A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00853385
• Collaborator: (none)
• Enrollment: 717
• Locations: 125
• Arms: 5
• Duration (Months): 22
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: CP 690,550; Drug: CP-690,550; Other: Placebo; Other: Placebo; Biological: Biologic TNFi	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 717 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5mg	Drug: CP 690,550; tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
Experimental: 10 mg	Drug: CP-690,550; tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
Placebo Comparator: Placebo Sequence 1	Other: Placebo; placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Placebo Comparator: Placebo Sequence 2	Other: Placebo; tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Active Comparator: adalimumab	Biological: Biologic TNFi; placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months; Other Names: Humira (Adalimumab)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 [Month 6]

   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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

2. Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 [Baseline, Month 3]

   HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

3. Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 [Month 6]

   DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (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) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Secondary Outcome Measures

1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 [Month 1, 3]

   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.

2. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 [Month 9, 12]

   ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; 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.

3. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 [Month 1, 3, 6]

   ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; 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.

4. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 [Month 9, 12]

   ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; 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.

5. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 [Month 1, 3, 6]

   ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; 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.

6. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 [Month 9, 12]

   ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; 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.

7. Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

   DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

8. Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 [Month 9, 12]

   DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

9. Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

   DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with 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 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

10. Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 [Month 9, 12]

    DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with 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 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

11. Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Baseline, Month 1, 3, 6, 9, 12]

    DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with 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 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

12. Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [Baseline, Month 1, 3, 6, 9, 12]

    DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.

13. Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 [Month 1, 3, 6]

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

14. Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 [Month 9, 12]

    HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.

15. Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

16. Patient Assessment of Arthritis Pain at Month 9 and 12 [Month 9, 12]

    Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.

17. Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

18. Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 [Month 9, 12]

    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.

19. Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

20. Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 [Month 9, 12]

    Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

21. 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.

22. 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 [Month 9, 12]

    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.

23. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    FACIT-Fatigue scale 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.

24. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 [Month 12]

    FACIT-Fatigue scale 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.

25. Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    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.

26. Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 [Month 12]

    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.

27. Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.

28. Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 [Month 12]

    MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.

29. Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

30. Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 [Month 12]

    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.

31. Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 [Month 3, 6]

    WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).

32. Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 [Baseline, Month 12]

    WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).

33. Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 [Baseline, Month 3, 6]

    Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.

34. Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 [Month 12]

    RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.

35. Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [Baseline, Month 3, 6]

    RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

36. Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 [Month 12]

    RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

37. Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [Baseline, Month 3, 6]

    RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

38. Number of Days as Assessed Using RA-HCRU at Month 12 [Month 12]

    RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.

39. Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 [Baseline, Month 3, 6]

    RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.

40. Number of Hours Per Day as Assessed RA-HCRU at Month 12 [Month 12]

    RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.

41. Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 [Baseline, Month 3, 6]

    Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

42. Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 [Month 12]

    Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.

• The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.

• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.

• The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

• Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L

• History of any other autoimmune rheumatic disease other than Sjogren's syndrome

• No malignancy or history of malignancy.

• History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug

• Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.

• Patients who have previously received adalimumab therapy for any reason.

• Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.

• Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Gilbert	Arizona	United States	85234
2	Pfizer Investigational Site	Glendale	Arizona	United States	85304
3	Pfizer Investigational Site	Mesa	Arizona	United States	85202
4	Pfizer Investigational Site	Paradise Valley	Arizona	United States	85253
5	Pfizer Investigational Site	Phoenix	Arizona	United States	85037
6	Pfizer Investigational Site	Jonesboro	Arkansas	United States	72401
7	Pfizer Investigational Site	Fair Oaks	California	United States	95628
8	Pfizer Investigational Site	San Diego	California	United States	92108
9	Pfizer Investigational Site	Boulder	Colorado	United States	80304
10	Pfizer Investigational Site	Largo	Florida	United States	33777
11	Pfizer Investigational Site	Naples	Florida	United States	34102
12	Pfizer Investigational Site	Palm Harbor	Florida	United States	34684
13	Pfizer Investigational Site	Pinellas Park	Florida	United States	33782
14	Pfizer Investigational Site	Plantation	Florida	United States	33324
15	Pfizer Investigational Site	St. Petersburg	Florida	United States	33710
16	Pfizer Investigational Site	Tampa	Florida	United States	33613
17	Pfizer Investigational Site	Decatur	Georgia	United States	30033
18	Pfizer Investigational Site	Marietta	Georgia	United States	30060
19	Pfizer Investigational Site	Rockford	Illinois	United States	61107
20	Pfizer Investigational Site	Evansville	Indiana	United States	47714
21	Pfizer Investigational Site	Wichita	Kansas	United States	67203
22	Pfizer Investigational Site	Lexington	Kentucky	United States	40504
23	Pfizer Investigational Site	Lexington	Kentucky	United States	40515
24	Pfizer Investigational Site	Baton Rouge	Louisiana	United States	70809
25	Pfizer Investigational Site	Haverhill	Massachusetts	United States	01830
26	Pfizer Investigational Site	Worcester	Massachusetts	United States	01610
27	Pfizer Investigational Site	Grand Rapids	Michigan	United States	49546
28	Pfizer Investigational Site	Cincinnati	Ohio	United States	45219
29	Pfizer Investigational Site	Oklahoma City	Oklahoma	United States	73112
30	Pfizer Investigational Site	Greenville	South Carolina	United States	29601
31	Pfizer Investigational Site	Austin	Texas	United States	78705
32	Pfizer Investigational Site	Dallas	Texas	United States	75231
33	Pfizer Investigational Site	Houston	Texas	United States	77034
34	Pfizer Investigational Site	Lubbock	Texas	United States	79424
35	Pfizer Investigational Site	Mesquite	Texas	United States	75150
36	Pfizer Investigational Site	Seattle	Washington	United States	98104
37	Pfizer Investigational Site	Seattle	Washington	United States	98122
38	Pfizer Investigational Site	Clarksburg	West Virginia	United States	26301
39	Pfizer Investigational Site	St Leonards	New South Wales	Australia	2065
40	Pfizer Investigational Site	Cairns	Queensland	Australia	4870
41	Pfizer Investigational Site	Maroochydore	Queensland	Australia	4558
42	Pfizer Investigational Site	Malvern East	Victoria	Australia	3145
43	Pfizer Investigational Site	Sarajevo		Bosnia and Herzegovina	71000
44	Pfizer Investigational Site	Pleven		Bulgaria	5800
45	Pfizer Investigational Site	Plovdiv		Bulgaria	4000
46	Pfizer Investigational Site	Plovdiv		Bulgaria	4002
47	Pfizer Investigational Site	Sevlievo		Bulgaria	5400
48	Pfizer Investigational Site	Sofia		Bulgaria	1606
49	Pfizer Investigational Site	Sofia		Bulgaria	1709
50	Pfizer Investigational Site	Vancouver	British Columbia	Canada	V5Z 1L7
51	Pfizer Investigational Site	Lunenburg	Nova Scotia	Canada	B0J 2C0
52	Pfizer Investigational Site	London	Ontario	Canada	N6A 4V2
53	Pfizer Investigational Site	Mississauga	Ontario	Canada	L5M 2V8
54	Pfizer Investigational Site	Toronto	Ontario	Canada	M5T 2S8
55	Pfizer Investigational Site	Trois-Rivieres	Quebec	Canada	G8Z 1Y2
56	Pfizer Investigational Site	Saskatoon	Saskatchewan	Canada	S7N 0W8
57	Pfizer Investigational Site	Quebec		Canada	G1W 4R4
58	Pfizer Investigational Site	Santiago	RM	Chile	7510186
59	Pfizer Investigational Site	Santiago	RM	Chile	8360156
60	Pfizer Investigational Site	Providencia	Santiago, RM	Chile	7530206
61	Pfizer Investigational Site	Rancagua	VI Region	Chile	2841959
62	Pfizer Investigational Site	Cartago		Costa Rica
63	Pfizer Investigational Site	San Jose		Costa Rica	00
64	Pfizer Investigational Site	San Jose		Costa Rica
65	Pfizer Investigational Site	Osijek		Croatia	31000
66	Pfizer Investigational Site	Split		Croatia	21000
67	Pfizer Investigational Site	Zagreb		Croatia	10000
68	Pfizer Investigational Site	Brno - Zidenice		Czech Republic	615 00
69	Pfizer Investigational Site	Brno		Czech Republic	60200
70	Pfizer Investigational Site	Brno		Czech Republic	656 91
71	Pfizer Investigational Site	Brno		Czech Republic	65691
72	Pfizer Investigational Site	Hlucin		Czech Republic	748 01
73	Pfizer Investigational Site	Pardubice		Czech Republic	530 02
74	Pfizer Investigational Site	Praha 11 - Chodov		Czech Republic	148 00
75	Pfizer Investigational Site	Praha 11		Czech Republic	14800
76	Pfizer Investigational Site	Praha 2		Czech Republic	128 50
77	Pfizer Investigational Site	Praha 4		Czech Republic	140 00
78	Pfizer Investigational Site	Zlin		Czech Republic	760 01
79	Pfizer Investigational Site	Frederiksberg		Denmark	2000
80	Pfizer Investigational Site	Randers NOE		Denmark	8930
81	Pfizer Investigational Site	Santo Domingo		Dominican Republic	00000
82	Pfizer Investigational Site	Hyvinkaa		Finland	05800
83	Pfizer Investigational Site	Aachen		Germany	52064
84	Pfizer Investigational Site	Berlin		Germany	14059
85	Pfizer Investigational Site	Frankfurt am Main		Germany	60590
86	Pfizer Investigational Site	Halle		Germany	06108
87	Pfizer Investigational Site	Halle		Germany	06128
88	Pfizer Investigational Site	Herne		Germany	44652
89	Pfizer Investigational Site	Ratingen		Germany	40882
90	Pfizer Investigational Site	Wuerzburg		Germany	97080
91	Pfizer Investigational Site	Daegu		Korea, Republic of	705-718
92	Pfizer Investigational Site	Gwangju		Korea, Republic of	501-757
93	Pfizer Investigational Site	Seoul		Korea, Republic of	110-744
94	Pfizer Investigational Site	Seoul		Korea, Republic of	133-792
95	Pfizer Investigational Site	Mexico	DF	Mexico	10700
96	Pfizer Investigational Site	Guadalajara	Jalisco	Mexico	44620
97	Pfizer Investigational Site	Morelia	Michoacan	Mexico	58249
98	Pfizer Investigational Site	San Luis Potosi	SLP	Mexico	78240
99	Pfizer Investigational Site	Lipa City	Batangas	Philippines	4217
100	Pfizer Investigational Site	Angeles City	Pampanga	Philippines	2009
101	Pfizer Investigational Site	Cebu City		Philippines	6000
102	Pfizer Investigational Site	Bialystok		Poland	15-337
103	Pfizer Investigational Site	Cieszyn		Poland	43-400
104	Pfizer Investigational Site	Koscian		Poland	64-000
105	Pfizer Investigational Site	Krakow		Poland	31-501
106	Pfizer Investigational Site	Sopot		Poland	81-759
107	Pfizer Investigational Site	Torun		Poland	87-100
108	Pfizer Investigational Site	Warszawa		Poland	02-118
109	Pfizer Investigational Site	Bratislava		Slovakia	82606
110	Pfizer Investigational Site	Dunajska Streda		Slovakia	92901
111	Pfizer Investigational Site	Kosice		Slovakia	040 01
112	Pfizer Investigational Site	Nove Zamky		Slovakia	94001
113	Pfizer Investigational Site	Povazska Dystrica		Slovakia	017 01
114	Pfizer Investigational Site	Zilina		Slovakia	010 01
115	Pfizer Investigational Site	Santiago de Compostela	A Coruña	Spain	15705
116	Pfizer Investigational Site	Vigo	Pontevedra	Spain	36200
117	Pfizer Investigational Site	A Coruña		Spain	15006
118	Pfizer Investigational Site	Madrid		Spain	28041
119	Pfizer Investigational Site	Sevilla		Spain	41009
120	Pfizer Investigational Site	Valencia		Spain	46026
121	Pfizer Investigational Site	Rajathevee	Bangkok	Thailand	10400
122	Pfizer Investigational Site	Amphoe Muang	Chiang Mai	Thailand	50200
123	Pfizer Investigational Site	Wirral	Merseyside	United Kingdom	CH49 5PE
124	Pfizer Investigational Site	Cannock	Staffs	United Kingdom	WS11 2XY
125	Pfizer Investigational Site	Dudley, West Midlands		United Kingdom	DY1 2HQ

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00853385
• Other Study ID Numbers: A3921064
• First Posted: Mar 2, 2009
• Last Update Posted: Jan 18, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Pfizer: oral DMARD; JAK inhibitor; clinical trial
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab; Tofacitinib

Study Results

Participant Flow

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Period Title: Overall Study
STARTED	204	201	56	52	204
COMPLETED	150	158	47	39	162
NOT COMPLETED	54	43	9	13	42

Baseline Characteristics

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab	Total
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.	Total of all reporting groups
Overall Participants	204	201	56	52	204	717
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.0 (11.9)	52.9 (11.8)	55.5 (13.7)	51.9 (13.7)	52.5 (11.7)	52.9 (12.1)
Sex: Female, Male (Count of Participants)
Female	174 85.3%	168 83.6%	43 76.8%	39 75%	162 79.4%	586 81.7%
Male	30 14.7%	33 16.4%	13 23.2%	13 25%	42 20.6%	131 18.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Description	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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

Full analysis set: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	106	199
Number [percentage of participants]	51.53 25.3%	52.55 26.1%	28.30 50.5%	47.24 90.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.
	Method	Normal approximation
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	24.24
	Confidence Interval	(2-Sided) 95%; 13.18 to 35.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant.
	Method	Normal approximation
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	23.22
	Confidence Interval	(2-Sided) 95%; 12.16 to 34.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments	Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0007
	Comments	Statistical testing was done at 5% significance level (2-sided).
	Method	Normal approximation
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	18.93
	Confidence Interval	(2-Sided) 95%; 7.90 to 29.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time Frame	Baseline, Month 3

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline (n=201, 199, 106, 201)	1.50 (0.64)	1.53 (0.63)	1.42 (0.68)	1.50 (0.59)
Month 3 (n=188, 185, 98, 190)	-0.49 (0.59)	-0.59 (0.58)	-0.17 (0.56)	-0.45 (0.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. For the comparison of 10 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95%; -0.50 to -0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.31
	Confidence Interval	(2-Sided) 95%; -0.43 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments	LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical testing was done at 5% significance level (2-sided).
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.37 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Description	DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (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) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	177	176	92	178
Number [percentage of participants]	6.21 3%	12.50 6.2%	1.09 1.9%	6.74 13%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A step-down procedure was used to control for multiple comparisons. For comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.
	Method	Normal approximation
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	11.41
	Confidence Interval	(2-Sided) 95%; 6.08 to 16.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0151
	Comments	Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.
	Method	Normal approximation
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	5.12
	Confidence Interval	(2-Sided) 95%; 0.98 to 9.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Adalimumab
	Comments	Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0091
	Comments	Statistical testing was done at 5% significance level (2-sided).
	Method	Normal approximation
	Comments
Method of Estimation	Estimation Parameter	Percent difference
	Estimated Value	5.65
	Confidence Interval	(2-Sided) 95%; 1.40 to 9.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
Description	ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Month 1, 3

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	106	199
Month 1	41.24 20.2%	45.92 22.8%	16.04 28.6%	37.88 72.8%
Month 3	60.71 29.8%	58.67 29.2%	26.42 47.2%	56.28 108.2%

5. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
Description	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	56	50	199
Month 9	49.49 24.3%	50.51 25.1%	30.36 54.2%	36.00 69.2%	47.24 23.2%
Month 12	49.49 24.3%	49.49 24.6%	33.93 60.6%	34.00 65.4%	49.25 24.1%

6. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
Description	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	106	199
Month 1	14.95 7.3%	16.33 8.1%	4.72 8.4%	12.12 23.3%
Month 3	34.18 16.8%	27.55 13.7%	6.60 11.8%	23.62 45.4%
Month 6	36.73 18%	34.69 17.3%	12.26 21.9%	27.64 53.2%

7. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
Description	ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	56	50	199
Month 9	35.71 17.5%	37.24 18.5%	17.86 31.9%	26.00 50%	29.15 14.3%
Month 12	36.73 18%	35.71 17.8%	21.43 38.3%	28.00 53.8%	33.67 16.5%

8. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
Description	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	106	199
Month 1	2.58 1.3%	4.08 2%	0.94 1.7%	3.03 5.8%
Month 3	12.24 6%	14.80 7.4%	1.89 3.4%	8.54 16.4%
Month 6	19.90 9.8%	21.94 10.9%	1.89 3.4%	9.05 17.4%

9. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
Description	ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	196	196	56	50	199
Month 9	18.37 9%	21.94 10.9%	8.93 15.9%	10.00 19.2%	11.06 5.4%
Month 12	22.96 11.3%	23.47 11.7%	10.71 19.1%	14.00 26.9%	16.58 8.1%

10. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Description	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	200	199	106	201
Baseline (n=200, 199, 106, 201)	5.43 (0.89)	5.43 (0.83)	5.44 (0.88)	5.33 (0.92)
Month 1 (n=193, 196, 104, 197)	4.26 (1.09)	4.21 (1.05)	5.09 (1.15)	4.27 (1.06)
Month 3 (n=187, 184, 99, 190)	3.78 (1.21)	3.77 (1.21)	4.83 (1.25)	3.88 (1.15)
Month 6 (n=174, 180, 46, 181)	3.51 (1.27)	3.29 (1.22)	3.85 (1.14)	3.63 (1.19)

11. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Description	DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint 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, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	160	167	49	41	171
Month 9 (n=160, 167, 49, 41, 171)	3.13 (1.11)	3.20 (1.20)	3.11 (1.11)	3.03 (1.10)	3.46 (1.21)
Month 12 (n=149, 150, 48, 37, 160)	3.05 (1.13)	3.00 (1.18)	3.12 (0.96)	3.02 (1.28)	3.18 (1.25)

12. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Description	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with 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 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	195	194	103	194
Baseline (n=195, 194, 103, 194)	6.56 (0.93)	6.48 (0.89)	6.45 (0.90)	6.36 (0.93)
Month 1 (n=172, 175, 90, 176)	5.23 (1.19)	5.14 (1.26)	5.93 (1.22)	5.13 (1.21)
Month 3 (n=170, 166, 87, 167)	4.64 (1.33)	4.66 (1.39)	5.60 (1.31)	4.66 (1.28)
Month 6 (n=155, 162, 41, 158)	4.40 (1.38)	4.21 (1.38)	4.61 (1.17)	4.37 (1.30)

13. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
Description	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with 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 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	140	151	45	35	149
Month 9 (n=140, 151, 45, 35, 149)	4.00 (1.21)	4.08 (1.33)	3.99 (1.25)	3.93 (1.17)	4.20 (1.39)
Month 12 (n=134, 136, 44, 32, 139)	3.85 (1.22)	3.88 (1.35)	4.00 (0.95)	3.70 (1.24)	3.95 (1.48)

14. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Description	DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with 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 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Baseline, Month 1, 3, 6, 9, 12

Outcome Measure Data

Analysis Population Description

Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	0	0	0	0

15. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Description	DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Time Frame	Baseline, Month 1, 3, 6, 9, 12

Outcome Measure Data

Analysis Population Description

Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	0	0	0	0

16. Secondary Outcome

Title	Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame	Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	194	196	106	198
Month 1 (n=194, 196, 106, 198)	1.15 (0.66)	1.11 (0.67)	1.32 (0.69)	1.12 (0.64)
Month 3 (n=188, 185, 99, 190)	1.00 (0.72)	0.94 (0.75)	1.25 (0.67)	1.05 (0.64)
Month 6 (n=174, 181, 46, 180)	0.92 (0.72)	0.89 (0.69)	1.15 (0.71)	0.98 (0.65)

17. Secondary Outcome

Title	Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
Description	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	158	167	49	41	171
Month 9 (n=158, 167, 49, 41, 171)	0.86 (0.66)	0.85 (0.66)	0.89 (0.69)	0.90 (0.64)	0.97 (0.67)
Month 12 (n=149, 149, 49, 38, 159)	0.83 (0.68)	0.81 (0.71)	0.88 (0.71)	0.91 (0.72)	0.90 (0.67)

18. Secondary Outcome

Title	Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Description	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline (n=201, 199, 106, 201)	59.29 (20.95)	59.01 (22.18)	55.20 (21.27)	56.46 (21.92)
Month 1 (n=194, 196, 106, 198)	39.71 (22.60)	36.77 (22.63)	49.92 (23.94)	39.27 (24.29)
Month 3 (n=188, 185, 99, 190)	32.98 (23.09)	31.27 (22.39)	48.53 (23.42)	36.27 (25.67)
Month 6 (n=174, 181, 46, 179)	30.40 (23.26)	28.36 (22.52)	35.04 (20.95)	32.78 (22.57)

19. Secondary Outcome

Title	Patient Assessment of Arthritis Pain at Month 9 and 12
Description	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	158	167	49	41	171
Month 9 (n=158, 167, 49, 41, 171)	27.04 (21.35)	27.99 (22.97)	31.31 (22.66)	24.93 (19.38)	32.70 (24.18)
Month 12 (n=150, 150, 49, 38, 160)	26.99 (21.97)	24.55 (20.68)	28.23 (17.86)	29.37 (20.57)	27.94 (22.70)

20. Secondary Outcome

Title	Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Description	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, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline (n=201, 199, 106, 201)	59.86 (21.38)	56.55 (23.83)	54.46 (21.27)	57.22 (22.22)
Month 1 (n=194, 196, 105, 197)	41.85 (23.02)	36.61 (23.51)	50.70 (24.24)	39.32 (23.83)
Month 3 (n=188, 185, 99, 190)	35.56 (23.81)	31.25 (22.23)	49.84 (22.45)	36.97 (25.28)
Month 6 (n=174, 181, 46, 180)	32.79 (25.56)	29.74 (22.41)	37.76 (20.86)	33.50 (21.97)

21. Secondary Outcome

Title	Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Description	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	158	167	49	41	171
Month 9 (n=158, 167, 49, 41, 171)	28.39 (22.31)	29.47 (21.99)	31.78 (20.75)	30.00 (20.31)	34.38 (24.93)
Month 12 (n=149, 150, 49, 37, 160)	26.86 (22.44)	27.70 (22.09)	30.78 (17.65)	29.70 (20.69)	30.33 (24.46)

22. Secondary Outcome

Title	Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Description	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, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	199	199	106	201
Baseline (n=199, 199, 106, 201)	59.92 (16.77)	59.56 (16.70)	60.28 (16.55)	58.64 (15.98)
Month 1 (n=193, 195, 106, 197)	38.90 (18.56)	36.16 (19.27)	50.73 (22.08)	38.81 (20.08)
Month 3 (n=186, 185, 99, 189)	30.28 (20.71)	29.91 (21.04)	45.12 (22.77)	32.40 (21.08)
Month 6 (n=174, 180, 46, 178)	24.97 (19.26)	24.46 (19.78)	29.76 (20.43)	27.77 (18.36)

23. Secondary Outcome

Title	Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
Description	Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	160	167	49	41	170
Month 9 (n=160, 167, 49, 41, 170)	19.93 (16.20)	21.92 (17.87)	25.82 (20.32)	23.78 (15.54)	25.45 (19.94)
Month 12 (n=149, 150, 48, 38, 157)	18.67 (16.18)	18.87 (16.05)	19.77 (13.88)	20.68 (14.51)	20.44 (16.94)

24. Secondary Outcome

Title	36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Description	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline: Physical functioning (n=201,199,106,201)	32.02 (9.48)	31.06 (9.52)	32.23 (9.43)	31.74 (8.95)
Baseline: Role physical (n=201,199,106,201)	34.00 (9.11)	33.54 (9.12)	34.70 (8.01)	34.79 (8.69)
Baseline: Social functioning (n=201,199,106,201)	36.15 (10.76)	36.27 (11.59)	39.36 (11.17)	36.23 (11.52)
Baseline: Bodily pain (n=201,199,106,201)	33.42 (7.51)	33.29 (7.42)	34.53 (6.57)	33.14 (7.33)
Baseline: Mental health (n=201,199,106,201)	39.04 (11.42)	39.15 (11.19)	41.11 (10.51)	39.64 (11.19)
Baseline: Role emotional (n=201,199,106,201)	34.15 (12.49)	34.11 (12.63)	37.32 (11.97)	35.54 (12.05)
Baseline: Vitality (n=201,199,106,201)	40.62 (9.23)	40.79 (9.36)	42.67 (8.85)	39.95 (9.54)
Baseline: General health (n=201,199,106,201)	35.22 (8.95)	35.81 (8.93)	36.29 (8.38)	35.18 (7.96)
Baseline:Mental component (n=201,199,106,201)	39.82 (11.68)	40.21 (11.14)	43.29 (10.58)	40.58 (11.64)
Baseline: Physical component (n=201,199,106,201)	33.10 (7.69)	32.62 (7.78)	33.02 (6.23)	32.74 (6.83)
Month 1: Physical functioning (n=194,196,106,198)	35.29 (9.94)	35.23 (10.57)	34.00 (9.68)	35.38 (9.79)
Month 1: Role physical (n=194,196,106,198)	38.19 (9.34)	38.45 (10.01)	36.79 (9.39)	38.37 (9.06)
Month 1: Social functioning (n=194,196,106,198)	40.77 (10.53)	42.22 (10.64)	41.74 (10.72)	40.98 (10.41)
Month 1: Bodily pain (n=194,196,106,198)	40.14 (8.54)	40.73 (8.46)	36.18 (7.52)	39.58 (8.36)
Month 1: Mental health (n=194,196,106,198)	42.31 (10.30)	43.35 (11.13)	41.79 (10.91)	42.83 (10.93)
Month 1: Role emotional (n=194,196,106,198)	38.29 (12.54)	38.64 (12.05)	38.18 (11.89)	39.10 (11.55)
Month 1: Vitality (n=194,196,106,198)	45.24 (9.33)	46.99 (9.58)	43.71 (8.74)	44.44 (10.00)
Month 1: General health (n=194,196,106,198)	38.53 (9.24)	39.98 (9.16)	37.41 (8.61)	38.35 (8.43)
Month 1: Mental component (n=194,196,106,198)	43.56 (10.60)	44.92 (11.21)	44.03 (11.04)	44.05 (10.79)
Month 1: Physical component (n=194,196,106,198)	37.50 (7.99)	37.86 (8.11)	35.01 (7.36)	37.08 (7.88)
Month 3: Physical functioning (n=187,185,99,190)	38.11 (10.39)	38.49 (11.12)	34.77 (8.92)	36.56 (10.24)
Month 3: Role physical (n=188,185,99,190)	39.79 (9.55)	40.93 (10.40)	37.25 (8.88)	39.51 (8.89)
Month 3: Social functioning (n=188,185,99,190)	41.59 (11.04)	44.34 (11.00)	41.41 (10.08)	40.84 (10.92)
Month 3: Bodily pain (n=187,185,99,190)	41.08 (9.15)	43.09 (9.58)	37.05 (7.91)	40.60 (9.54)
Month 3: Mental health (n=188,185,99,190)	42.43 (11.02)	44.79 (11.25)	42.44 (10.04)	43.05 (10.45)
Month 3: Role emotional (n=188,185,99,190)	38.74 (12.56)	41.76 (12.66)	38.59 (12.42)	39.24 (11.53)
Month 3: Vitality (n=188,185,99,190)	45.63 (9.91)	48.09 (10.79)	44.06 (9.22)	45.57 (9.76)
Month 3: General health (n=188,185,99,189)	39.15 (9.52)	41.35 (8.93)	37.51 (8.08)	39.33 (9.32)
Month 3: Mental component (n=187,185,99,189)	43.31 (11.47)	46.49 (11.45)	44.20 (10.65)	43.90 (10.84)
Month 3: Physical component (n=187,185,99,189)	39.57 (8.76)	40.30 (8.94)	35.59 (7.33)	38.58 (8.36)
Month 6: Physical functioning (n=173,181,46,179)	39.31 (10.92)	38.56 (11.35)	37.00 (8.99)	37.29 (10.40)
Month 6: Role physical (n=173,181,46,179)	40.42 (10.03)	41.29 (9.73)	38.62 (7.95)	39.99 (9.14)
Month 6: Social functioning (n=173,181,46,180)	43.85 (11.17)	43.98 (11.30)	42.49 (9.92)	42.36 (10.43)
Month 6: Bodily pain (n=173,181,46,180)	42.79 (9.41)	43.63 (9.31)	39.79 (8.05)	41.59 (8.95)
Month 6: Mental health (n=173,181,46,180)	44.31 (11.29)	45.32 (11.43)	41.21 (11.70)	43.13 (11.35)
Month 6: Role emotional (n=173,181, 46,179)	40.78 (12.03)	40.68 (11.77)	39.22 (11.82)	39.54 (11.85)
Month 6: Vitality (n=173,181,46,180)	47.35 (10.37)	48.66 (10.08)	45.06 (9.36)	45.93 (9.88)
Month 6: General health (n=173,180,46,180)	40.53 (9.44)	41.95 (8.89)	39.03 (9.30)	39.91 (8.72)
Month 6: Mental component (n=173,180,46,179)	45.44 (11.19)	46.14 (11.43)	43.43 (10.60)	44.24 (11.69)
Month 6: Physical component (n=173,180,46,179)	40.45 (9.29)	40.86 (8.71)	38.44 (6.67)	39.36 (8.39)

25. Secondary Outcome

Title	36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Description	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	159	167	49	41	171
Month 9: Physical functioning(n=158,167,49,41,171)	39.77 (10.29)	38.74 (11.31)	38.94 (9.81)	38.59 (10.08)	38.75 (10.23)
Month 9: Role physical (n=159,167,49,41,171)	41.66 (9.62)	40.55 (10.15)	41.77 (8.36)	39.75 (9.20)	41.12 (9.44)
Month 9: Social functioning (n=159,167,49,41,171)	43.52 (10.65)	44.42 (9.96)	44.55 (9.82)	42.76 (9.78)	42.03 (11.55)
Month 9: Bodily pain (n=159,166,49,41,171)	43.45 (9.02)	42.75 (9.50)	44.68 (8.86)	42.26 (7.77)	41.81 (9.73)
Month 9: Mental health (n=159,166,49,41,171)	44.47 (10.27)	45.42 (10.44)	44.83 (10.70)	43.70 (10.16)	43.44 (12.04)
Month 9: Role emotional (n=159,167,49,41,171)	39.98 (11.99)	40.58 (12.07)	39.84 (11.40)	41.46 (11.81)	40.07 (12.15)
Month 9: Vitality (n=159,166,49,41,171)	47.76 (9.51)	48.69 (9.68)	47.80 (8.94)	46.41 (10.03)	46.11 (10.28)
Month 9: General health (n=159,166,49,41,171)	41.15 (9.79)	41.34 (9.20)	41.39 (8.54)	40.57 (9.34)	40.12 (9.58)
Month9:Mental component (n=158,165,49,41,171)	44.79 (10.76)	46.55 (10.52)	45.31 (9.75)	45.23 (11.22)	44.08 (11.45)
Month 9: Physical component (n=158,165,49,41,171)	41.55 (8.57)	40.32 (9.44)	41.65 (8.20)	39.73 (7.73)	40.35 (8.31)
Month 12:Physical functioning(n=149,149,49,38,160)	40.16 (10.25)	40.34 (11.59)	39.24 (10.07)	40.42 (9.84)	39.21 (10.63)
Month 12: Role physical (n=150,150,49,38,160)	41.15 (9.35)	42.34 (10.32)	40.16 (8.73)	41.18 (9.30)	41.07 (9.29)
Month 12: Social functioning (n=150,150,49,38,160)	43.14 (10.46)	44.07 (10.44)	43.78 (9.97)	44.94 (9.78)	42.96 (10.92)
Month 12: Bodily pain (n=150,150,49,38,160)	43.44 (9.48)	44.02 (10.02)	43.90 (8.28)	43.18 (7.76)	42.73 (9.77)
Month 12: Mental health (n=150,149,49,38,159)	44.83 (10.02)	45.06 (10.49)	44.09 (9.20)	45.28 (10.94)	44.23 (10.93)
Month 12:Role emotional (n=150,150,49,38,159)	40.18 (11.46)	42.25 (11.68)	40.23 (10.79)	41.03 (12.67)	39.89 (11.63)
Month 12: Vitality (n=150,149,49,38,159)	47.60 (9.01)	49.12 (9.95)	47.31 (9.13)	48.17 (9.36)	46.27 (9.65)
Month 12:General health (n=150,150,49,38,160)	41.07 (9.85)	42.33 (9.05)	40.47 (9.44)	40.77 (8.31)	40.40 (9.13)
Month 12:Mental component (n=149,149,49,38,158)	45.02 (10.14)	46.29 (10.56)	45.02 (9.29)	46.12 (11.75)	44.42 (10.70)
Month 12: Physical component(n=149,149,49,38,158)	41.44 (8.81)	41.96 (9.40)	40.82 (8.01)	41.12 (6.49)	40.72 (8.84)

26. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Description	FACIT-Fatigue scale 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, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline (n=201, 199, 106, 201)	28.18 (10.48)	28.56 (10.84)	30.49 (10.23)	27.95 (10.07)
Month 1 (n=192, 196, 106, 198)	32.54 (9.94)	33.95 (10.54)	31.66 (10.09)	31.94 (10.48)
Month 3 (n=187, 185, 99, 190)	33.86 (10.18)	35.12 (11.07)	30.96 (10.21)	32.72 (10.27)
Month 6 (n=173, 181, 46, 180)	34.58 (10.53)	36.09 (10.07)	32.37 (8.92)	33.69 (10.58)

27. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
Description	FACIT-Fatigue scale 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	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	150	151	49	38	159
Mean (Standard Deviation) [units on a scale]	35.76 (9.53)	37.53 (10.41)	36.71 (7.81)	35.71 (9.65)	34.30 (9.83)

28. Secondary Outcome

Title	Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Description	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, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	199	198	105	200
Baseline: SPS (n=199, 198, 105, 200)	42.13 (20.58)	40.20 (19.48)	39.14 (19.04)	40.90 (19.68)
Baseline: OSP (n=199, 198, 105, 200)	43.24 (19.91)	42.27 (19.32)	41.27 (19.47)	43.12 (19.50)
Baseline: Ade (n=200, 198, 105, 200)	42.95 (27.92)	44.04 (28.21)	47.43 (26.06)	44.25 (27.83)
Baseline: ASOB (n=200, 198, 105, 200)	19.10 (24.91)	15.96 (21.70)	18.67 (24.54)	20.00 (24.31)
Baseline: SD (n=200, 198, 105, 200)	45.46 (26.30)	44.67 (25.96)	43.95 (27.40)	46.55 (26.31)
Baseline: Qua (n=200, 198, 104, 199)	6.46 (1.36)	6.61 (1.70)	6.70 (1.51)	6.65 (1.82)
Baseline: Sno (n=198, 197, 105, 199)	36.06 (31.78)	34.62 (31.71)	30.10 (28.16)	34.77 (30.50)
Baseline: Som (n=199, 198, 105, 199)	36.52 (21.22)	35.66 (22.28)	36.70 (20.55)	33.47 (19.68)
Month 1: SPS (n=194, 195, 105, 198)	36.25 (19.19)	34.03 (18.74)	37.62 (18.83)	38.16 (20.30)
Month 1: OSP (n=194, 195, 105, 198)	36.70 (18.13)	34.81 (18.64)	38.77 (18.45)	39.18 (19.67)
Month 1: Ade (n=194, 195, 105, 198)	48.97 (27.11)	52.62 (27.62)	49.81 (25.87)	46.87 (27.30)
Month 1: ASOB (n=194, 195, 105, 198)	18.35 (22.52)	14.56 (20.13)	19.81 (23.78)	18.69 (25.26)
Month 1: SD (n=194, 195, 105, 198)	36.52 (23.48)	35.46 (24.25)	40.43 (26.13)	39.41 (25.42)
Month 1: Qua (n=193, 195, 105, 197)	6.70 (1.38)	6.97 (1.49)	6.74 (1.49)	6.89 (1.55)
Month 1: Sno (n=194, 193, 104, 196)	36.08 (32.53)	34.30 (29.56)	31.35 (27.13)	32.76 (28.19)
Month 1: Som (n=194, 195, 105, 198)	31.68 (21.26)	31.04 (22.02)	33.90 (21.80)	33.91 (19.60)
Month 3: SPS (n=186, 185, 99, 190)	35.39 (18.66)	32.86 (20.91)	37.54 (19.18)	37.21 (20.47)
Month 3: OSP (n=186, 185, 99, 190)	35.74 (18.30)	33.44 (20.23)	38.55 (18.97)	38.32 (20.05)
Month 3: Ade (n=187, 185, 99, 190)	50.59 (27.67)	53.24 (28.90)	48.99 (28.16)	49.21 (28.65)
Month 3: ASOB (n=187, 185, 99, 190)	18.18 (22.12)	14.81 (20.62)	18.59 (20.85)	18.42 (24.42)
Month 3: SD (n=186, 185, 99, 190)	35.93 (24.29)	32.86 (25.10)	38.66 (26.24)	39.95 (25.83)
Month 3: Qua (n=188, 185, 99, 190)	6.82 (1.32)	7.03 (1.45)	6.51 (1.56)	6.83 (1.47)
Month 3: Sno (n=186, 184, 99, 189)	33.66 (30.78)	34.35 (30.06)	30.10 (22.92)	34.60 (27.80)
Month 3: Som (n=187, 185, 99, 190)	29.41 (19.66)	30.74 (22.65)	36.50 (20.10)	31.05 (20.26)
Month 6: SPS (n=173, 181, 46, 179)	32.66 (18.60)	31.79 (18.64)	36.52 (19.89)	36.31 (19.25)
Month 6: OSP (n=173, 181, 46, 179)	33.28 (17.93)	32.46 (18.50)	36.87 (18.51)	36.73 (19.04)
Month 6: Ade (n=173, 181, 46, 179)	53.12 (28.85)	53.76 (27.87)	50.00 (26.83)	50.22 (27.33)
Month 6: ASOB (n=173, 181, 46, 179)	16.65 (22.00)	13.48 (20.21)	16.52 (20.79)	19.22 (22.37)
Month 6: SD (n=173, 181, 46, 179)	32.95 (23.76)	32.00 (24.30)	37.31 (24.73)	36.39 (24.20)
Month 6: Qua (n=173, 181, 45, 178)	6.86 (1.18)	7.10 (1.60)	6.71 (1.50)	6.81 (1.36)
Month 6: Sno (n=171, 180, 46, 179)	31.46 (31.43)	35.00 (29.13)	23.91 (23.33)	33.18 (27.32)
Month 6: Som (n=173, 181, 46, 179)	28.17 (17.55)	30.39 (22.37)	33.62 (17.72)	31.84 (20.38)

29. Secondary Outcome

Title	Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Description	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	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	148	150	49	37	158
SPS (n=148, 150, 49, 37, 159)	34.62 (18.58)	30.64 (18.42)	34.69 (19.10)	34.68 (21.32)	35.72 (20.25)
OSP (n=148, 150, 49, 37, 158)	34.86 (17.87)	31.49 (17.90)	36.00 (17.63)	35.38 (20.40)	36.52 (19.68)
Ade (n=149, 150, 49, 37, 159)	51.21 (26.96)	57.20 (28.48)	54.29 (27.84)	50.00 (30.18)	49.81 (27.20)
ASOB (n=149, 150, 49, 37, 159)	16.78 (19.74)	14.13 (20.67)	21.22 (22.14)	18.38 (18.49)	17.48 (21.79)
SD (n=149, 150, 49, 37, 159)	34.82 (23.95)	32.32 (22.41)	37.12 (23.55)	34.86 (23.94)	37.36 (25.19)
Qua (n=148, 150, 49, 37, 158)	6.78 (1.19)	7.03 (1.47)	6.86 (1.34)	6.84 (1.34)	6.72 (1.31)
Sno (n=148, 150, 48, 37, 159)	33.78 (29.95)	30.53 (27.29)	27.50 (22.83)	32.43 (26.81)	34.47 (30.01)
Som (n=148, 150, 49, 37, 158)	29.41 (18.95)	27.07 (19.36)	32.38 (17.53)	29.37 (22.25)	30.00 (21.21)

30. Secondary Outcome

Title	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Description	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline (n=201, 199, 106, 201)	94 46.1%	94 46.8%	49 87.5%	88 169.2%
Month 1 (n=194, 196, 106, 198)	93 45.6%	107 53.2%	55 98.2%	95 182.7%
Month 3 (n=188, 185, 99, 190)	100 49%	110 54.7%	37 66.1%	93 178.8%
Month 6 (n=174, 181, 94, 182)	100 49%	100 49.8%	46 82.1%	93 178.8%

31. Secondary Outcome

Title	Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Description	MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	150	151	49	38	160
Number [participants]	80 39.2%	84 41.8%	28 50%	19 36.5%	75 36.8%

32. Secondary Outcome

Title	Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	200	199	106	201
Baseline (n=200, 199, 106, 201)	0.43 (0.32)	0.43 (0.32)	0.50 (0.28)	0.45 (0.29)
Month 1 (n=192, 195, 106, 198)	0.61 (0.23)	0.60 (0.25)	0.56 (0.25)	0.58 (0.27)
Month 3 (n=187, 184, 99, 189)	0.62 (0.28)	0.64 (0.28)	0.55 (0.27)	0.61 (0.26)
Month 6 (n=172, 180, 46, 178)	0.66 (0.26)	0.65 (0.25)	0.58 (0.28)	0.64 (0.24)

33. Secondary Outcome

Title	Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
Description	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	147	151	49	38	159
Mean (Standard Deviation) [units on a scale]	0.69 (0.22)	0.69 (0.22)	0.68 (0.20)	0.66 (0.19)	0.66 (0.27)

34. Secondary Outcome

Title	Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Description	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame	Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	85	81	42	78
Baseline: TMS (n=79, 77, 40, 76)	41.46 (23.42)	42.09 (28.98)	37.65 (23.69)	46.43 (25.94)
Baseline: PDS (n=85, 76, 40, 77)	49.99 (23.16)	52.14 (24.22)	53.24 (23.62)	44.51 (21.15)
Baseline: MIDS (n=82, 79, 41, 77)	26.80 (22.80)	27.30 (22.32)	24.85 (28.33)	28.45 (23.77)
Baseline: ODS (n=80, 74, 40, 77)	36.34 (26.55)	37.29 (28.16)	29.28 (26.41)	36.82 (22.71)
Baseline: WLI (n=85, 81, 42, 81)	9.76 (5.34)	9.85 (5.67)	8.83 (5.90)	9.92 (5.01)
Month 3: TMS (n=74, 68, 40, 70)	31.31 (25.50)	21.97 (25.52)	34.26 (26.40)	35.73 (28.50)
Month 3: PDS (n=77, 72, 39, 76)	53.03 (26.21)	47.04 (33.97)	55.57 (27.38)	54.38 (28.15)
Month 3: MIDS (n=78, 72, 41, 73)	21.45 (22.03)	15.14 (20.53)	23.20 (26.04)	22.64 (21.97)
Month 3: ODS (n=75, 70, 39, 76)	26.64 (23.61)	19.31 (23.89)	27.44 (25.18)	26.57 (22.50)
Month 3: WLI (n=80, 74, 41, 78)	7.89 (5.12)	5.92 (5.17)	8.39 (5.73)	8.23 (5.47)
Month 6: PDS (n=66, 65, 15, 71)	55.62 (30.05)	53.57 (36.13)	55.03 (29.84)	52.17 (28.69)
Month 6: TMS (n=68, 65, 16, 67)	29.87 (26.81)	21.30 (27.67)	24.53 (24.19)	29.70 (25.24)
Month 6: MIDS (n=70, 68, 16, 71)	17.50 (21.18)	12.87 (22.77)	18.26 (23.15)	22.61 (22.38)
Month 6: ODS (n=67, 67, 16, 69)	23.18 (25.53)	16.44 (23.79)	19.69 (20.77)	25.82 (22.93)
Month 6: WLI (n= 70, 69, 16, 73)	7.32 (5.47)	5.69 (5.54)	6.89 (4.90)	7.84 (5.04)

35. Secondary Outcome

Title	Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
Description	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	57	55	21	14	60
TMS (n=55, 53, 20, 14, 57)	25.59 (25.10)	20.77 (28.68)	32.69 (29.07)	28.75 (28.26)	26.57 (26.68)
PDS (n=55, 52, 18, 14, 58)	54.35 (32.96)	55.69 (38.22)	51.81 (32.57)	59.02 (36.59)	50.41 (33.98)
MIDS (n=55, 51, 21, 14, 58)	14.72 (19.96)	13.96 (23.76)	21.46 (27.11)	19.44 (24.29)	17.99 (20.10)
ODS (n=57, 50, 19, 14, 58)	20.51 (23.13)	17.35 (27.77)	27.11 (27.29)	25.36 (29.64)	21.55 (22.63)
WLI (n=57, 55, 21, 14, 60)	6.61 (5.07)	5.78 (5.59)	7.75 (6.53)	8.06 (6.01)	6.85 (5.21)

36. Secondary Outcome

Title	Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Description	Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	201	199	106	201
Baseline: Seen any doctor (n=201, 199, 106, 201)	1.16 (0.37)	1.13 (0.34)	1.15 (0.36)	1.15 (0.36)
Baseline: Treated in ER (n=201, 199, 106, 201)	1.95 (0.23)	1.93 (0.26)	1.93 (0.25)	1.94 (0.25)
Baseline: Admitted overnight stay (n=11,14,6,12)	0.45 (0.82)	0.21 (0.43)	0.17 (0.41)	0.08 (0.29)
Baseline: Hospitalization (n=201, 199, 106, 201)	1.94 (0.24)	1.97 (0.17)	1.93 (0.25)	1.95 (0.23)
Baseline: Outpatient surgeries (n=200,199,106,201)	1.96 (0.20)	1.97 (0.17)	1.98 (0.14)	1.97 (0.18)
Baseline: Diagnostic tests (n=200,199,106,200)	1.81 (0.39)	1.83 (0.37)	1.82 (0.39)	1.82 (0.39)
Baseline: In nursing home (n=201, 199, 106, 201)	1.99 (0.12)	2.00 (0.00)	2.00 (0.00)	1.98 (0.14)
Baseline: Home HC services (n=201, 198, 106, 201)	1.99 (0.10)	1.99 (0.10)	1.99 (0.10)	1.99 (0.12)
Baseline:Required aids/devices (n=201,199,106,201)	1.92 (0.28)	1.86 (0.35)	1.92 (0.28)	1.91 (0.29)
Baseline: Seen NM practitioner (n=201,199,106,201)	1.99 (0.12)	1.97 (0.17)	1.98 (0.14)	1.97 (0.17)
Baseline: Currently employed (n=201,199,106,201)	1.64 (0.48)	1.65 (0.48)	1.64 (0.48)	1.65 (0.48)
Baseline: Feel well enough to work (n=73,83,39,81)	1.90 (0.30)	1.89 (0.31)	1.82 (0.39)	1.80 (0.40)
Baseline: Retired (n=80,88,45,89)	1.41 (0.50)	1.41 (0.49)	1.40 (0.50)	1.39 (0.49)
Baseline: Lost job/retired early(n=66,82,39,81)	1.50 (0.50)	1.70 (0.46)	1.74 (0.44)	1.57 (0.50)
Baseline: Unable to work due to RA (n=76,84,40,78)	1.36 (0.48)	1.37 (0.49)	1.45 (0.50)	1.37 (0.49)
Baseline: Work disabled due to RA (n=66,82,40,79)	1.56 (0.50)	1.70 (0.46)	1.70 (0.46)	1.65 (0.48)
Baseline: Sick leave due to RA (n=167,166,92,167)	1.85 (0.36)	1.86 (0.35)	1.84 (0.37)	1.83 (0.38)
Baseline: Part time work (n=169,166,92,167)	1.92 (0.27)	1.92 (0.27)	1.93 (0.25)	1.94 (0.24)
Baseline: Performed paid work(n=169,166,91,167)	1.69 (0.46)	1.70 (0.46)	1.66 (0.48)	1.67 (0.47)
Baseline: Unable to do chores (n=201,199,105,198)	1.41 (0.49)	1.46 (0.50)	1.53 (0.50)	1.41 (0.49)
Baseline: Chores by housekeeper(n=201,199,106,201)	1.89 (0.32)	1.90 (0.29)	1.93 (0.25)	1.91 (0.29)
Baseline: Chores by family (n=200,199,106,201)	1.50 (0.50)	1.48 (0.50)	1.62 (0.49)	1.51 (0.50)
Month 3: Seen any doctor (n=186,185,99,190)	1.27 (0.45)	1.28 (0.45)	1.22 (0.42)	1.29 (0.45)
Month 3: Treated in ER (n=186,185,99,190)	1.96 (0.20)	1.96 (0.19)	1.96 (0.20)	1.95 (0.22)
Month 3: Admitted overnight stay (n=8,8,4,9)	0.25 (0.46)	0.88 (0.99)	0.00 (0.00)	0.22 (0.44)
Month 3: Hospitalization (n=185,185,99,190)	1.98 (0.15)	1.97 (0.16)	1.99 (0.10)	1.98 (0.12)
Month 3: Outpatient surgeries (n=185,185,99,190)	1.98 (0.13)	1.98 (0.15)	1.96 (0.20)	1.97 (0.18)
Month 3: Diagnostic tests (n=184,185,99,190)	1.90 (0.30)	1.87 (0.34)	1.91 (0.29)	1.89 (0.31)
Month 3: In nursing home (n=185,185,99,190)	1.99 (0.07)	2.00 (0.00)	2.00 (0.00)	1.99 (0.10)
Month 3: Home HC services (n=184,185,99,190)	1.99 (0.07)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)
Month 3: Required aids/devices (n=185,185,99,190)	1.94 (0.25)	1.91 (0.29)	1.92 (0.27)	1.92 (0.28)
Month 3: Seen NM practitioner (n=185,185,99,190)	1.97 (0.16)	2.00 (0.00)	1.98 (0.14)	1.98 (0.12)
Month 3: Currently employed (n=185,185,99,190)	1.62 (0.49)	1.64 (0.48)	1.63 (0.49)	1.64 (0.48)
Month 3: Feel well enough to work (n=74,79,41,80)	1.70 (0.46)	1.73 (0.44)	1.93 (0.26)	1.74 (0.44)
Month 3: Retired (n=80,86,47,86)	1.39 (0.49)	1.34 (0.48)	1.38 (0.49)	1.38 (0.49)
Month 3: Lost job/retired early(n=73,78,40,79)	1.55 (0.50)	1.59 (0.50)	1.75 (0.44)	1.65 (0.48)
Month 3: Unable to work due to RA (n=76,83,44,77)	1.42 (0.50)	1.46 (0.50)	1.45 (0.50)	1.58 (0.50)
Month 3: Work disabled due to RA (n=71,82,41,73)	1.63 (0.49)	1.68 (0.47)	1.61 (0.49)	1.74 (0.44)
Month 3: Sick leave due to RA (n=153,146,85,157)	1.93 (0.26)	1.94 (0.24)	1.81 (0.39)	1.90 (0.29)
Month 3: Part time work (n=153,145,85,155)	1.95 (0.21)	1.97 (0.16)	1.94 (0.24)	1.94 (0.25)
Month 3: Performed paid work(n=153,145,85,157)	1.73 (0.45)	1.81 (0.39)	1.68 (0.47)	1.70 (0.46)
Month 3: Unable to do chores(n=182,182,99,189)	1.62 (0.49)	1.71 (0.46)	1.59 (0.50)	1.66 (0.47)
Month 3: Chores by housekeeper (n=184,183,99,190)	1.91 (0.29)	1.94 (0.24)	1.93 (0.26)	1.94 (0.24)
Month 3: Chores by family (n=183,183,99,190)	1.67 (0.47)	1.74 (0.44)	1.66 (0.48)	1.68 (0.47)
Month 6: Seen any doctor (n=173,180,45,179)	1.25 (0.43)	1.28 (0.45)	1.27 (0.45)	1.31 (0.46)
Month 6: Treated in ER (n=173,180,46,179)	1.93 (0.25)	1.97 (0.18)	1.91 (0.28)	1.98 (0.15)
Month 6: Admitted overnight stay (n=12,6,4,3)	0.58 (0.67)	0.17 (0.41)	0.00 (0.00)	0.00 (0.00)
Month 6: Hospitalization (n=172,180,46,179)	1.95 (0.22)	1.97 (0.16)	1.96 (0.21)	1.99 (0.07)
Month 6: Outpatient surgeries (n=173,180,46,178)	1.98 (0.15)	1.96 (0.19)	1.98 (0.15)	1.99 (0.11)
Month 6: Diagnostic tests (n=173,180,46,178)	1.87 (0.33)	1.86 (0.35)	1.89 (0.31)	1.89 (0.31)
Month 6: In nursing home (n=173,180,46,178)	1.99 (0.11)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)
Month 6: Home HC services (n=173,180,46,177)	1.99 (0.11)	1.99 (0.11)	2.00 (0.00)	2.00 (0.00)
Month 6: Required aids/devices (n=173,180,46,178)	1.91 (0.28)	1.91 (0.29)	1.87 (0.34)	1.92 (0.27)
Month 6: Seen NM practitioner (n=173,180,45,178)	2.00 (0.00)	1.98 (0.13)	2.00 (0.00)	1.99 (0.07)
Month 6: Currently employed (n=173,180,46,179)	1.62 (0.49)	1.66 (0.48)	1.63 (0.49)	1.63 (0.48)
Month 6: Feel well enough to work (72,81,23,76)	1.75 (0.44)	1.77 (0.43)	1.83 (0.39)	1.71 (0.46)
Month 6: Retired (n=77,87,22,82)	1.32 (0.47)	1.30 (0.46)	1.32 (0.48)	1.35 (0.48)
Month 6: Lost job/retired early (n=70,82,22,72)	1.57 (0.50)	1.66 (0.48)	1.68 (0.48)	1.67 (0.47)
Month 6: Unable to work due to RA (n=73,83,23,74)	1.51 (0.50)	1.54 (0.50)	1.48 (0.51)	1.57 (0.50)
Month 6: Work disabled due to RA (n=67,80,22,72)	1.72 (0.45)	1.70 (0.46)	1.73 (0.46)	1.72 (0.45)
Month 6: Sick leave due to RA (n=138,134,38,144)	1.93 (0.25)	1.93 (0.25)	1.92 (0.27)	1.94 (0.24)
Month 6: Part time work (n=135,134,37,142)	1.94 (0.24)	1.96 (0.21)	1.97 (0.16)	1.95 (0.22)
Month 6: Performed paid work (n=136,136,38,142)	1.75 (0.43)	1.80 (0.40)	1.74 (0.45)	1.76 (0.43)
Month 6: Unable to do chores(n=171,178,45,175)	1.70 (0.46)	1.74 (0.44)	1.62 (0.49)	1.67 (0.47)
Month 6: Chores by housekeeper (n=172,180,45,180)	1.92 (0.27)	1.94 (0.23)	1.93 (0.25)	1.96 (0.19)
Month 6: Chores by family (n=172,180,46,180)	1.72 (0.45)	1.74 (0.44)	1.67 (0.47)	1.71 (0.45)

37. Secondary Outcome

Title	Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Description	RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	148	151	49	38	160
Seen any doctor (n=148,151,49,38,160)	1.31 (0.46)	1.27 (0.45)	1.24 (0.43)	1.24 (0.43)	1.23 (0.42)
Treated in ER (n=149,151,49,38,160)	1.98 (0.14)	1.97 (0.18)	2.00 (0.00)	1.97 (0.16)	1.96 (0.19)
Admitted overnight stay (n=3,5,0,1,6)	0.33 (0.58)	0.20 (0.45)	NA (NA)	0.00 (NA)	0.17 (0.41)
Hospitalization (n=148,151,49,38,160)	1.98 (0.14)	1.97 (0.18)	1.98 (0.14)	1.97 (0.16)	1.98 (0.14)
Outpatient surgeries (n=148,151,49,38,160)	1.97 (0.18)	1.99 (0.11)	2.00 (0.00)	1.95 (0.23)	1.97 (0.17)
Diagnostic tests (n=149,151,49,38,159)	1.94 (0.24)	1.87 (0.33)	1.88 (0.33)	1.84 (0.37)	1.86 (0.35)
In nursing home (n=149,151,49,38,159)	1.99 (0.12)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)	1.99 (0.08)
Home HC services (n=148,151,49,38,159)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)	1.99 (0.08)
Required aids/devices (n=148,151,49,38,160)	1.93 (0.26)	1.92 (0.27)	1.94 (0.24)	1.92 (0.27)	1.91 (0.29)
Seen NM practitioner(n=149,151,49,38,160)	1.98 (0.14)	1.97 (0.16)	1.98 (0.14)	1.95 (0.23)	2.00 (0.00)
Currently employed (n=148,151,49,38,160)	1.59 (0.49)	1.68 (0.47)	1.61 (0.49)	1.61 (0.50)	1.64 (0.48)
Feel well enough to work (n=61,79,19,19,76)	1.72 (0.45)	1.75 (0.44)	1.84 (0.37)	1.84 (0.37)	1.68 (0.47)
Retired (n=64,84,21,19,80)	1.25 (0.44)	1.31 (0.47)	1.19 (0.40)	1.53 (0.51)	1.35 (0.48)
Lost job/retired early (n=58,75,19,18,75)	1.53 (0.50)	1.72 (0.45)	1.68 (0.48)	1.78 (0.43)	1.67 (0.47)
Unable to work due to RA (n=59,77,19,19,77)	1.56 (0.50)	1.61 (0.49)	1.58 (0.51)	1.58 (0.51)	1.57 (0.50)
Work disabled due to RA (n=58,76,19,18,75)	1.64 (0.48)	1.75 (0.44)	1.79 (0.42)	1.67 (0.49)	1.67 (0.47)
Sick leave due to RA (n=118,112,37,30,124)	1.96 (0.20)	1.96 (0.19)	1.95 (0.23)	2.00 (0.00)	1.97 (0.18)
Part time work (n=117,112,37,30,123)	1.95 (0.22)	1.99 (0.09)	2.00 (0.00)	2.00 (0.00)	1.99 (0.09)
Performed paid work (n=118,114,37,31,123)	1.83 (0.38)	1.82 (0.39)	1.78 (0.42)	1.71 (0.46)	1.82 (0.38)
Unable to do chores (n=146,150,47,38,154)	1.81 (0.40)	1.75 (0.44)	1.79 (0.41)	1.84 (0.37)	1.73 (0.45)
Chores by housekeeper (n=148,151,49,38,160)	1.94 (0.24)	1.97 (0.16)	1.96 (0.20)	1.95 (0.23)	1.93 (0.25)
Chores by family (n=145,151,49,38,160)	1.76 (0.43)	1.80 (0.40)	1.84 (0.37)	1.71 (0.46)	1.71 (0.45)

38. Secondary Outcome

Title	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	168	174	90	172
Baseline: Doctor visits (n=168,174,90,172)	4.26 (3.51)	4.06 (3.57)	4.50 (5.32)	3.87 (3.74)
Baseline: NM practitioners visits (n=3,6,2,6)	1.33 (0.58)	3.00 (1.79)	4.50 (4.95)	10.00 (10.51)
Baseline: Hospital ER visits (n=12,14,7,12)	1.08 (0.51)	1.93 (1.59)	1.57 (0.79)	1.58 (1.73)
Baseline: Number visits hospitalized(n=11,5,7,11)	2.82 (5.71)	1.00 (0.00)	1.00 (0.00)	1.27 (0.90)
Baseline:Number of outpatient surgeries(n=8,6,2,7)	1.13 (0.35)	1.33 (0.82)	1.00 (0.00)	2.57 (4.16)
Baseline:Non-study diagnostic tests(n=37,33,19,36)	1.73 (1.04)	1.79 (1.17)	1.21 (0.54)	1.64 (1.10)
Baseline:RA related doctor visit(n=169,175,91,172)	1.33 (1.03)	1.17 (0.70)	1.26 (0.81)	1.19 (0.73)
Baseline: RA related ER visit (n=11,14,6,12)	0.64 (0.81)	0.64 (0.74)	0.17 (0.41)	0.25 (0.45)
Baseline: RA diagnostic tests (n=38,33,19,37)	0.50 (0.76)	0.55 (0.62)	0.47 (0.61)	0.84 (0.73)
Baseline: RA related hospitalization (n=11,6,7,11)	0.91 (0.83)	0.67 (0.52)	0.57 (0.79)	0.82 (0.60)
Baseline: RA related outpatient surgery(n=7,6,3,7)	0.43 (0.79)	0.33 (0.82)	0.33 (0.58)	0.43 (0.79)
Baseline: RA related NM visit (n=3,6,2,6)	0.67 (0.58)	0.50 (0.84)	1.00 (0.00)	1.00 (0.63)
Month 3: Doctor visits (n=136,138,78,136)	3.62 (4.25)	2.86 (2.99)	3.27 (3.93)	3.05 (2.87)
Month 3: NM practitioners visits (n=5,0,2,2)	2.40 (0.89)	NA (NA)	17.00 (21.21)	7.50 (9.19)
Month 3: Hospital ER visits (n=8,8,4,10)	1.38 (0.74)	1.00 (0.00)	1.75 (1.50)	1.90 (1.10)
Month 3: Number visits hospitalized (n=4,6,1,3)	1.50 (1.00)	1.00 (0.00)	1.00 (NA)	1.00 (0.00)
Month 3: Number of outpatient surgeries(n=3,4,4,6)	1.67 (0.58)	1.00 (0.00)	1.00 (0.00)	1.33 (0.52)
Month 3: Non-study diagnostic tests (n=18,23,9,20)	1.72 (1.41)	1.52 (0.79)	1.56 (0.88)	1.45 (0.83)
Month 3: RA related doctor visit(n=136,138,78,136)	0.91 (0.75)	0.92 (0.67)	0.90 (0.71)	0.93 (0.65)
Month 3: RA related ER visit (n=8,8,4,9)	0.25 (0.46)	0.50 (0.76)	0.00 (0.00)	0.00 (0.00)
Month 3: RA-diagnostic tests (n=19,24,9,21)	0.11 (0.32)	0.21 (0.51)	0.11 (0.33)	0.24 (0.44)
Month 3: RA related hospitalization (n=4,6,1,3)	0.00 (0.00)	0.17 (0.41)	0.00 (NA)	0.67 (1.15)
Month 3: RA related outpatient surgery (n=3,4,4,6)	0.00 (0.00)	0.25 (0.50)	0.25 (0.50)	0.00 (0.00)
Month 3: RA related NM visit (n=5,0,2,2)	0.60 (0.89)	NA (NA)	1.50 (0.71)	0.50 (0.71)
Month 6: Doctor visits (n=132,131,33,128)	3.30 (4.17)	2.86 (4.23)	2.52 (1.91)	2.73 (2.96)
Month 6: NM practitioners visits (n=1,3,0,1)	1.00 (NA)	2.67 (2.89)	NA (NA)	14.00 (NA)
Month 6: Hospital ER visits (n=12,6,4,4)	1.08 (0.29)	1.17 (0.41)	1.00 (0.00)	1.75 (0.96)
Month 6: Number visits hospitalized (n=9,5,2,1)	1.00 (0.00)	1.00 (0.00)	1.00 (0.00)	1.00 (NA)
Month 6: Number of outpatient surgeries(n=4,7,1,2)	1.25 (0.50)	1.14 (0.38)	1.00 (NA)	1.50 (0.71)
Month 6: Non-study diagnostic tests (n=21,25,5,19)	2.33 (3.89)	1.96 (1.31)	1.80 (0.45)	1.53 (0.61)
Month 6: RA related doctor visit(n=132,131,33,129)	0.81 (0.63)	0.96 (0.74)	0.88 (0.86)	1.00 (0.56)
Month 6: RA related ER visit (n=12,6,4,3)	0.25 (0.62)	0.67 (0.82)	0.00 (0.00)	0.00 (0.00)
Month 6: RA-diagnostic tests (n=21,25,5,19)	0.18 (0.50)	0.16 (0.37)	0.20 (0.45)	0.11 (0.32)
Month 6: RA related hospitalization (n=9,5,2,1)	0.22 (0.67)	0.40 (0.89)	0.00 (0.00)	0.00 (NA)
Month 6: RA related outpatient surgery (n=4,7,1,2)	0.00 (0.00)	0.43 (0.79)	0.00 (NA)	1.00 (1.41)
Month 6: RA related NM visit (n=1,3,0,1)	0.00 (NA)	0.67 (1.15)	NA (NA)	0.00 (NA)

39. Secondary Outcome

Title	Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	104	111	37	30	125
Doctor visit (n=102,111,37,30,125)	2.73 (2.78)	2.80 (2.46)	3.92 (5.97)	3.50 (3.34)	2.94 (3.93)
NM practitioners visits (n=3,4,1,2,0)	10.67 (11.72)	9.75 (10.97)	192.00 (NA)	10.50 (6.36)	NA (NA)
Hospital ER visits (n=3,5,0,1,6)	1.00 (0.00)	2.40 (1.34)	NA (NA)	3.00 (NA)	1.00 (0.00)
Number of visits hospitalized (n=3,5,1,1,3)	1.00 (0.00)	1.00 (0.00)	1.00 (NA)	1.00 (NA)	1.00 (0.00)
Number of outpatient surgeries (n=5,2,0,2,5)	1.40 (0.89)	1.50 (0.71)	NA (NA)	1.00 (0.00)	2.20 (2.17)
Non-study diagnostic tests (n=8,19,6,6,22)	1.13 (0.35)	1.95 (1.31)	3.17 (2.64)	1.33 (0.82)	1.64 (0.90)
RA related doctor visit (n=104,111,37,30,125)	0.82 (0.59)	0.93 (0.57)	0.89 (0.52)	0.87 (0.68)	0.84 (0.80)
RA related ER visits (n=3,5,0,1,6)	0.33 (0.58)	0.00 (0.00)	NA (NA)	0.00 (NA)	0.17 (0.41)
RA-diagnostic tests (n=9,19,6,6,22)	0.11 (0.33)	0.21 (0.42)	0.17 (0.41)	0.00 (0.00)	0.05 (0.21)
RA related hospitalization (n=3,5,1,1,3)	0.00 (0.00)	0.00 (0.00)	0.00 (NA)	0.00 (NA)	0.67 (0.58)
RA related outpatient surgery (n=5,2,0,2,5)	0.00 (0.00)	0.00 (0.00)	NA (NA)	0.00 (0.00)	0.00 (0.00)
RA related NM visits (n=3,4,1,2,0)	0.00 (0.00)	0.50 (1.00)	0.00 (NA)	0.00 (0.00)	NA (NA)

40. Secondary Outcome

Title	Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	101	102	39	97
Baseline: Hospital length of stay (n=11,6,7,11)	13.64 (12.91)	10.83 (9.89)	13.43 (9.78)	12.82 (10.93)
Baseline: Days in nursing home (n=3,0,0,4)	19.33 (17.56)	NA (NA)	NA (NA)	14.25 (9.95)
Baseline: Days devices/aids used (n=17,28,8,16)	133.88 (111.17)	67.32 (61.88)	172.75 (94.28)	66.13 (65.33)
Baseline: Days of work per week (n=71,69,38,70)	4.94 (1.18)	4.80 (1.05)	4.95 (0.98)	5.01 (1.04)
Baseline: Chores by housekeeper (n=23,19,6,18)	15.57 (25.73)	14.95 (27.24)	38.83 (41.44)	6.94 (6.86)
Baseline: Chores by family (n=101,102,39,97)	24.06 (29.27)	26.57 (31.02)	26.95 (32.87)	29.80 (32.91)
Baseline: Days on sick leave (n=24,24,15,29)	19.58 (27.78)	16.33 (27.21)	29.60 (34.88)	16.31 (26.05)
Baseline: Days of part time work (n=13,13,6,10)	13.31 (18.94)	25.31 (61.19)	5.33 (3.44)	18.50 (26.88)
Baseline: Paid work, bothered by RA(n=51,47,31,53)	29.10 (27.47)	29.45 (31.37)	28.74 (28.76)	42.74 (31.81)
Baseline: RA related devices/aids (n=17,28,9,17)	1.76 (1.15)	1.39 (0.69)	2.33 (1.66)	1.65 (1.06)
Month 3: Hospital length of stay (n=4,6,1,3)	6.25 (4.03)	10.00 (10.75)	2.00 (NA)	10.33 (8.14)
Month 3: Days in nursing home (n=0,0,0,2)	NA (NA)	NA (NA)	NA (NA)	17.50 (4.95)
Month 3: Days devices/aids used (n=11,17,6,15)	117.91 (112.91)	60.41 (88.79)	163.83 (153.63)	91.80 (95.18)
Month 3: Days of work per week (n=70,66,38,68)	4.83 (0.95)	4.68 (1.18)	4.95 (0.80)	4.75 (1.25)
Month 3: Chores by housekeeper (n=17,11,7,12)	12.59 (23.15)	6.00 (8.63)	8.00 (12.54)	10.50 (16.08)
Month 3: Chores by family (n=60,47,34,58)	24.10 (32.38)	18.32 (24.03)	24.97 (31.72)	25.41 (30.46)
Month 3: Days on sick leave (n=11,9,17,15)	24.27 (33.73)	18.44 (29.37)	27.12 (31.42)	5.13 (4.60)
Month 3: Days of part time work (n=7,4,6,10)	13.29 (13.76)	25.50 (27.77)	5.50 (3.27)	14.90 (27.04)
Month 3: Paid work, bothered by RA (n=39,28,28,44)	16.08 (21.77)	26.57 (32.41)	19.93 (20.79)	33.61 (30.31)
Month 3: RA related devices/aids (n=12,17,8,16)	1.75 (1.22)	1.12 (1.36)	2.38 (1.60)	1.81 (0.98)
Month 6: Hospital length of stay (n=9,5,2,1)	10.00 (8.20)	12.80 (16.71)	8.50 (2.12)	6.00 (NA)
Month 6: Days in nursing home (n=2,0,0,0)	27.00 (18.38)	NA (NA)	NA (NA)	NA (NA)
Month 6: Days devices/aids used (n=14,16,5,14)	102.29 (115.01)	126.25 (134.08)	80.20 (73.45)	94.21 (76.92)
Month 6: Days of work per week (n=65,61,17,66)	4.94 (0.85)	4.70 (1.09)	5.35 (0.93)	4.95 (0.92)
Month 6: Chores by housekeeper (n=11,10,3,7)	7.73 (8.25)	15.80 (22.73)	44.00 (42.57)	7.29 (3.82)
Month 6: Chores by family (n=46,46,15,50)	13.59 (16.95)	29.09 (35.16)	35.53 (39.39)	22.64 (29.51)
Month 6: Days on sick leave (n=7,9,3,9)	29.57 (41.48)	12.44 (14.60)	3.00 (2.00)	8.67 (13.13)
Month 6: Days of part time work (n=7,6,1,7)	7.57 (6.80)	24.67 (33.07)	4.00 (NA)	9.29 (8.67)
Month 6: Paid work, bothered by RA (n=31,25,10,33)	14.71 (18.47)	20.40 (25.93)	11.00 (9.13)	24.55 (26.88)
Month 6: RA related devices/aids (n=15,16,6,14)	2.00 (1.73)	1.56 (1.46)	2.17 (1.83)	2.07 (1.27)

41. Secondary Outcome

Title	Number of Days as Assessed Using RA-HCRU at Month 12
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	60	49	19	15	58
Hospital length of stay (n=3,5,1,1,3)	8.00 (6.93)	5.60 (2.70)	15.00 (NA)	1.00 (NA)	15.33 (4.51)
Days in nursing home (n=2,0,0,0,1)	24.50 (4.95)	NA (NA)	NA (NA)	NA (NA)	10.00 (NA)
Days devices/aids used (n=11,12,3,2,15)	144.55 (258.85)	51.75 (41.51)	163.67 (173.70)	321.50 (327.39)	79.33 (74.00)
Days of work per week (n=60,49,19,15,58)	4.83 (1.04)	5.04 (0.93)	5.16 (0.90)	4.93 (0.70)	4.95 (1.07)
Chores by housekeeper (n=9,4,1,2,10)	4.44 (3.40)	7.75 (5.06)	90.00 (NA)	24.00 (16.97)	4.90 (3.78)
Chores by family (n=35,30,8,10,45)	22.06 (27.84)	13.13 (12.28)	51.88 (40.91)	28.40 (33.88)	23.49 (28.68)
Days on sick leave (n=5,3,2,0,4)	10.40 (11.41)	36.00 (45.97)	50.00 (56.57)	NA (NA)	18.25 (14.06)
Days of part time work (n=6,1,0,0,1)	11.33 (12.55)	33.00 (NA)	NA (NA)	NA (NA)	30.00 (NA)
Paid work, bothered by RA (n=20,20,7,9,22)	24.10 (30.75)	20.40 (27.90)	11.43 (8.60)	12.33 (12.32)	22.86 (24.20)
RA related devices/aids used (n=11,12,3,3,15)	2.18 (2.79)	0.75 (0.62)	2.33 (1.53)	3.00 (2.65)	1.53 (0.74)

42. Secondary Outcome

Title	Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	101	102	39	95
Baseline: Home HC services (n=2,2,1,2)	3.00 (2.83)	1.50 (0.71)	2.00 (NA)	1.00 (0.00)
Baseline: Work done (n=72,69,38,70)	7.76 (2.40)	7.54 (2.25)	7.79 (1.76)	8.16 (2.85)
Baseline: Chores by housekeeper (n=22,19,7,18)	5.23 (4.60)	5.53 (5.36)	8.00 (7.55)	3.89 (2.37)
Baseline: Chores by family (n=101,102,39,95)	4.24 (4.75)	3.31 (2.76)	4.21 (4.71)	2.82 (1.79)
Baseline: Missed work due to RA (n=13,13,6,10)	6.38 (7.22)	5.00 (5.85)	4.00 (1.26)	4.00 (4.11)
Baseline: RA related home HC services (n=2,2,1,3)	0.50 (0.71)	1.00 (0.00)	1.00 (NA)	0.33 (0.58)
Month 3: Home HC services (n=1,0,0,0)	1.00 (NA)	NA (NA)	NA (NA)	NA (NA)
Month 3: Work done (n=70,66,38,68)	8.06 (3.59)	7.53 (1.92)	8.53 (5.62)	8.38 (4.89)
Month 3: Chores by housekeeper (n=17,11,7,12)	4.00 (2.12)	5.73 (2.61)	5.00 (2.00)	4.17 (1.99)
Month 3: Chores by family (n=59,46,34,59)	3.46 (3.67)	3.28 (2.60)	3.41 (2.72)	3.68 (3.72)
Month 3: Missed work due to RA (n=7,4,6,9)	4.57 (5.03)	20.75 (39.51)	5.50 (5.01)	3.56 (1.59)
Month 3: RA related home HC services (n=1,0,0,0)	1.00 (NA)	NA (NA)	NA (NA)	NA (NA)
Month 6: Home HC services (n=2,2,0,0)	2.50 (2.12)	16.00 (5.66)	NA (NA)	NA (NA)
Month 6: Work done (n=65,61,17,66)	8.35 (4.46)	7.72 (2.24)	9.71 (7.59)	8.00 (4.27)
Month 6: Chores by housekeeper (n=11,10,3,7)	3.36 (2.58)	5.40 (2.50)	5.33 (1.53)	6.29 (7.95)
Month 6: Chores by family (n=47,45,13,51)	3.30 (2.69)	2.91 (2.00)	3.69 (2.32)	3.33 (3.55)
Month 6: Missed work due to RA (n=7,6,1,7)	4.57 (5.19)	3.17 (2.32)	5.00 (NA)	3.29 (1.70)
Month 6: RA related home HC services (n=2,2,0,0)	1.00 (1.41)	0.50 (0.71)	NA (NA)	NA (NA)

43. Secondary Outcome

Title	Number of Hours Per Day as Assessed RA-HCRU at Month 12
Description	RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	60	49	19	15	58
Home HC services (n=0,0,0,0,1)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	1.00 (NA)
Work done (n=60,49,19,15,58)	7.52 (2.27)	7.82 (1.60)	9.53 (7.65)	7.73 (2.40)	7.93 (3.12)
Chores by housekeeper (n=8,4,1,2,10)	4.63 (3.16)	4.75 (0.96)	3.00 (NA)	6.00 (1.41)	4.10 (2.08)
Chores by family (n=34,30,8,10,44)	2.65 (1.95)	4.00 (4.11)	2.88 (2.17)	2.70 (2.26)	2.55 (1.81)
Missed work due to RA (n=6,1,0,0,1)	2.00 (1.67)	4.00 (NA)	NA (NA)	NA (NA)	4.00 (NA)
RA related home HC services (n=0,0,0,0,1)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	1.00 (NA)

44. Secondary Outcome

Title	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Description	Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	139	141	83	142
Baseline (n=139,141,83,142)	4.16 (3.05)	4.16 (3.33)	4.08 (3.32)	4.19 (3.09)
Month 3 (n=137,129,76,139)	2.68 (2.75)	2.81 (2.89)	3.38 (2.84)	3.09 (2.81)
Month 6 (n=125,125,35,127)	2.31 (2.51)	2.39 (2.84)	2.17 (2.64)	2.66 (2.54)

45. Secondary Outcome

Title	Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Description	Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo, Then CP-690,550 5 mg	Placebo, Then CP-690,550 10 mg	Adalimumab
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.	Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Measure Participants	101	101	32	30	107
Mean (Standard Deviation) [units on a scale]	2.18 (2.65)	1.92 (2.50)	2.69 (2.66)	2.23 (3.02)	1.93 (2.45)

Adverse Events

Time Frame	Baseline Through Month 12
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	CP-690,550 5 mg (Up To Month 3)		CP-690,550 10 mg (Up To Month 3)		Placebo (Up To Month 3)		Adalimumab (Up To Month 3)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Adalimumab (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Adalimumab (Post Month 6)
Arm/Group Description	CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.		CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.		Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.		Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.		CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.		CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.		Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.		Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.		CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.		CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.		Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
All Cause Mortality
	CP-690,550 5 mg (Up To Month 3)		CP-690,550 10 mg (Up To Month 3)		Placebo (Up To Month 3)		Adalimumab (Up To Month 3)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Adalimumab (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Adalimumab (Post Month 6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CP-690,550 5 mg (Up To Month 3)		CP-690,550 10 mg (Up To Month 3)		Placebo (Up To Month 3)		Adalimumab (Up To Month 3)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Adalimumab (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Adalimumab (Post Month 6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/204 (5.9%)		10/201 (5%)		2/108 (1.9%)		5/204 (2.5%)		10/232 (4.3%)		7/222 (3.2%)		2/59 (3.4%)		6/204 (2.9%)		11/260 (4.2%)		10/253 (4%)		7/204 (3.4%)
Cardiac disorders
Acute myocardial infarction	0/204 (0%)		0/201 (0%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Atrioventricular block complete	0/204 (0%)		0/201 (0%)		1/108 (0.9%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cardiac arrest	0/204 (0%)		0/201 (0%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Myocardial infarction	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		1/204 (0.5%)
Myocardial ischaemia	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cardiac failure congestive	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Ear and labyrinth disorders
Vertigo	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Endocrine disorders
Autoimmune thyroiditis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Eye disorders
Retinal detachment	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Gastrointestinal disorders
Anal polyp	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Diverticular perforation	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Salivary gland calculus	0/204 (0%)		0/201 (0%)		1/108 (0.9%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Haematemesis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Haematochezia	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Peptic ulcer haemorrhage	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Abdominal hernia	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		1/204 (0.5%)
Ileus	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
General disorders
Impaired healing	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Pyrexia	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Chest pain	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		1/204 (0.5%)
Hepatobiliary disorders
Cholecystitis	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cholecystitis acute	0/204 (0%)		0/201 (0%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cholelithiasis	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Infections and infestations
Arthritis bacterial	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cellulitis	2/204 (1%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Herpes zoster	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Labyrinthitis	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Osteomyelitis	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Sialoadenitis	0/204 (0%)		0/201 (0%)		1/108 (0.9%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Tooth abscess	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Urinary tract infection	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Breast abscess	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Clostridial infection	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Erysipelas	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Gallbladder empyema	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Gastroenteritis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Localised infection	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Septic shock	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Lung abscess	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Pneumonia	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		1/253 (0.4%)		0/204 (0%)
Pulmonary tuberculosis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		2/253 (0.8%)		0/204 (0%)
Salpingo-oophoritis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Injury, poisoning and procedural complications
Fall	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Femur fracture	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Humerus fracture	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Fibula fracture	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Scapula fracture	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Tendon rupture	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Joint dislocation	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		1/204 (0.5%)
Lower limb fracture	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Tibia fracture	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		2/232 (0.9%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Musculoskeletal and connective tissue disorders
Spinal column stenosis	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Tendon disorder	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Rheumatoid arthritis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		1/204 (0.5%)
Spondylolisthesis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Bursitis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		1/204 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Metastatic renal cell carcinoma	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Ovarian germ cell teratoma benign	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Benign salivary gland neoplasm	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cervix carcinoma	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Cholesteatoma	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		1/222 (0.5%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Myelodysplastic syndrome	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Neuroma	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Non-small cell lung cancer	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		1/204 (0.5%)
Nervous system disorders
Dysarthria	0/204 (0%)		0/201 (0%)		1/108 (0.9%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Ischaemic stroke	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		1/59 (1.7%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Headache	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Renal and urinary disorders
IgA nephropathy	0/204 (0%)		0/201 (0%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Renal failure acute	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Reproductive system and breast disorders
Cervix disorder	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Ovarian cyst	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		1/59 (1.7%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Ovarian torsion	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Metrorrhagia	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Hydrothorax	0/204 (0%)		0/201 (0%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Pleuritic pain	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Interstitial lung disease	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Pulmonary sarcoidosis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		0/253 (0%)		0/204 (0%)
Skin and subcutaneous tissue disorders
Prurigo	1/204 (0.5%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Surgical and medical procedures
Cholecystectomy	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		1/253 (0.4%)		0/204 (0%)
Vascular disorders
Hypertension	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Venous thrombosis limb	0/204 (0%)		1/201 (0.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Other (Not Including Serious) Adverse Events
	CP-690,550 5 mg (Up To Month 3)		CP-690,550 10 mg (Up To Month 3)		Placebo (Up To Month 3)		Adalimumab (Up To Month 3)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Adalimumab (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Adalimumab (Post Month 6)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/204 (25%)		44/201 (21.9%)		18/108 (16.7%)		50/204 (24.5%)		18/232 (7.8%)		8/222 (3.6%)		3/59 (5.1%)		18/204 (8.8%)		36/260 (13.8%)		44/253 (17.4%)		24/204 (11.8%)
Gastrointestinal disorders
Abdominal pain upper	4/204 (2%)		2/201 (1%)		1/108 (0.9%)		3/204 (1.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		1/260 (0.4%)		7/253 (2.8%)		0/204 (0%)
Diarrhoea	5/204 (2.5%)		2/201 (1%)		0/108 (0%)		2/204 (1%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Dyspepsia	4/204 (2%)		3/201 (1.5%)		2/108 (1.9%)		3/204 (1.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Vomiting	4/204 (2%)		0/201 (0%)		1/108 (0.9%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
General disorders
Oedema peripheral	3/204 (1.5%)		4/201 (2%)		3/108 (2.8%)		3/204 (1.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Infections and infestations
Bronchitis	2/204 (1%)		3/201 (1.5%)		1/108 (0.9%)		4/204 (2%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		7/260 (2.7%)		10/253 (4%)		4/204 (2%)
Herpes zoster	0/204 (0%)		5/201 (2.5%)		0/108 (0%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		3/260 (1.2%)		6/253 (2.4%)		4/204 (2%)
Nasopharyngitis	8/204 (3.9%)		4/201 (2%)		0/108 (0%)		7/204 (3.4%)		5/232 (2.2%)		2/222 (0.9%)		1/59 (1.7%)		3/204 (1.5%)		8/260 (3.1%)		3/253 (1.2%)		5/204 (2.5%)
Upper respiratory tract infection	9/204 (4.4%)		7/201 (3.5%)		1/108 (0.9%)		7/204 (3.4%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		9/260 (3.5%)		6/253 (2.4%)		4/204 (2%)
Urinary tract infection	5/204 (2.5%)		2/201 (1%)		0/108 (0%)		7/204 (3.4%)		5/232 (2.2%)		1/222 (0.5%)		0/59 (0%)		6/204 (2.9%)		2/260 (0.8%)		4/253 (1.6%)		5/204 (2.5%)
Pharyngitis	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		1/232 (0.4%)		1/222 (0.5%)		0/59 (0%)		4/204 (2%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Injury, poisoning and procedural complications
Fall	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		4/232 (1.7%)		2/222 (0.9%)		2/59 (3.4%)		1/204 (0.5%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Investigations
Alanine aminotransferase increased	3/204 (1.5%)		4/201 (2%)		0/108 (0%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		3/260 (1.2%)		5/253 (2%)		1/204 (0.5%)
Blood creatine phosphokinase increased	1/204 (0.5%)		4/201 (2%)		1/108 (0.9%)		1/204 (0.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/204 (1%)		1/201 (0.5%)		1/108 (0.9%)		4/204 (2%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		7/253 (2.8%)		1/204 (0.5%)
Rheumatoid arthritis	4/204 (2%)		0/201 (0%)		2/108 (1.9%)		1/204 (0.5%)		3/232 (1.3%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Back pain	0/204 (0%)		0/201 (0%)		0/108 (0%)		0/204 (0%)		3/232 (1.3%)		2/222 (0.9%)		0/59 (0%)		5/204 (2.5%)		2/260 (0.8%)		3/253 (1.2%)		1/204 (0.5%)
Nervous system disorders
Headache	8/204 (3.9%)		6/201 (3%)		2/108 (1.9%)		5/204 (2.5%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/204 (0%)		2/201 (1%)		3/108 (2.8%)		4/204 (2%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Skin and subcutaneous tissue disorders
Rash	1/204 (0.5%)		3/201 (1.5%)		1/108 (0.9%)		4/204 (2%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		0/260 (0%)		0/253 (0%)		0/204 (0%)
Vascular disorders
Hypertension	2/204 (1%)		5/201 (2.5%)		2/108 (1.9%)		0/204 (0%)		0/232 (0%)		0/222 (0%)		0/59 (0%)		0/204 (0%)		7/260 (2.7%)		3/253 (1.2%)		2/204 (1%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.