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CompletedNCT00550446Updated Jan 3, 2013Results posted

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

A Phase 2 interventional study of Adalimumab and CP-690-550 in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 63 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
386
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

02

Conditions studied

  • Arthritis, Rheumatoid

Keywords

  • Janus Kinase 3 Clinical Trial
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 386 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects must have active rheumatoid arthritis
  • Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
  • Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion criteria

Exclusion Criteria:

  • Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
  • Subjects who previously received adalimumab (Humira®) therapy for any reason.
  • Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
386 participants (actual)

Study arms

  • Active comparator
    1

    Drug: Adalimumab

  • Experimental
    2

    Drug: CP-690-550

  • Experimental
    3

    Drug: CP-690-550

  • Experimental
    4

    Drug: CP-690-550

  • Experimental
    5

    Drug: CP-690,550

  • Experimental
    6

    Drug: CP-690,550

  • Placebo comparator
    7

    Drug: Placebo

Interventions

  • DrugAdalimumab

    40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.

  • DrugCP-690-550

    15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

  • DrugCP-690-550

    10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

  • DrugCP-690-550

    5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

  • DrugCP-690,550

    3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

  • DrugCP-690,550

    1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

  • DrugPlacebo

    Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

    ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint 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).

    Time frame: Week 12

Secondary outcomes

  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

    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, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)

  2. Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response

    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, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  3. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

    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, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  4. Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response

    ACR90 response: \>= 90% improvement in TJC or SJC and 90% 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, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  5. Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

    ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

    Time frame: Baseline up to Week 2, 4, 6, 8, 10, 12

  6. Tender Joint Count (TJC)

    Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  7. Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET

    Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  8. Swollen Joint Counts (SJC)

    Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  9. Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24

    Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  10. Patient Assessment of Arthritis Pain

    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, 4, 6, 8, 10, 12, 16, 20, 24/ET

  11. Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

    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, 4, 6, 8, 10, 12, 16, 20 and 24/ET

  12. Patient Global Assessment (PtGA) of Arthritis Pain

    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, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  13. Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

    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, 4, 6, 8, 10, 12, 16, 20, 24/ET

  14. Physician Global Assessment (PGA) 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, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  15. Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

    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, 4, 6, 8, 10, 12, 16, 20, 24/ET

  16. C-Reactive Protein (CRP)

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  17. Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  18. 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; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  19. Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

    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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  20. Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

    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) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 = remission.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

  21. Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

    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 \< 2.6 = remission.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

  22. Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

    DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implies low disease activity and \> 3.2 to 5.1 implies moderate to high disease activity, and \< 2.6 = remission.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

  23. Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET

    DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR \[mm/hour\] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implies low disease activity and \> 3.2 to 5.1 implies moderate to high disease activity, and \< 2.6 = remission.

    Time frame: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  24. Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)

    Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of \>1.2 and a present score of \<=3.2; none: an improvement of \<=0.6 or \>0.6 to \<=1.2 with a present score of \>5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.

    Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

  25. Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)

    CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).

    Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

  26. Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)

    DAS28-3 (CRP) defined remission was classified as a score of \<2.6.

    Time frame: Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

  27. 36-Item Short-Form Health Survey (SF-36)

    SF-36 is a standardized survey evaluating 8 domains (of 2 components \[C\]; physical \[Ph\] and mental \[Mn\]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). 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 12, 24/ ET

  28. Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET

    SF-36 is a standardized survey evaluating 8 domains (of 2 components \[C\]; physical \[Ph\] and mental \[Mn\]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). 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 12, 24/ ET

  29. Euro Quality of Life 5 Dimension (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, Week 12, 24/ ET

  30. Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET

    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, Week 12, 24/ ET

Other outcomes

  1. Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels

    Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.

    Time frame: Baseline, Week 24/ ET

  2. Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24

    Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.

    Time frame: Baseline, Week 24/ ET

  3. Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers

    The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

    Time frame: Baseline, Week 24/ ET

  4. Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24

    The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

    Time frame: Baseline, Week 24/ ET

  5. Medical Outcome Study- Sleep Scale (MOS-SS)

    Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

    Time frame: Baseline, Week 2, 12, 24/ ET

  6. Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET

    Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\*100); total score range: 0 to 100; higher score = greater intensity of attribute.

    Time frame: Baseline, Week 2, 12, 24/ ET

  7. 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, Week 2, 12, 24/ ET

  8. Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET

    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, Week 2, 12, 24/ ET

07

Results

Posted Jan 3, 2013

Participant flow

Up To Week 12
Participant flow — Up To Week 12
MilestoneCP-690,550 1 mgCP-690,550 3 mgCP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabPlaceboCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mg to CP-690,550 5 mg (R)Adalimumab to CP-690,550 5 mg (R)Placebo to CP-690,550 5 mg (R)
Started545250615753590000
Treated545149615753590000
Completed444746585445460000
Not completed1054338130000
Withdrew: Adverse event22002210000
Withdrew: Lack of efficacy31010330000
Withdrew: Lost to follow-up01001120000
Withdrew: Withdrawal by subject20320130000
Withdrew: Other30000140000
Withdrew: Randomized not treated01100000000
Post Week 12
Participant flow — Post Week 12
MilestoneCP-690,550 1 mgCP-690,550 3 mgCP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabPlaceboCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mg to CP-690,550 5 mg (R)Adalimumab to CP-690,550 5 mg (R)Placebo to CP-690,550 5 mg (R)
Started273046585412117174425
Completed242843555201916153724
Not completed32332121271
Withdrew: Adverse event21111100040
Withdrew: Lack of efficacy00100001121
Withdrew: Lost to follow-up00110010000
Withdrew: Withdrawal by subject00001000000
Withdrew: Other11010010110

Outcome measures

PrimaryPercentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint 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).

Time frame:
Week 12
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
percentage of participantsCP-690,550 1 mgCP-690,550 3 mgCP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabPlacebo
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1231.4845.1061.2272.1371.9339.6223.73
SecondaryPercentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

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, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)16.67NA31.37NA32.6550.8238.6026.42NA15.25NA
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)22.22NA37.25NA40.8252.4663.1628.30NA27.12NA
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)38.89NA47.06NA63.2763.9366.6730.19NA25.42NA
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)37.04NA47.06NA63.2765.5771.9335.85NA27.12NA
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)35.19NA37.25NA57.1475.4175.4435.85NA23.73NA
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)51.40.058.80.067.370.571.90.00.035.30.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)45.90.064.70.069.473.871.90.00.032.40.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)35.10.058.80.057.173.868.40.00.047.10.0
SecondaryPercentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response

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, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)1.85NA7.84NA8.1618.0317.547.55NA1.69NA
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)9.26NA13.73NA10.2031.1540.359.43NA5.08NA
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)14.81NA15.69NA14.2936.0742.1116.98NA6.78NA
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)12.96NA21.57NA24.4929.5149.1216.98NA8.47NA
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)12.96NA17.65NA34.6950.8243.8615.09NA6.78NA
Week 12 (n=54,0,51,0,49,61,57,53,0,59,0)11.11NA25.49NA38.7845.9050.8820.75NA10.17NA
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)18.90.038.20.034.742.656.10.00.020.60.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)18.90.044.10.032.742.659.60.00.017.60.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)10.80.044.10.036.745.954.40.00.017.60.0
SecondaryPercentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

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, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)1.85NA1.96NA2.043.287.021.89NA0.00NA
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)0.00NA5.88NA2.0411.488.775.66NA1.69NA
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)3.70NA1.96NA4.0819.6717.545.66NA1.69NA
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)9.26NA3.92NA8.1618.0324.565.66NA1.69NA
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)3.70NA7.84NA16.3326.2321.053.77NA1.69NA
Week 12 (n=54,0,51,0,49,61,57,53,0,59,0)5.56NA11.76NA14.2924.5926.323.77NA3.39NA
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)10.80.026.50.020.429.533.30.00.00.00.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)10.80.017.60.018.431.131.60.00.08.80.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)8.10.023.50.022.437.733.30.00.011.80.0
SecondaryPercentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response

ACR90 response: \>= 90% improvement in TJC or SJC and 90% 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, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Number · percentage of participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)1.85NA0.00NA0.001.640.000.00NA0.00NA
Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)0.00NA0.00NA2.043.281.750.00NA0.00NA
Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)0.00NA0.00NA2.046.561.750.00NA0.00NA
Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)1.85NA0.00NA2.049.841.750.00NA0.00NA
Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)1.85NA1.96NA4.089.8410.531.89NA0.00NA
Week 12 (n=54,0,51,0,49,61,57,53,0,59,0)1.85NA1.96NA4.0811.487.020.00NA0.00NA
Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)2.70.05.90.08.213.18.80.00.00.00.0
Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)2.70.02.90.06.111.510.50.00.00.00.0
Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)2.70.05.90.06.114.812.30.00.00.00.0
SecondaryArea Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

Time frame:
Baseline up to Week 2, 4, 6, 8, 10, 12
Reported as:
Mean · units on a scale
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
units on a scaleCP-690,550 1 mgCP-690,550 3 mgCP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabPlacebo
Week 2-99.17 ± 430.60-21.41 ± 348.6036.11 ± 254.60117.91 ± 236.4016.24 ± 507.70-82.12 ± 436.48-97.56 ± 362.62
Week 4-328.58 ± 1190.65-31.17 ± 1068.34165.07 ± 685.88421.90 ± 700.43184.76 ± 1317.14-211.66 ± 1178.51-268.25 ± 906.61
Week 6-488.95 ± 2121.82-7.91 ± 1840.80416.04 ± 1117.60839.12 ± 1219.16584.69 ± 1864.04-280.67 ± 1925.43-430.41 ± 1471.10
Week 8-545.16 ± 3121.0930.98 ± 2675.04761.40 ± 1552.541311.99 ± 1736.671077.41 ± 2543.43-331.79 ± 2727.74-531.80 ± 2095.50
Week 10-588.77 ± 4109.7481.85 ± 3510.171163.37 ± 1985.691857.57 ± 2203.001539.51 ± 3768.28-337.47 ± 3478.31-642.56 ± 2805.90
Week 12-675.05 ± 5160.91145.08 ± 4380.781579.56 ± 2447.052443.62 ± 2701.932053.03 ± 4745.53-242.83 ± 4111.62-803.67 ± 3548.72
SecondaryTender Joint Count (TJC)

Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Mean · tender joints
Tender Joint Count (TJC)
tender jointsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,61,57,53,0,59,0)27.02 ± 15.39NA ± NA24.55 ± 11.31NA ± NA27.14 ± 14.6225.70 ± 13.9225.88 ± 13.3724.11 ± 13.86NA ± NA25.92 ± 12.92NA ± NA
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)21.98 ± 14.45NA ± NA16.94 ± 10.75NA ± NA18.79 ± 12.4215.33 ± 12.7417.42 ± 14.3319.40 ± 14.76NA ± NA20.00 ± 11.82NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)20.54 ± 17.43NA ± NA13.83 ± 11.80NA ± NA17.43 ± 13.0112.84 ± 12.5513.16 ± 14.9516.78 ± 14.79NA ± NA18.94 ± 13.30NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)15.13 ± 13.52NA ± NA12.67 ± 12.06NA ± NA14.33 ± 11.0610.95 ± 11.9511.27 ± 14.8915.73 ± 13.94NA ± NA17.77 ± 14.45NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)16.30 ± 14.14NA ± NA13.40 ± 12.74NA ± NA13.68 ± 12.5710.00 ± 11.819.15 ± 12.1814.87 ± 13.11NA ± NA15.93 ± 12.33NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)17.15 ± 17.32NA ± NA12.65 ± 11.89NA ± NA11.87 ± 11.177.68 ± 10.949.23 ± 12.8814.47 ± 15.20NA ± NA17.22 ± 14.38NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)18.32 ± 16.77NA ± NA12.33 ± 12.88NA ± NA11.52 ± 12.358.09 ± 12.028.44 ± 11.2614.74 ± 14.73NA ± NA15.50 ± 13.14NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)7.44 ± 8.3819.47 ± 14.066.27 ± 6.4919.41 ± 12.2510.85 ± 11.117.57 ± 11.087.22 ± 11.34NA ± NA8.70 ± 9.478.30 ± 9.0712.40 ± 12.24
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)10.41 ± 10.6916.19 ± 9.726.76 ± 8.2518.25 ± 15.6511.80 ± 12.826.66 ± 10.626.79 ± 9.69NA ± NA8.95 ± 10.568.16 ± 8.7412.60 ± 13.28
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)11.92 ± 13.6421.31 ± 14.816.59 ± 10.5816.60 ± 13.4910.47 ± 11.506.25 ± 10.127.27 ± 11.35NA ± NA10.44 ± 9.978.75 ± 8.5910.54 ± 13.09
SecondaryChange From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET

Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Mean · tender joints
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET
tender jointsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)-5.04 ± 12.12NA ± NA-7.61 ± 9.31NA ± NA-8.23 ± 12.61-10.28 ± 12.57-8.46 ± 12.87-4.72 ± 10.97NA ± NA-6.19 ± 11.84NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)-6.56 ± 14.49NA ± NA-10.43 ± 10.53NA ± NA-10.33 ± 10.76-13.00 ± 12.73-12.85 ± 14.91-7.67 ± 11.40NA ± NA-7.23 ± 11.39NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)-11.96 ± 15.35NA ± NA-11.38 ± 11.02NA ± NA-13.40 ± 13.50-14.49 ± 13.52-14.38 ± 14.86-8.83 ± 13.02NA ± NA-8.69 ± 13.86NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)-11.83 ± 13.56NA ± NA-10.65 ± 11.06NA ± NA-13.70 ± 13.86-15.61 ± 13.82-15.57 ± 13.80-8.57 ± 12.44NA ± NA-9.67 ± 11.63NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)-11.07 ± 16.23NA ± NA-11.65 ± 10.87NA ± NA-15.93 ± 13.92-17.51 ± 14.08-15.77 ± 12.77-9.89 ± 12.54NA ± NA-8.72 ± 13.22NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)-9.57 ± 15.80NA ± NA-11.04 ± 11.42NA ± NA-16.24 ± 13.32-16.74 ± 14.23-16.28 ± 12.25-9.30 ± 11.96NA ± NA-10.43 ± 14.72NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)-19.11 ± 13.88-10.53 ± 12.43-15.03 ± 9.88-8.47 ± 12.51-16.91 ± 13.06-17.48 ± 13.24-17.50 ± 13.29NA ± NA-15.09 ± 12.35-19.55 ± 13.02-12.40 ± 10.17
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)-16.15 ± 16.26-13.38 ± 11.59-15.28 ± 11.11-10.00 ± 13.23-15.98 ± 13.20-17.53 ± 12.86-17.57 ± 13.62NA ± NA-15.18 ± 11.25-18.16 ± 13.00-12.20 ± 12.02
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)-12.63 ± 14.37-8.25 ± 13.75-15.45 ± 13.03-10.47 ± 13.60-17.58 ± 15.22-18.42 ± 13.64-17.02 ± 14.14NA ± NA-13.10 ± 12.94-19.10 ± 14.88-14.21 ± 12.25
SecondarySwollen Joint Counts (SJC)

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Mean · swollen joints
Swollen Joint Counts (SJC)
swollen jointsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,61,57,53,0,59,0)16.70 ± 8.89NA ± NA15.90 ± 8.50NA ± NA17.35 ± 10.2616.33 ± 8.2816.93 ± 9.0314.91 ± 8.12NA ± NA16.90 ± 9.77NA ± NA
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)11.87 ± 7.69NA ± NA12.82 ± 10.23NA ± NA12.27 ± 8.9010.55 ± 9.1311.25 ± 8.9111.58 ± 9.96NA ± NA13.25 ± 8.95NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)12.78 ± 13.24NA ± NA10.98 ± 10.67NA ± NA10.43 ± 9.158.50 ± 7.607.55 ± 8.8910.08 ± 8.75NA ± NA13.11 ± 9.10NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)9.58 ± 9.11NA ± NA10.08 ± 9.55NA ± NA8.29 ± 5.777.03 ± 7.246.55 ± 8.029.27 ± 9.52NA ± NA13.44 ± 11.47NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)11.11 ± 11.67NA ± NA9.88 ± 10.87NA ± NA8.15 ± 7.467.02 ± 8.635.91 ± 7.658.89 ± 10.84NA ± NA11.37 ± 9.64NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)10.63 ± 10.89NA ± NA9.35 ± 9.52NA ± NA6.93 ± 7.115.39 ± 7.475.68 ± 7.969.11 ± 11.81NA ± NA12.76 ± 11.21NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)11.39 ± 11.23NA ± NA9.26 ± 10.74NA ± NA7.33 ± 7.155.58 ± 7.845.11 ± 7.157.41 ± 7.83NA ± NA11.85 ± 9.64NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)6.44 ± 7.2910.82 ± 7.634.50 ± 5.4814.88 ± 13.155.96 ± 6.545.34 ± 7.914.46 ± 7.64NA ± NA4.56 ± 5.595.90 ± 6.029.76 ± 8.53
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)7.89 ± 7.9510.31 ± 8.555.03 ± 7.5914.38 ± 13.996.71 ± 6.964.60 ± 7.824.36 ± 7.17NA ± NA5.52 ± 7.685.21 ± 4.507.92 ± 6.95
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)8.92 ± 11.0110.94 ± 9.044.86 ± 7.8113.27 ± 13.015.88 ± 6.384.44 ± 7.784.10 ± 6.83NA ± NA5.67 ± 7.465.95 ± 6.266.04 ± 6.40
SecondaryChange From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Mean · swollen joints
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24
swollen jointsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)-4.83 ± 7.04NA ± NA-3.08 ± 8.86NA ± NA-4.85 ± 9.65-5.67 ± 6.94-5.68 ± 9.98-3.32 ± 9.25NA ± NA-3.74 ± 8.33NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)-4.08 ± 10.31NA ± NA-4.66 ± 9.88NA ± NA-6.63 ± 9.01-8.02 ± 7.03-9.55 ± 11.00-4.57 ± 8.52NA ± NA-4.06 ± 8.76NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)-7.88 ± 9.28NA ± NA-5.54 ± 9.76NA ± NA-8.69 ± 9.13-9.36 ± 7.60-10.51 ± 10.61-5.75 ± 8.32NA ± NA-3.87 ± 10.53NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)-6.36 ± 10.05NA ± NA-5.75 ± 9.94NA ± NA-8.70 ± 9.60-9.19 ± 7.70-10.85 ± 10.60-6.17 ± 8.50NA ± NA-5.33 ± 9.12NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)-6.70 ± 8.60NA ± NA-6.33 ± 9.40NA ± NA-9.89 ± 9.78-11.11 ± 7.99-11.28 ± 10.79-6.00 ± 9.66NA ± NA-3.50 ± 11.31NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)-6.07 ± 9.67NA ± NA-5.85 ± 10.70NA ± NA-9.74 ± 10.28-10.91 ± 8.48-11.65 ± 10.26-7.83 ± 7.52NA ± NA-4.41 ± 9.89NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)-11.00 ± 8.75-6.65 ± 9.84-9.97 ± 6.98-1.24 ± 13.15-11.11 ± 9.87-11.27 ± 8.86-12.30 ± 10.98NA ± NA-10.86 ± 8.03-10.25 ± 6.77-7.00 ± 11.08
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)-9.56 ± 9.21-6.06 ± 9.70-9.90 ± 9.32-2.19 ± 14.28-10.40 ± 10.40-11.17 ± 7.92-12.68 ± 10.65NA ± NA-9.91 ± 7.50-11.47 ± 7.46-8.84 ± 9.92
Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)-8.58 ± 8.98-5.44 ± 9.33-10.07 ± 9.70-1.60 ± 14.34-11.60 ± 11.55-11.75 ± 7.82-13.10 ± 10.44NA ± NA-9.46 ± 9.37-10.20 ± 7.78-11.00 ± 11.16
SecondaryPatient Assessment of Arthritis Pain

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, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mm
Patient Assessment of Arthritis Pain
mmCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,61,56,53,0,59,0)59.74 ± 23.56NA ± NA61.25 ± 23.93NA ± NA64.14 ± 23.5562.92 ± 18.7463.46 ± 25.2664.36 ± 21.46NA ± NA60.29 ± 23.23NA ± NA
Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)53.76 ± 24.49NA ± NA45.25 ± 24.19NA ± NA47.10 ± 24.4843.90 ± 23.4341.28 ± 28.0648.00 ± 25.09NA ± NA55.26 ± 26.70NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)51.72 ± 24.91NA ± NA41.91 ± 23.80NA ± NA43.65 ± 22.5633.28 ± 22.3732.69 ± 23.7746.78 ± 23.85NA ± NA50.89 ± 23.50NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)47.31 ± 24.21NA ± NA42.75 ± 22.17NA ± NA39.24 ± 22.7333.68 ± 22.5230.24 ± 25.4646.27 ± 28.16NA ± NA49.63 ± 24.08NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)47.28 ± 25.46NA ± NA41.21 ± 22.19NA ± NA33.91 ± 23.5633.05 ± 22.3426.74 ± 26.0143.17 ± 25.22NA ± NA47.26 ± 23.25NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)45.70 ± 26.30NA ± NA43.24 ± 23.23NA ± NA34.67 ± 24.3428.11 ± 21.8023.38 ± 22.0348.73 ± 27.32NA ± NA44.96 ± 24.72NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)47.25 ± 25.81NA ± NA42.30 ± 26.89NA ± NA32.70 ± 25.2328.14 ± 22.7927.26 ± 25.8842.87 ± 25.76NA ± NA43.93 ± 24.16NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)35.00 ± 26.6349.29 ± 29.8134.97 ± 29.1647.88 ± 25.8731.39 ± 23.7229.05 ± 26.2324.24 ± 23.60NA ± NA30.16 ± 21.5237.55 ± 22.4228.16 ± 22.28
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)39.67 ± 27.2843.38 ± 24.6934.66 ± 29.7538.81 ± 25.4533.13 ± 24.5727.43 ± 23.9823.21 ± 22.60NA ± NA31.68 ± 22.6836.95 ± 25.8031.64 ± 20.22
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)44.13 ± 24.3244.00 ± 28.6330.62 ± 28.3631.87 ± 20.4731.81 ± 27.7222.85 ± 22.0425.31 ± 22.28NA ± NA34.33 ± 24.8731.35 ± 22.5129.83 ± 18.37
SecondaryChange From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

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, 4, 6, 8, 10, 12, 16, 20 and 24/ET
Reported as:
Mean · mm
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
mmCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,48,60,56,53,0,57,0)-5.98 ± 25.77NA ± NA-16.00 ± 17.89NA ± NA-16.33 ± 20.70-19.33 ± 22.50-23.11 ± 29.72-16.36 ± 23.18NA ± NA-5.14 ± 25.64NA ± NA
Week 4 (n=50,0,47,0,46,58,54,49,0,53,0)-6.78 ± 30.17NA ± NA-19.04 ± 19.15NA ± NA-20.28 ± 21.33-28.60 ± 24.09-32.41 ± 29.39-16.96 ± 28.05NA ± NA-7.89 ± 23.27NA ± NA
Week 6 (n=48,0,48,0,45,59,54,48,0,52,0)-11.42 ± 28.68NA ± NA-17.23 ± 23.04NA ± NA-25.04 ± 22.63-28.80 ± 22.13-33.50 ± 29.39-18.35 ± 26.77NA ± NA-9.08 ± 22.68NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)-11.68 ± 29.48NA ± NA-18.77 ± 20.45NA ± NA-30.02 ± 25.59-29.07 ± 23.84-35.83 ± 30.52-20.83 ± 27.49NA ± NA-10.28 ± 23.46NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)-13.98 ± 27.46NA ± NA-17.39 ± 22.24NA ± NA-29.30 ± 26.46-34.77 ± 25.60-38.94 ± 29.33-16.80 ± 26.12NA ± NA-12.63 ± 21.45NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)-11.61 ± 31.51NA ± NA-16.04 ± 22.11NA ± NA-31.24 ± 24.72-34.47 ± 25.63-35.31 ± 31.92-23.15 ± 27.70NA ± NA-13.65 ± 24.40NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)-19.00 ± 33.30-17.29 ± 29.71-18.73 ± 25.91-21.00 ± 22.29-32.54 ± 23.55-33.77 ± 27.27-38.33 ± 30.31NA ± NA-36.37 ± 22.95-16.05 ± 24.30-33.40 ± 25.97
Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)-14.33 ± 28.92-22.19 ± 29.73-19.66 ± 25.00-29.50 ± 25.80-31.67 ± 20.98-34.66 ± 23.72-39.55 ± 31.04NA ± NA-35.09 ± 27.62-15.58 ± 25.51-29.92 ± 23.24
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)-9.83 ± 29.65-21.56 ± 35.86-23.69 ± 24.12-36.00 ± 18.57-32.84 ± 25.37-39.69 ± 22.62-37.83 ± 28.84NA ± NA-31.48 ± 28.90-22.25 ± 25.21-31.63 ± 24.22
SecondaryPatient Global Assessment (PtGA) of Arthritis Pain

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, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mm
Patient Global Assessment (PtGA) of Arthritis Pain
mmCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,61,57,53,0,59,0)60.74 ± 24.83NA ± NA59.76 ± 22.75NA ± NA67.55 ± 22.4462.41 ± 19.9462.77 ± 27.2462.15 ± 21.87NA ± NA61.41 ± 21.32NA ± NA
Week 2 (n=53,0,51,0,48,60,57,53,0,57,0)54.36 ± 23.84NA ± NA48.49 ± 24.49NA ± NA50.58 ± 24.5541.82 ± 24.0942.02 ± 25.7748.00 ± 24.15NA ± NA58.93 ± 25.12NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)52.96 ± 23.69NA ± NA44.68 ± 23.55NA ± NA44.54 ± 23.1034.86 ± 23.1534.73 ± 25.0546.24 ± 23.10NA ± NA51.40 ± 23.47NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)47.08 ± 23.11NA ± NA41.52 ± 21.65NA ± NA39.07 ± 22.4733.63 ± 22.0131.09 ± 25.2043.46 ± 25.41NA ± NA49.71 ± 22.73NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)46.57 ± 27.58NA ± NA43.02 ± 23.13NA ± NA34.81 ± 23.9533.42 ± 23.3928.07 ± 26.8643.85 ± 23.60NA ± NA46.74 ± 23.66NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)45.80 ± 27.90NA ± NA43.57 ± 24.39NA ± NA35.04 ± 24.2629.09 ± 21.5222.72 ± 23.3646.11 ± 25.71NA ± NA47.24 ± 24.12NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)45.39 ± 26.12NA ± NA40.78 ± 26.08NA ± NA33.52 ± 24.2629.02 ± 23.0926.39 ± 26.5544.04 ± 25.24NA ± NA44.85 ± 23.59NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)36.07 ± 25.8852.00 ± 28.9335.03 ± 29.5244.24 ± 25.7830.37 ± 23.5830.71 ± 25.6924.72 ± 23.11NA ± NA31.33 ± 18.8038.65 ± 22.3732.48 ± 20.69
Week 20 (n=27,16,29,16,45,53,52,0,44,19,25)39.74 ± 27.7247.19 ± 24.3635.41 ± 29.1341.44 ± 24.8633.91 ± 24.9028.06 ± 23.2623.90 ± 22.38NA ± NA30.95 ± 21.4735.84 ± 26.2136.20 ± 21.44
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)43.08 ± 23.9245.69 ± 26.1533.07 ± 27.9033.20 ± 19.7733.77 ± 28.4424.85 ± 22.2926.58 ± 23.04NA ± NA34.45 ± 23.6032.05 ± 22.6328.13 ± 17.42
SecondaryChange From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

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, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mm
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
mmCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=53,0,51,0,48,60,57,53,0,57,0)-5.72 ± 22.55NA ± NA-11.27 ± 18.57NA ± NA-16.33 ± 26.14-21.48 ± 25.18-20.75 ± 28.26-14.15 ± 25.21NA ± NA-2.84 ± 26.71NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)-6.62 ± 28.20NA ± NA-15.51 ± 22.14NA ± NA-23.15 ± 24.65-26.52 ± 25.06-28.29 ± 28.34-15.35 ± 25.66NA ± NA-9.64 ± 22.16NA ± NA
Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)-13.58 ± 29.19NA ± NA-17.77 ± 25.31NA ± NA-28.89 ± 24.62-28.39 ± 25.53-31.49 ± 29.39-18.69 ± 24.71NA ± NA-11.27 ± 18.60NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)-13.79 ± 27.05NA ± NA-16.27 ± 21.81NA ± NA-32.91 ± 28.68-28.18 ± 26.81-34.11 ± 29.33-18.23 ± 29.39NA ± NA-13.24 ± 19.77NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)-14.70 ± 26.43NA ± NA-16.21 ± 21.93NA ± NA-32.93 ± 28.11-33.21 ± 27.96-39.25 ± 28.87-17.42 ± 26.53NA ± NA-12.93 ± 22.30NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)-15.05 ± 29.31NA ± NA-16.96 ± 22.92NA ± NA-34.17 ± 25.62-33.09 ± 28.82-35.80 ± 30.90-19.80 ± 29.70NA ± NA-15.33 ± 22.06NA ± NA
Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)-19.81 ± 29.62-15.65 ± 29.98-20.60 ± 24.26-19.35 ± 22.34-37.33 ± 25.23-31.50 ± 28.85-37.46 ± 29.80NA ± NA-33.19 ± 25.10-16.75 ± 24.67-32.44 ± 22.40
Week 20 (n=27,16,29,16,45,53,52,0,44,19,25)-16.15 ± 30.54-19.69 ± 31.12-20.38 ± 23.79-21.00 ± 17.74-34.73 ± 24.52-32.87 ± 24.10-37.65 ± 32.14NA ± NA-33.64 ± 28.30-18.74 ± 20.40-28.72 ± 22.80
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)-12.96 ± 26.46-21.19 ± 33.96-22.72 ± 25.10-27.93 ± 15.08-34.72 ± 26.19-37.31 ± 25.58-36.10 ± 29.30NA ± NA-29.33 ± 34.25-23.35 ± 16.74-36.75 ± 21.95
SecondaryPhysician Global Assessment (PGA) 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, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mm
Physician Global Assessment (PGA) of Arthritis
mmCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,50,0,48,60,57,53,0,59,0)62.13 ± 16.69NA ± NA62.10 ± 18.37NA ± NA65.85 ± 14.3661.05 ± 15.7867.19 ± 17.9362.77 ± 15.18NA ± NA63.02 ± 18.74NA ± NA
Week 2 (n=54,0,51,0,46,60,57,53,0,57,0)52.30 ± 21.90NA ± NA47.88 ± 20.86NA ± NA50.37 ± 21.9039.85 ± 18.6944.98 ± 21.6147.58 ± 20.95NA ± NA55.19 ± 19.98NA ± NA
Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)47.30 ± 20.40NA ± NA41.23 ± 20.80NA ± NA43.3 ± 19.4934.55 ± 20.6831.89 ± 20.3844.02 ± 20.06NA ± NA50.15 ± 20.92NA ± NA
Week 6 (n=48,0,47,0,45,59,55,48,0,52,0)39.75 ± 21.73NA ± NA34.98 ± 21.30NA ± NA39.40 ± 20.4031.22 ± 19.5128.56 ± 21.4739.83 ± 22.75NA ± NA46.12 ± 24.57NA ± NA
Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)40.06 ± 22.39NA ± NA36.54 ± 23.22NA ± NA31.79 ± 19.9429.56 ± 18.6025.20 ± 21.8538.34 ± 21.38NA ± NA43.91 ± 20.78NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)41.65 ± 23.12NA ± NA38.78 ± 24.18NA ± NA33.70 ± 20.0324.72 ± 18.8323.68 ± 18.7640.69 ± 25.21NA ± NA44.83 ± 21.34NA ± NA
Week 12 (n=43,0,46,0,46,57,54,46,0,46,0)41.72 ± 23.11NA ± NA36.65 ± 23.47NA ± NA29.80 ± 19.1325.37 ± 20.0124.20 ± 18.7438.22 ± 23.33NA ± NA44.76 ± 24.90NA ± NA
Week 16 (n=27,17,30,17,46,56,53,0,43,20,25)29.93 ± 19.5848.59 ± 20.9226.97 ± 23.5344.59 ± 21.9929.74 ± 20.3124.39 ± 19.1421.09 ± 19.71NA ± NA25.74 ± 15.9628.70 ± 22.7634.00 ± 20.65
Week 20 (n=27,16,29,16,45,52,53,0,44,19,25)32.59 ± 20.1745.69 ± 15.9823.86 ± 20.4541.25 ± 23.7727.04 ± 17.1619.35 ± 14.1019.42 ± 17.92NA ± NA26.36 ± 17.7629.95 ± 21.3132.40 ± 19.24
Week 24 (n=24,15,28,15,43,55,51,0,40,20,24)35.21 ± 23.9141.20 ± 19.2722.50 ± 23.3732.00 ± 19.1330.26 ± 20.9120.13 ± 16.5019.06 ± 16.73NA ± NA27.05 ± 17.5524.05 ± 17.7529.42 ± 21.01
SecondaryChange From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

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, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mm
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
mmCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,50,0,46,59,57,53,0,57,0)-9.83 ± 18.32NA ± NA-14.24 ± 19.94NA ± NA-14.93 ± 22.19-21.14 ± 20.74-22.21 ± 26.01-15.19 ± 19.07NA ± NA-8.00 ± 21.96NA ± NA
Week 4 (n=50,0,46,0,45,57,55,49,0,53,0)-14.24 ± 18.08NA ± NA-21.93 ± 22.49NA ± NA-22.24 ± 21.63-26.61 ± 23.51-36.24 ± 26.36-18.65 ± 23.07NA ± NA-12.47 ± 25.24NA ± NA
Week 6 (n=48,0,47,0,44,58,55,48,0,52,0)-22.10 ± 22.45NA ± NA-26.70 ± 23.32NA ± NA-26.36 ± 21.04-30.48 ± 22.57-38.24 ± 27.62-23.44 ± 21.38NA ± NA-17.38 ± 27.00NA ± NA
Week 8 (n=47,0,47,0,46,56,54,47,0,46,0)-21.72 ± 21.14NA ± NA-25.53 ± 24.00NA ± NA-33.48 ± 22.13-31.88 ± 21.14-41.04 ± 26.88-24.45 ± 21.70NA ± NA-20.22 ± 25.40NA ± NA
Week 10 (n=46,0,48,0,45,56,53,45,0,46,0)-20.04 ± 22.75NA ± NA-23.31 ± 24.67NA ± NA-32.20 ± 23.25-36.93 ± 23.90-42.70 ± 25.85-23.31 ± 24.37NA ± NA-19.41 ± 24.91NA ± NA
Week 12 (n=43,0,46,0,45,56,54,46,0,46,0)-19.33 ± 20.91NA ± NA-24.57 ± 23.98NA ± NA-35.84 ± 20.73-36.50 ± 22.13-42.04 ± 24.60-25.74 ± 23.17NA ± NA-19.48 ± 27.84NA ± NA
Week 16 (n=27,17,29,17,45,55,53,0,43,20,25)-28.11 ± 19.93-18.59 ± 24.63-31.24 ± 31.83-23.59 ± 17.14-35.60 ± 22.92-37.87 ± 21.09-44.66 ± 26.28NA ± NA-37.28 ± 19.72-35.15 ± 25.29-29.96 ± 23.75
Week 20 (n=27,16,28,16,44,51,53,0,44,19,25)-25.44 ± 17.89-20.38 ± 20.91-33.29 ± 28.80-25.19 ± 18.46-38.55 ± 21.77-41.49 ± 18.87-47.11 ± 23.87NA ± NA-36.86 ± 20.07-32.89 ± 19.37-31.56 ± 24.08
Week 24 (n=24,15,27,15,42,54,51,0,40,20,24)-24.38 ± 13.92-24.87 ± 25.37-34.78 ± 32.39-33.73 ± 17.12-35.55 ± 24.81-41.59 ± 18.94-47.12 ± 23.42NA ± NA-35.83 ± 22.06-39.80 ± 24.35-35.13 ± 23.70
SecondaryC-Reactive Protein (CRP)

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mg/L
C-Reactive Protein (CRP)
mg/LCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,61,57,53,0,59,0)21.39 ± 22.17NA ± NA16.22 ± 19.53NA ± NA24.51 ± 30.3916.66 ± 16.8521.70 ± 33.0120.09 ± 23.47NA ± NA23.53 ± 27.07NA ± NA
Week 2 (n=53,0,51,0,48,60,57,52,0,56,0)16.09 ± 17.96NA ± NA11.63 ± 16.13NA ± NA9.33 ± 17.714.37 ± 5.986.18 ± 9.459.54 ± 13.93NA ± NA31.14 ± 36.74NA ± NA
Week 4 (n=50,0,48,0,45,57,53,49,0,53,0)16.81 ± 19.66NA ± NA9.33 ± 13.20NA ± NA7.32 ± 10.203.15 ± 5.935.04 ± 7.1513.74 ± 19.51NA ± NA26.69 ± 35.34NA ± NA
Week 6 (n=47,0,48,0,45,58,55,48,0,52,0)15.47 ± 16.19NA ± NA8.76 ± 12.52NA ± NA7.73 ± 9.804.00 ± 7.254.43 ± 6.2115.47 ± 21.75NA ± NA27.13 ± 33.02NA ± NA
Week 8 (n=47,0,48,0,47,56,53,47,0,45,0)21.80 ± 33.09NA ± NA12.61 ± 26.98NA ± NA7.22 ± 11.353.52 ± 5.824.50 ± 7.8013.60 ± 18.86NA ± NA27.06 ± 33.94NA ± NA
Week 10 (n=46,0,48,0,46,57,52,45,0,46,0)15.89 ± 21.85NA ± NA8.20 ± 12.04NA ± NA7.49 ± 10.772.34 ± 1.903.14 ± 4.4514.31 ± 18.37NA ± NA29.87 ± 36.82NA ± NA
Week 12 (n=43,0,46,0,45,54,52,45,0,45,0)16.89 ± 21.34NA ± NA9.23 ± 12.64NA ± NA8.13 ± 12.013.12 ± 3.483.62 ± 3.8814.53 ± 20.30NA ± NA37.00 ± 52.65NA ± NA
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)11.64 ± 15.989.86 ± 18.857.64 ± 11.069.21 ± 12.038.03 ± 16.574.65 ± 7.384.50 ± 7.05NA ± NA5.73 ± 7.6621.98 ± 28.436.04 ± 7.33
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)8.90 ± 7.914.02 ± 3.327.32 ± 8.757.20 ± 12.144.72 ± 4.572.85 ± 3.815.34 ± 9.65NA ± NA6.82 ± 9.2117.89 ± 15.344.65 ± 5.85
Week 24 (n=24,16,28,15,41,55,52,0,40,20,24)12.41 ± 13.5110.51 ± 18.3310.02 ± 15.125.74 ± 6.426.31 ± 7.795.65 ± 10.512.51 ± 2.50NA ± NA6.01 ± 9.0218.35 ± 17.495.39 ± 8.57
SecondaryChange From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · mg/L
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
mg/LCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=53,0,51,0,48,60,57,52,0,56,0)-5.59 ± 12.00NA ± NA-4.59 ± 11.53NA ± NA-15.32 ± 25.84-11.77 ± 16.87-15.53 ± 28.18-10.82 ± 17.70NA ± NA7.63 ± 20.15NA ± NA
Week 4 (n=50,0,48,0,45,57,53,49,0,53,0)-5.35 ± 15.23NA ± NA-6.84 ± 13.87NA ± NA-16.47 ± 27.76-13.88 ± 15.71-16.29 ± 32.42-6.73 ± 19.31NA ± NA3.68 ± 30.09NA ± NA
Week 6 (n=47,0,48,0,45,58,55,48,0,52,0)-7.04 ± 17.82NA ± NA-7.46 ± 15.68NA ± NA-18.20 ± 25.77-13.09 ± 18.13-17.78 ± 31.72-5.64 ± 21.52NA ± NA4.13 ± 24.29NA ± NA
Week 8 (n=47,0,48,0,47,56,53,47,0,45,0)-0.88 ± 34.23NA ± NA-3.61 ± 29.34NA ± NA-17.68 ± 26.27-12.70 ± 16.84-18.12 ± 33.97-7.65 ± 22.81NA ± NA1.68 ± 25.86NA ± NA
Week 10 (n=46,0,48,0,46,57,52,45,0,46,0)-7.41 ± 17.95NA ± NA-7.97 ± 16.96NA ± NA-17.80 ± 30.17-14.46 ± 17.28-19.68 ± 33.41-7.02 ± 21.73NA ± NA6.60 ± 26.07NA ± NA
Week 12 (n=43,0,46,0,45,54,52,45,0,45,0)-5.62 ± 19.89NA ± NA-6.79 ± 18.44NA ± NA-15.67 ± 27.63-13.28 ± 16.77-17.12 ± 29.92-7.29 ± 23.48NA ± NA13.27 ± 45.76NA ± NA
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)-5.08 ± 21.05-21.54 ± 34.58-4.63 ± 17.15-12.89 ± 23.41-15.57 ± 28.20-12.54 ± 19.07-18.41 ± 33.75NA ± NA-16.19 ± 25.25-0.54 ± 19.76-18.29 ± 27.14
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)-8.39 ± 13.06-25.36 ± 28.34-5.33 ± 17.10-14.73 ± 25.04-19.21 ± 28.52-14.08 ± 17.85-17.67 ± 35.23NA ± NA-15.09 ± 25.59-6.87 ± 17.01-19.68 ± 30.10
Week 24 (n=24,16,28,15,41,55,52,0,40,20,24)-4.19 ± 14.90-18.87 ± 31.77-2.25 ± 20.44-17.13 ± 26.10-19.43 ± 29.21-10.50 ± 19.53-20.43 ± 33.71NA ± NA-16.00 ± 25.94-4.18 ± 21.73-19.77 ± 30.92
SecondaryHealth 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; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · units on a scale
Health Assessment Questionnaire-Disability Index (HAQ-DI)
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,60,57,53,0,58,0)1.57 ± 0.69NA ± NA1.53 ± 0.63NA ± NA1.40 ± 0.731.49 ± 0.741.62 ± 0.701.44 ± 0.64NA ± NA1.54 ± 0.68NA ± NA
Week 2 (n=54,0,51,0,48,60,57,53,0,56,0)1.45 ± 0.66NA ± NA1.28 ± 0.63NA ± NA1.22 ± 0.731.22 ± 0.681.26 ± 0.661.23 ± 0.68NA ± NA1.49 ± 0.67NA ± NA
Week 4 (n=50,0,46,0,45,57,55,49,0,53,0)1.45 ± 0.65NA ± NA1.23 ± 0.69NA ± NA1.14 ± 0.671.04 ± 0.741.08 ± 0.681.31 ± 0.77NA ± NA1.38 ± 0.72NA ± NA
Week 6 (n=48,0,48,0,44,59,54,48,0,52,0)1.30 ± 0.63NA ± NA1.24 ± 0.65NA ± NA1.14 ± 0.711.00 ± 0.720.93 ± 0.711.19 ± 0.83NA ± NA1.31 ± 0.70NA ± NA
Week 8 (n=47,0,48,0,46,57,54,47,0,46,0)1.29 ± 0.72NA ± NA1.12 ± 0.70NA ± NA0.99 ± 0.650.97 ± 0.750.86 ± 0.681.12 ± 0.75NA ± NA1.24 ± 0.70NA ± NA
Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)1.25 ± 0.77NA ± NA1.20 ± 0.70NA ± NA0.94 ± 0.750.86 ± 0.680.81 ± 0.711.18 ± 0.73NA ± NA1.24 ± 0.68NA ± NA
Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)1.28 ± 0.72NA ± NA1.09 ± 0.72NA ± NA0.94 ± 0.730.81 ± 0.680.78 ± 0.661.13 ± 0.74NA ± NA1.24 ± 0.76NA ± NA
Week 16 (n=27,17,29,17,46,56,54,0,43,20,25)1.02 ± 0.721.34 ± 0.811.04 ± 0.791.31 ± 0.720.91 ± 0.740.85 ± 0.720.73 ± 0.63NA ± NA0.95 ± 0.671.28 ± 0.660.86 ± 0.82
Week 20 (n=27,16,29,15,45,53,52,0,44,19,25)1.05 ± 0.711.20 ± 0.651.00 ± 0.781.04 ± 0.670.96 ± 0.760.80 ± 0.750.71 ± 0.65NA ± NA0.95 ± 0.711.30 ± 0.690.82 ± 0.78
Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)1.02 ± 0.651.29 ± 0.660.96 ± 0.831.00 ± 0.740.95 ± 0.810.81 ± 0.730.79 ± 0.67NA ± NA0.93 ± 0.651.20 ± 0.810.69 ± 0.75
SecondaryChange From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · units on a scale
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,48,59,57,53,0,56,0)-0.13 ± 0.41NA ± NA-0.25 ± 0.44NA ± NA-0.16 ± 0.47-0.27 ± 0.37-0.36 ± 0.63-0.21 ± 0.44NA ± NA-0.04 ± 0.40NA ± NA
Week 4 (n=50,0,46,0,45,56,55,49,0,52,0)-0.14 ± 0.62NA ± NA-0.30 ± 0.53NA ± NA-0.26 ± 0.51-0.44 ± 0.60-0.55 ± 0.61-0.14 ± 0.68NA ± NA-0.09 ± 0.67NA ± NA
Week 6 (n=48,0,48,0,44,58,54,48,0,51,0)-0.31 ± 0.48NA ± NA-0.28 ± 0.60NA ± NA-0.30 ± 0.56-0.49 ± 0.49-0.68 ± 0.73-0.25 ± 0.63NA ± NA-0.17 ± 0.46NA ± NA
Week 8 (n=47,0,48,0,46,56,54,47,0,45,0)-0.34 ± 0.56NA ± NA-0.40 ± 0.63NA ± NA-0.37 ± 0.61-0.54 ± 0.60-0.73 ± 0.66-0.32 ± 0.62NA ± NA-0.24 ± 0.51NA ± NA
Week 10 (n=46,0,49,0,46,56,53,45,0,45,0)-0.36 ± 0.51NA ± NA-0.34 ± 0.52NA ± NA-0.45 ± 0.68-0.59 ± 0.56-0.78 ± 0.67-0.29 ± 0.66NA ± NA-0.24 ± 0.52NA ± NA
Week 12 (n=44,0,46,0,46,56,54,46,0,45,0)-0.30 ± 0.51NA ± NA-0.42 ± 0.63NA ± NA-0.43 ± 0.65-0.63 ± 0.58-0.81 ± 0.71-0.32 ± 0.59NA ± NA-0.24 ± 0.52NA ± NA
Week 16 (n=27,17,29,17,46,55,54,0,43,20,24)-0.54 ± 0.63-0.29 ± 0.58-0.46 ± 0.55-0.31 ± 0.54-0.47 ± 0.66-0.60 ± 0.68-0.86 ± 0.67NA ± NA-0.49 ± 0.56-0.33 ± 0.52-0.55 ± 0.65
Week 20 (n=27,16,29,15,45,52,52,0,44,19,24)-0.51 ± 0.73-0.35 ± 0.57-0.49 ± 0.56-0.51 ± 0.69-0.42 ± 0.66-0.62 ± 0.67-0.87 ± 0.68NA ± NA-0.50 ± 0.66-0.28 ± 0.39-0.59 ± 0.62
Week 24 (n=24,16,29,15,43,54,52,0,40,20,23)-0.58 ± 0.67-0.26 ± 0.62-0.53 ± 0.59-0.56 ± 0.75-0.45 ± 0.75-0.63 ± 0.66-0.82 ± 0.67NA ± NA-0.53 ± 0.66-0.41 ± 0.60-0.72 ± 0.55
SecondaryDisease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])

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) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 = remission.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Reported as:
Mean · units on a scale
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,47,59,57,52,0,58,0)5.51 ± 0.88NA ± NA5.37 ± 0.87NA ± NA5.58 ± 0.885.46 ± 0.825.46 ± 0.965.35 ± 0.98NA ± NA5.62 ± 0.87NA ± NA
Week 2 (n=53,0,51,0,48,60,57,52,0,56,0)4.96 ± 1.11NA ± NA4.60 ± 1.23NA ± NA4.63 ± 1.154.16 ± 0.964.32 ± 1.094.59 ± 1.26NA ± NA5.24 ± 1.03NA ± NA
Week 4 (n=50,0,47,0,45,57,53,49,0,53,0)4.77 ± 1.25NA ± NA4.16 ± 1.22NA ± NA4.36 ± 1.003.71 ± 1.153.71 ± 1.094.40 ± 1.45NA ± NA5.01 ± 1.13NA ± NA
Week 6 (n=47,0,48,0,45,58,55,48,0,52,0)4.42 ± 1.17NA ± NA4.02 ± 1.26NA ± NA4.16 ± 1.063.45 ± 1.113.34 ± 1.294.19 ± 1.55NA ± NA4.92 ± 1.35NA ± NA
Week 8 (n=47,0,48,0,47,56,53,47,0,45,0)4.52 ± 1.27NA ± NA4.00 ± 1.37NA ± NA4.01 ± 1.253.37 ± 1.063.13 ± 1.214.23 ± 1.33NA ± NA4.84 ± 1.24NA ± NA
Week 10 (n=46,0,48,0,46,57,52,45,0,46,0)4.37 ± 1.46NA ± NA3.92 ± 1.27NA ± NA3.80 ± 1.213.06 ± 0.983.05 ± 1.184.12 ± 1.56NA ± NA4.83 ± 1.36NA ± NA
Week 12 (n=43,0,46,0,45,54,52,45,0,45,0)4.57 ± 1.51NA ± NA3.96 ± 1.36NA ± NA3.76 ± 1.383.11 ± 1.183.06 ± 1.134.13 ± 1.33NA ± NA4.83 ± 1.42NA ± NA
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)3.63 ± 1.354.47 ± 1.133.30 ± 1.074.75 ± 1.163.55 ± 1.413.06 ± 1.132.92 ± 1.14NA ± NA3.32 ± 1.133.93 ± 1.224.01 ± 1.08
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)3.94 ± 1.404.14 ± 0.923.26 ± 1.004.44 ± 1.323.68 ± 1.382.85 ± 1.102.93 ± 1.20NA ± NA3.33 ± 1.173.97 ± 1.083.78 ± 1.11
Week 24 (n=24,16,28,15,41,55,52,0,39,20,24)4.11 ± 1.264.42 ± 1.123.11 ± 1.254.33 ± 1.283.64 ± 1.222.92 ± 1.032.82 ± 1.17NA ± NA3.40 ± 1.173.96 ± 1.363.61 ± 1.13
SecondaryChange From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

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 \< 2.6 = remission.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Reported as:
Mean · units on a scale
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=53,0,51,0,46,58,57,51,0,55,0)-0.55 ± 0.91NA ± NA-0.77 ± 0.95NA ± NA-0.95 ± 0.85-1.28 ± 0.99-1.14 ± 1.03-0.73 ± 0.90NA ± NA-0.37 ± 0.80NA ± NA
Week 4 (n=50,0,47,0,43,56,53,48,0,52,0)-0.75 ± 1.05NA ± NA-1.17 ± 1.07NA ± NA-1.26 ± 0.95-1.75 ± 1.23-1.72 ± 1.27-0.91 ± 1.13NA ± NA-0.63 ± 0.97NA ± NA
Week 6 (n=47,0,48,0,43,56,55,47,0,51,0)-1.17 ± 1.00NA ± NA-1.31 ± 1.18NA ± NA-1.50 ± 0.95-1.99 ± 1.25-2.14 ± 1.44-1.12 ± 1.31NA ± NA-0.73 ± 1.17NA ± NA
Week 8 (n=47,0,48,0,45,54,53,46,0,44,0)-1.09 ± 1.07NA ± NA-1.34 ± 1.23NA ± NA-1.60 ± 1.09-2.05 ± 1.13-2.31 ± 1.44-1.08 ± 1.23NA ± NA-0.84 ± 1.14NA ± NA
Week 10 (n=46,0,48,0,44,56,52,44,0,45,0)-1.24 ± 1.13NA ± NA-1.43 ± 1.13NA ± NA-1.87 ± 1.18-2.40 ± 1.12-2.41 ± 1.25-1.23 ± 1.24NA ± NA-0.76 ± 1.21NA ± NA
Week 12 (n=43,0,46,0,43,53,52,44,0,44,0)-1.04 ± 1.26NA ± NA-1.36 ± 1.20NA ± NA-1.87 ± 1.29-2.29 ± 1.25-2.37 ± 1.26-1.18 ± 1.12NA ± NA-0.80 ± 1.33NA ± NA
Week 16 (n=27,17,30,17,44,54,51,0,43,20,24)-1.83 ± 1.25-1.36 ± 1.07-1.80 ± 1.19-0.95 ± 0.96-2.05 ± 1.33-2.41 ± 1.20-2.49 ± 1.31NA ± NA-2.01 ± 1.12-1.73 ± 1.19-1.54 ± 1.16
Week 20 (n=26,16,29,16,43,52,52,0,43,18,24)-1.52 ± 1.39-1.61 ± 1.23-1.96 ± 1.18-1.25 ± 1.13-1.96 ± 1.33-2.54 ± 1.17-2.52 ± 1.40NA ± NA-2.01 ± 1.07-1.77 ± 0.91-1.76 ± 1.27
Week 24 (n=24,16,28,15,39,54,52,0,39,20,23)-1.27 ± 1.22-1.33 ± 1.36-2.08 ± 1.34-1.28 ± 1.02-2.07 ± 1.24-2.51 ± 1.20-2.62 ± 1.47NA ± NA-1.94 ± 1.29-1.71 ± 1.26-2.04 ± 1.43
SecondaryDisease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implies low disease activity and \> 3.2 to 5.1 implies moderate to high disease activity, and \< 2.6 = remission.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Reported as:
Mean · units on a scale
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=49,0,49,0,47,59,54,51,0,56,0)6.51 ± 0.90NA ± NA6.35 ± 0.95NA ± NA6.57 ± 0.876.46 ± 0.856.46 ± 0.956.30 ± 0.97NA ± NA6.56 ± 0.95NA ± NA
Week 2 (n=51,0,50,0,47,60,54,51,0,53,0)5.92 ± 1.20NA ± NA5.57 ± 1.30NA ± NA5.61 ± 1.345.20 ± 1.075.20 ± 1.295.53 ± 1.33NA ± NA6.04 ± 1.15NA ± NA
Week 4 (n=49,0,46,0,46,57,53,46,0,51,0)5.73 ± 1.25NA ± NA5.10 ± 1.48NA ± NA5.23 ± 1.094.69 ± 1.314.46 ± 1.435.22 ± 1.52NA ± NA5.70 ± 1.30NA ± NA
Week 6 (n=46,0,47,0,45,58,54,47,0,51,0)5.36 ± 1.10NA ± NA4.91 ± 1.55NA ± NA4.90 ± 1.194.33 ± 1.324.02 ± 1.574.99 ± 1.70NA ± NA5.64 ± 1.39NA ± NA
Week 8 (n=47,0,48,0,47,56,54,46,0,44,0)5.31 ± 1.46NA ± NA4.89 ± 1.50NA ± NA4.70 ± 1.244.22 ± 1.183.80 ± 1.455.01 ± 1.42NA ± NA5.56 ± 1.40NA ± NA
Week 10 (n=46,0,49,0,45,56,53,43,0,44,0)5.22 ± 1.55NA ± NA4.81 ± 1.52NA ± NA4.50 ± 1.313.93 ± 1.173.71 ± 1.314.98 ± 1.72NA ± NA5.54 ± 1.53NA ± NA
Week 12 (n=44,0,46,0,46,56,53,45,0,45,0)5.41 ± 1.56NA ± NA4.78 ± 1.64NA ± NA4.37 ± 1.433.95 ± 1.383.77 ± 1.325.00 ± 1.50NA ± NA5.39 ± 1.57NA ± NA
Week 16 (n=27,17,30,17,45,55,54,0,42,20,24)4.39 ± 1.335.36 ± 1.233.96 ± 1.315.70 ± 1.224.25 ± 1.473.86 ± 1.363.63 ± 1.39NA ± NA4.08 ± 1.194.53 ± 1.344.95 ± 1.30
Week 20 (n=26,16,29,16,45,51,52,0,43,19,24)4.76 ± 1.505.22 ± 0.934.08 ± 1.305.31 ± 1.374.47 ± 1.473.67 ± 1.393.54 ± 1.29NA ± NA4.04 ± 1.354.47 ± 1.504.62 ± 1.27
Week 24 (n=24,16,29,15,43,54,51,0,38,20,23)4.87 ± 1.435.27 ± 1.423.72 ± 1.585.19 ± 1.234.33 ± 1.403.62 ± 1.263.61 ± 1.31NA ± NA4.22 ± 1.264.51 ± 1.414.28 ± 1.20
SecondaryChange From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR \[mm/hour\] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implies low disease activity and \> 3.2 to 5.1 implies moderate to high disease activity, and \< 2.6 = remission.

Time frame:
Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Mean · units on a scale
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=48,0,49,0,45,58,52,50,0,53,0)-0.56 ± 1.01NA ± NA-0.81 ± 1.01NA ± NA-0.98 ± 0.88-1.32 ± 1.05-1.27 ± 1.28-0.82 ± 1.00NA ± NA-0.53 ± 1.02NA ± NA
Week 4 (n=46,0,45,0,44,55,51,45,0,50,0)-0.82 ± 1.15NA ± NA-1.29 ± 1.27NA ± NA-1.31 ± 0.89-1.81 ± 1.32-1.95 ± 1.50-1.14 ± 1.26NA ± NA-0.87 ± 1.09NA ± NA
Week 6 (n=43,0,46,0,43,56,52,46,0,49,0)-1.26 ± 1.19NA ± NA-1.41 ± 1.42NA ± NA-1.67 ± 0.97-2.16 ± 1.40-2.39 ± 1.58-1.29 ± 1.37NA ± NA-0.97 ± 1.22NA ± NA
Week 8 (n=43,0,46,0,45,54,52,45,0,42,0)-1.30 ± 1.35NA ± NA-1.40 ± 1.36NA ± NA-1.84 ± 0.99-2.28 ± 1.21-2.63 ± 1.56-1.29 ± 1.33NA ± NA-1.00 ± 1.19NA ± NA
Week 10 (n=42,0,47,0,43,54,51,42,0,42,0)-1.37 ± 1.29NA ± NA-1.48 ± 1.26NA ± NA-2.05 ± 1.28-2.55 ± 1.30-2.78 ± 1.42-1.37 ± 1.31NA ± NA-1.00 ± 1.29NA ± NA
Week 12 (n=40,0,44,0,44,54,51,44,0,43,0)-1.16 ± 1.44NA ± NA-1.52 ± 1.43NA ± NA-2.16 ± 1.32-2.55 ± 1.46-2.65 ± 1.41-1.35 ± 1.29NA ± NA-1.17 ± 1.40NA ± NA
Week 16 (n=25,15,29,16,43,53,52,0,41,20,22)-1.97 ± 1.42-1.51 ± 1.08-2.06 ± 1.38-1.18 ± 0.93-2.30 ± 1.29-2.63 ± 1.37-2.83 ± 1.53NA ± NA-2.29 ± 1.15-1.97 ± 1.28-1.63 ± 0.93
Week 20 (n=24,15,28,15,43,49,50,0,42,19,22)-1.54 ± 1.58-1.58 ± 1.34-2.02 ± 1.37-1.47 ± 1.15-2.02 ± 1.34-2.68 ± 1.29-2.88 ± 1.46NA ± NA-2.33 ± 1.28-2.03 ± 1.11-1.91 ± 1.03
Week 24 (n=22,15,28,14,41,52,49,0,37,20,21)-1.33 ± 1.46-1.58 ± 1.58-2.38 ± 1.50-1.51 ± 1.04-2.24 ± 1.31-2.79 ± 1.37-2.78 ± 1.52NA ± NA-2.08 ± 1.32-1.99 ± 1.27-2.30 ± 1.24
SecondaryPercentage of Participants With Disease Improvement Based on DAS28-4 (ESR)

Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of \>1.2 and a present score of \<=3.2; none: an improvement of \<=0.6 or \>0.6 to \<=1.2 with a present score of \>5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.

Time frame:
Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2: Good (n=51,0,50,0,47,60,54,51,0,53,0)3.9NA2.0NA4.33.37.43.9NA0.0NA
Week 2: Mod (n=51,0,50,0,47,60,54,51,0,53,0)13.7NA28.0NA31.953.342.639.2NA26.4NA
Week 2: None (n=51,0,50,0,47,60,54,51,0,53,0)76.5NA68.0NA59.640.046.354.9NA73.6NA
Week 4: Good (n=49,0,46,0,46,57,53,46,0,51,0)2.0NA10.9NA2.214.017.010.9NA2.0NA
Week 4: Mod (n=49,0,46,0,46,57,53,46,0,51,0)28.6NA43.5NA56.552.650.943.5NA41.2NA
Week 4: None (n=49,0,46,0,46,57,53,46,0,51,0)63.3NA43.5NA37.029.828.343.5NA54.9NA
Week 6: Good (n=46,0,47,0,45,58,54,47,0,51,0)2.2NA14.9NA2.222.429.614.9NA3.9NA
Week 6: Mod (n=46,0,47,0,45,58,54,47,0,51,0)47.8NA46.8NA66.753.450.042.6NA41.2NA
Week 6: None (n=46,0,47,0,45,58,54,47,0,51,0)43.5NA36.2NA26.720.716.740.4NA51.0NA
Week 8: Good (n=47,0,48,0,47,56,54,46,0,44,0)6.4NA12.5NA8.517.937.010.9NA6.8NA
Week 8: Mod (n=47,0,48,0,47,56,54,46,0,44,0)44.7NA43.8NA68.164.340.743.5NA36.4NA
Week 8: None (n=47,0,48,0,47,56,54,46,0,44,0)40.4NA39.6NA19.114.318.543.5NA52.3NA
Week 10: Good (n=46,0,49,0,45,56,53,43,0,44,0)8.7NA10.2NA15.625.041.59.3NA2.3NA
Week 10: Mod (n=46,0,49,0,45,56,53,43,0,44,0)45.7NA55.1NA57.860.745.346.5NA45.5NA
Week 10: None (n=46,0,49,0,45,56,53,43,0,44,0)37.0NA30.6NA22.210.79.441.9NA47.7NA
Week 12: Good (n=44,0,46,0,46,56,53,45,0,45,0)9.1NA15.2NA21.732.137.711.1NA6.7NA
Week 12: Mod (n=44,0,46,0,46,56,53,45,0,45,0)31.8NA43.5NA54.350.047.242.2NA42.2NA
Week 12: None (n=44,0,46,0,46,56,53,45,0,45,0)50.0NA37.0NA19.614.311.344.4NA46.7NA
Week 16: Good (n=27,17,30,17,45,55,54,0,42,20,24)18.55.926.75.922.232.744.4NA23.820.08.3
Week 16: Mod (n=27,17,30,17,45,55,54,0,42,20,24)44.452.950.035.360.052.740.7NA61.950.054.2
Week 16: None (n=27,17,30,17,45,55,54,0,42,20,24)29.629.420.052.913.310.911.1NA11.930.029.2
Week 20: Good (n=26,16,29,16,45,51,52,0,43,19,24)11.50.027.60.020.037.338.5NA27.926.312.5
Week 20: Mod (n=26,16,29,16,45,51,52,0,43,19,24)42.356.355.262.548.952.948.1NA60.547.462.5
Week 20: None (n=26,16,29,16,45,51,52,0,43,19,24)38.537.513.831.326.75.99.6NA9.326.316.7
Week 24: Good (n=24,16,29,15,43,54,51,0,38,20,23)12.512.541.46.720.938.943.1NA23.720.08.7
Week 24: Mod (n=24,16,29,15,43,54,51,0,38,20,23)37.543.841.460.058.148.145.1NA57.960.065.2
Week 24: None (n=24,16,29,15,43,54,51,0,38,20,23)41.737.513.826.716.39.37.8NA15.820.017.4
SecondaryPercentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)

CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).

Time frame:
Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=43,0,33,0,40,45,39,40,0,37,0)25.58NA33.33NA62.5071.1166.6740.00NA2.70NA
Week 4 (n=40,0,30,0,37,43,37,37,0,35,0)30.00NA33.33NA62.1683.7262.1635.14NA5.71NA
Week 6 (n=39,0,30,0,39,44,37,36,0,34,0)20.51NA43.33NA56.4179.5567.5730.56NA5.88NA
Week 8 (n=39,0,30,0,39,42,36,35,0,31,0)25.64NA46.67NA66.6778.5775.0025.71NA9.68NA
Week 10 (n=38,0,30,0,38,43,34,33,0,30,0)26.32NA53.33NA65.7990.7079.4121.21NA3.33NA
Week 12 (n=36,0,28,0,37,41,35,33,0,30,0)22.22NA42.86NA62.1675.6168.5730.30NA6.67NA
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)48.141.253.364.769.678.282.4NA67.435.068.0
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)46.275.058.675.068.988.776.9NA67.416.772.0
Week 24 (n=24,16,28,15,41,55,52,0,40,20,24)33.375.046.460.065.972.784.6NA72.530.066.7
SecondaryPercentage of Participants With Disease Remission Based on DAS28-3 (CRP)

DAS28-3 (CRP) defined remission was classified as a score of \<2.6.

Time frame:
Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)
percentage of participantsCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=53,0,50,0,48,60,57,52,0,56,0)1.89NA4.00NA4.175.007.021.92NA0.00NA
Week 4 (n=50,0,46,0,45,57,53,49,0,53,0)6.00NA6.52NA4.4417.5415.0912.24NA1.89NA
Week 6 (n=47,0,47,0,45,58,55,48,0,52,0)8.51NA12.77NA8.8924.1432.7312.50NA1.92NA
Week 8 (n=47,0,47,0,47,56,53,47,0,45,0)2.13NA12.77NA14.8921.4341.5112.77NA4.44NA
Week 10 (n=46,0,47,0,46,57,52,45,0,46,0)10.87NA8.51NA21.7431.5838.4615.56NA4.35NA
Week 12 (n=43,0,45,0,45,54,52,45,0,45,0)9.30NA8.89NA24.4433.3340.384.44NA6.67NA
Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)22.25.930.05.928.336.443.1NA25.615.012.0
Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)19.26.320.76.320.043.442.3NA25.65.612.0
Week 24 (n=24,16,28,15,41,55,52,0,39,20,24)16.76.339.36.722.036.450.0NA23.115.025.0
Secondary36-Item Short-Form Health Survey (SF-36)

SF-36 is a standardized survey evaluating 8 domains (of 2 components \[C\]; physical \[Ph\] and mental \[Mn\]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). 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 12, 24/ ET
Reported as:
Mean · units on a scale
36-Item Short-Form Health Survey (SF-36)
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline: Ph Fn (n=54,0,51,0,49,61,57,53,0,59,0)29.75 ± 10.40NA ± NA29.88 ± 11.61NA ± NA29.93 ± 11.7530.30 ± 10.6530.08 ± 9.6630.55 ± 8.64NA ± NA30.25 ± 9.79NA ± NA
Baseline: R-P (n=54,0,51,0,49,61,57,53,0,59,0)32.82 ± 9.11NA ± NA33.21 ± 9.87NA ± NA32.31 ± 10.4631.44 ± 9.3231.63 ± 8.0732.87 ± 10.60NA ± NA32.20 ± 8.71NA ± NA
Baseline: BP (n=54,0,51,0,49,61,57,53,0,59,0)32.60 ± 7.89NA ± NA33.41 ± 8.54NA ± NA32.21 ± 7.3033.48 ± 6.4832.54 ± 7.2532.23 ± 6.76NA ± NA33.19 ± 8.04NA ± NA
Baseline: GH (n=54,0,51,0,49,61,56,53,0,59,0)34.80 ± 8.29NA ± NA35.60 ± 8.88NA ± NA33.89 ± 8.5734.24 ± 8.2334.58 ± 8.8135.55 ± 9.60NA ± NA34.35 ± 7.85NA ± NA
Baseline: Vit (n=54,0,51,0,49,61,57,53,0,59,0)40.30 ± 10.21NA ± NA40.46 ± 11.21NA ± NA39.28 ± 10.9538.94 ± 10.4338.34 ± 10.7036.42 ± 10.29NA ± NA39.87 ± 9.30NA ± NA
Baseline: So Fn (n=54,0,51,0,49,61,57,53,0,59,0)36.35 ± 11.46NA ± NA37.17 ± 11.85NA ± NA35.14 ± 10.8835.93 ± 10.7336.28 ± 12.1133.28 ± 10.95NA ± NA35.50 ± 10.68NA ± NA
Baseline: R-E (n=54,0,51,0,49,61,57,53,0,59,0)33.28 ± 11.38NA ± NA33.09 ± 12.32NA ± NA34.14 ± 11.7434.40 ± 14.3532.21 ± 12.9232.26 ± 12.75NA ± NA33.21 ± 14.49NA ± NA
Baseline: MnH (n=54,0,51,0,49,61,57,53,0,59,0)39.16 ± 11.57NA ± NA37.58 ± 11.04NA ± NA37.94 ± 12.0237.73 ± 12.1037.80 ± 12.6236.22 ± 12.78NA ± NA37.45 ± 11.66NA ± NA
Baseline: Ph C (n=54,0,51,0,49,61,56,53,0,59,0)31.49 ± 7.32NA ± NA32.52 ± 9.33NA ± NA31.12 ± 9.5231.44 ± 8.1631.82 ± 7.5932.67 ± 7.38NA ± NA31.94 ± 6.71NA ± NA
Baseline: Mn C (n=54,0,51,0,49,61,56,53,0,59,0)40.23 ± 11.04NA ± NA39.47 ± 11.11NA ± NA39.52 ± 11.8239.56 ± 12.1738.64 ± 12.4536.46 ± 12.03NA ± NA38.96 ± 12.17NA ± NA
Week 12: Ph Fn (n=44,0,46,0,45,57,54,45,0,46,0)32.59 ± 11.82NA ± NA35.48 ± 11.31NA ± NA36.36 ± 10.7439.42 ± 11.9938.44 ± 11.6535.61 ± 10.91NA ± NA33.11 ± 11.43NA ± NA
Week 12: R-P (n=44,0,46,0,45,57,54,45,0,46,0)37.60 ± 8.48NA ± NA38.27 ± 10.02NA ± NA39.00 ± 9.3140.78 ± 10.6741.75 ± 11.4536.83 ± 10.02NA ± NA37.21 ± 9.84NA ± NA
Week 12: BP (n=44,0,46,0,45,57,54,45,0,46,0)39.14 ± 7.96NA ± NA39.87 ± 9.18NA ± NA41.26 ± 9.1345.65 ± 9.4046.24 ± 10.3037.67 ± 9.50NA ± NA38.50 ± 9.31NA ± NA
Week 12: GH (n=44,0,46,0,45,57,54,45,0,46,0)38.99 ± 7.72NA ± NA39.45 ± 9.35NA ± NA40.00 ± 7.9040.11 ± 11.1040.80 ± 11.0738.42 ± 11.41NA ± NA38.05 ± 8.19NA ± NA
Week 12: Vit (n=44,0,46,0,45,57,54,45,0,46,0)45.92 ± 10.27NA ± NA45.37 ± 10.41NA ± NA45.22 ± 10.1548.59 ± 11.7449.20 ± 11.7344.88 ± 10.16NA ± NA43.20 ± 11.23NA ± NA
Week 12: So Fn (n=44,0,46,0,45,57,54,45,0,46,0)41.11 ± 11.36NA ± NA41.55 ± 11.76NA ± NA43.15 ± 9.2043.93 ± 11.7844.43 ± 12.1538.43 ± 12.04NA ± NA41.44 ± 11.22NA ± NA
Week 12: R-E (n=44,0,46,0,45,57,53,45,0,46,0)37.86 ± 10.67NA ± NA37.03 ± 13.74NA ± NA39.98 ± 10.3539.72 ± 12.8039.23 ± 13.3939.98 ± 12.70NA ± NA39.23 ± 12.58NA ± NA
Week 12: MnH (n=44,0,46,0,45,57,54,45,0,46,0)43.61 ± 11.80NA ± NA41.50 ± 11.47NA ± NA44.44 ± 10.8643.29 ± 12.6843.91 ± 13.6042.94 ± 12.46NA ± NA43.89 ± 10.98NA ± NA
Week 12: Ph C (n=44,0,46,0,45,57,53,45,0,46,0)35.76 ± 7.89NA ± NA38.17 ± 8.70NA ± NA38.15 ± 9.3041.89 ± 9.7042.44 ± 9.7135.89 ± 10.39NA ± NA35.00 ± 9.77NA ± NA
Week 12: Mn C (n=44,0,46,0,45,57,53,45,0,46,0)45.03 ± 11.01NA ± NA42.82 ± 11.64NA ± NA45.49 ± 9.9644.46 ± 12.8944.91 ± 14.0544.22 ± 12.02NA ± NA45.22 ± 10.88NA ± NA
Week 24: Ph Fn (n=24,15,29,15,43,55,52,0,40,20,24)35.64 ± 10.4035.57 ± 11.7237.66 ± 12.2533.32 ± 12.7936.23 ± 12.0440.43 ± 11.6739.67 ± 10.91NA ± NA38.36 ± 10.7434.94 ± 10.7641.60 ± 10.62
Week 24: R-P (n=24,15,29,15,43,55,52,0,40,20,24)37.06 ± 9.1339.38 ± 10.2642.33 ± 9.0034.98 ± 9.6439.82 ± 11.0241.80 ± 10.7541.17 ± 9.61NA ± NA38.98 ± 9.5137.14 ± 9.8843.38 ± 9.50
Week 24: BP (n=24,15,29,15,43,55,52,0,40,20,24)39.26 ± 8.9938.11 ± 9.4142.15 ± 10.9541.89 ± 9.0342.05 ± 10.0746.73 ± 10.0945.37 ± 9.66NA ± NA42.66 ± 9.2239.91 ± 7.6743.96 ± 10.01
Week 24: GH (n=24,15,29,15,43,55,52,0,40,20,24)41.20 ± 10.4938.47 ± 8.4342.53 ± 10.2337.11 ± 7.1439.56 ± 8.7941.46 ± 11.8539.63 ± 10.19NA ± NA39.62 ± 9.2038.16 ± 8.7442.84 ± 9.18
Week 24: Vit (n=24,15,29,15,43,55,52,0,40,20,24)45.85 ± 12.2144.18 ± 8.7449.29 ± 9.7145.78 ± 9.4746.28 ± 10.0047.61 ± 11.2446.51 ± 10.98NA ± NA46.24 ± 9.3346.47 ± 10.7049.10 ± 9.72
Week 24: So Fn (n=24,15,29,15,43,55,52,0,40,20,24)42.08 ± 11.3139.40 ± 9.2644.25 ± 9.4640.12 ± 8.8641.76 ± 10.1644.26 ± 12.3242.69 ± 11.39NA ± NA41.71 ± 9.9941.85 ± 8.2847.08 ± 9.37
Week 24: R-E (n=24,15,29,15,43,55,52,0,40,20,24)36.12 ± 13.5139.03 ± 13.4443.14 ± 10.3832.81 ± 13.4238.97 ± 12.2940.82 ± 12.8540.33 ± 11.52NA ± NA41.20 ± 11.6638.39 ± 10.8142.27 ± 10.38
Week 24: MnH (n=24,15,29,15,43,55,52,0,40,20,24)45.55 ± 10.6041.00 ± 8.9244.76 ± 11.2839.87 ± 8.3743.20 ± 11.5344.63 ± 12.7543.08 ± 13.13NA ± NA44.94 ± 10.1343.53 ± 11.3445.55 ± 11.08
Week 24: Ph C (n=24,15,29,15,43,55,52,0,40,20,24)37.35 ± 8.6237.51 ± 9.2540.21 ± 10.2137.35 ± 9.0739.03 ± 9.9642.81 ± 9.8941.80 ± 10.03NA ± NA39.03 ± 9.5036.55 ± 9.6442.87 ± 9.13
Week 24: Mn C (n=24,15,29,15,43,55,52,0,40,20,24)44.79 ± 12.5742.61 ± 9.0147.43 ± 9.5140.65 ± 8.0444.18 ± 10.9144.97 ± 12.8743.73 ± 12.76NA ± NA45.53 ± 10.2945.01 ± 10.1346.93 ± 10.63
SecondaryChange From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET

SF-36 is a standardized survey evaluating 8 domains (of 2 components \[C\]; physical \[Ph\] and mental \[Mn\]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). 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 12, 24/ ET
Reported as:
Mean · units on a scale
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 12: Ph Fn (n=44,0,46,0,45,57,54,45,0,46,0)3.11 ± 11.59NA ± NA4.90 ± 8.72NA ± NA6.64 ± 10.608.90 ± 9.858.18 ± 10.115.05 ± 8.09NA ± NA1.83 ± 9.89NA ± NA
Week 12: R-P (n=44,0,46,0,45,57,54,45,0,46,0)4.34 ± 10.95NA ± NA4.01 ± 9.01NA ± NA6.64 ± 9.878.98 ± 9.949.71 ± 11.643.43 ± 12.06NA ± NA4.84 ± 9.88NA ± NA
Week 12: BP (n=44,0,46,0,45,57,54,45,0,46,0)6.36 ± 8.79NA ± NA5.37 ± 9.19NA ± NA9.15 ± 8.4012.06 ± 9.2113.73 ± 10.955.91 ± 8.98NA ± NA4.91 ± 8.51NA ± NA
Week 12: GH (n=44,0,46,0,45,57,53,45,0,46,0)3.46 ± 7.75NA ± NA3.59 ± 8.51NA ± NA6.21 ± 7.486.00 ± 8.926.63 ± 9.644.05 ± 9.96NA ± NA3.41 ± 6.49NA ± NA
Week 12: Vit (n=44,0,46,0,45,57,54,45,0,46,0)5.25 ± 9.37NA ± NA3.87 ± 9.31NA ± NA5.76 ± 8.939.75 ± 11.5310.75 ± 12.768.12 ± 10.70NA ± NA3.73 ± 10.00NA ± NA
Week 12: So Fn (n=44,0,46,0,45,57,54,45,0,46,0)12.71 ± 1.92NA ± NA10.31 ± 1.52NA ± NA10.03 ± 1.5011.91 ± 1.5813.88 ± 1.8914.01 ± 2.09NA ± NA12.71 ± 1.87NA ± NA
Week 12: R-E (n=44,0,46,0,45,57,53,45,0,46,0)5.12 ± 12.65NA ± NA2.70 ± 12.67NA ± NA5.53 ± 13.455.86 ± 11.485.94 ± 14.196.82 ± 15.75NA ± NA6.17 ± 13.85NA ± NA
Week 12: MnH (n=44,0,46,0,45,57,54,45,0,46,0)4.86 ± 11.15NA ± NA3.12 ± 9.92NA ± NA6.13 ± 11.636.08 ± 8.395.42 ± 14.027.48 ± 10.42NA ± NA6.00 ± 10.91NA ± NA
Week 12: Ph C (n=44,0,46,0,45,57,52,45,0,46,0)3.78 ± 7.40NA ± NA4.96 ± 8.33NA ± NA7.29 ± 7.9510.01 ± 9.3110.70 ± 9.833.47 ± 8.25NA ± NA2.43 ± 9.05NA ± NA
Week 12: Mn C (n=44,0,46,0,45,57,52,45,0,46,0)5.23 ± 10.18NA ± NA2.33 ± 9.78NA ± NA5.45 ± 11.775.38 ± 9.616.12 ± 13.577.59 ± 11.64NA ± NA6.74 ± 9.72NA ± NA
Week 24: Ph Fn (n=24,15,29,15,43,55,52,0,40,20,24)5.52 ± 8.287.30 ± 10.845.01 ± 10.606.87 ± 9.856.12 ± 11.549.60 ± 9.639.67 ± 11.58NA ± NA7.21 ± 9.806.63 ± 7.017.80 ± 11.06
Week 24: R-P (n=24,15,29,15,43,55,52,0,40,20,24)4.39 ± 12.066.86 ± 9.497.18 ± 9.003.65 ± 11.917.18 ± 9.1910.02 ± 11.199.37 ± 9.78NA ± NA5.14 ± 12.416.61 ± 7.958.98 ± 9.30
Week 24: BP (n=24,15,29,15,43,55,52,0,40,20,24)4.65 ± 10.487.86 ± 11.867.40 ± 9.788.93 ± 9.709.89 ± 9.0713.19 ± 9.6413.13 ± 10.51NA ± NA10.51 ± 9.556.23 ± 7.2411.11 ± 10.03
Week 24: GH (n=24,15,29,15,43,55,51,0,40,20,24)4.23 ± 11.065.91 ± 8.605.10 ± 8.042.51 ± 7.655.64 ± 7.187.37 ± 9.155.44 ± 9.03NA ± NA5.77 ± 8.355.46 ± 6.546.87 ± 10.73
Week 24: Vit (n=24,15,29,15,43,55,52,0,40,20,24)3.38 ± 9.208.12 ± 10.005.49 ± 9.018.46 ± 12.536.75 ± 8.319.20 ± 10.898.17 ± 12.01NA ± NA9.13 ± 10.137.80 ± 10.109.37 ± 7.92
Week 24: So Fn (n=24,15,29,15,43,55,52,0,40,20,24)4.54 ± 11.107.27 ± 12.822.07 ± 11.617.64 ± 7.386.21 ± 11.517.93 ± 12.466.61 ± 13.46NA ± NA7.77 ± 13.4710.36 ± 10.1510.23 ± 9.69
Week 24: R-E (n=24,15,29,15,43,55,52,0,40,20,24)2.75 ± 16.157.77 ± 14.096.43 ± 9.133.11 ± 13.724.70 ± 10.377.07 ± 14.417.55 ± 11.09NA ± NA7.77 ± 16.066.22 ± 16.327.45 ± 12.18
Week 24: MnH (n=24,15,29,15,43,55,52,0,40,20,24)5.28 ± 8.927.51 ± 10.733.50 ± 9.185.44 ± 7.335.37 ± 13.107.68 ± 8.324.55 ± 13.22NA ± NA9.19 ± 12.035.63 ± 10.817.86 ± 10.14
Week 24: Ph C (n=24,15,29,15,43,55,51,0,40,20,24)4.78 ± 7.896.50 ± 7.446.40 ± 9.316.05 ± 10.517.72 ± 9.1210.77 ± 9.8010.58 ± 10.83NA ± NA6.32 ± 9.216.18 ± 6.218.73 ± 9.45
Week 24: Mn C (n=24,15,29,15,43,55,51,0,40,20,24)3.45 ± 9.847.51 ± 11.203.50 ± 7.245.10 ± 8.704.57 ± 11.286.25 ± 10.224.23 ± 12.36NA ± NA8.67 ± 12.287.03 ± 12.027.91 ± 10.04
SecondaryEuro Quality of Life 5 Dimension (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, Week 12, 24/ ET
Reported as:
Mean · units on a scale
Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,61,57,53,0,59,0)0.41 ± 0.32NA ± NA0.33 ± 0.32NA ± NA0.39 ± 0.370.41 ± 0.300.34 ± 0.350.36 ± 0.31NA ± NA0.38 ± 0.32NA ± NA
Week 12 (n=43,0,46,0,45,56,54,45,0,45,0)0.56 ± 0.26NA ± NA0.50 ± 0.32NA ± NA0.60 ± 0.270.68 ± 0.250.66 ± 0.270.51 ± 0.26NA ± NA0.53 ± 0.32NA ± NA
Week 24 (n=24,15,29,14,43,55,52,0,40,20,24)0.64 ± 0.230.55 ± 0.300.67 ± 0.220.58 ± 0.250.61 ± 0.300.68 ± 0.260.67 ± 0.26NA ± NA0.60 ± 0.240.63 ± 0.220.73 ± 0.17
SecondaryChange From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET

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, Week 12, 24/ ET
Reported as:
Mean · units on a scale
Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 12 (n=43,0,46,0,45,56,54,45,0,45,0)0.15 ± 0.36NA ± NA0.14 ± 0.33NA ± NA0.21 ± 0.330.27 ± 0.290.30 ± 0.370.16 ± 0.33NA ± NA0.11 ± 0.37NA ± NA
Week 24 (n=24,15,29,14,43,55,52,0,40,20,24)0.23 ± 0.330.15 ± 0.340.23 ± 0.280.36 ± 0.360.23 ± 0.320.27 ± 0.310.32 ± 0.40NA ± NA0.24 ± 0.360.21 ± 0.280.32 ± 0.28
Other pre-specifiedSerum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels

Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.

Time frame:
Baseline, Week 24/ ET
Reported as:
Mean · milligram per deciliter (mg/dL)
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels
milligram per deciliter (mg/dL)CP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline: IgG (n=50,0,47,0,45,58,53,49,0,54,0)1261.68 ± 331.53NA ± NA1157.79 ± 290.29NA ± NA1219.31 ± 326.921219.38 ± 397.931157.57 ± 271.581143.78 ± 359.41NA ± NA1221.28 ± 402.84NA ± NA
Baseline: IgM (n=50,0,47,0,45,58,53,49,0,54,0)154.20 ± 77.36NA ± NA172.81 ± 72.41NA ± NA115.04 ± 48.12160.69 ± 75.04156.04 ± 73.34144.27 ± 103.26NA ± NA169.78 ± 83.80NA ± NA
Baseline: IgA (n=50,0,47,0,45,58,51,49,0,54,0)356.76 ± 242.48NA ± NA285.34 ± 121.73NA ± NA321.58 ± 171.12316.60 ± 140.26304.14 ± 164.97323.49 ± 134.21NA ± NA327.00 ± 177.70NA ± NA
Week 24: IgG (n=21,15,24,12,35,48,44,0,34,17,22)1207.57 ± 330.541148.07 ± 439.241068.08 ± 266.711142.75 ± 315.331169.97 ± 280.161111.42 ± 286.081073.66 ± 274.31NA ± NA1143.91 ± 290.221153.76 ± 350.081213.86 ± 379.24
Week 24: IgM (n=21,15,24,12,35,48,44,0,34,17,22)145.71 ± 86.21144.73 ± 73.08161.96 ± 62.54153.08 ± 69.05122.46 ± 46.08140.06 ± 59.51128.25 ± 56.26NA ± NA143.29 ± 73.11153.24 ± 80.78167.95 ± 82.86
Week 24: IgA (n=21,15,24,12,35,48,43,0,34,17,22)305.62 ± 160.91435.00 ± 405.07237.00 ± 87.21287.50 ± 107.94294.97 ± 136.28280.65 ± 118.50232.51 ± 100.39NA ± NA294.35 ± 131.76329.65 ± 152.74305.18 ± 150.23
Other pre-specifiedChange From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24

Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.

Time frame:
Baseline, Week 24/ ET
Reported as:
Mean · mg/dL
Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24
mg/dLCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
IgG-13.50 ± 159.02-114.27 ± 321.37-71.55 ± 152.89-145.36 ± 267.20-53.81 ± 164.31-131.50 ± 183.76-86.44 ± 175.79-49.81 ± 192.2831.00 ± 129.17-59.75 ± 163.33
IgM7.83 ± 21.88-9.73 ± 35.26-11.86 ± 25.02-3.73 ± 27.324.25 ± 16.41-17.02 ± 41.65-22.73 ± 33.64-3.69 ± 46.723.00 ± 30.44-2.50 ± 37.27
IgA6.28 ± 44.817.07 ± 164.76-38.50 ± 55.58-45.36 ± 59.51-24.53 ± 48.01-42.50 ± 72.55-68.41 ± 104.16-26.03 ± 82.048.60 ± 45.09-18.15 ± 52.51
Other pre-specifiedFluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers

The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

Time frame:
Baseline, Week 24/ ET
Reported as:
Mean · cells per micro liter (cells/mcL)
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers
cells per micro liter (cells/mcL)CP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline: CD3 (n=30,0,35,0,29,37,34,32,0,40,0)1.29 ± 0.59NA ± NA1.31 ± 0.46NA ± NA1.31 ± 0.731.24 ± 0.611.30 ± 0.511.36 ± 0.52NA ± NA1.17 ± 0.49NA ± NA
Baseline: CD4 (n=30,0,35,0,29,37,34,32,0,40,0)0.84 ± 0.41NA ± NA0.93 ± 0.35NA ± NA0.93 ± 0.560.85 ± 0.490.89 ± 0.350.91 ± 0.40NA ± NA0.80 ± 0.34NA ± NA
Baseline: CD8 (n=30,0,35,0,29,37,34,32,0,40,0)0.44 ± 0.29NA ± NA0.37 ± 0.20NA ± NA0.37 ± 0.260.37 ± 0.190.40 ± 0.210.43 ± 0.23NA ± NA0.35 ± 0.21NA ± NA
Baseline: CD19 (n=30,0,34,0,29,37,34,32,0,40,0)0.21 ± 0.16NA ± NA0.20 ± 0.11NA ± NA0.22 ± 0.230.19 ± 0.090.20 ± 0.120.18 ± 0.10NA ± NA0.16 ± 0.10NA ± NA
Baseline: CD56 (n=30,0,34,0,29,37,34,32,0,40,0)0.15 ± 0.09NA ± NA0.14 ± 0.10NA ± NA0.14 ± 0.100.14 ± 0.120.14 ± 0.100.14 ± 0.12NA ± NA0.12 ± 0.09NA ± NA
Week 24: CD3 (n=16,6,17,7,22,29,26,0,19,9,12)1.16 ± 0.671.45 ± 0.571.45 ± 0.821.20 ± 0.461.10 ± 0.431.27 ± 0.611.14 ± 0.36NA ± NA1.46 ± 0.481.63 ± 0.691.26 ± 0.57
Week 24: CD4 (n=16,6,17,7,22,29,26,0,19,9,12)0.75 ± 0.420.87 ± 0.331.01 ± 0.650.86 ± 0.350.77 ± 0.300.92 ± 0.510.82 ± 0.26NA ± NA0.98 ± 0.351.01 ± 0.520.91 ± 0.45
Week 24: CD8 (n=16,6,17,7,22,29,26,0,19,9,12)0.38 ± 0.260.58 ± 0.430.42 ± 0.250.30 ± 0.130.31 ± 0.180.33 ± 0.150.32 ± 0.14NA ± NA0.45 ± 0.340.58 ± 0.340.33 ± 0.14
Week 24: CD19 (n=16,6,17,7,22,29,25,0,19,9,12)0.23 ± 0.180.27 ± 0.140.22 ± 0.110.27 ± 0.150.17 ± 0.110.31 ± 0.160.24 ± 0.09NA ± NA0.29 ± 0.150.12 ± 0.050.31 ± 0.21
Week 24: CD56 (n=16,6,17,7,22,29,26,0,19,9,12)0.10 ± 0.060.12 ± 0.090.11 ± 0.080.08 ± 0.100.07 ± 0.050.05 ± 0.050.04 ± 0.03NA ± NA0.09 ± 0.090.15 ± 0.120.07 ± 0.06
Other pre-specifiedChange From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24

The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

Time frame:
Baseline, Week 24/ ET
Reported as:
Mean · cells/mcL
Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24
cells/mcLCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
CD30.01 ± 0.770.00 ± 0.440.07 ± 0.620.07 ± 0.39-0.19 ± 0.520.01 ± 0.45-0.13 ± 0.440.12 ± 0.600.36 ± 0.380.20 ± 0.50
CD4-0.03 ± 0.50-0.05 ± 0.310.06 ± 0.480.07 ± 0.30-0.16 ± 0.410.03 ± 0.32-0.11 ± 0.310.08 ± 0.490.20 ± 0.330.18 ± 0.37
CD80.01 ± 0.280.04 ± 0.140.01 ± 0.17-0.01 ± 0.14-0.03 ± 0.18-0.02 ± 0.15-0.03 ± 0.140.04 ± 0.190.11 ± 0.110.03 ± 0.14
CD190.03 ± 0.240.01 ± 0.10-0.00 ± 0.170.07 ± 0.07-0.03 ± 0.210.12 ± 0.140.06 ± 0.100.09 ± 0.130.02 ± 0.030.13 ± 0.12
CD56-0.05 ± 0.050.03 ± 0.08-0.03 ± 0.05-0.06 ± 0.15-0.06 ± 0.09-0.06 ± 0.07-0.08 ± 0.04-0.03 ± 0.080.01 ± 0.07-0.05 ± 0.08
Other pre-specifiedMedical Outcome Study- Sleep Scale (MOS-SS)

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

Time frame:
Baseline, Week 2, 12, 24/ ET
Reported as:
Mean · units on a scale
Medical Outcome Study- Sleep Scale (MOS-SS)
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline: SPS (n=54,0,51,0,49,61,57,53,0,58,0)45.06 ± 22.24NA ± NA45.56 ± 19.63NA ± NA39.86 ± 17.3544.86 ± 17.6044.39 ± 23.3544.72 ± 22.42NA ± NA44.77 ± 18.83NA ± NA
Baseline: OSP (n=54,0,51,0,49,61,57,53,0,58,0)44.87 ± 22.05NA ± NA48.34 ± 19.98NA ± NA42.51 ± 18.3545.82 ± 15.7945.77 ± 22.6845.94 ± 22.65NA ± NA46.12 ± 18.54NA ± NA
Baseline: Ade (n=54,0,51,0,49,61,57,53,0,58,0)40.74 ± 27.26NA ± NA44.31 ± 27.44NA ± NA45.10 ± 23.7341.31 ± 24.9340.18 ± 27.8739.81 ± 27.56NA ± NA38.62 ± 23.28NA ± NA
Baseline: A SOB (n=54,0,51,0,49,61,57,53,0,58,0)22.96 ± 22.79NA ± NA29.41 ± 30.03NA ± NA20.82 ± 22.3523.61 ± 27.6927.72 ± 30.1821.51 ± 28.24NA ± NA23.10 ± 27.99NA ± NA
Baseline: SD (n=54,0,51,0,49,61,57,53,0,58,0)46.60 ± 28.00NA ± NA52.40 ± 25.12NA ± NA44.52 ± 25.7348.34 ± 22.6145.09 ± 28.5347.90 ± 28.81NA ± NA49.72 ± 24.24NA ± NA
Baseline: Opt (n=54,0,51,0,49,61,57,53,0,59,0)0.31 ± 0.47NA ± NA0.45 ± 0.50NA ± NA0.51 ± 0.510.31 ± 0.470.42 ± 0.500.57 ± 0.50NA ± NA0.47 ± 0.50NA ± NA
Baseline: Qua (n=54,0,51,0,49,61,57,53,0,59,0)6.11 ± 1.50NA ± NA6.51 ± 1.62NA ± NA6.76 ± 1.396.59 ± 1.766.33 ± 1.386.72 ± 2.20NA ± NA6.63 ± 1.48NA ± NA
Baseline: Sno (n=54,0,51,0,49,61,57,53,0,58,0)30.00 ± 34.04NA ± NA40.39 ± 36.33NA ± NA31.84 ± 34.1433.11 ± 31.6032.28 ± 32.0242.26 ± 32.02NA ± NA27.24 ± 31.50NA ± NA
Baseline: Som (n=54,0,51,0,49,61,57,53,0,58,0)36.05 ± 22.60NA ± NA38.69 ± 21.95NA ± NA36.05 ± 22.2738.91 ± 25.5738.36 ± 18.7838.74 ± 25.95NA ± NA33.68 ± 21.13NA ± NA
Week 2: SPS (n=54,0,50,0,48,59,57,52,0,56,0)41.79 ± 21.15NA ± NA43.73 ± 19.87NA ± NA37.22 ± 17.4137.57 ± 17.6835.50 ± 21.2738.46 ± 21.36NA ± NA40.18 ± 19.48NA ± NA
Week 2: OSP (n=54,0,50,0,48,59,57,52,0,56,0)41.64 ± 20.16NA ± NA43.19 ± 19.05NA ± NA38.61 ± 17.1737.75 ± 16.8036.15 ± 21.0439.24 ± 21.81NA ± NA40.35 ± 18.90NA ± NA
Week 2: Ade (n=54,0,51,0,48,59,57,52,0,56,0)46.11 ± 27.22NA ± NA43.14 ± 26.72NA ± NA51.04 ± 25.5447.80 ± 26.4052.63 ± 29.0048.65 ± 30.74NA ± NA43.21 ± 25.31NA ± NA
Week 2: A SOB (n=54,0,50,0,48,59,57,52,0,56,0)23.33 ± 24.80NA ± NA26.80 ± 28.46NA ± NA26.25 ± 28.0319.32 ± 23.1823.16 ± 28.9819.23 ± 25.35NA ± NA16.79 ± 22.49NA ± NA
Week 2: SD (n=54,0,50,0,48,59,57,52,0,56,0)42.01 ± 25.44NA ± NA44.48 ± 25.12NA ± NA37.81 ± 23.4038.24 ± 23.3436.69 ± 26.4739.16 ± 27.48NA ± NA41.32 ± 24.19NA ± NA
Week 2: Opt (n=54,0,51,0,48,60,57,53,0,58,0)0.39 ± 0.49NA ± NA0.35 ± 0.48NA ± NA0.60 ± 0.490.45 ± 0.500.47 ± 0.500.43 ± 0.50NA ± NA0.48 ± 0.50NA ± NA
Week 2: Qua (n=54,0,51,0,48,60,57,52,0,57,0)6.31 ± 1.56NA ± NA6.41 ± 1.42NA ± NA6.98 ± 1.236.85 ± 1.696.72 ± 1.266.71 ± 2.40NA ± NA6.74 ± 1.33NA ± NA
Week 2: Sno (n=54,0,51,0,48,59,57,52,0,56,0)27.04 ± 28.59NA ± NA32.16 ± 30.22NA ± NA30.83 ± 30.0230.85 ± 29.7932.28 ± 28.9740.38 ± 31.31NA ± NA26.43 ± 29.57NA ± NA
Week 2: Som (n=54,0,51,0,48,59,57,52,0,56,0)36.05 ± 21.34NA ± NA33.20 ± 18.40NA ± NA35.69 ± 22.2031.75 ± 22.5730.53 ± 18.1738.33 ± 28.59NA ± NA32.86 ± 21.34NA ± NA
Week 12: SPS (n=44,0,46,0,45,57,53,45,0,45,0)35.61 ± 22.63NA ± NA38.48 ± 21.95NA ± NA35.85 ± 16.9135.09 ± 18.3231.26 ± 22.8436.37 ± 20.72NA ± NA33.56 ± 18.52NA ± NA
Week 12: OSP (n=44,0,46,0,45,57,53,45,0,45,0)36.44 ± 22.04NA ± NA38.93 ± 21.68NA ± NA37.51 ± 17.8135.19 ± 17.5632.11 ± 22.3337.09 ± 20.82NA ± NA34.26 ± 18.20NA ± NA
Week 12: Ade (n=44,0,46,0,45,57,53,45,0,45,0)58.18 ± 27.39NA ± NA51.30 ± 28.17NA ± NA48.67 ± 24.3649.82 ± 28.0657.55 ± 31.0649.56 ± 24.49NA ± NA53.11 ± 24.94NA ± NA
Week 12: A SOB (n=44,0,46,0,45,57,53,45,0,45,0)19.09 ± 21.55NA ± NA22.17 ± 26.07NA ± NA16.00 ± 22.4017.19 ± 19.8023.02 ± 27.0019.11 ± 24.85NA ± NA16.44 ± 23.85NA ± NA
Week 12: SD (n=44,0,46,0,45,57,53,45,0,45,0)38.58 ± 27.93NA ± NA41.39 ± 26.18NA ± NA37.94 ± 25.3136.47 ± 25.9031.30 ± 25.4537.22 ± 28.22NA ± NA35.08 ± 21.96NA ± NA
Week 12: Opt (n=44,0,46,0,45,57,54,45,0,46,0)0.45 ± 0.50NA ± NA0.43 ± 0.50NA ± NA0.47 ± 0.500.51 ± 0.500.52 ± 0.500.58 ± 0.50NA ± NA0.61 ± 0.49NA ± NA
Week 12: Qua (n=44,0,46,0,45,56,53,45,0,46,0)6.77 ± 1.71NA ± NA6.65 ± 1.61NA ± NA6.91 ± 1.286.80 ± 1.556.68 ± 1.256.78 ± 1.20NA ± NA7.09 ± 1.24NA ± NA
Week 12: Sno (n=44,0,46,0,45,57,53,45,0,45,0)30.45 ± 30.65NA ± NA36.96 ± 33.19NA ± NA34.67 ± 32.5930.53 ± 25.1028.68 ± 29.4936.89 ± 32.18NA ± NA23.56 ± 25.69NA ± NA
Week 12: Som (n=44,0,46,0,45,57,53,45,0,45,0)34.70 ± 22.07NA ± NA31.59 ± 21.84NA ± NA33.19 ± 24.3929.12 ± 21.4427.80 ± 19.4235.26 ± 26.92NA ± NA30.37 ± 19.67NA ± NA
Week 24: SPS (n=24,15,29,15,43,55,52,0,40,20,24)30.83 ± 18.5545.56 ± 20.7732.07 ± 18.2239.33 ± 22.5433.72 ± 18.4234.18 ± 18.6633.85 ± 21.69NA ± NA32.75 ± 19.4831.17 ± 21.2033.19 ± 17.54
Week 24: OSP (n=24,15,29,15,43,55,52,0,40,20,24)30.93 ± 18.0643.37 ± 19.8632.32 ± 18.9339.67 ± 21.0334.30 ± 18.6934.18 ± 17.7933.57 ± 19.91NA ± NA33.14 ± 19.8031.39 ± 19.8533.89 ± 15.61
Week 24: Ade (n=24,15,29,15,43,55,52,0,40,20,24)60.00 ± 28.8940.67 ± 29.3959.66 ± 26.5245.33 ± 26.9653.26 ± 24.0850.00 ± 28.4151.73 ± 30.53NA ± NA59.50 ± 25.3160.50 ± 25.6454.58 ± 22.06
Week 24: A SOB (n=24,15,29,15,43,55,52,0,40,20,24)25.00 ± 27.8236.00 ± 21.6524.14 ± 27.9730.67 ± 33.6922.79 ± 29.7921.45 ± 21.7223.46 ± 26.78NA ± NA25.50 ± 30.3817.00 ± 23.6413.33 ± 18.34
Week 24: SD (n=24,15,29,15,43,55,52,0,40,20,24)29.79 ± 21.3341.58 ± 23.2934.27 ± 24.8038.58 ± 24.3033.58 ± 22.9833.09 ± 23.2331.59 ± 23.31NA ± NA33.81 ± 27.1433.13 ± 24.5836.46 ± 21.42
Week 24: Opt (n=24,15,29,15,43,55,52,0,40,20,24)0.58 ± 0.500.31 ± 0.480.55 ± 0.510.33 ± 0.490.72 ± 0.450.38 ± 0.490.50 ± 0.50NA ± NA0.55 ± 0.500.75 ± 0.440.50 ± 0.51
Week 24: Qua (n=24,14,29,15,43,55,52,0,40,20,24)7.04 ± 1.637.00 ± 1.416.83 ± 1.426.60 ± 1.357.14 ± 1.066.73 ± 1.606.92 ± 1.44NA ± NA6.95 ± 1.417.20 ± 1.067.00 ± 1.25
Week 24: Sno (n=24,15,29,15,43,55,52,0,40,20,24)23.33 ± 20.1433.33 ± 36.7738.62 ± 32.0436.00 ± 33.9734.42 ± 31.2728.73 ± 27.9631.54 ± 29.73NA ± NA40.50 ± 32.1834.00 ± 31.1932.50 ± 24.18
Week 24: Som (n=24,15,29,15,43,55,52,0,40,20,24)29.44 ± 20.8030.67 ± 18.1426.44 ± 19.4831.11 ± 22.2130.39 ± 17.5427.39 ± 20.4726.54 ± 17.83NA ± NA30.17 ± 22.8028.00 ± 18.1728.33 ± 17.72
Other pre-specifiedChange From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\*100); total score range: 0 to 100; higher score = greater intensity of attribute.

Time frame:
Baseline, Week 2, 12, 24/ ET
Reported as:
Mean · units on a scale
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2: SPS (n=54,0,50,0,48,59,57,52,0,55,0)-3.27 ± 14.06NA ± NA-2.13 ± 12.63NA ± NA-2.50 ± 18.09-7.12 ± 15.14-8.89 ± 17.59-6.99 ± 16.29NA ± NA-4.85 ± 15.95NA ± NA
Week 2: OSP (n=54,0,50,0,48,59,57,52,0,55,0)-3.23 ± 13.46NA ± NA-5.36 ± 11.58NA ± NA-3.62 ± 17.59-7.95 ± 15.26-9.62 ± 16.95-7.41 ± 15.38NA ± NA-5.89 ± 16.19NA ± NA
Week 2: Ade (n=54,0,51,0,48,59,57,52,0,55,0)5.37 ± 20.62NA ± NA-1.18 ± 20.65NA ± NA5.83 ± 23.957.29 ± 23.3312.46 ± 25.4410.00 ± 24.73NA ± NA5.82 ± 19.79NA ± NA
Week 2: A SOB (n=54,0,50,0,48,59,57,52,0,55,0)0.37 ± 21.80NA ± NA-3.20 ± 26.30NA ± NA5.83 ± 25.75-4.07 ± 30.80-4.56 ± 21.39-1.92 ± 23.85NA ± NA-6.18 ± 18.81NA ± NA
Week 2: SD (n=54,0,50,0,48,59,57,52,0,55,0)-4.58 ± 18.39NA ± NA-8.25 ± 14.46NA ± NA-6.38 ± 22.80-9.83 ± 19.04-8.40 ± 23.32-9.66 ± 18.94NA ± NA-7.89 ± 23.77NA ± NA
Week 2: Opt (n=54,0,51,0,48,60,57,53,0,58,0)0.07 ± 0.43NA ± NA-0.10 ± 0.50NA ± NA0.08 ± 0.500.13 ± 0.500.05 ± 0.61-0.13 ± 0.44NA ± NA0.00 ± 0.56NA ± NA
Week 2: Qua (n=54,0,51,0,48,60,57,52,0,57,0)0.20 ± 1.26NA ± NA-0.10 ± 1.12NA ± NA0.19 ± 1.160.20 ± 1.220.39 ± 1.060.02 ± 1.49NA ± NA0.11 ± 1.19NA ± NA
Week 2: Sno (n=54,0,51,0,48,59,57,52,0,55,0)-2.96 ± 19.58NA ± NA-8.24 ± 22.33NA ± NA-1.67 ± 15.34-1.69 ± 19.750.00 ± 27.26-1.15 ± 16.53NA ± NA-0.36 ± 18.25NA ± NA
Week 2: Som (n=54,0,51,0,48,59,57,52,0,55,0)-0.00 ± 19.38NA ± NA-5.49 ± 17.22NA ± NA-0.14 ± 18.63-6.33 ± 19.20-7.84 ± 17.05-0.90 ± 16.38NA ± NA-1.21 ± 14.75NA ± NA
Week 12: SPS (n=44,0,46,0,45,57,53,45,0,44,0)-8.56 ± 19.55NA ± NA-6.59 ± 17.72NA ± NA-4.74 ± 17.05-9.82 ± 18.09-11.70 ± 18.44-6.96 ± 16.30NA ± NA-9.32 ± 18.57NA ± NA
Week 12: OSP (n=44,0,46,0,45,57,53,45,0,44,0)-7.16 ± 18.36NA ± NA-8.85 ± 16.99NA ± NA-5.73 ± 16.87-10.75 ± 17.25-12.16 ± 17.51-7.36 ± 15.12NA ± NA-10.19 ± 18.39NA ± NA
Week 12: Ade (n=44,0,46,0,45,57,53,45,0,44,0)15.45 ± 28.73NA ± NA6.52 ± 26.52NA ± NA3.56 ± 25.339.30 ± 27.3815.28 ± 26.799.33 ± 27.91NA ± NA11.14 ± 21.15NA ± NA
Week 12: A SOB (n=44,0,46,0,45,57,53,45,0,44,0)-6.36 ± 19.18NA ± NA-7.83 ± 31.97NA ± NA-4.89 ± 20.96-6.67 ± 25.45-3.40 ± 24.72-0.89 ± 27.29NA ± NA-6.82 ± 23.21NA ± NA
Week 12: SD (n=44,0,46,0,45,57,53,45,0,44,0)-6.56 ± 21.22NA ± NA-10.24 ± 22.44NA ± NA-7.89 ± 25.34-12.52 ± 22.44-12.08 ± 23.49-9.11 ± 21.04NA ± NA-13.04 ± 25.94NA ± NA
Week 12: Opt (n=44,0,46,0,45,57,54,45,0,46,0)0.09 ± 0.47NA ± NA-0.02 ± 0.54NA ± NA-0.02 ± 0.540.19 ± 0.520.07 ± 0.64-0.04 ± 0.47NA ± NA0.11 ± 0.57NA ± NA
Week 12: Qua (n=44,0,46,0,45,56,53,45,0,46,0)0.52 ± 1.49NA ± NA0.15 ± 1.26NA ± NA0.16 ± 1.110.27 ± 1.360.30 ± 1.340.07 ± 2.20NA ± NA0.35 ± 1.57NA ± NA
Week 12: Sno (n=44,0,46,0,45,57,53,45,0,44,0)1.82 ± 29.83NA ± NA-3.91 ± 28.16NA ± NA1.78 ± 20.37-1.40 ± 25.60-1.51 ± 19.55-3.11 ± 25.21NA ± NA-6.36 ± 23.93NA ± NA
Week 12: Som (n=44,0,46,0,45,57,53,45,0,44,0)0.30 ± 22.55NA ± NA-6.96 ± 17.94NA ± NA-3.41 ± 21.63-8.30 ± 22.37-9.43 ± 18.65-1.04 ± 21.08NA ± NA-1.67 ± 18.53NA ± NA
Week 24: SPS (n=24,15,29,15,43,55,52,0,40,19,24)-8.89 ± 16.32-11.78 ± 25.66-12.18 ± 17.21-5.11 ± 21.34-6.90 ± 18.39-11.09 ± 18.31-10.00 ± 20.69NA ± NA-11.50 ± 22.93-8.60 ± 13.21-11.94 ± 22.76
Week 24: OSP (n=24,15,29,15,43,55,52,0,40,19,24)-8.43 ± 14.30-12.48 ± 24.26-14.44 ± 17.70-8.52 ± 19.53-9.10 ± 18.33-12.14 ± 17.76-11.68 ± 17.94NA ± NA-12.25 ± 20.59-10.35 ± 13.71-12.64 ± 19.16
Week 24: Ade (n=24,15,29,15,43,55,52,0,40,19,24)12.92 ± 30.2911.33 ± 32.049.66 ± 26.394.67 ± 27.747.21 ± 26.7610.00 ± 29.1910.77 ± 26.33NA ± NA21.00 ± 26.6813.16 ± 16.6817.50 ± 28.93
Week 24: A SOB (n=24,15,29,15,43,55,52,0,40,19,24)4.17 ± 25.011.33 ± 34.20-8.97 ± 32.336.67 ± 31.770.93 ± 27.59-2.91 ± 27.60-3.08 ± 29.48NA ± NA5.00 ± 29.26-5.26 ± 16.11-5.83 ± 27.96
Week 24: SD (n=24,15,29,15,43,55,52,0,40,19,24)-11.88 ± 20.92-16.42 ± 30.92-16.98 ± 24.82-11.50 ± 23.66-12.33 ± 24.35-16.14 ± 22.21-13.20 ± 23.25NA ± NA-13.44 ± 26.54-10.92 ± 20.62-16.15 ± 23.75
Week 24: Opt (n=24,16,29,15,43,55,52,0,40,20,24)0.17 ± 0.560.00 ± 0.520.07 ± 0.53-0.13 ± 0.640.23 ± 0.530.05 ± 0.520.08 ± 0.52NA ± NA-0.08 ± 0.620.20 ± 0.620.08 ± 0.50
Week 24: Qua (n=24,14,29,15,43,55,52,0,40,20,24)0.83 ± 0.920.57 ± 1.020.45 ± 1.50-0.27 ± 1.530.37 ± 1.200.18 ± 1.590.62 ± 1.24NA ± NA0.23 ± 2.390.50 ± 1.190.33 ± 1.31
Week 24: Sno (n=24,15,29,15,43,55,52,0,40,19,24)0.00 ± 26.38-4.00 ± 18.82-4.83 ± 27.60-2.67 ± 19.812.33 ± 26.26-2.18 ± 24.550.77 ± 27.99NA ± NA2.50 ± 22.27-2.11 ± 39.385.83 ± 18.16
Week 24: Som (n=24,15,29,15,43,55,52,0,40,19,24)0.00 ± 19.66-13.33 ± 20.00-11.95 ± 21.04-9.78 ± 19.33-7.29 ± 18.56-10.42 ± 23.40-11.03 ± 22.05NA ± NA-5.50 ± 23.24-5.26 ± 16.27-2.50 ± 13.59
Other pre-specifiedFunctional 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, Week 2, 12, 24/ ET
Reported as:
Mean · units on a scale
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Baseline (n=54,0,51,0,49,60,57,53,0,59,0)28.39 ± 11.55NA ± NA26.90 ± 9.66NA ± NA26.84 ± 11.8526.75 ± 12.1925.74 ± 11.3225.87 ± 11.93NA ± NA27.49 ± 9.96NA ± NA
Week 2 (n=54,0,51,0,48,60,56,52,0,57,0)29.06 ± 10.94NA ± NA30.52 ± 9.70NA ± NA30.31 ± 11.8431.80 ± 11.5731.66 ± 10.9929.15 ± 12.08NA ± NA28.23 ± 10.38NA ± NA
Week 12 (n=44,0,46,0,45,56,54,45,0,46,0)34.57 ± 10.82NA ± NA33.37 ± 10.05NA ± NA34.11 ± 11.2937.11 ± 11.5035.30 ± 11.6330.58 ± 10.85NA ± NA31.09 ± 10.91NA ± NA
Week 24 (n=24,15,29,15,43,55,52,0,40,20,24)35.21 ± 12.2431.53 ± 9.9837.48 ± 10.0831.80 ± 8.7935.00 ± 10.3435.82 ± 11.5934.03 ± 10.87NA ± NA34.90 ± 10.4735.45 ± 7.2737.25 ± 8.52
Other pre-specifiedChange From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET

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, Week 2, 12, 24/ ET
Reported as:
Mean · units on a scale
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET
units on a scaleCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Week 2 (n=54,0,51,0,48,59,56,52,0,57,0)0.67 ± 7.79NA ± NA3.62 ± 7.07NA ± NA3.38 ± 9.765.10 ± 9.326.07 ± 10.343.54 ± 9.18NA ± NA0.70 ± 8.25NA ± NA
Week 12 (n=44,0,46,0,45,55,54,45,0,46,0)5.14 ± 9.42NA ± NA6.00 ± 8.20NA ± NA7.47 ± 8.709.40 ± 11.528.85 ± 11.843.78 ± 11.39NA ± NA3.33 ± 9.97NA ± NA
Week 24 (n=24,15,29,15,43,55,52,0,40,20,24)4.96 ± 10.755.93 ± 9.936.97 ± 8.979.13 ± 6.838.81 ± 8.868.73 ± 11.877.59 ± 9.93NA ± NA7.80 ± 12.398.90 ± 8.728.63 ± 6.01

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CP-690,550 1 mg—2/37 (5.4%)18/37 (48.6%)
CP-690,550 1 mg to CP-690,550 5 mg (R)—0/17 (0%)5/17 (29.4%)
CP-690,550 3 mg—1/34 (2.9%)18/34 (52.9%)
CP-690,550 3 mg to CP-690,550 5 mg (R)—0/17 (0%)6/17 (35.3%)
CP-690,550 5 mg—0/49 (0%)27/49 (55.1%)
CP-690,550 10 mg—1/61 (1.6%)31/61 (50.8%)
CP-690,550 15 mg—4/57 (7%)31/57 (54.4%)
Adalimumab—0/9 (0%)5/9 (55.6%)
Adalimumab to CP-690,550 5 mg (R)—4/44 (9.1%)26/44 (59.1%)
Placebo—2/34 (5.9%)14/34 (41.2%)
Placebo to CP-690,550 5 mg (R)—0/25 (0%)13/25 (52%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
PneumoniaInfections and infestations2/370/170/340/170/490/610/570/90/440/340/25
AnaemiaBlood and lymphatic system disorders0/370/171/340/170/490/610/570/90/440/340/25
Gastric ulcerGastrointestinal disorders0/370/171/340/170/490/610/570/90/440/340/25
Wound infectionInfections and infestations0/370/170/340/170/490/610/570/90/441/340/25
Panic attackPsychiatric disorders0/370/170/340/170/490/610/570/90/441/340/25
Pyelonephritis acuteInfections and infestations0/370/170/340/170/490/610/570/91/440/340/25
Renal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/370/170/340/170/490/610/570/91/440/340/25
Postmenopausal haemorrhageReproductive system and breast disorders0/370/170/340/170/490/610/570/91/440/340/25
Knee arthroplastySurgical and medical procedures0/370/170/340/170/490/610/570/91/440/340/25
GastritisGastrointestinal disorders0/370/170/340/170/490/611/570/90/440/340/25
Most frequent other events
Showing 10 of 144
Most frequent other events
EventCP-690,550 1 mgCP-690,550 1 mg to CP-690,550 5 mg (R)CP-690,550 3 mgCP-690,550 3 mg to CP-690,550 5 mg (R)CP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabAdalimumab to CP-690,550 5 mg (R)PlaceboPlacebo to CP-690,550 5 mg (R)
Abdominal pain upperGastrointestinal disorders1/370/171/341/170/490/612/570/91/440/343/25
ConstipationGastrointestinal disorders0/370/170/340/171/492/611/571/90/441/341/25
SinusitisInfections and infestations0/370/170/340/171/492/611/571/90/440/340/25
Blood creatinine increasedInvestigations1/370/171/340/170/491/610/571/91/440/340/25
Transaminases increasedInvestigations0/370/170/340/171/490/610/571/90/440/340/25
Dermatitis allergicSkin and subcutaneous tissue disorders0/370/170/340/170/490/610/571/90/440/340/25
Urinary tract infectionInfections and infestations3/370/172/341/175/493/616/570/92/442/341/25
HeadacheNervous system disorders0/370/172/340/172/496/613/570/93/441/340/25
RashSkin and subcutaneous tissue disorders1/370/170/340/171/490/613/570/94/440/341/25
DiarrhoeaGastrointestinal disorders2/370/173/340/173/494/611/570/91/440/341/25

Baseline characteristics

Age Continuous
Age Continuous(years)CP-690,550 1 mgCP-690,550 3 mgCP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabPlaceboTotal
Mean55.1 ± 13.353.4 ± 12.253.7 ± 13.552.4 ± 10.953.2 ± 13.053.5 ± 11.952.5 ± 13.753.3 ± 12.6
Sex: Female, Male
Sex: Female, Male(Participants)CP-690,550 1 mgCP-690,550 3 mgCP-690,550 5 mgCP-690,550 10 mgCP-690,550 15 mgAdalimumabPlaceboTotal
Female46444353504552333
Male876878751
08

Study locations

63 sites
  • Pfizer Investigational Site
    Mesa, Arizona 85208, United States
  • Pfizer Investigational Site
    Little Rock, Arkansas 72205, United States
  • Pfizer Investigational Site
    Northridge, California 91325, United States
  • Pfizer Investigational Site
    Palo Alto, California 94304, United States
  • Pfizer Investigational Site
    Stanford, California 94305, United States
  • Pfizer Investigational Site
    Tarzana, California 91356, United States
  • Pfizer Investigational Site
    Upland, California 91786, United States
  • Pfizer Investigational Site
    Orlando, Florida 32804, United States
  • Pfizer Investigational Site
    Tampa, Florida 33614, United States
  • Pfizer Investigational Site
    Morton Grove, Illinois 60053, United States
  • Pfizer Investigational Site
    Rockford, Illinois 61107, United States
  • Pfizer Investigational Site
    Cedar Rapids, Iowa 52401-2112, United States
  • Pfizer Investigational Site
    Wichita, Kansas 67203, United States
  • Pfizer Investigational Site
    Wichita, Kansas 67208, United States
  • Pfizer Investigational Site
    New Orleans, Louisiana 70115, United States
  • Pfizer Investigational Site
    Hickory, North Carolina 28601, United States
  • Pfizer Investigational Site
    Hickory, North Carolina 28602, United States
  • Pfizer Investigational Site
    Dayton, Ohio 45408, United States
  • Pfizer Investigational Site
    Duncansville, Pennsylvania 16635, United States
  • Pfizer Investigational Site
    Knoxville, Tennessee 37909-1600, United States
  • Pfizer Investigational Site
    Dallas, Texas 75235, United States
  • Pfizer Investigational Site
    Mesquite, Texas 75150, United States
  • Pfizer Investigational Site
    Porto Alegre, RS 90035-903, Brazil
  • Pfizer Investigational Site
    Sao Paulo, SP 01323-903, Brazil
  • Pfizer Investigational Site
    Pleven, 5800, Bulgaria
  • Pfizer Investigational Site
    Sofia 1606, Bulgaria
  • Pfizer Investigational Site
    Sofia, 1612, Bulgaria
  • Pfizer Investigational Site
    Sofia, 1709, Bulgaria
  • Pfizer Investigational Site
    Santiago, RM 8331030, Chile
  • Pfizer Investigational Site
    Santiago, RM 8360156, Chile
  • Pfizer Investigational Site
    Providencia, Santiago, RM 7530206, Chile
  • Pfizer Investigational Site
    Split, 21000, Croatia
  • Pfizer Investigational Site
    Zagreb, 10000, Croatia
  • Pfizer Investigational Site
    Brno, 656 91, Czech Republic
  • Pfizer Investigational Site
    Praha 11 - Chodov, 148 00, Czech Republic
  • Pfizer Investigational Site
    Praha 2, 128 50, Czech Republic
  • Pfizer Investigational Site
    Praha 4, 140 59, Czech Republic
  • Pfizer Investigational Site
    Zlin, 760 01, Czech Republic
  • Pfizer Investigational Site
    Dresden, 01067, Germany
  • Pfizer Investigational Site
    Hamburg, 22081, Germany
  • Pfizer Investigational Site
    Hildesheim, 31134, Germany
  • Pfizer Investigational Site
    Leipzig, 04103, Germany
  • Pfizer Investigational Site
    Goudi, Athens 11527, Greece
  • Pfizer Investigational Site
    Thessaloniki, 54 636, Greece
  • Pfizer Investigational Site
    Szolnok, H-5000, Hungary
  • Pfizer Investigational Site
    Firenze, 50139, Italy
  • Pfizer Investigational Site
    Genova, 16132, Italy
  • Pfizer Investigational Site
    Seoul, 110-744, Korea, Republic of
  • Pfizer Investigational Site
    Seoul, 133-792, Korea, Republic of
  • Pfizer Investigational Site
    Mexico, D.f. 06100, Mexico
  • Pfizer Investigational Site
    Metepec, Estado de Mexico 52140, Mexico
  • Pfizer Investigational Site
    Guadalajara, Jalisco 44650, Mexico
  • Pfizer Investigational Site
    Cuernavaca, Morelos 62270, Mexico
  • Pfizer Investigational Site
    Bucuresti, 011172, Romania
  • Pfizer Investigational Site
    Constanta, 900591, Romania
  • Pfizer Investigational Site
    Iasi, 700661, Romania
  • Pfizer Investigational Site
    Piestany, 921 12, Slovakia
  • Pfizer Investigational Site
    Zilina, 012 07, Slovakia
  • Pfizer Investigational Site
    Kharkiv, 61000, Ukraine
  • Pfizer Investigational Site
    Kyiv, 04114, Ukraine
  • Pfizer Investigational Site
    Lviv, 79011, Ukraine
  • Pfizer Investigational Site
    Vinnitsa, 21018, Ukraine
  • Pfizer Investigational Site
    Zaporizhzhia, 69118, Ukraine
09

References and documents

Publications

  • Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6. PubMed 34870800 ↗
  • Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395. PubMed 33127856 ↗
  • Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z. PubMed 32816215 ↗
  • Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12. PubMed 31512746 ↗
  • Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2. PubMed 28941219 ↗
  • Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31. PubMed 28143815 ↗
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  • Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, Connell CA, Gruben D, Krishnaswami S, Wallenstein G, Wilkinson BE, Zwillich SH. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012 Mar;64(3):617-29. doi: 10.1002/art.33383. PubMed 21952978 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00550446
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 29, 2007
Start date
Sep 2007
Primary completion
Jan 2009
Completion
Jan 2009
Results posted
Jan 3, 2013
Last update
Jan 3, 2013

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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