5.40 ± 4.61 | 4.00 ± 2.55 |
| Month 3: chores by family | 3.44 ± 3.77 | 3.35 ± 3.50 | 3.61 ± 4.19 |
| Month 6: home healthcare services | 5.00 ± 6.08 | 4.50 ± 0.71 | — |
| Month 6: RA-related home HC services | 0.67 ± 0.58 | 2.00 ± 2.83 | — |
| Month 6: work done | 7.97 ± 2.84 | 8.29 ± 4.40 | 7.85 ± 1.47 |
| Month 6: missed work due to RA | 4.14 ± 2.67 | 4.11 ± 3.44 | 6.33 ± 5.75 |
| Month 6: chores by housekeeper | 4.93 ± 2.70 | 5.17 ± 2.92 | 4.80 ± 2.20 |
| Month 6: chores by family | 3.86 ± 2.84 | 3.28 ± 2.29 | 4.22 ± 6.14 |
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
| hours per day | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: home healthcare services | 2.00 ± 0.00 | 25.00 ± 32.53 | — |
| Month 12:RA-related home HC services | 0.00 ± 0.00 | 0.00 ± 0.00 | — |
| Month 12: work done | 8.38 ± 3.90 | 7.99 ± 3.59 | 8.34 ± 4.32 |
| Month 12: missed work due to RA | 2.25 ± 1.28 | 4.83 ± 5.34 | 3.50 ± 0.71 |
| Month 12: chores by housekeeper | 6.64 ± 4.67 | 4.60 ± 2.29 | 3.80 ± 1.92 |
| Month 12: chores by family | 3.44 ± 3.66 | 3.29 ± 2.40 | 3.19 ± 2.25 |
| Month 18: home healthcare services | 2.00 ± NA | — | — |
| Month 18:RA-related home HC services | 0.00 ± NA | — | — |
| Month 18: work done | 8.18 ± 3.73 | 8.32 ± 4.16 | 8.02 ± 1.45 |
| Month 18: missed work due to RA | 3.00 ± 2.53 | 1.80 ± 1.64 | 2.50 ± 0.71 |
| Month 18: chores by housekeeper | 5.60 ± 1.34 | 4.92 ± 2.94 | 4.33 ± 3.01 |
| Month 18: chores by family | 3.74 ± 4.42 | 3.70 ± 3.28 | 3.44 ± 2.57 |
| Month 24:home healthcare services | — | 2.67 ± 1.15 | 2.00 ± NA |
| Month 24: RA-related home HC services | — | 0.00 ± 0.00 | 2.00 ± NA |
| Month 24: work done | 8.63 ± 4.69 | 7.84 ± 2.36 | 8.02 ± 1.48 |
| Month 24: missed work due to RA | 6.50 ± 6.61 | 2.00 ± 0.00 | 4.50 ± 7.72 |
| Month 24: chores by housekeeper | 8.50 ± 8.63 | 5.25 ± 2.93 | 4.33 ± 0.58 |
| Month 24: chores by family | 2.97 ± 2.14 | 2.81 ± 2.22 | 3.75 ± 3.19 |
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 4.94 ± 3.26 | 4.71 ± 3.07 | 4.57 ± 3.15 |
| Month 3 | 3.59 ± 2.92 | 3.25 ± 3.78 | 3.57 ± 2.80 |
| Month 6 | 2.97 ± 3.58 | 2.27 ± 2.58 | 3.04 ± 2.75 |
| Month 12 | 2.69 ± 2.75 | 2.08 ± 2.38 | 2.94 ± 3.85 |
| Month 18 | 2.33 ± 2.63 | 2.11 ± 2.47 | 2.11 ± 2.38 |
| Month 24 | 2.47 ± 2.63 | 2.35 ± 2.75 | 2.52 ± 2.68 |
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 3: seen any doctor | 0.24 ± 0.49 | 0.18 ± 0.48 | 0.18 ± 0.46 |
| Month 3: treated in ER | 0.01 ± 0.25 | 0.04 ± 0.32 | 0.06 ± 0.31 |
| Month 3:admitted for overnight stay | 0.00 ± 0.00 | -0.60 ± 0.89 | — |
| Month 3:hospitalization | 0.10 ± 0.33 | 0.07 ± 0.26 | 0.12 ± 0.36 |
| Month 3: outpatient surgery | 0.01 ± 0.19 | 0.02 ± 0.24 | 0.01 ± 0.17 |
| Month 3: non-study diagnostic test | 0.16 ± 0.51 | 0.17 ± 0.47 | 0.23 ± 0.50 |
| Month 3: in nursing home | -0.00 ± 0.05 | 0.00 ± 0.11 | 0.02 ± 0.13 |
| Month 3: home healthcare services | 0.01 ± 0.12 | 0.00 ± 0.11 | 0.02 ± 0.13 |
| Month 3: required aids/devices | 0.05 ± 0.29 | 0.04 ± 0.27 | -0.01 ± 0.25 |
| Month 3: non-medical practitioner | 0.01 ± 0.18 | 0.03 ± 0.20 | 0.03 ± 0.20 |
| Month 3: currently employed | -0.03 ± 0.26 | -0.00 ± 0.27 | 0.00 ± 0.27 |
| Month 3: feel well enough to work | -0.16 ± 0.46 | -0.17 ± 0.45 | -0.11 ± 0.45 |
| Month 3: unable to work due to RA | 0.12 ± 0.44 | 0.13 ± 0.52 | 0.05 ± 0.55 |
| Month 3: lost job/retired early | -0.07 ± 0.47 | -0.02 ± 0.38 | 0.05 ± 0.45 |
| Month 3: work disabled due to RA | 0.10 ± 0.42 | 0.11 ± 0.49 | 0.06 ± 0.43 |
| Month 3: retired | -0.01 ± 0.24 | -0.02 ± 0.28 | 0.01 ± 0.33 |
| Month 3: sick leave due to RA | 0.14 ± 0.42 | 0.18 ± 0.45 | 0.13 ± 0.44 |
| Month 3: performed part-time work | 0.04 ± 0.31 | 0.08 ± 0.36 | 0.09 ± 0.41 |
| Month 3: performed paid work | 0.09 ± 0.48 | 0.16 ± 0.51 | 0.12 ± 0.46 |
| Month 3: unable to do chores | 0.28 ± 0.57 | 0.32 ± 0.54 | 0.09 ± 0.53 |
| Month 3: chores by housekeeper | 0.04 ± 0.29 | 0.05 ± 0.29 | -0.04 ± 0.29 |
| Month 3: chores by family/friends | 0.21 ± 0.53 | 0.21 ± 0.49 | 0.09 ± 0.53 |
| Month 6: seen any doctor | 0.28 ± 0.53 | 0.26 ± 0.50 | 0.22 ± 0.47 |
| Month 6: treated in ER | 0.00 ± 0.29 | 0.03 ± 0.33 | 0.05 ± 0.29 |
| Month 6:admitted for overnight stay | — | -0.20 ± 0.45 | — |
| Month 6: Hospitalization | 0.10 ± 0.33 | 0.06 ± 0.29 | 0.09 ± 0.35 |
| Month 6: outpatient surgery | 0.01 ± 0.21 | 0.02 ± 0.24 | -0.01 ± 0.21 |
| Month 6: non-study diagnostic test | 0.17 ± 0.54 | 0.15 ± 0.52 | 0.18 ± 0.54 |
| Month 6: in nursing home | -0.00 ± 0.05 | 0.01 ± 0.09 | 0.01 ± 0.14 |
| Month 6: home healthcare services | 0.00 ± 0.14 | 0.01 ± 0.14 | 0.01 ± 0.11 |
| Month 6: required aids/devices | 0.04 ± 0.28 | 0.05 ± 0.29 | 0.04 ± 0.27 |
| Month 6: non-medical practitioner | 0.01 ± 0.18 | 0.04 ± 0.20 | 0.00 ± 0.20 |
| Month 6: currently employed | -0.04 ± 0.28 | -0.01 ± 0.27 | 0.00 ± 0.28 |
| Month 6: feel well enough to work | -0.24 ± 0.55 | -0.19 ± 0.45 | -0.10 ± 0.53 |
| Month 6: unable to work due to RA | 0.18 ± 0.54 | 0.15 ± 0.50 | 0.05 ± 0.55 |
| Month 6: lost job/retired early | 0.00 ± 0.47 | 0.01 ± 0.35 | 0.04 ± 0.46 |
| Month 6: work disabled due to RA | 0.14 ± 0.49 | 0.13 ± 0.44 | 0.07 ± 0.42 |
| Month 6: retired | -0.01 ± 0.30 | -0.03 ± 0.30 | 0.03 ± 0.36 |
| Month 6: sick leave due to RA | 0.21 ± 0.46 | 0.23 ± 0.43 | 0.17 ± 0.44 |
| Month 6: performed part-time work | 0.09 ± 0.34 | 0.09 ± 0.33 | 0.12 ± 0.45 |
| Month 6: performed paid work | 0.18 ± 0.51 | 0.26 ± 0.52 | 0.14 ± 0.48 |
| Month 6: unable to do chores | 0.37 ± 0.54 | 0.41 ± 0.54 | 0.24 ± 0.56 |
| Month 6: chores by housekeeper | 0.04 ± 0.25 | 0.08 ± 0.32 | 0.01 ± 0.24 |
| Month 6: chores by family/friends | 0.30 ± 0.52 | 0.34 ± 0.50 | 0.22 ± 0.56 |
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: seen any doctor | 0.34 ± 0.51 | 0.31 ± 0.52 | 0.26 ± 0.46 |
| Month 12: treated in ER | 0.00 ± 0.27 | 0.05 ± 0.29 | 0.04 ± 0.31 |
| Month12:admitted for overnight stay | 0.00 ± 0.00 | 0.50 ± 0.71 | 0.00 ± NA |
| Month 12: hospitalized | 0.08 ± 0.33 | 0.06 ± 0.29 | 0.09 ± 0.33 |
| Month 12:any outpatient surgery | -0.00 ± 0.23 | 0.01 ± 0.23 | -0.01 ± 0.19 |
| Month 12:non-study diagnostic tests | 0.15 ± 0.51 | 0.13 ± 0.51 | 0.21 ± 0.51 |
| Month 12: in a nursing home | 0.00 ± 0.00 | 0.01 ± 0.08 | 0.01 ± 0.15 |
| Month 12: home healthcare services | 0.01 ± 0.14 | 0.01 ± 0.14 | 0.01 ± 0.12 |
| Month 12: used aids/devices | 0.04 ± 0.28 | 0.06 ± 0.29 | 0.06 ± 0.29 |
| Month 12: non-medical practitioner | 0.03 ± 0.18 | 0.03 ± 0.18 | 0.02 ± 0.15 |
| Month 12: currently employed | -0.03 ± 0.34 | -0.01 ± 0.34 | -0.02 ± 0.26 |
| Month 12: feel well enough to work | -0.17 ± 0.52 | -0.18 ± 0.47 | -0.19 ± 0.50 |
| Month 12: unable to work due to RA | 0.18 ± 0.52 | 0.23 ± 0.53 | 0.18 ± 0.58 |
| Month 12: Lost job/retired early | 0.02 ± 0.43 | -0.01 ± 0.44 | 0.02 ± 0.49 |
| Month 12: work disabled due to RA | 0.10 ± 0.55 | 0.13 ± 0.48 | 0.11 ± 0.48 |
| Month 12: retired | -0.02 ± 0.35 | -0.07 ± 0.35 | -0.03 ± 0.43 |
| Month 12: sick leave due to RA | 0.21 ± 0.45 | 0.27 ± 0.46 | 0.20 ± 0.45 |
| Month 12: performed part time work | 0.09 ± 0.32 | 0.09 ± 0.33 | 0.17 ± 0.42 |
| Month 12: performed paid work | 0.22 ± 0.50 | 0.28 ± 0.54 | 0.18 ± 0.52 |
| Month 12: unable to do chores | 0.36 ± 0.56 | 0.44 ± 0.56 | 0.30 ± 0.55 |
| Month 12: chores by housekeeper | 0.04 ± 0.26 | 0.09 ± 0.30 | 0.01 ± 0.21 |
| Month 12: chores by family/friends | 0.35 ± 0.53 | 0.36 ± 0.51 | 0.28 ± 0.54 |
| Month 18: seen any doctor | 0.32 ± 0.54 | 0.36 ± 0.55 | 0.28 ± 0.54 |
| Month 18: treated in ER | 0.01 ± 0.27 | 0.04 ± 0.31 | 0.03 ± 0.28 |
| Month18:admitted for overnight stay | 0.00 ± NA | 2.00 ± NA | 0.00 ± 0.00 |
| Month 18:hospitalization | 0.10 ± 0.33 | 0.05 ± 0.30 | 0.08 ± 0.33 |
| Month 18: outpatient surgery | 0.01 ± 0.21 | 0.01 ± 0.24 | -0.01 ± 0.21 |
| Month 18:non-study diagnostic tests | 0.16 ± 0.49 | 0.17 ± 0.54 | 0.19 ± 0.57 |
| Month 18: in nursing home | -0.00 ± 0.06 | 0.01 ± 0.12 | 0.02 ± 0.13 |
| Month 18: home healthcare services | 0.01 ± 0.13 | 0.01 ± 0.10 | 0.02 ± 0.13 |
| Month 18: required aids/devices | 0.06 ± 0.25 | 0.06 ± 0.29 | 0.07 ± 0.29 |
| Month 18: non-medical practitioner | 0.02 ± 0.18 | 0.03 ± 0.18 | 0.02 ± 0.19 |
| Month 18: currently employed | -0.03 ± 0.36 | -0.03 ± 0.39 | 0.01 ± 0.28 |
| Month 18: feel well enough to work | -0.27 ± 0.54 | -0.17 ± 0.44 | -0.08 ± 0.55 |
| Month 18: unable to work due to RA | 0.28 ± 0.57 | 0.21 ± 0.58 | 0.15 ± 0.56 |
| Month 18: lost job/retired early | 0.05 ± 0.46 | 0.03 ± 0.48 | 0.00 ± 0.51 |
| Month 18: work disabled due to RA | 0.21 ± 0.56 | 0.17 ± 0.48 | 0.02 ± 0.49 |
| Month 18: retired | -0.04 ± 0.38 | -0.05 ± 0.39 | 0.02 ± 0.49 |
| Month 18: sick leave due to RA | 0.20 ± 0.49 | 0.26 ± 0.46 | 0.22 ± 0.47 |
| Month 18: performed part-time work | 0.09 ± 0.31 | 0.11 ± 0.36 | 0.19 ± 0.43 |
| Month 18: performed paid work | 0.18 ± 0.55 | 0.27 ± 0.52 | 0.27 ± 0.54 |
| Month 18: unable to do chores | 0.41 ± 0.53 | 0.47 ± 0.56 | 0.29 ± 0.58 |
| Month 18: chores by housekeeper | 0.06 ± 0.27 | 0.10 ± 0.33 | 0.00 ± 0.26 |
| Month 18: chores by family/friends | 0.37 ± 0.53 | 0.41 ± 0.51 | 0.34 ± 0.54 |
| Month 24: seen any doctor | 0.34 ± 0.53 | 0.36 ± 0.55 | 0.34 ± 0.50 |
| Month 24: treated in ER | 0.01 ± 0.25 | 0.03 ± 0.33 | 0.03 ± 0.29 |
| Month24:admitted for overnight stay | 0.00 ± 0.00 | 0.00 ± NA | — |
| Month 24: Hospitalization | 0.09 ± 0.32 | 0.06 ± 0.29 | 0.07 ± 0.32 |
| Month 24: outpatient surgery | 0.01 ± 0.17 | 0.02 ± 0.23 | 0.01 ± 0.17 |
| Month 24:non-study diagnostic test | 0.18 ± 0.52 | 0.16 ± 0.53 | 0.13 ± 0.60 |
| Month 24: in nursing home | -0.00 ± 0.06 | 0.01 ± 0.13 | 0.00 ± 0.20 |
| Month 24: home healthcare services | 0.02 ± 0.12 | 0.00 ± 0.15 | -0.01 ± 0.10 |
| Month 24: required aids/devices | 0.05 ± 0.27 | 0.04 ± 0.30 | 0.08 ± 0.27 |
| Month 24: non-medical practitioner | 0.02 ± 0.19 | 0.02 ± 0.17 | 0.03 ± 0.17 |
| Month 24: currently employed | -0.04 ± 0.37 | 0.00 ± 0.40 | 0.01 ± 0.32 |
| Month 24: feel well enough to work | -0.26 ± 0.58 | -0.19 ± 0.51 | -0.13 ± 0.54 |
| Month 24: unable to work due to RA | 0.30 ± 0.58 | 0.27 ± 0.61 | 0.08 ± 0.50 |
| Month 24: lost job/retired early | 0.00 ± 0.50 | 0.04 ± 0.46 | 0.04 ± 0.41 |
| Month 24: work disabled due to RA | 0.18 ± 0.52 | 0.19 ± 0.57 | 0.13 ± 0.53 |
| Month 24: retired | -0.05 ± 0.38 | -0.05 ± 0.44 | 0.08 ± 0.49 |
| Month 24: sick leave due to RA | 0.22 ± 0.44 | 0.29 ± 0.46 | 0.16 ± 0.56 |
| Month 24: performed part-time work | 0.10 ± 0.33 | 0.12 ± 0.34 | 0.15 ± 0.46 |
| Month 24: performed paid work | 0.24 ± 0.56 | 0.28 ± 0.53 | 0.20 ± 0.56 |
| Month 24: unable to do chores | 0.41 ± 0.52 | 0.47 ± 0.56 | 0.32 ± 0.58 |
| Month 24: chores by housekeeper | 0.04 ± 0.27 | 0.08 ± 0.33 | 0.03 ± 0.22 |
| Month 24: chores by family/friends | 0.40 ± 0.52 | 0.40 ± 0.53 | 0.31 ± 0.54 |
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
| events | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 3: doctor visits | -1.83 ± 5.24 | -1.12 ± 4.13 | -1.52 ± 5.46 |
| Month 3: RA-related doctor visit | -0.55 ± 1.30 | -0.50 ± 1.14 | -0.48 ± 0.99 |
| Month 3: hospital ER visit | -4.33 ± 5.86 | 1.60 ± 3.78 | — |
| Month 3: RA-related ER visit | -0.67 ± 1.15 | -1.00 ± 1.58 | — |
| Month 3: hospitalization | — | 0.00 ± 0.00 | — |
| Month 3: RA-related hospitalization | — | -0.50 ± 0.71 | — |
| Month 3: non-study diagnostic test | -0.73 ± 2.24 | -0.61 ± 1.50 | 0.38 ± 1.19 |
| Month 3: RA-related diagnostic test | -0.73 ± 1.01 | -0.67 ± 1.20 | -0.50 ± 0.93 |
| Month 3:non-medical practitioner visit | -62.33 ± 102.11 | -2.33 ± 2.52 | 0.00 ± NA |
| Month 3:RA-related non-medical visit | -0.67 ± 0.58 | -0.33 ± 0.58 | 0.00 ± NA |
| Month 6: doctor visit | -2.44 ± 4.87 | -1.98 ± 4.65 | -2.72 ± 5.43 |
| Month 6: RA-related doctor visit | -0.69 ± 1.27 | -0.66 ± 1.23 | -0.77 ± 1.10 |
| Month 6: hospital ER visit | — | 0.60 ± 1.34 | — |
| Month 6: RA-related ER visit | — | -0.40 ± 1.14 | — |
| Month 6: hospitalization | — | 0.00 ± 0.00 | 0.00 ± NA |
| Month 6: RA-related hospitalization | — | -1.50 ± 0.71 | 0.00 ± NA |
| Month 6: non-study diagnostic test | -0.60 ± 1.52 | -0.40 ± 1.30 | -0.67 ± 2.16 |
| Month 6: RA related diagnostic test | -0.80 ± 1.64 | -0.88 ± 1.09 | -0.67 ± 0.82 |
| Month 6:non-medical practitioner visit | -8.00 ± 2.83 | -5.00 ± NA | 1.00 ± NA |
| Month 6:RA-related non-medical visit | 0.00 ± 0.00 | -1.00 ± NA | 1.00 ± NA |
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
| events | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: doctor visit | -2.57 ± 5.87 | -2.32 ± 4.33 | -3.17 ± 5.86 |
| Month 12: RA-related doctor visit | -0.72 ± 1.30 | -0.68 ± 1.12 | -0.72 ± 1.14 |
| Month 12: hospital ER visit | -3.50 ± 5.07 | 0.00 ± 0.00 | — |
| Month 12: RA-related ER visit | -1.25 ± 0.96 | -1.00 ± 1.41 | 0.00 ± NA |
| Month 12: hospitalization | 0.00 ± 0.00 | — | — |
| Month 12: RA-related hospitalization | -0.50 ± 0.71 | — | — |
| Month 12:non-study diagnostic tests | -0.09 ± 2.88 | -0.71 ± 1.69 | -1.00 ± 1.00 |
| Month 12: RA-related diagnostic tests | -0.82 ± 1.25 | -0.88 ± 1.69 | -0.60 ± 0.89 |
| Month 12:non-medical practitioner visit | -8.00 ± NA | 8.00 ± 11.31 | — |
| Month 12:RA-related non-medical visit | -2.00 ± NA | 0.00 ± 0.00 | — |
| Month 18: doctor visits | -2.58 ± 4.37 | -1.98 ± 3.67 | -2.20 ± 6.97 |
| Month 18: RA-related doctor visit | -0.69 ± 1.17 | -0.51 ± 1.03 | -0.69 ± 1.21 |
| Month 18: hospital ER visit | 0.00 ± NA | -1.00 ± NA | — |
| Month 18: RA-related ER visit | 1.00 ± NA | -1.00 ± NA | -0.50 ± 0.71 |
| Month 18: hospitalization | — | — | 0.00 ± NA |
| Month 18:RA-related hospitalization | — | — | -1.00 ± NA |
| Month 18: outpatient surgery | 0.00 ± NA | — | — |
| Month 18:RA-related outpatient surgery | 2.00 ± NA | — | — |
| Month 18:non-study diagnostic test | -1.55 ± 2.73 | 0.00 ± 2.24 | -0.50 ± 2.12 |
| Month 24:RA-related diagnostic test | -0.33 ± 0.58 | -0.64 ± 0.67 | -0.50 ± 0.71 |
| Month 18:non-medical practitioner visit | -10.00 ± NA | -15.67 ± 28.01 | — |
| Month 18:RA-related non-medical visit | 0.00 ± NA | 0.33 ± 1.53 | — |
| Month 24: doctor visit | -2.78 ± 6.00 | -1.65 ± 5.42 | -2.41 ± 6.48 |
| Month 24: RA-related doctor visit | -0.71 ± 1.37 | -0.63 ± 1.15 | -0.63 ± 1.10 |
| Month 24: hospital ER visit | 0.00 ± 0.00 | -1.00 ± NA | — |
| Month 24: RA-related ER visit | -0.67 ± 1.15 | -2.00 ± NA | — |
| Month 24: outpatient surgery | 4.00 ± NA | — | — |
| Month 24:RA-relate outpatient surgery | -1.00 ± NA | — | — |
| Month 24:non-study diagnostic test | -1.50 ± 4.20 | -0.18 ± 1.08 | -0.50 ± 0.71 |
| Month 24:RA related diagnostic test | -0.33 ± 0.58 | -0.64 ± 0.67 | -0.50 ± 0.71 |
| Month 24:non-medical practitioner visit | -168.00 ± NA | -1.00 ± 1.41 | — |
| Month 24:RA-related non-medical visit | 0.00 ± NA | -0.33 ± 0.58 | — |
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
| days | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 3: hospital length of stay | — | -10.00 ± 7.07 | — |
| Month 3: days in nursing home | — | 0.00 ± NA | — |
| Month 3: days aids/devices used | -45.92 ± 91.00 | -12.36 ± 173.11 | -65.50 ± 200.00 |
| Month 3: RA-related aids used | -0.31 ± 1.11 | -0.43 ± 1.91 | -0.25 ± 2.05 |
| Month 3: days of work per week | 0.13 ± 0.69 | 0.06 ± 0.74 | -0.01 ± 0.54 |
| Month 3:days on sick leave due to RA | 0.40 ± 32.44 | 7.58 ± 26.57 | 10.94 ± 33.96 |
| Month 3: days of part time work | 1.92 ± 32.76 | 15.14 ± 34.60 | -0.17 ± 26.90 |
| Month 3: paid work, bothered by RA | -15.31 ± 39.58 | -15.16 ± 34.88 | -9.30 ± 31.97 |
| Month 3: chores by housekeeper | -20.70 ± 35.90 | -11.61 ± 31.25 | -9.29 ± 36.09 |
| Month 3: chores by family | -19.14 ± 40.06 | -17.71 ± 36.57 | -12.18 ± 35.70 |
| Month 6: hospital length of stay | — | -22.00 ± 2.83 | 8.00 ± NA |
| Month 6: days in nursing home | — | 0.00 ± NA | — |
| Month 6: days aids/devices used | -46.93 ± 127.42 | 58.00 ± 126.45 | -93.20 ± 211.52 |
| Month 6: RA-related aids used | -0.64 ± 1.50 | 0.13 ± 0.99 | -1.60 ± 2.70 |
| Month 6: days of work per week | 0.07 ± 0.67 | 0.03 ± 0.73 | 0.00 ± 0.50 |
| Month 6:days on sick leave due to RA | -18.27 ± 17.19 | 13.56 ± 27.92 | 13.82 ± 46.97 |
| Month 6: days of part time work | 11.50 ± 14.34 | -2.60 ± 18.57 | 0.00 ± NA |
| Month 6: paid work, bothered by RA | -15.90 ± 36.80 | -16.43 ± 30.15 | -7.81 ± 38.47 |
| Month 6: chores by housekeeper | -13.80 ± 19.66 | -11.94 ± 33.28 | -2.40 ± 7.70 |
| Month 6: chores by family | -14.94 ± 39.94 | -20.54 ± 37.40 | -20.94 ± 40.56 |
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
| days | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10,15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: hospital length of stay | -2.00 ± 2.83 | — | — |
| Month 12: days in nursing home | — | 3.50 ± 4.95 | — |
| Month 12: days aids/devices used | -27.07 ± 159.25 | -5.00 ± 81.85 | -75.00 ± 63.64 |
| Month 12: RA-related aids used | -0.46 ± 1.71 | 0.00 ± 0.82 | 0.00 ± 0.00 |
| Month 12: days of work per week | 0.11 ± 0.86 | -0.01 ± 0.66 | 0.04 ± 0.42 |
| Month 12:days on sick leave due to RA | 5.25 ± 28.21 | -2.80 ± 16.41 | -2.20 ± 2.49 |
| Month 12: days of part-time work | 2.20 ± 6.83 | -15.00 ± 17.00 | — |
| Month 12:paid work, bothered by RA | -18.49 ± 28.09 | -12.63 ± 34.77 | -12.35 ± 37.16 |
| Month 12: chores by housekeeper | -8.43 ± 14.55 | -1.92 ± 6.19 | 4.67 ± 5.03 |
| Month 12: chores by family | -13.11 ± 34.25 | -20.05 ± 44.57 | -15.24 ± 29.17 |
| Month 18: hospital length of stay | — | — | 21.00 ± NA |
| Month 18: days aids/devices used | 65.09 ± 81.85 | 96.00 ± 53.39 | -77.33 ± 289.83 |
| Month 18: RA-related aids used | 0.82 ± 0.87 | 1.00 ± 0.82 | 0.00 ± 1.73 |
| Month 18: days of work per week | 0.13 ± 0.85 | -0.04 ± 0.85 | -0.06 ± 0.60 |
| Month 18:days on sick leave due to RA | -4.80 ± 13.18 | -6.78 ± 8.94 | -31.67 ± 47.93 |
| Month 18: days of part time work | -1.00 ± 4.85 | -35.00 ± NA | — |
| Month 18:paid work, bothered by RA | -15.19 ± 39.72 | -20.12 ± 33.90 | -15.07 ± 43.23 |
| Month 18: chores by housekeeper | -24.50 ± 32.54 | -19.22 ± 28.80 | -5.50 ± 7.78 |
| Month 18: chores by family | -9.15 ± 34.94 | -14.17 ± 35.55 | 3.36 ± 30.47 |
| Month 24: days aids/devices used | 79.90 ± 127.89 | -38.50 ± 50.79 | -45.00 ± 198.24 |
| Month 24: RA-related aids used | 1.10 ± 1.20 | -0.50 ± 1.00 | -0.75 ± 2.36 |
| Month 24: days of work per week | 0.06 ± 0.87 | 0.05 ± 0.78 | 0.05 ± 0.79 |
| Month 24:days on sick leave due to RA | -3.86 ± 7.06 | -3.00 ± 5.66 | -5.00 ± NA |
| Month 24: days of part time work | 1.67 ± 6.03 | -45.00 ± NA | — |
| Month 24: paid work, bothered by RA | -12.54 ± 37.97 | -23.63 ± 26.77 | -22.47 ± 25.29 |
| Month 24: chores by housekeeper | -15.33 ± 24.10 | -12.00 ± 29.28 | 0.00 ± 5.66 |
| Month 24: chores by family | -7.30 ± 31.83 | -27.54 ± 37.94 | -13.86 ± 37.70 |
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
| hours per day | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 3: home healthcare services | — | -1.00 ± 1.41 | — |
| Month 3:RA-related home HC services | — | 0.00 ± 0.00 | — |
| Month 3: work done | 0.23 ± 4.19 | 0.34 ± 6.12 | 0.80 ± 3.82 |
| Month 3: missed work due to RA | -1.00 ± 8.94 | 1.29 ± 5.06 | 3.00 ± 9.36 |
| Month 3: chores by housekeeper | -0.80 ± 1.62 | -0.61 ± 2.37 | -1.14 ± 1.86 |
| Month 3: chores by family | -1.98 ± 4.92 | -0.39 ± 3.90 | -1.63 ± 5.14 |
| Month 6: work done | -0.34 ± 4.32 | 0.03 ± 4.79 | 0.23 ± 1.48 |
| Month 6: missed work due to RA | -1.67 ± 5.13 | -0.40 ± 1.14 | -4.00 ± NA |
| Month 6: chores by housekeeper | -1.10 ± 2.38 | -0.25 ± 3.19 | -0.20 ± 1.30 |
| Month 6: chores by family | -0.68 ± 4.15 | -0.51 ± 3.02 | -0.45 ± 6.24 |
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
| hours per day | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 12: work done | 0.34 ± 4.30 | -0.21 ± 4.37 | 0.75 ± 4.43 |
| Month 12: missed work due to RA | -1.60 ± 4.93 | 0.00 ± 1.00 | — |
| Month 12: chores by housekeeper | 0.29 ± 2.63 | -5.23 ± 18.66 | -0.50 ± 0.71 |
| Month 12: chores by family | -0.67 ± 4.67 | -1.35 ± 6.69 | -0.24 ± 3.10 |
| Month 18: work done | 0.17 ± 4.56 | 0.16 ± 5.24 | 0.04 ± 1.37 |
| Month 18: missed work due to RA | -5.80 ± 11.97 | 1.00 ± NA | — |
| Month 18: chores by housekeeper | -2.00 ± 2.16 | -8.78 ± 22.26 | 0.00 ± NA |
| Month 18: chores by family | 0.03 ± 3.43 | -1.57 ± 5.25 | -0.17 ± 1.19 |
| Month 24: work done | 0.42 ± 5.37 | -0.04 ± 2.51 | 0.17 ± 1.32 |
| Month 24: missed work due to RA | -5.33 ± 7.57 | 0.00 ± NA | — |
| Month 24: chores by housekeeper | 0.17 ± 3.06 | 0.50 ± 1.51 | 1.00 ± NA |
| Month 24: chores by family | -0.97 ± 3.40 | -1.00 ± 3.00 | -0.47 ± 1.36 |
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 3 | -1.40 ± 2.88 | -1.45 ± 3.90 | -0.81 ± 2.94 |
| Month 6 | -2.11 ± 2.92 | -2.44 ± 2.97 | -1.22 ± 3.39 |
| Month 12 | -2.15 ± 3.22 | -2.68 ± 3.17 | -1.51 ± 2.93 |
| Month 18 | -2.28 ± 3.25 | -2.62 ± 3.15 | -2.22 ± 3.33 |
| Month 24 | -2.24 ± 3.36 | -2.38 ± 3.11 | -1.88 ± 3.24 |
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| BL: overall sleep problem | 42.65 ± 19.48 | 42.82 ± 20.51 | 42.84 ± 18.07 |
| BL: sleep problem summary | 40.66 ± 19.84 | 41.43 ± 20.77 | 41.13 ± 18.20 |
| BL: somnolence | 35.77 ± 21.68 | 36.68 ± 22.28 | 38.21 ± 21.19 |
| BL: snoring | 34.30 ± 32.90 | 31.99 ± 32.37 | 32.58 ± 32.13 |
| BL: sleep disturbance | 45.61 ± 25.91 | 44.77 ± 26.54 | 44.30 ± 25.52 |
| BL: awaken short of breath | 20.43 ± 25.52 | 19.35 ± 24.42 | 18.71 ± 23.40 |
| BL: adequacy | 46.29 ± 26.63 | 44.41 ± 26.95 | 44.65 ± 26.22 |
| Month 1: overall sleep problem | 33.74 ± 18.23 | 33.60 ± 20.19 | 38.15 ± 17.57 |
| Month 1: sleep problem summary | 33.11 ± 18.84 | 33.21 ± 20.83 | 37.28 ± 18.17 |
| Month 1: somnolence | 29.75 ± 19.71 | 29.15 ± 19.65 | 35.11 ± 19.21 |
| Month 1: snoring | 30.30 ± 29.30 | 28.21 ± 30.26 | 30.76 ± 31.63 |
| Month 1: sleep disturbance | 33.81 ± 22.52 | 33.58 ± 24.94 | 37.09 ± 23.70 |
| Month 1: awaken short of breath | 16.66 ± 22.84 | 17.40 ± 23.90 | 17.07 ± 22.76 |
| Month 1: adequacy | 53.64 ± 26.20 | 54.08 ± 27.32 | 47.23 ± 24.62 |
| Month 2: overall sleep problem | 31.73 ± 18.37 | 32.76 ± 20.25 | 35.25 ± 17.24 |
| Month 2: sleep problem summary | 31.26 ± 18.68 | 32.71 ± 20.63 | 34.66 ± 17.19 |
| Month 2: somnolence | 27.96 ± 19.32 | 29.02 ± 21.10 | 31.65 ± 19.75 |
| Month 2: snoring | 31.09 ± 28.38 | 28.92 ± 30.40 | 28.20 ± 28.56 |
| Month 2: sleep disturbance | 30.93 ± 23.06 | 32.31 ± 24.56 | 34.56 ± 22.32 |
| Month 2: awaken short of breath | 15.44 ± 21.04 | 17.16 ± 22.07 | 15.96 ± 20.21 |
| Month 2: adequacy | 54.83 ± 26.71 | 55.08 ± 27.81 | 50.84 ± 25.73 |
| Month 3: overall sleep problem | 30.07 ± 18.59 | 31.55 ± 19.86 | 33.93 ± 18.86 |
| Month 3: sleep problem summary | 29.87 ± 19.22 | 31.76 ± 20.55 | 33.66 ± 19.82 |
| Month 3: somnolence | 27.18 ± 18.34 | 29.16 ± 20.99 | 30.39 ± 19.13 |
| Month 3: snoring | 30.06 ± 30.12 | 27.94 ± 30.11 | 28.60 ± 28.46 |
| Month 3: sleep disturbance | 29.24 ± 22.54 | 29.83 ± 24.10 | 32.76 ± 23.87 |
| Month 3: awaken short of breath | 16.76 ± 22.64 | 16.87 ± 22.25 | 16.74 ± 21.71 |
| Month 3: adequacy | 58.55 ± 27.53 | 55.27 ± 27.60 | 51.74 ± 26.72 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported
| percentage of participants | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 55.31 | 55.22 | 51.09 |
| Month 2 | 57.06 | 55.41 | 48.88 |
| Month 3 | 58.71 | 60.05 | 51.74 |
| Month 6 | 61.76 | 58.04 | 58.23 |
| Month 12 | 58.10 | 58.43 | 50.00 |
| Month 18 | 63.03 | 62.37 | 52.59 |
| Month 24 | 61.74 | 55.87 | 55.66 |
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 6: overall sleep problem | 30.73 ± 18.51 | 30.05 ± 20.09 | 32.71 ± 19.54 |
| Month 6: sleep problem summary | 30.59 ± 19.02 | 29.81 ± 20.75 | 32.17 ± 19.47 |
| Month 6: somnolence | 26.82 ± 18.62 | 27.34 ± 20.69 | 29.79 ± 19.76 |
| Month 6: snoring | 30.12 ± 29.49 | 31.01 ± 30.68 | 27.39 ± 29.11 |
| Month 6: sleep disturbance | 29.26 ± 22.20 | 28.61 ± 24.64 | 31.76 ± 25.72 |
| Month 6: awaken short of breath | 17.00 ± 22.24 | 14.70 ± 21.28 | 14.68 ± 20.98 |
| Month 6: adequacy | 56.09 ± 26.92 | 56.45 ± 27.84 | 53.61 ± 26.74 |
| Month 12: overall sleep problem | 30.01 ± 17.75 | 29.30 ± 18.50 | 33.49 ± 18.56 |
| Month 12: sleep problem summary | 29.89 ± 18.87 | 29.10 ± 18.99 | 33.70 ± 19.36 |
| Month 12: somnolence | 26.62 ± 18.29 | 27.17 ± 20.09 | 31.11 ± 18.47 |
| Month 12: snoring | 32.13 ± 28.80 | 31.76 ± 31.54 | 30.67 ± 27.84 |
| Month 12: sleep disturbance | 28.73 ± 20.85 | 27.75 ± 22.73 | 32.44 ± 23.52 |
| Month 12: awaken short of breath | 15.81 ± 22.01 | 14.73 ± 21.89 | 16.59 ± 21.10 |
| Month 12: adequacy | 56.98 ± 27.00 | 58.18 ± 27.13 | 54.15 ± 26.80 |
| Month 18: overall sleep problem | 29.99 ± 17.44 | 28.54 ± 17.92 | 31.93 ± 19.62 |
| Month 18: sleep problem summary | 29.94 ± 17.82 | 28.15 ± 18.38 | 32.24 ± 20.72 |
| Month 18: somnolence | 25.77 ± 17.62 | 26.73 ± 18.78 | 28.68 ± 19.90 |
| Month 18:snoring | 33.07 ± 28.88 | 31.13 ± 29.89 | 29.74 ± 29.90 |
| Month 18: sleep disturbance | 29.04 ± 21.28 | 27.30 ± 21.32 | 29.31 ± 22.59 |
| Month 18: awaken short of breath | 15.42 ± 20.11 | 13.38 ± 19.82 | 16.55 ± 21.47 |
| Month 18: adequacy | 57.11 ± 26.35 | 59.01 ± 27.11 | 53.62 ± 29.50 |
| Month 24: overall sleep problem | 29.78 ± 17.64 | 29.55 ± 19.26 | 32.25 ± 19.17 |
| Month 24: sleep problem summary | 30.01 ± 18.21 | 29.57 ± 19.80 | 31.79 ± 19.69 |
| Month 24: somnolence | 25.71 ± 18.41 | 26.98 ± 20.53 | 28.36 ± 18.36 |
| Month 24: snoring | 32.44 ± 29.18 | 30.22 ± 30.53 | 30.00 ± 28.32 |
| Month 24: sleep disturbance | 29.03 ± 21.00 | 27.74 ± 23.40 | 31.43 ± 23.59 |
| Month 24: awaken short of breath | 15.45 ± 21.23 | 15.90 ± 20.86 | 16.60 ± 19.99 |
| Month 24: adequacy | 57.46 ± 28.15 | 57.52 ± 27.70 | 56.42 ± 26.66 |
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1: overall sleep problem | -8.95 ± 0.86 | -9.14 ± 0.83 | -4.72 ± 1.19 |
| Month 1: sleep problem summary | -7.85 ± 0.90 | -8.12 ± 0.86 | -3.98 ± 1.24 |
| Month 1: somnolence | -6.35 ± 0.95 | -7.31 ± 0.91 | -2.15 ± 1.31 |
| Month 1: snoring | -3.12 ± 1.19 | -3.72 ± 1.14 | -1.66 ± 1.65 |
| Month 1: quantity | 0.41 ± 0.06 | 0.38 ± 0.06 | 0.26 ± 0.09 |
| Month 1: sleep disturbance | -11.28 ± 1.07 | -11.06 ± 1.03 | -7.36 ± 1.48 |
| Month 1: awaken short of breath | -2.81 ± 1.04 | -1.92 ± 1.00 | -2.00 ± 1.44 |
| Month 1: adequacy | 8.56 ± 1.33 | 9.73 ± 1.28 | 2.83 ± 1.84 |
| Month 2: overall sleep problem | -11.08 ± 0.87 | -10.15 ± 0.83 | -7.62 ± 1.20 |
| Month 2: sleep problem summary | -9.81 ± 0.90 | -8.75 ± 0.86 | -6.54 ± 1.25 |
| Month 2: somnolence | -8.11 ± 0.95 | -7.56 ± 0.91 | -5.45 ± 1.33 |
| Month 2: snoring | -2.31 ± 1.20 | -3.16 ± 1.14 | -4.54 ± 1.67 |
| Month 2: quantity | 0.42 ± 0.06 | 0.43 ± 0.06 | 0.31 ± 0.09 |
| Month 2: sleep disturbance | -14.27 ± 1.08 | -12.53 ± 1.03 | -9.97 ± 1.50 |
| Month 2: awaken short of breath | -4.12 ± 1.05 | -2.15 ± 1.00 | -3.32 ± 1.46 |
| Month 2: adequacy | 9.90 ± 1.34 | 10.84 ± 1.28 | 6.24 ± 1.87 |
| Month 3: overall sleep problem | -12.46 ± 0.87 | -11.16 ± 0.83 | -8.99 ± 1.22 |
| Month 3: sleep problem summary | -10.98 ± 0.90 | -9.58 ± 0.86 | -7.65 ± 1.26 |
| Month 3: somnolence | -8.71 ± 0.96 | -7.35 ± 0.91 | -6.39 ± 1.34 |
| Month 3: snoring | -3.36 ± 1.21 | -4.25 ± 1.15 | -3.36 ± 1.69 |
| Month 3: quantity | 0.45 ± 0.06 | 0.46 ± 0.06 | 0.40 ± 0.09 |
| Month 3: sleep disturbance | -15.67 ± 1.08 | -14.67 ± 1.03 | -11.90 ± 1.52 |
| Month 3: awaken short of breath | -2.60 ± 1.06 | -2.48 ± 1.01 | -2.67 ± 1.48 |
| Month 3: adequacy | 13.46 ± 1.35 | 11.00 ± 1.29 | 7.14 ± 1.89 |
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 6: overall sleep problem | -11.62 ± 0.88 | -12.24 ± 0.84 | -9.77 ± 1.24 |
| Month 6: sleep problem summary | -10.13 ± 0.91 | -11.12 ± 0.87 | -8.64 ± 1.29 |
| Month 6: somnolence | -8.86 ± 0.97 | -8.83 ± 0.93 | -6.60 ± 1.37 |
| Month 6: snoring | -3.21 ± 1.22 | -1.11 ± 1.17 | -4.00 ± 1.74 |
| Month 6: quantity | 0.47 ± 0.07 | 0.44 ± 0.06 | 0.44 ± 0.09 |
| Month 6: sleep disturbance | -15.44 ± 1.10 | -15.60 ± 1.05 | -12.69 ± 1.55 |
| Month 6: awaken short of breath | -2.54 ± 1.07 | -4.33 ± 1.02 | -4.23 ± 1.53 |
| Month 6: adequacy | 10.76 ± 1.36 | 11.57 ± 1.30 | 8.41 ± 1.94 |
| Month 12: overall sleep problem | -12.21 ± 0.90 | -11.94 ± 0.86 | -9.10 ± 1.30 |
| Month 12: sleep problem summary | -10.61 ± 0.93 | -10.76 ± 0.90 | -7.41 ± 1.35 |
| Month 12: somnolence | -8.85 ± 0.99 | -8.24 ± 0.95 | -5.46 ± 1.44 |
| Month 12: snoring | -1.44 ± 1.25 | 0.20 ± 1.20 | -1.49 ± 1.82 |
| Month 12: quantity | 0.49 ± 0.07 | 0.37 ± 0.06 | 0.20 ± 0.10 |
| Month 12: sleep disturbance | -15.94 ± 1.12 | -15.24 ± 1.08 | -12.00 ± 1.63 |
| Month 12: awaken short of breath | -3.65 ± 1.10 | -4.04 ± 1.06 | -2.12 ± 1.62 |
| Month 12: adequacy | 11.41 ± 1.40 | 12.15 ± 1.35 | 9.30 ± 2.05 |
| Month 18: overall sleep problem | -11.55 ± 0.92 | -12.82 ± 0.89 | -11.27 ± 1.36 |
| Month 18: sleep problem summary | -10.02 ± 0.96 | -11.88 ± 0.93 | -9.41 ± 1.41 |
| Month 18: somnolence | -9.19 ± 1.02 | -8.70 ± 0.99 | -7.88 ± 1.51 |
| Month 18:snoring | -0.45 ± 1.29 | -0.59 ± 1.25 | -3.61 ± 1.92 |
| Month 18: quantity | 0.47 ± 0.07 | 0.38 ± 0.07 | 0.44 ± 0.10 |
| Month 18: sleep disturbance | -14.89 ± 1.15 | -15.77 ± 1.12 | -15.97 ± 1.71 |
| Month 18: awaken short of breath | -3.69 ± 1.14 | -5.50 ± 1.11 | -1.55 ± 1.71 |
| Month 18: adequacy | 10.91 ± 1.44 | 13.26 ± 1.40 | 9.71 ± 2.15 |
| Month 24: overall sleep problem | -11.64 ± 0.94 | -11.93 ± 0.90 | -10.84 ± 1.39 |
| Month 24: sleep problem summary | -9.83 ± 0.98 | -10.59 ± 0.94 | -9.64 ± 1.45 |
| Month 24: somnolence | -9.29 ± 1.04 | -8.63 ± 1.00 | -8.24 ± 1.55 |
| Month 24: snoring | -1.00 ± 1.32 | -1.22 ± 1.27 | -3.49 ± 1.97 |
| Month 24: quantity | 0.41 ± 0.07 | 0.31 ± 0.07 | 0.42 ± 0.11 |
| Month 24: sleep disturbance | -14.67 ± 1.18 | -15.43 ± 1.13 | -14.20 ± 1.76 |
| Month 24: awaken short of breath | -3.77 ± 1.17 | -3.16 ± 1.13 | -1.69 ± 1.77 |
| Month 24: adequacy | 11.02 ± 1.47 | 11.87 ± 1.43 | 11.35 ± 2.22 |
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Baseline | 28.47 ± 10.90 | 29.06 ± 10.72 | 28.55 ± 10.54 |
| Month 1 | 34.39 ± 10.06 | 36.03 ± 10.25 | 31.70 ± 10.20 |
| Month 2 | 36.08 ± 10.16 | 36.76 ± 10.20 | 32.83 ± 10.20 |
| Month 3 | 36.93 ± 10.09 | 37.63 ± 10.30 | 34.09 ± 9.56 |
| Month 6 | 37.55 ± 9.96 | 38.38 ± 9.93 | 35.38 ± 10.15 |
| Month 12 | 37.85 ± 10.00 | 38.95 ± 9.73 | 35.99 ± 9.40 |
| Month 18 | 38.45 ± 9.20 | 39.22 ± 9.39 | 35.97 ± 10.12 |
| Month 24 | 38.52 ± 9.37 | 39.38 ± 9.91 | 35.16 ± 10.65 |
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
| units on a scale | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | 5.79 ± 0.47 | 7.14 ± 0.45 | 3.15 ± 0.66 |
| Month 2 | 7.44 ± 0.48 | 7.86 ± 0.45 | 4.22 ± 0.66 |
| Month 3 | 8.12 ± 0.48 | 8.70 ± 0.46 | 5.25 ± 0.67 |
| Month 6 | 8.71 ± 0.48 | 9.12 ± 0.46 | 6.33 ± 0.68 |
| Month 12 | 8.75 ± 0.49 | 9.18 ± 0.47 | 6.89 ± 0.71 |
| Month 18 | 8.98 ± 0.50 | 9.41 ± 0.49 | 7.14 ± 0.74 |
| Month 24 | 8.97 ± 0.51 | 9.57 ± 0.49 | 6.24 ± 0.75 |
| beats per minute | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -1.64 ± 8.15 | -1.83 ± 8.34 | -0.73 ± 7.96 |
| Month 2 | -1.37 ± 8.48 | -1.02 ± 9.33 | -2.19 ± 7.72 |
| Month 3 | -1.91 ± 9.27 | -1.76 ± 9.40 | -2.37 ± 8.48 |
| Month 6 | -1.62 ± 8.64 | -1.70 ± 9.13 | -2.24 ± 8.65 |
| Month 9 | -1.31 ± 9.07 | -1.66 ± 9.23 | -3.50 ± 9.36 |
| Month 12 | -2.36 ± 9.69 | -2.88 ± 9.12 | -4.08 ± 10.42 |
| Month 15 | -1.60 ± 9.22 | -2.12 ± 10.24 | -3.78 ± 9.66 |
| Month 18 | -2.45 ± 9.38 | -2.03 ± 8.78 | -2.23 ± 8.47 |
| Month 21 | -1.77 ± 9.97 | -2.25 ± 8.71 | -3.34 ± 9.24 |
| Month 24 | -3.08 ± 10.16 | -3.31 ± 9.69 | -4.26 ± 10.17 |
| degrees centigrade | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| Month 1 | -0.07 ± 0.30 | -0.05 ± 0.31 | -0.05 ± 0.32 |
| Month 2 | -0.07 ± 0.32 | -0.03 ± 0.37 | -0.04 ± 0.35 |
| Month 3 | -0.08 ± 0.34 | -0.04 ± 0.34 | -0.05 ± 0.36 |
| Month 6 | -0.07 ± 0.35 | -0.04 ± 0.36 | -0.09 ± 0.38 |
| Month 9 | -0.07 ± 0.37 | -0.06 ± 0.39 | -0.08 ± 0.36 |
| Month 12 | -0.10 ± 0.34 | -0.03 ± 0.39 | -0.12 ± 0.37 |
| Month 15 | -0.08 ± 0.35 | -0.05 ± 0.42 | -0.10 ± 0.35 |
| Month 18 | -0.07 ± 0.41 | -0.03 ± 0.42 | -0.11 ± 0.38 |
| Month 21 | -0.09 ± 0.36 | -0.07 ± 0.40 | -0.13 ± 0.40 |
| Month 24 | -0.10 ± 0.37 | -0.07 ± 0.40 | -0.12 ± 0.37 |
Collected over Baseline up to 28 days after last administration of investigational product.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CP-690,550 5 mg BID | — | 40/373 (10.7%) | 252/373 (67.6%) |
| CP-690,550 10 mg BID | — | 43/397 (10.8%) | 279/397 (70.3%) |
| MTX 10, 15, or 20 mg, Weekly | — | 22/186 (11.8%) | 122/186 (65.6%) |
| Event | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/373 | 3/397 | 0/186 |
| Atrial fibrillationCardiac disorders | 0/373 | 0/397 | 1/186 |
| Atrial flutterCardiac disorders | 0/373 | 0/397 | 1/186 |
| Atrioventicular block first degreeCardiac disorders | 0/373 | 0/397 | 1/186 |
| HaemorrhoidsGastrointestinal disorders | 0/373 | 0/397 | 1/186 |
| Inguinal herniaGastrointestinal disorders | 0/373 | 0/397 | 1/186 |
| PancreatitisGastrointestinal disorders | 0/373 | 0/397 | 1/186 |
| Salivary gland calculusGastrointestinal disorders | 0/373 | 0/397 | 1/186 |
| CholelithiasisHepatobiliary disorders | 0/373 | 0/397 | 1/186 |
| Chronic hepatitis CInfections and infestations | 0/373 | 0/397 | 1/186 |
| Event | CP-690,550 5 mg BID | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly |
|---|---|---|---|
| NauseaGastrointestinal disorders | 27/373 | 30/397 | 40/186 |
| NasopharyngitisInfections and infestations | 28/373 | 39/397 | 12/186 |
| Upper respiratory tract infectionInfections and infestations | 30/373 | 36/397 | 15/186 |
| Blood creatine Phosphokinase increasedInvestigations | 16/373 | 36/397 | 2/186 |
| HeadacheNervous system disorders | 26/373 | 34/397 | 12/186 |
| DiarrhoeaGastrointestinal disorders | 15/373 | 24/397 | 15/186 |
| HypertensionVascular disorders | 26/373 | 29/397 | 7/186 |
| BronchitisInfections and infestations | 20/373 | 27/397 | 4/186 |
| Urinary tract infectionInfections and infestations | 17/373 | 26/397 | 7/186 |
| VomitingGastrointestinal disorders | 11/373 | 13/397 | 11/186 |
All participants randomized to the study who received at least 1 dose of study drug (CP-690,550) or MTX.
| Age, Continuous(years) | CP-690,550 5 mg Twice Daily (BID) | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly | Total |
|---|---|---|---|---|
| Mean | 50.3 ± 12.2 | 49.3 ± 12.8 | 48.8 ± 13.3 | 49.6 ± 12.7 |
| Sex: Female, Male(Participants) | CP-690,550 5 mg Twice Daily (BID) | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly | Total |
|---|---|---|---|---|
| Female | 286 | 327 | 145 | 758 |
| Male | 87 | 70 | 41 | 198 |
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