A Phase 3 interventional study of CP-690,550 and CP-690,550 in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 92 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-19.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 399 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Drug: CP-690,550
Drug: CP-690,550
Drug: Placebo · Drug: CP-690,550
Drug: Placebo · Drug: CP-690,550
Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
Also known as: double-blind, placebo-controlled phase
Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
Also known as: double-blind, extension phase
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
Also known as: double-blind, placebo-controlled phase
Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
Also known as: double-blind, extension phase
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Month 3
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; 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;3=unable to do. 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. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Baseline, Month 3
Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Month 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1, 3
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4.5 and 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1, 3
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6
ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4.5, 6
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Baseline, Week 2, Month 1, 3
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Month 4.5, 6
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Baseline, Month 3
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Month 6
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; 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; 3=unable to do. 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: Week 2, Month 1, 3
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; 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; 3=unable to do. 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: Month 4.5, 6
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Baseline, Week 2, Month 1, 3
Patient Assessment of Arthritis Pain at Month 4.5 and 6
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: Month 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3
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 mm = very well and 100 mm = very poorly.
Time frame: Baseline, Week 2, Month 1, 3
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6
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 mm = very well and 100 mm = very poorly.
Time frame: Month 4.5, 6
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3
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, Week 2, Month 1, 3
Physician Global Assessment of Arthritis at Month 4.5 and 6
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: Month 4.5, 6
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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, Week 2, Month 1, 3
36-Item Short-Form Health Survey (SF-36) at Month 6
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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: Month 6
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=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, Week 2, Month 1, 3
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=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: Month 6
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3
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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Time frame: Baseline, Week 2, Month 1, 3
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Time frame: Month 6
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
FACIT-Fatigue Scale (FS):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-FS 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, Month 3
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
FACIT-FS: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-FS 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: Month 6
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3
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, Month 1, 3
Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6
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: Month 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3
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, over-night 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, Month 3
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
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, over-night 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: Month 6
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
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, Month 3
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 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: Month 6
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
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 were reported.
Time frame: Baseline, Month 3
Number of Days as Assessed Using RA-HCRU at Month 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 were reported.
Time frame: Month 6
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
RA-HCRU assessed healthcare 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, hours affected per day and average number of hours missed work per day were reported.
Time frame: Baseline, Month 3
Number of Hours Per Day as Assessed RA-HCRU at Month 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 hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time frame: Month 6
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Month 3
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time frame: Month 6
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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, Month 3
Work Limitations Questionnaire (WLQ) Score at Month 6
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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: Month 6
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Week 2, Month 1, 3
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Month 4.5, 6
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Month 3
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Month 6
| Milestone | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Started | 133 | 134 | 66 | 66 |
| Completed | 107 | 103 | 53 | 48 |
| Not completed | 26 | 31 | 13 | 18 |
| Withdrew: Death | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 12 | 12 | 4 | 4 |
| Withdrew: Lack of efficacy | 2 | 5 | 3 | 8 |
| Withdrew: Protocol violation | 2 | 8 | 3 | 4 |
| Withdrew: Withdrawal by subject | 9 | 5 | 2 | 1 |
| Withdrew: Other | 1 | 1 | 1 | 0 |
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | 41.67 | 48.12 | 24.43 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; 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;3=unable to do. 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. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
| Units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=132,134,132) | 1.60 ± 0.66 | 1.50 ± 0.61 | 1.63 ± 0.66 |
| Change at Month 3 (n=117,125,118) | -0.41 ± 0.52 | -0.41 ± 0.52 | -0.17 ± 0.41 |
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 6.72 | 11.20 | 1.67 |
ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Week 2 | 27.69 | 32.81 | 16.67 |
| Month 1 | 42.42 | 44.36 | 27.48 |
ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 | 54.55 | 47.37 | 50.00 | 46.15 |
| Month 6 | 51.52 | 54.89 | 45.45 | 40.00 |
ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Week 2 | 7.69 | 5.47 | 1.59 |
| Month 1 | 12.88 | 17.29 | 6.11 |
| Month 3 | 26.52 | 27.82 | 8.40 |
ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 | 28.79 | 28.57 | 30.30 | 20.00 |
| Month 6 | 37.12 | 30.08 | 28.79 | 20.00 |
ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Week 2 | 2.31 | 2.34 | 0.00 |
| Month 1 | 7.58 | 6.77 | 0.00 |
| Month 3 | 13.64 | 10.53 | 1.53 |
ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
| percentage of participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 | 10.61 | 12.78 | 12.12 | 7.69 |
| Month 6 | 15.91 | 15.79 | 10.61 | 9.23 |
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=133,134,132) | 5.38 ± 1.00 | 5.31 ± 0.90 | 5.39 ± 0.95 |
| Week 2 (n=127,125,124) | 4.46 ± 1.23 | 4.13 ± 1.04 | 5.10 ± 1.13 |
| Month 1 (n=123,123,123) | 4.14 ± 1.27 | 3.92 ± 1.19 | 4.92 ± 1.20 |
| Month 3 (n=118,124,118) | 3.74 ± 1.31 | 3.45 ± 1.32 | 4.78 ± 1.34 |
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 (n=112,113,56,51) | 3.43 ± 1.25 | 3.30 ± 1.37 | 3.57 ± 1.15 | 3.69 ± 1.15 |
| Month 6 (n=100,102,51,48) | 3.36 ± 1.24 | 3.07 ± 1.18 | 3.46 ± 1.13 | 3.68 ± 1.19 |
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=126,128,130) | 6.48 ± 1.03 | 6.40 ± 0.89 | 6.47 ± 0.98 |
| Month 3 (n=112,121,110) | 4.58 ± 1.39 | 4.26 ± 1.48 | 5.56 ± 1.45 |
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 3.99 ± 1.41 | 3.70 ± 1.25 | 4.07 ± 1.26 | 4.39 ± 1.27 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; 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; 3=unable to do. 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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Week 2 (n=130,128,125) | 1.38 ± 0.71 | 1.28 ± 0.58 | 1.49 ± 0.63 |
| Month 1 (n=123,123,123) | 1.37 ± 0.68 | 1.19 ± 0.65 | 1.38 ± 0.72 |
| Month 3 (n=118,125,118) | 1.20 ± 0.72 | 1.10 ± 0.66 | 1.44 ± 0.72 |
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; 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; 3=unable to do. 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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 (n=112,114,57,53) | 1.19 ± 0.69 | 1.10 ± 0.70 | 1.08 ± 0.60 | 1.26 ± 0.75 |
| Month 6 (n=104,103,51,49) | 1.10 ± 0.70 | 1.02 ± 0.65 | 1.00 ± 0.59 | 1.29 ± 0.72 |
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=127,128,131) | 65.73 ± 22.79 | 60.10 ± 23.16 | 60.74 ± 23.50 |
| Week 2 (n=130,128,125) | 49.79 ± 26.60 | 42.35 ± 22.11 | 55.88 ± 23.85 |
| Month 1 (n=124,122,123) | 45.59 ± 26.02 | 39.09 ± 24.05 | 52.29 ± 25.65 |
| Month 3 (n=119,124,116) | 38.91 ± 27.11 | 37.72 ± 26.99 | 53.40 ± 26.52 |
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.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 (n=112,115,56,53) | 38.93 ± 26.40 | 35.01 ± 24.60 | 33.11 ± 23.44 | 40.62 ± 26.67 |
| Month 6 (n=104,103,51,49) | 34.38 ± 25.33 | 29.56 ± 22.77 | 31.37 ± 24.76 | 40.71 ± 25.88 |
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 mm = very well and 100 mm = very poorly.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=127,128,131) | 64.69 ± 23.22 | 58.79 ± 23.59 | 61.87 ± 22.92 |
| Week 2 (n=130,128,124) | 48.24 ± 25.54 | 41.75 ± 21.79 | 57.70 ± 23.77 |
| Month 1 (n=124,123,123) | 44.86 ± 25.62 | 38.35 ± 23.38 | 51.39 ± 26.01 |
| Month 3 (n=119,125,118) | 41.23 ± 27.06 | 37.23 ± 25.65 | 52.85 ± 25.64 |
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 mm = very well and 100 mm = very poorly.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 (n=112,115,56,53) | 37.40 ± 24.65 | 36.01 ± 25.46 | 34.38 ± 23.47 | 38.79 ± 26.17 |
| Month 6 (n=104,103,51,49) | 34.59 ± 24.82 | 31.25 ± 23.25 | 34.88 ± 23.84 | 38.61 ± 22.27 |
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=126,128,131) | 65.38 ± 18.21 | 58.68 ± 19.42 | 64.36 ± 16.70 |
| Week 2 (n=129,128,123) | 46.51 ± 23.38 | 41.29 ± 20.58 | 51.36 ± 21.87 |
| Month 1 (n=123,122,123) | 39.88 ± 22.19 | 36.28 ± 21.52 | 47.67 ± 20.84 |
| Month 3 (n=117,124,116) | 34.94 ± 25.22 | 30.64 ± 22.20 | 44.08 ± 23.53 |
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5 (n=110,114,55,53) | 27.50 ± 18.87 | 26.12 ± 22.28 | 28.67 ± 19.77 | 28.17 ± 21.50 |
| Month 6 (n=101,101,51,48) | 24.17 ± 18.55 | 19.65 ± 17.15 | 23.55 ± 18.30 | 23.75 ± 16.20 |
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline:Physical Functioning (n=133,134,132) | 30.54 ± 10.76 | 31.61 ± 8.58 | 28.32 ± 9.30 |
| Baseline:Role Physical (n=133,134,132) | 33.66 ± 10.21 | 34.08 ± 9.67 | 32.53 ± 9.66 |
| Baseline:Bodily Pain (n=133,134,132) | 31.09 ± 8.13 | 32.55 ± 7.45 | 31.95 ± 7.70 |
| Baseline:General Health (n=133,134,132) | 35.84 ± 9.50 | 37.73 ± 9.18 | 34.82 ± 8.67 |
| Baseline:Vitality (n=133,134,132) | 39.71 ± 9.87 | 40.11 ± 10.26 | 38.41 ± 10.77 |
| Baseline:Social Functioning (n=133,134,132) | 37.40 ± 13.10 | 39.47 ± 12.11 | 35.95 ± 12.39 |
| Baseline:Role Emotional (n=133,134,132) | 37.58 ± 14.08 | 36.75 ± 13.58 | 35.52 ± 14.22 |
| Baseline:Mental Health (n=133,134,132) | 40.66 ± 11.63 | 41.91 ± 11.99 | 39.69 ± 12.66 |
| Baseline:Physical Component Score(n=133,134,132) | 30.72 ± 9.29 | 32.13 ± 7.58 | 29.98 ± 7.99 |
| Baseline: Mental Component Score (n=133,134,132) | 42.82 ± 12.69 | 43.24 ± 12.81 | 41.34 ± 13.25 |
| Week 2:Physical Functioning (n=130,128,125) | 33.28 ± 11.06 | 34.25 ± 9.30 | 30.25 ± 10.30 |
| Week 2:Role Physical (n=130,128,125) | 36.71 ± 10.23 | 38.45 ± 9.04 | 36.05 ± 10.48 |
| Week 2:Bodily Pain (n=130,128,125) | 37.01 ± 9.34 | 38.42 ± 7.70 | 33.77 ± 7.80 |
| Week 2:General Health (n=130,128,125) | 37.38 ± 8.52 | 38.57 ± 8.61 | 35.85 ± 8.76 |
| Week 2:Vitality (n=130,128,125) | 43.02 ± 10.18 | 43.89 ± 10.71 | 41.11 ± 10.62 |
| Week 2:Social Functioning (n=130,128,125) | 41.18 ± 12.79 | 42.29 ± 11.29 | 38.08 ± 12.18 |
| Week 2:Role Emotional (n=130,128,125) | 40.54 ± 12.94 | 40.62 ± 11.99 | 37.69 ± 13.49 |
| Week 2:Mental Health (n=130,128,125) | 43.72 ± 11.48 | 44.25 ± 11.19 | 42.07 ± 12.31 |
| Week 2:Physical Component Score (n=130,128,125) | 34.04 ± 9.51 | 35.69 ± 7.74 | 31.99 ± 8.58 |
| Week 2:Mental Component Score (n=130,128,125) | 45.77 ± 11.93 | 45.98 ± 11.95 | 43.57 ± 12.74 |
| Month 1:Physical Functioning (n=124,123,123) | 33.56 ± 11.14 | 35.64 ± 10.06 | 31.01 ± 10.15 |
| Month 1: Role Physical (n=124,123,123) | 38.25 ± 10.06 | 39.59 ± 9.98 | 36.33 ± 10.56 |
| Month 1:Bodily Pain(n=124,123,123) | 37.50 ± 9.45 | 40.02 ± 8.42 | 35.35 ± 8.77 |
| Month 1:General Health (n=124,123,123) | 38.09 ± 9.32 | 39.82 ± 9.25 | 36.64 ± 8.75 |
| Month 1:Vitality (n=124,123,123) | 44.33 ± 9.35 | 45.65 ± 11.47 | 41.85 ± 11.50 |
| Month 1:Social Functioning (n=124,123,123) | 40.96 ± 11.62 | 44.12 ± 11.65 | 39.00 ± 12.49 |
| Month 1:Role Emotional (n=124,123,123) | 41.05 ± 13.23 | 40.84 ± 12.86 | 38.87 ± 12.84 |
| Month 1:Mental Health (n=124,123,123) | 44.13 ± 11.68 | 46.18 ± 11.64 | 42.89 ± 11.92 |
| Month 1:Physical Component Score (n=124,123,123) | 34.88 ± 9.24 | 37.07 ± 8.40 | 32.72 ± 9.18 |
| Month 1:Mental Component Score (n=124,123,123) | 46.13 ± 11.94 | 47.28 ± 12.47 | 44.53 ± 12.42 |
| Month 3:Physical Functioning (n=118,125,117) | 34.78 ± 11.43 | 36.70 ± 10.56 | 30.54 ± 10.67 |
| Month 3: Role Physical (n=118,125,117) | 38.40 ± 10.49 | 40.19 ± 10.95 | 35.09 ± 10.66 |
| Month 3:Bodily Pain (n=118,125,117) | 39.25 ± 9.78 | 40.93 ± 9.67 | 34.26 ± 9.62 |
| Month 3:General Health (n=118,125,117) | 39.22 ± 9.78 | 40.21 ± 9.46 | 35.30 ± 9.30 |
| Month 3:Vitality (n=118,125,117) | 45.23 ± 10.89 | 46.23 ± 11.73 | 40.30 ± 11.71 |
| Month 3:Social Functioning (n=118,125,117) | 41.91 ± 12.37 | 44.49 ± 11.21 | 37.74 ± 12.12 |
| Month 3:Role Emotional (n=118,125,116) | 41.21 ± 12.57 | 41.84 ± 12.67 | 36.16 ± 14.50 |
| Month 3:Mental Health (n=118,125,117) | 44.58 ± 11.95 | 45.83 ± 11.59 | 40.89 ± 12.46 |
| Month 3:Physical Component Score (n=118,125,116) | 36.18 ± 9.96 | 38.01 ± 9.35 | 32.38 ± 9.35 |
| Month 3:Mental Component Score (n=118,125,116) | 46.40 ± 11.87 | 47.37 ± 12.01 | 41.91 ± 12.85 |
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6:Physical Functioning | 35.62 ± 11.63 | 38.47 ± 10.14 | 35.00 ± 10.31 | 33.97 ± 10.58 |
| Month 6: Role Physical | 40.72 ± 9.95 | 43.51 ± 11.21 | 39.54 ± 10.55 | 38.02 ± 9.81 |
| Month 6:Bodily Pain | 41.53 ± 9.61 | 43.63 ± 9.27 | 42.40 ± 10.22 | 39.60 ± 9.01 |
| Month 6:General Health | 39.49 ± 9.54 | 41.68 ± 10.35 | 38.95 ± 9.51 | 37.89 ± 8.45 |
| Month 6:Vitality | 46.49 ± 9.82 | 47.59 ± 10.93 | 45.09 ± 12.26 | 44.26 ± 8.73 |
| Month 6:Social Functioning | 44.05 ± 10.93 | 44.66 ± 11.92 | 43.33 ± 12.27 | 40.38 ± 11.11 |
| Month 6:Role Emotional | 42.36 ± 13.34 | 45.06 ± 12.27 | 41.07 ± 13.18 | 39.53 ± 12.93 |
| Month 6:Mental Health | 45.29 ± 12.12 | 47.48 ± 11.61 | 44.85 ± 14.61 | 46.19 ± 9.65 |
| Month 6:Physical Component Score | 37.78 ± 9.20 | 40.21 ± 9.24 | 37.84 ± 9.59 | 35.43 ± 8.69 |
| Month 6:Mental Component Score | 47.41 ± 12.32 | 48.83 ± 12.65 | 46.17 ± 15.06 | 46.03 ± 11.52 |
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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Sleep Problem Summary (n=133,132,129) | 40.55 ± 21.13 | 39.87 ± 18.03 | 44.65 ± 20.56 |
| Baseline: Overall Sleep Problem (n=133,132,129) | 43.10 ± 21.00 | 41.57 ± 17.88 | 46.08 ± 20.73 |
| Baseline: Sleep Adequacy (n=133,133,129) | 46.39 ± 27.89 | 43.16 ± 25.89 | 39.53 ± 27.95 |
| Baseline: Awakened Short of Breath (n=133,133,130) | 16.99 ± 24.56 | 19.10 ± 24.10 | 21.54 ± 26.19 |
| Baseline: Sleep Disturbance (n=133,133,129) | 47.43 ± 28.39 | 43.20 ± 24.83 | 47.98 ± 27.00 |
| Baseline: Sleep Quantity (n=132,131,129) | 6.47 ± 1.55 | 6.44 ± 1.35 | 6.33 ± 1.46 |
| Baseline: Snoring (n=131,131,127) | 42.14 ± 31.89 | 37.10 ± 33.75 | 40.00 ± 33.62 |
| Baseline: Somnolence (n=133,132,129) | 36.39 ± 22.47 | 34.19 ± 22.83 | 38.55 ± 23.60 |
| Week 2: Sleep Problem Summary (n=129,127,125) | 36.87 ± 20.84 | 37.03 ± 18.97 | 40.35 ± 20.10 |
| Week 2: Overall Sleep Problem (n=129,127,124) | 38.04 ± 20.78 | 37.69 ± 18.83 | 41.47 ± 20.01 |
| Week 2: Sleep Adequacy (n=129,127,125) | 48.06 ± 28.70 | 44.17 ± 28.35 | 42.72 ± 26.77 |
| Week 2: Awakened Short of Breath (n=129,127,125) | 17.83 ± 25.28 | 17.32 ± 21.58 | 18.72 ± 25.75 |
| Week 2: Sleep Disturbance (n=129,127,125) | 39.59 ± 28.24 | 36.41 ± 22.89 | 42.28 ± 26.45 |
| Week 2: Sleep Quantity (n=129,127,124) | 6.40 ± 1.57 | 6.68 ± 1.41 | 6.48 ± 1.75 |
| Week 2: Snoring (n=128,125,122) | 36.25 ± 34.21 | 35.84 ± 34.48 | 40.49 ± 32.67 |
| Week 2: Somnolence (n=129,127,124) | 31.78 ± 21.85 | 32.18 ± 23.47 | 36.45 ± 23.18 |
| Month 1: Sleep Problem Summary (n=124,123,123) | 36.21 ± 20.69 | 34.53 ± 20.08 | 37.37 ± 20.42 |
| Month 1: Overall Sleep Problem (n=124,123,123) | 37.23 ± 20.70 | 35.40 ± 19.94 | 38.79 ± 20.58 |
| Month 1: Sleep Adequacy (n=124,123,123) | 49.84 ± 28.31 | 48.13 ± 29.35 | 49.11 ± 28.86 |
| Month 1: Awakened Short of Breath (n=124,123,123) | 15.81 ± 21.53 | 15.45 ± 23.16 | 19.84 ± 26.30 |
| Month 1: Sleep Disturbance (n=124,123,123) | 39.12 ± 28.16 | 34.82 ± 25.12 | 39.64 ± 26.26 |
| Month 1: Sleep Quantity (n=124,123,123) | 6.59 ± 1.34 | 6.80 ± 1.43 | 6.43 ± 1.42 |
| Month 1: Snoring (n=124,122,120) | 36.13 ± 33.42 | 34.10 ± 32.80 | 41.50 ± 33.12 |
| Month 1: Somnolence (n=124,123,123) | 30.91 ± 22.30 | 30.84 ± 23.97 | 34.91 ± 23.67 |
| Month 3: Sleep Problem Summary (n=117,125,117) | 36.81 ± 21.10 | 35.68 ± 19.36 | 40.14 ± 20.20 |
| Month 3: Overall Sleep Problem (n=117,125,117) | 37.23 ± 20.72 | 36.08 ± 19.40 | 42.00 ± 20.41 |
| Month 3: Sleep Adequacy (n=118,125,117) | 48.64 ± 30.32 | 48.56 ± 29.04 | 43.68 ± 27.47 |
| Month 3: Awakened Short of Breath (n=118,125,117) | 18.14 ± 23.68 | 19.68 ± 24.09 | 17.95 ± 24.27 |
| Month 3: Sleep Disturbance (n=118,125,117) | 38.44 ± 28.37 | 34.61 ± 23.21 | 43.27 ± 26.45 |
| Month 3: Sleep Quantity (n=117,124,117) | 6.58 ± 1.50 | 6.71 ± 1.42 | 6.27 ± 1.49 |
| Month 3: Snoring (n=118,123,117) | 36.44 ± 32.83 | 36.26 ± 32.63 | 41.37 ± 31.92 |
| Month 3: Somnolence (n=117,125,117) | 30.14 ± 23.53 | 31.31 ± 23.68 | 36.47 ± 23.10 |
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/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: Sleep Problem Summary | 35.32 ± 21.46 | 32.03 ± 18.42 | 38.78 ± 20.81 | 35.35 ± 19.05 |
| Month 6: Overall Sleep Problem | 35.75 ± 20.68 | 32.92 ± 18.33 | 39.73 ± 20.85 | 36.02 ± 18.45 |
| Month 6: Sleep Adequacy | 50.48 ± 30.64 | 52.75 ± 28.46 | 43.47 ± 30.99 | 50.42 ± 26.89 |
| Month 6: Awakened Short of Breath | 16.73 ± 24.15 | 14.12 ± 22.62 | 18.37 ± 21.54 | 17.92 ± 21.13 |
| Month 6: Sleep Disturbance | 36.84 ± 26.19 | 33.88 ± 23.51 | 40.92 ± 26.89 | 35.10 ± 25.26 |
| Month 6: Sleep Quantity | 6.56 ± 1.45 | 6.93 ± 1.29 | 6.27 ± 1.29 | 6.80 ± 1.26 |
| Month 6: Snoring | 34.62 ± 31.80 | 35.84 ± 31.79 | 37.96 ± 31.95 | 38.75 ± 32.59 |
| Month 6: Somnolence | 29.74 ± 22.24 | 26.14 ± 19.40 | 30.61 ± 22.56 | 33.19 ± 20.09 |
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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n= 133, 134, 132) | 53 | 59 | 48 |
| Week 2 (n= 130, 128, 126) | 52 | 62 | 50 |
| Month 1 (n= 124, 123, 124) | 59 | 58 | 53 |
| Month 3 (n= 118, 125, 118) | 53 | 56 | 47 |
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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 50 | 57 | 21 | 24 |
FACIT-Fatigue Scale (FS):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-FS 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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=132,134,129) | 27.84 ± 11.12 | 29.48 ± 11.39 | 26.98 ± 11.52 |
| Month 3 (n=118,125,117) | 33.30 ± 11.72 | 33.66 ± 12.27 | 27.93 ± 12.36 |
FACIT-FS: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-FS 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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 34.69 ± 10.81 | 35.98 ± 11.55 | 33.57 ± 12.21 | 31.63 ± 10.16 |
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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=131,134,129) | 0.38 ± 0.34 | 0.47 ± 0.32 | 0.38 ± 0.33 |
| Month 1 (n=122,121,120) | 0.56 ± 0.28 | 0.63 ± 0.24 | 0.49 ± 0.30 |
| Month 3 (n=117,123,117) | 0.55 ± 0.30 | 0.62 ± 0.25 | 0.43 ± 0.35 |
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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6 | 0.62 ± 0.28 | 0.68 ± 0.24 | 0.60 ± 0.24 | 0.55 ± 0.29 |
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, over-night 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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Seen any doctor (n=133,133,130) | 1.11 ± 0.31 | 1.09 ± 0.29 | 1.15 ± 0.35 |
| Baseline: Treated in ER (n=133,134,130) | 1.89 ± 0.32 | 1.96 ± 0.19 | 1.93 ± 0.25 |
| Baseline: Admitted for overnight stay (n=16,6,9) | 0.19 ± 0.54 | 0.17 ± 0.41 | 0.33 ± 0.71 |
| Baseline: Hospitalization (n=133,134,130) | 1.97 ± 0.17 | 1.97 ± 0.17 | 1.95 ± 0.23 |
| Baseline: Had outpatient surgeries (n=133,134,130) | 1.95 ± 0.21 | 1.97 ± 0.17 | 1.93 ± 0.25 |
| Baseline:Non-study diagnostic tests(n=133,134,130) | 1.74 ± 0.44 | 1.75 ± 0.43 | 1.74 ± 0.44 |
| Baseline: In nursing home (n=133,134,130) | 1.99 ± 0.09 | 1.99 ± 0.09 | 1.99 ± 0.09 |
| Baseline: Home HC services (n=133,134,130) | 1.98 ± 0.12 | 1.99 ± 0.09 | 1.96 ± 0.19 |
| Baseline: Home healthcare services (n=2,2,5) | 1.50 ± 0.71 | 0.50 ± 0.71 | 0.80 ± 0.84 |
| Baseline:Required aids/devices (n=133,134,130) | 1.77 ± 0.42 | 1.86 ± 0.35 | 1.82 ± 0.39 |
| Baseline: Seen NM practitioner (n=133,134,130) | 1.97 ± 0.17 | 1.96 ± 0.21 | 1.96 ± 0.19 |
| Baseline: Currently employed (n=132,134,130) | 1.70 ± 0.46 | 1.66 ± 0.48 | 1.68 ± 0.47 |
| Baseline: Feel well enough to work (n=84,78,83) | 1.85 ± 0.36 | 1.82 ± 0.39 | 1.82 ± 0.39 |
| Baseline: Retired (n=85,80,86) | 1.49 ± 0.50 | 1.43 ± 0.50 | 1.49 ± 0.50 |
| Baseline: Lost job/retired early (n=83,77,80) | 1.58 ± 0.50 | 1.69 ± 0.47 | 1.55 ± 0.50 |
| Baseline: Unable to work due to RA (n=84,77,83) | 1.36 ± 0.48 | 1.48 ± 0.50 | 1.40 ± 0.49 |
| Baseline: Work disabled due to RA (n=83,77,79) | 1.46 ± 0.50 | 1.55 ± 0.50 | 1.48 ± 0.50 |
| Baseline: Sick leave due to RA (n=104,109,100) | 1.83 ± 0.38 | 1.80 ± 0.40 | 1.71 ± 0.46 |
| Baseline: Performed part time work (n=103,108,100) | 1.94 ± 0.24 | 1.94 ± 0.25 | 1.88 ± 0.33 |
| Baseline: Performed paid work (n=102,109,98) | 1.65 ± 0.48 | 1.63 ± 0.48 | 1.65 ± 0.48 |
| Baseline: Unable to do chores (n=130,130,126) | 1.37 ± 0.48 | 1.42 ± 0.49 | 1.27 ± 0.45 |
| Baseline: Chores by housekeeper (n=130,134,130) | 1.85 ± 0.36 | 1.86 ± 0.35 | 1.82 ± 0.39 |
| Baseline: Chores by family/friends (n=131,134,130) | 1.44 ± 0.50 | 1.49 ± 0.50 | 1.48 ± 0.50 |
| Month 3: Seen any doctor (n=117,125,117) | 1.23 ± 0.42 | 1.21 ± 0.41 | 1.21 ± 0.41 |
| Month 3: Treated in ER (n=116,125,117) | 1.94 ± 0.24 | 1.94 ± 0.25 | 1.93 ± 0.25 |
| Month 3: Admitted for overnight stay (n=7,8,8) | 0.29 ± 0.76 | 0.00 ± 0.00 | 0.13 ± 0.35 |
| Month 3: Hospitalization (n=116,124,117) | 1.99 ± 0.09 | 2.00 ± 0.00 | 1.98 ± 0.13 |
| Month 3: Had outpatient surgeries (n=116,125,117) | 1.94 ± 0.24 | 1.98 ± 0.15 | 1.97 ± 0.18 |
| Month 3:Non study diagnostic tests (n=116,125,117) | 1.80 ± 0.40 | 1.82 ± 0.38 | 1.77 ± 0.42 |
| Month 3: In nursing home (n=116,125,117) | 1.99 ± 0.09 | 1.99 ± 0.09 | 1.99 ± 0.09 |
| Month 3: Home HC services (n=116,123,117) | 1.97 ± 0.16 | 1.99 ± 0.09 | 1.97 ± 0.16 |
| Month 3: Required aids/devices (n=116,125,117) | 1.81 ± 0.39 | 1.91 ± 0.28 | 1.76 ± 0.43 |
| Month 3: Seen NM practitioner (n=116,125,117) | 1.97 ± 0.18 | 1.97 ± 0.18 | 1.97 ± 0.18 |
| Month 3: Currently employed (n=115,125,117) | 1.70 ± 0.46 | 1.62 ± 0.49 | 1.68 ± 0.47 |
| Month 3: Feel well enough to work (n=68,67,70) | 1.82 ± 0.38 | 1.78 ± 0.42 | 1.83 ± 0.38 |
| Month 3: Retired (n=68,66,72) | 1.56 ± 0.50 | 1.36 ± 0.48 | 1.53 ± 0.50 |
| Month 3: Lost job/retired early (n=67,68,69) | 1.70 ± 0.46 | 1.69 ± 0.47 | 1.59 ± 0.49 |
| Month 3: Unable to work due to RA (n=68,66,71) | 1.41 ± 0.50 | 1.53 ± 0.50 | 1.44 ± 0.50 |
| Month 3: Work disabled due to RA (n=67,67,69) | 1.48 ± 0.50 | 1.57 ± 0.50 | 1.54 ± 0.50 |
| Month 3: Sick leave due to RA (n=95,100,97) | 1.88 ± 0.32 | 1.86 ± 0.35 | 1.82 ± 0.38 |
| Month 3: Performed part time work (n=96,100,96) | 1.96 ± 0.20 | 1.94 ± 0.24 | 1.94 ± 0.24 |
| Month 3: Performed paid work (n=96,99,97) | 1.78 ± 0.42 | 1.69 ± 0.47 | 1.67 ± 0.47 |
| Month 3: Unable to do chores (n=112,120,113) | 1.57 ± 0.50 | 1.63 ± 0.49 | 1.45 ± 0.50 |
| Month 3: Chores by housekeeper (n=116,122,117) | 1.86 ± 0.35 | 1.89 ± 0.32 | 1.85 ± 0.35 |
| Month 3: Chores by family/friends (n=116,122,116) | 1.55 ± 0.50 | 1.66 ± 0.48 | 1.53 ± 0.50 |
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, over-night 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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: Seen any doctor (n=102,101,50,49) | 1.29 ± 0.46 | 1.22 ± 0.41 | 1.20 ± 0.40 | 1.27 ± 0.45 |
| Month 6: Treated in ER (n=103,102,50,49) | 1.96 ± 0.19 | 1.93 ± 0.25 | 1.94 ± 0.24 | 1.98 ± 0.14 |
| Month 6: Admitted for overnight stay (n=5,7,3,1) | 0.20 ± 0.45 | 0.00 ± 0.00 | 1.33 ± 1.15 | 0.00 ± NA |
| Month 6: Hospitalization (n=102,102,50,49) | 1.98 ± 0.14 | 1.99 ± 0.10 | 1.96 ± 0.20 | 1.98 ± 0.14 |
| Month 6:Had outpatient surgeries (n=103,102,50,49) | 2.00 ± 0.00 | 1.95 ± 0.22 | 1.96 ± 0.20 | 1.96 ± 0.20 |
| Month 6:Non-study diagnostic test(n=103,102,50,49) | 1.85 ± 0.35 | 1.84 ± 0.37 | 1.74 ± 0.44 | 1.86 ± 0.35 |
| Month 6: In nursing home (n=103,102,50,49) | 1.98 ± 0.14 | 2.00 ± 0.00 | 2.00 ± 0.00 | 1.96 ± 0.20 |
| Month 6: Home HC services (n=101,102,50,49) | 2.00 ± 0.00 | 1.98 ± 0.14 | 2.00 ± 0.00 | 2.00 ± 0.00 |
| Month 6: Required aids/devices (n=103,102,50,48) | 1.82 ± 0.39 | 1.91 ± 0.29 | 1.90 ± 0.30 | 1.83 ± 0.38 |
| Month 6: Seen NM practitioner (n=103,102,50,49) | 1.99 ± 0.10 | 1.96 ± 0.20 | 1.98 ± 0.14 | 1.96 ± 0.20 |
| Month 6: Currently employed (n=103,102,50,49) | 1.67 ± 0.47 | 1.63 ± 0.49 | 1.60 ± 0.49 | 1.71 ± 0.46 |
| Month 6: Feel well enough to work (n=62,57,27,32) | 1.81 ± 0.40 | 1.68 ± 0.47 | 1.70 ± 0.47 | 1.88 ± 0.34 |
| Month 6: Retired (n=62,56,28,31) | 1.45 ± 0.50 | 1.36 ± 0.48 | 1.43 ± 0.50 | 1.39 ± 0.50 |
| Month 6: Lost job/retired early (n=62,54,27,32) | 1.71 ± 0.46 | 1.74 ± 0.44 | 1.59 ± 0.50 | 1.44 ± 0.50 |
| Month 6: Unable to work due to RA (n=62,55,27,32) | 1.48 ± 0.50 | 1.67 ± 0.47 | 1.56 ± 0.51 | 1.41 ± 0.50 |
| Month 6: Work disabled due to RA (n=61,53,27,32) | 1.57 ± 0.50 | 1.70 ± 0.46 | 1.56 ± 0.51 | 1.50 ± 0.51 |
| Month 6: Sick leave due to RA (n=85,84,41,37) | 1.92 ± 0.28 | 1.88 ± 0.33 | 1.88 ± 0.33 | 1.86 ± 0.35 |
| Month 6: Performed part time work (n=85,84,40,36) | 1.96 ± 0.19 | 1.95 ± 0.21 | 2.00 ± 0.00 | 1.92 ± 0.28 |
| Month 6: Performed paid work (n=83,84,40,36) | 1.71 ± 0.46 | 1.75 ± 0.44 | 1.65 ± 0.48 | 1.64 ± 0.49 |
| Month 6: Unable to do chores (n=101,98,49,48) | 1.65 ± 0.48 | 1.73 ± 0.44 | 1.51 ± 0.51 | 1.44 ± 0.50 |
| Month 6: Chores by housekeeper (n=103,99,50,49) | 1.92 ± 0.27 | 1.91 ± 0.29 | 1.82 ± 0.39 | 1.90 ± 0.31 |
| Month 6: Chores by family/friends (n=103,99,50,49) | 1.69 ± 0.47 | 1.77 ± 0.42 | 1.62 ± 0.49 | 1.55 ± 0.50 |
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.
| number of events | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Doctor visit (n=119,121,111) | 5.07 ± 5.00 | 5.09 ± 5.10 | 4.58 ± 3.82 |
| Baseline: NM practitioner visits (n=4,6,5) | 5.75 ± 4.35 | 4.83 ± 3.25 | 21.40 ± 29.75 |
| Baseline: Hospital ER visit (n=14,5,9) | 1.79 ± 1.53 | 2.00 ± 1.73 | 1.22 ± 0.44 |
| Baseline: Hospitalization (n=4,4,7) | 1.25 ± 0.50 | 1.00 ± 0.00 | 1.14 ± 0.38 |
| Baseline: Outpatient surgery (n=6,4,8) | 1.17 ± 0.41 | 1.00 ± 0.00 | 1.00 ± 0.00 |
| Baseline: Non-study diagnostic tests (n=34,32,32) | 1.85 ± 1.02 | 2.06 ± 1.72 | 1.69 ± 0.97 |
| Baseline: RA related doctor visit (n=117,120,111) | 1.46 ± 0.91 | 1.18 ± 0.84 | 1.44 ± 0.93 |
| Baseline: RA related ER visit (n=15,6,9) | 0.67 ± 0.90 | 0.67 ± 0.82 | 0.89 ± 0.93 |
| Baseline: RA related diagnostic test (n=35,33,34) | 0.71 ± 0.83 | 0.79 ± 1.14 | 0.82 ± 0.76 |
| Baseline: RA related hospitalization (n=4,5,7) | 0.75 ± 0.96 | 0.80 ± 1.10 | 0.86 ± 0.69 |
| Baseline: RA related outpatient surgery (n=6,5,9) | 0.33 ± 0.82 | 0.80 ± 0.84 | 0.89 ± 0.93 |
| Baselin:RA related NM visit (n=4,7,5) | 1.25 ± 0.96 | 0.57 ± 0.53 | 1.00 ± 1.00 |
| Month 3: Doctor visit (n=89,99,93) | 3.30 ± 2.91 | 3.69 ± 3.73 | 4.04 ± 4.59 |
| Month 3: NM practitioners visits (n=4,4,4) | 36.25 ± 40.25 | 5.00 ± 2.00 | 8.75 ± 10.63 |
| Month 3: Hospital ER visit (n=7,8,8) | 1.00 ± 0.00 | 1.38 ± 1.06 | 1.38 ± 0.74 |
| Month 3: Hospitalization (n=1,0,2) | 1.00 ± NA | NA ± NA | 1.00 ± 0.00 |
| Month 3: Outpatient surgery (n=7,3,4) | 1.14 ± 0.38 | 1.00 ± 0.00 | 1.00 ± 0.00 |
| Month 3: Non-study diagnostic tests (n=22,22,26) | 1.82 ± 1.65 | 1.14 ± 0.35 | 1.62 ± 1.27 |
| Month 3: RA related doctor visit (n=90,98,93) | 1.16 ± 1.08 | 0.82 ± 0.65 | 1.13 ± 0.92 |
| Month 3: RA related ER visit (n=7,8,8) | 0.43 ± 0.79 | 0.00 ± 0.00 | 0.75 ± 1.39 |
| Month 3: RA related diagnostic test (n=23,22,26) | 0.30 ± 0.47 | 0.23 ± 0.43 | 0.35 ± 0.56 |
| Month 3: RA related hospitalization (n=1,0,2) | 0.00 ± NA | NA ± NA | 0.00 ± 0.00 |
| Month 3:RA related outpatient surgery (n=7,3,4) | 0.43 ± 0.79 | 0.67 ± 1.15 | 1.00 ± 1.15 |
| Month 3:RA related NM visit (n=4,4,4) | 0.75 ± 0.96 | 1.25 ± 0.96 | 1.25 ± 0.96 |
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.
| number of events | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: Doctor visit (n=73,80,39,36) | 3.26 ± 2.83 | 3.84 ± 4.25 | 3.64 ± 4.03 | 4.97 ± 6.73 |
| Month 6: NM practitioner visit (n=1,4,1,2) | 5.00 ± NA | 15.50 ± 10.63 | 20.00 ± NA | 4.00 ± 0.00 |
| Month 6: Hospital ER visit (n=4,7,3,1) | 1.25 ± 0.50 | 1.43 ± 0.79 | 1.67 ± 1.15 | 1.00 ± NA |
| Month 6: Hospitalization (n=2,1,2,1) | 2.00 ± 0.00 | 1.00 ± NA | 1.00 ± 0.00 | 1.00 ± NA |
| Month 6: Outpatient surgery (n=0,5,2,2) | NA ± NA | 1.00 ± 0.00 | 2.50 ± 0.71 | 1.50 ± 0.71 |
| Month 6: Non-study diagnostic test (n=15,16,13,7) | 2.07 ± 2.02 | 1.19 ± 0.54 | 1.85 ± 0.99 | 1.14 ± 0.38 |
| Month 6: RA related doctor visit (n=73,80,40,36) | 1.10 ± 0.87 | 0.86 ± 0.76 | 0.85 ± 0.83 | 1.00 ± 0.96 |
| Month 6: RA related ER visit (n=4,7,3,1) | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± NA |
| Month 6: RA related diagnostic test (n=16,16,13,7) | 0.44 ± 0.73 | 0.00 ± 0.00 | 0.31 ± 0.85 | 0.29 ± 0.49 |
| Month 6: RA related hospitalization (n=2,1,2,1) | 0.00 ± 0.00 | 0.00 ± NA | 0.00 ± 0.00 | 2.00 ± NA |
| Month 6:RA related outpatient surgery (n=5,2,0,2) | 0.00 ± 0.00 | 2.00 ± 0.00 | NA ± NA | 0.00 ± 0.00 |
| Month6:RA related NM practitioner visit(n=1,4,1,2) | 1.00 ± NA | 2.00 ± 1.63 | 0.00 ± NA | 1.00 ± 1.41 |
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 were reported.
| days | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Hospital length of stay (n=4,4,7) | 1.75 ± 0.96 | 7.00 ± 7.57 | 5.43 ± 3.78 |
| Baseline: Days in nursing home (n=1,1,1) | 2.00 ± NA | 28.00 ± NA | 28.00 ± NA |
| Baseline: Days devices/aids used (n=31,18,24) | 122.94 ± 139.56 | 100.28 ± 122.82 | 94.63 ± 86.62 |
| Baseline: Days of work per week (n=39,46,41) | 4.67 ± 1.24 | 4.83 ± 1.29 | 4.90 ± 1.18 |
| Baseline: Chores by housekeeper (n=20,18,24) | 13.35 ± 20.32 | 20.56 ± 32.53 | 15.88 ± 23.45 |
| Baseline: Chores by family/friend (n=71,65,66) | 27.55 ± 31.88 | 26.31 ± 32.27 | 27.38 ± 30.75 |
| Baseline: Days on sick leave (n=17,22,28) | 19.76 ± 25.59 | 13.09 ± 16.15 | 23.71 ± 31.28 |
| Baseline: Days of part time work (n=6,6,11) | 41.33 ± 40.41 | 6.83 ± 4.96 | 12.36 ± 16.20 |
| Baseline: Paid work, bothered by RA (n=36,40,32) | 50.72 ± 63.36 | 39.75 ± 32.85 | 31.00 ± 30.79 |
| Baseline: RA related devices/aids used (31,20,24) | 2.06 ± 1.59 | 1.75 ± 1.48 | 1.79 ± 0.88 |
| Month 3: Hospital length of stay (n=1,0,2) | 12.00 ± NA | NA ± NA | 11.00 ± 12.73 |
| Month 3: Days in nursing home (n=1,1,1) | 9.00 ± NA | 21.00 ± NA | 21.00 ± NA |
| Month 3: Days devices/aids used (n=21,10,26) | 113.24 ± 102.65 | 264.10 ± 429.48 | 73.85 ± 70.60 |
| Month 3: Days of work per week (n=33,47,37) | 4.94 ± 1.09 | 4.89 ± 1.09 | 4.65 ± 1.06 |
| Month 3: Chores by housekeeper (n=15,14,17) | 13.00 ± 16.76 | 16.93 ± 31.22 | 10.12 ± 12.84 |
| Month 3: Chores by family/friend (n=50,41,52) | 27.30 ± 31.13 | 24.24 ± 32.54 | 25.19 ± 36.03 |
| Month 3: Days on sick leave (n=11,13,16) | 22.09 ± 28.51 | 6.62 ± 4.94 | 13.69 ± 20.16 |
| Month 3: Days of part time work (n=4,4,5) | 8.25 ± 9.46 | 9.25 ± 7.89 | 8.20 ± 11.12 |
| Month 3: Paid work, bothered by RA (n=19,29,28) | 26.58 ± 30.30 | 17.76 ± 23.98 | 30.54 ± 30.39 |
| Month 3: RA related devices/aids used (22,11,27) | 2.09 ± 1.31 | 3.00 ± 4.45 | 2.04 ± 1.26 |
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 were reported.
| days | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: Hospital length of stay (n=2,1,2,1) | 32.00 ± 33.94 | 3.00 ± NA | 25.00 ± 21.21 | 24.00 ± NA |
| Month 6: Days in nursing home (n=2,0,0,2) | 21.50 ± 0.71 | NA ± NA | NA ± NA | 13.50 ± 2.12 |
| Month 6: Days devices/aids used (n=18,7,5,8) | 141.28 ± 105.31 | 68.43 ± 30.12 | 182.40 ± 87.11 | 75.00 ± 79.33 |
| Month 6: Days of work per week (n=34,36,20,14) | 4.62 ± 1.33 | 4.97 ± 1.00 | 4.85 ± 0.99 | 4.71 ± 1.49 |
| Month 6: Chores by housekeeper (n=8,9,9,5) | 12.75 ± 13.21 | 24.89 ± 36.09 | 9.22 ± 10.73 | 7.80 ± 4.55 |
| Month 6: Chores by family/friend (n=32,23,18,19) | 28.91 ± 32.10 | 18.83 ± 26.97 | 19.33 ± 24.14 | 17.63 ± 26.46 |
| Month 6: Days on sick leave (n=7,10,5,5) | 21.00 ± 31.86 | 10.40 ± 14.49 | 9.20 ± 11.17 | 42.60 ± 44.81 |
| Month 6: Days of part time work (n=3,3,0,3) | 5.67 ± 8.08 | 9.33 ± 5.03 | NA ± NA | 21.33 ± 33.49 |
| Month 6: Paid work, bothered by RA (n=21,19,12,11) | 25.00 ± 32.76 | 14.95 ± 20.85 | 22.17 ± 31.98 | 19.64 ± 21.73 |
| Month 6: RA related devices/aids used (19,8,5,8) | 2.05 ± 1.22 | 1.13 ± 0.64 | 2.20 ± 0.84 | 1.63 ± 1.19 |
RA-HCRU assessed healthcare 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, hours affected per day and average number of hours missed work per day were reported.
| hours per day | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: Home healthcare services (n=2,1,4) | 5.00 ± 4.24 | 3.00 ± NA | 7.25 ± 11.18 |
| Baseline: Work done (n=39,45,41) | 9.41 ± 8.52 | 8.18 ± 7.18 | 8.98 ± 7.35 |
| Baseline: Chores by housekeeper (n=19,18,23) | 4.68 ± 3.23 | 3.83 ± 1.54 | 4.78 ± 2.37 |
| Baseline: Chores by family/friend (n=71,63,66) | 2.85 ± 1.89 | 4.44 ± 11.21 | 3.42 ± 2.61 |
| Baseline: Missed work due to RA (n=6,6,11) | 2.67 ± 1.97 | 3.17 ± 2.23 | 7.55 ± 7.31 |
| Baseline: RA related home HC services (n=2,2,5) | 1.50 ± 0.71 | 0.50 ± 0.71 | 0.80 ± 0.84 |
| Month 3: Home healthcare services (n=3,1,3) | 4.00 ± 3.46 | 2.00 ± NA | 9.33 ± 12.70 |
| Month 3: Work done (n=34,46,37) | 7.97 ± 4.72 | 9.20 ± 8.52 | 7.76 ± 1.98 |
| Month 3: Chores by housekeeper (n=15,14,17) | 4.00 ± 2.20 | 3.71 ± 1.14 | 5.41 ± 5.26 |
| Month 3: Chores by family/friend (n=50,41,49) | 3.50 ± 3.72 | 2.83 ± 2.57 | 4.00 ± 5.34 |
| Month 3: Missed work due to RA (n=4,4,5) | 3.00 ± 2.00 | 6.25 ± 6.18 | 7.80 ± 9.12 |
| Month 3: RA related home HC services (n=3,1,3) | 1.33 ± 0.58 | 1.00 ± NA | 1.67 ± 0.58 |
RA-HCRU assessed healthcare 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, hours affected per day and average number of hours missed work per day were reported.
| hours per day | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: Home healthcare services (n=0,2,0,0) | NA ± NA | 2.00 ± 1.41 | NA ± NA | NA ± NA |
| Month 6: Work done (n=34,36,20,14) | 7.53 ± 2.19 | 10.36 ± 9.85 | 7.65 ± 2.16 | 10.21 ± 8.78 |
| Month 6: Chores by housekeeper (n=8,9,9,5) | 2.88 ± 2.36 | 3.78 ± 1.20 | 5.00 ± 3.28 | 5.00 ± 1.58 |
| Month 6: Chores by family/friend (n=31,22,18,19) | 3.16 ± 2.57 | 2.05 ± 1.05 | 2.72 ± 1.67 | 3.63 ± 5.58 |
| Month 6: Missed work due to RA (n=3,3,0,3) | 4.00 ± 0.00 | 2.67 ± 1.15 | NA ± NA | 2.00 ± 1.73 |
| Month 6: RA related home HC services (n=0,2,0,0) | NA ± NA | 1.00 ± 0.00 | NA ± NA | NA ± NA |
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline (n=73,76,72) | 4.27 ± 3.20 | 4.38 ± 3.12 | 4.65 ± 3.23 |
| Month 3 (n=63,72,73) | 3.52 ± 3.24 | 3.51 ± 4.73 | 4.04 ± 3.37 |
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
| units on a scale | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 3.27 ± 2.94 | 2.63 ± 2.75 | 3.33 ± 3.22 | 4.83 ± 3.33 |
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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 | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Baseline: TMS (n=42,54,48) | 43.96 ± 26.39 | 48.53 ± 25.03 | 50.91 ± 28.08 |
| Baseline: PDS (n=43,55,55) | 49.44 ± 28.49 | 48.95 ± 21.50 | 51.86 ± 25.25 |
| Baseline: MIDS (n=42,54,56) | 28.44 ± 24.35 | 31.79 ± 23.66 | 34.36 ± 27.68 |
| Baseline: ODS (n=41,50,52) | 41.95 ± 31.50 | 37.30 ± 25.74 | 40.20 ± 25.89 |
| Baseline: WLI (n=44,57,57) | 10.51 ± 6.07 | 10.27 ± 5.71 | 10.99 ± 5.96 |
| Month 3: TMS (n=38,50,42) | 36.09 ± 26.83 | 36.47 ± 26.72 | 47.62 ± 29.23 |
| Month 3: PDS (n=40,51,43) | 52.08 ± 30.74 | 47.20 ± 26.39 | 42.31 ± 24.32 |
| Month 3: MIDS (n=40,54,44) | 27.82 ± 28.80 | 28.60 ± 27.34 | 37.22 ± 28.70 |
| Month 3: ODS (n=39,51,43) | 26.30 ± 29.16 | 30.78 ± 26.12 | 42.67 ± 28.97 |
| Month 3: WLI (n=43,56,44) | 8.30 ± 6.57 | 8.73 ± 6.11 | 11.67 ± 6.29 |
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), 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 | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: TMS (n=39,42,23,18) | 26.96 ± 29.72 | 30.77 ± 27.83 | 32.50 ± 30.79 | 32.73 ± 25.10 |
| Month 6: PDS (n=38,42,24,18) | 47.53 ± 36.97 | 44.65 ± 30.60 | 40.94 ± 27.82 | 47.15 ± 29.47 |
| Month 6: MIDS (n=40,45,24,19) | 18.50 ± 26.90 | 29.84 ± 29.03 | 31.95 ± 32.26 | 30.68 ± 32.09 |
| Month 6: ODS (n=39,44,24,19) | 21.32 ± 27.74 | 29.20 ± 29.00 | 30.50 ± 31.94 | 33.68 ± 28.02 |
| Month 6: WLI (n=40,45,24,19) | 6.87 ± 6.53 | 8.78 ± 7.07 | 9.27 ± 7.06 | 9.62 ± 7.41 |
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Week 2: DAS28-3(CRP) <2.6 (n=127,125,124) | 8 | 12 | 2 |
| Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124) | 19 | 23 | 4 |
| Month 1: DAS28-3(CRP) <2.6 (n=132,133,131) | 14 | 7 | 3 |
| Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131) | 27 | 42 | 11 |
| Month 3: DAS28-3(CRP) <2.6 (n=132,133,131) | 27 | 35 | 6 |
| Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131) | 45 | 57 | 13 |
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 4.5: DAS28-3(CRP) <2.6 | 31 | 42 | 14 | 12 |
| Month 4.5: DAS28-3(CRP) <=3.2 | 50 | 57 | 21 | 19 |
| Month 6: DAS28-3(CRP) <2.6 | 35 | 36 | 11 | 9 |
| Month 6: DAS28-3(CRP) <=3.2 | 57 | 59 | 23 | 19 |
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo |
|---|---|---|---|
| Month 3: DAS28-4 (ESR) <2.6 | 8 | 14 | 2 |
| Month 3: DAS28-4 (ESR) <=3.2 | 17 | 28 | 6 |
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
| participants | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg |
|---|---|---|---|---|
| Month 6: DAS28-4(ESR) <2.6 | 13 | 20 | 7 | 2 |
| Month 6: DAS28-4 (ESR) <=3.2 | 35 | 37 | 11 | 11 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CP-690,550 5 mg Up to Month 3 | — | 2/133 (1.5%) | 37/133 (27.8%) |
| CP-690,550 10 mg Up to Month 3 | — | 2/134 (1.5%) | 43/134 (32.1%) |
| Placebo Up to Month 3 | — | 6/132 (4.5%) | 46/132 (34.8%) |
| CP-690,550 5 mg From Month 3 to 6 | — | 8/199 (4%) | 35/199 (17.6%) |
| CP-690,550 10 mg From Month 3 to 6 | — | 8/200 (4%) | 30/200 (15%) |
| Event | CP-690,550 5 mg Up to Month 3 | CP-690,550 10 mg Up to Month 3 | Placebo Up to Month 3 | CP-690,550 5 mg From Month 3 to 6 | CP-690,550 10 mg From Month 3 to 6 |
|---|---|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 1/133 | 0/134 | 0/132 | 2/199 | 0/200 |
| AnaemiaBlood and lymphatic system disorders | 0/133 | 0/134 | 0/132 | 0/199 | 2/200 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/133 | 0/134 | 0/132 | 0/199 | 2/200 |
| Drug ineffectiveGeneral disorders | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| GastroenteritisInfections and infestations | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| ContusionInjury, poisoning and procedural complications | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| Foot fractureInjury, poisoning and procedural complications | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| Joint sprainInjury, poisoning and procedural complications | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| DehydrationMetabolism and nutrition disorders | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| HyponatraemiaMetabolism and nutrition disorders | 0/133 | 0/134 | 1/132 | 0/199 | 0/200 |
| Event | CP-690,550 5 mg Up to Month 3 | CP-690,550 10 mg Up to Month 3 | Placebo Up to Month 3 | CP-690,550 5 mg From Month 3 to 6 | CP-690,550 10 mg From Month 3 to 6 |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 4/133 | 2/134 | 9/132 | 4/199 | 1/200 |
| DiarrhoeaGastrointestinal disorders | 8/133 | 5/134 | 5/132 | 0/199 | 0/200 |
| HeadacheNervous system disorders | 3/133 | 8/134 | 1/132 | 1/199 | 4/200 |
| NasopharyngitisInfections and infestations | 5/133 | 6/134 | 4/132 | 6/199 | 5/200 |
| Upper respiratory tract infectionInfections and infestations | 5/133 | 2/134 | 4/132 | 5/199 | 8/200 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/133 | 0/134 | 5/132 | 0/199 | 0/200 |
| Oedema peripheralGeneral disorders | 3/133 | 1/134 | 5/132 | 0/199 | 0/200 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/133 | 1/134 | 5/132 | 0/199 | 0/200 |
| Urinary tract infectionInfections and infestations | 5/133 | 3/134 | 3/132 | 4/199 | 2/200 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 3/133 | 1/134 | 4/132 | 7/199 | 0/200 |
| Age, Continuous(years) | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg | Total |
|---|---|---|---|---|---|
| Mean | 55.4 ± 11.5 | 55.1 ± 11.3 | 54.3 ± 11.7 | 54.5 ± 11.0 | 55.0 ± 11.3 |
| Sex: Female, Male(Participants) | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg | Total |
|---|---|---|---|---|---|
| Female | 113 | 116 | 53 | 53 | 335 |
| Male | 20 | 18 | 13 | 13 | 64 |
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