A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00856544

Collaborator

(none)

795

Enrollment

133

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with 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 the Phase 2 rheumatoid arthritis studies.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: CP-690,550 Drug: CP-690,550 Drug: Placebo Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

795 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, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active 5 mg	Drug: CP-690,550 Film coated tablet, 5 mg PO BID, 1 year
Experimental: Active 10 mg	Drug: CP-690,550 Film coated tablet, 10 mg PO BID, 1 year
Placebo Comparator: Placebo Sequence 1 Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.	Drug: Placebo Film coated tablet, 1 tablet PO BID, 3-6 months
Placebo Comparator: Placebo Sequence 2 Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.	Drug: Placebo Film coated tablet, 1 tablet PO BID, 3-6 months

Outcome Measures

Primary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 [Month 6]
ACR20 response: greater than or equal to (>=) 20 percent (%) 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.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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.
Percentage of Participants Achieving 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) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 [Week 2, Month 1, 2, 3, 4.5, 6]
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 HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) 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 HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 [Week 2, Month 1, 2, 3, 4.5, 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 HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) 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 HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 [Week 2, Month 1, 2, 3, 4.5, 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 HAQ); and CRP.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) 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 HAQ); and CRP.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 [Week 2, Month 1, 2, 3, 4.5, 6]
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.
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.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 [Baseline, Month 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.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12 [Month 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.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12]
DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores 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, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [Baseline, Month 3, 6, 12]
DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). 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.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 [Baseline, Week 2, Month 1, 2, 3, 4.5, 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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 [Month 9, Month 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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 [Baseline, Week 2, Month 1, 2, 3, 4.5, 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.
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.
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 [Baseline, Week 2, Month 1, 2, 3, 4.5, 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 = very well and 100 = very poorly.
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 = very well and 100 = very poorly.
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 [Baseline, Week 2, Month 1, 2, 3, 4.5, 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.
Physician Global Assessment (PGA) of Arthritis 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.
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 is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
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 is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 [Baseline, Month 1, 3, 6]
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
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.
Medical Outcome Study (MOS) Sleep Scale at Month 12 [Month 12]
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
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.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 [Baseline, Month 1, 3, 6]
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 [Month 12]
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 [Baseline, Month 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.
Euro Quality of Life (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.
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 [Baseline, 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: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Work Limitations Questionnaire (WLQ) Score at Month 12 [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: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
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:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 [Month 12]
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
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.
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.
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.
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.
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, work done and work missed were reported.
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, work done and work missed were reported.
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 a 0 to 10-point scale, where higher score indicated lower work performance.
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 a 0 to 10-point scale, where higher score indicated lower work performance.

Other Outcome Measures

Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis [2 weeks]
Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain [2 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
Patient must remain on at least one background traditional disease modifying antirheumatic drug.
No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

Exclusion Criteria:

Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
History of any other rheumatic autoimmune 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Huntsville	Alabama	United States	35801
2	Pfizer Investigational Site	Jonesboro	Arkansas	United States	72401
3	Pfizer Investigational Site	Palo Alto	California	United States	94304
4	Pfizer Investigational Site	Stanford	California	United States	94305
5	Pfizer Investigational Site	Boulder	Colorado	United States	80304
6	Pfizer Investigational Site	Denver	Colorado	United States	80206
7	Pfizer Investigational Site	Danbury	Connecticut	United States	06810
8	Pfizer Investigational Site	Hamden	Connecticut	United States	06518
9	Pfizer Investigational Site	Trumbull	Connecticut	United States	06611
10	Pfizer Investigational Site	New Port Richey	Florida	United States	34652
11	Pfizer Investigational Site	Ocala	Florida	United States	34474
12	Pfizer Investigational Site	Plantation	Florida	United States	33324
13	Pfizer Investigational Site	Port Richey	Florida	United States	34668
14	Pfizer Investigational Site	Tamarac	Florida	United States	33321
15	Pfizer Investigational Site	Tampa	Florida	United States	33613
16	Pfizer Investigational Site	Decatur	Georgia	United States	30033
17	Pfizer Investigational Site	Marietta	Georgia	United States	30060
18	Pfizer Investigational Site	Maywood	Illinois	United States	60153
19	Pfizer Investigational Site	Oakbrook Terrace	Illinois	United States	60181
20	Pfizer Investigational Site	Rockford	Illinois	United States	61103-3692
21	Pfizer Investigational Site	Springfield	Illinois	United States	62702
22	Pfizer Investigational Site	Springfield	Illinois	United States	62703
23	Pfizer Investigational Site	Vernon Hills	Illinois	United States	60061
24	Pfizer Investigational Site	Evansville	Indiana	United States	47714
25	Pfizer Investigational Site	Indianapolis	Indiana	United States	46227
26	Pfizer Investigational Site	Wichita	Kansas	United States	67203
27	Pfizer Investigational Site	Lexington	Kentucky	United States	40505
28	Pfizer Investigational Site	Leominster	Massachusetts	United States	01453
29	Pfizer Investigational Site	Worcester	Massachusetts	United States	01605
30	Pfizer Investigational Site	Edina	Minnesota	United States	55435
31	Pfizer Investigational Site	Lincoln	Nebraska	United States	68516
32	Pfizer Investigational Site	Albany	New York	United States	12206
33	Pfizer Investigational Site	Orchard Park	New York	United States	14127
34	Pfizer Investigational Site	Rochester	New York	United States	14618
35	Pfizer Investigational Site	Asheville	North Carolina	United States	28801
36	Pfizer Investigational Site	Charlotte	North Carolina	United States	28210
37	Pfizer Investigational Site	Bethlehem	Pennsylvania	United States	18015
38	Pfizer Investigational Site	Wyomissing	Pennsylvania	United States	19610
39	Pfizer Investigational Site	Greenville	South Carolina	United States	29601
40	Pfizer Investigational Site	Knoxville	Tennessee	United States	37909
41	Pfizer Investigational Site	Austin	Texas	United States	78705
42	Pfizer Investigational Site	Dallas	Texas	United States	75235
43	Pfizer Investigational Site	Seattle	Washington	United States	98133
44	Pfizer Investigational Site	Tacoma	Washington	United States	98405-2308
45	Pfizer Investigational Site	Tacoma	Washington	United States	98405
46	Pfizer Investigational Site	Clarksburg	West Virginia	United States	26301
47	Pfizer Investigational Site	Campsie	New South Wales	Australia	2194
48	Pfizer Investigational Site	Cairns	Queensland	Australia	4870
49	Pfizer Investigational Site	Maroochydore	Queensland	Australia	4558
50	Pfizer Investigational Site	Woodville	South Australia	Australia	5011
51	Pfizer Investigational Site	Malvern East	Victoria	Australia	3145
52	Pfizer Investigational Site	Shenton Park	Western Australia	Australia	6008
53	Pfizer Investigational Site	Santiago	RM	Chile	7510186
54	Pfizer Investigational Site	Santiago	RM	Chile	8360156
55	Pfizer Investigational Site	Providencia	Santiago, RM	Chile	7530206
56	Pfizer Investigational Site	Vina del Mar	V Region	Chile	2570017
57	Pfizer Investigational Site	Vina del Mar		Chile	2570017
58	Pfizer Investigational Site	Hefei	Anhui	China	230001
59	Pfizer Investigational Site	Hefei	Anhui	China	230022
60	Pfizer Investigational Site	Guangzhou	Guangdong	China	510260
61	Pfizer Investigational Site	Guangzhou	Guangdong	China	510630
62	Pfizer Investigational Site	Wuhan	Hubei	China	430030
63	Pfizer Investigational Site	Changsha	Hunan	China	410008
64	Pfizer Investigational Site	Nanjing	Jiangsu	China	210029
65	Pfizer Investigational Site	Suzhou	Jiangsu	China	215006
66	Pfizer Investigational Site	Jinan	Shandong	China	250012
67	Pfizer Investigational Site	Qingdao	Shandong	China	266011
68	Pfizer Investigational Site	Xi'an	Shanxi	China	710032
69	Pfizer Investigational Site	Chengdu	Sichuan	China	610041
70	Pfizer Investigational Site	Hangzhou	Zhejiang	China	310009
71	Pfizer Investigational Site	Beijing		China	100020
72	Pfizer Investigational Site	Beijing		China	100044
73	Pfizer Investigational Site	Beijing		China	100853
74	Pfizer Investigational Site	Shanghai		China	200001
75	Pfizer Investigational Site	Shanghai		China	200003
76	Pfizer Investigational Site	Shanghai		China	200433
77	Pfizer Investigational Site	Tianjin		China	300052
78	Pfizer Investigational Site	Barranquilla	Atlantico	Colombia	0000
79	Pfizer Investigational Site	Bogota	Cundinamarca	Colombia
80	Pfizer Investigational Site	Bucaramanga	Santander	Colombia
81	Pfizer Investigational Site	Opatija		Croatia	51410
82	Pfizer Investigational Site	Zagreb		Croatia	10000
83	Pfizer Investigational Site	Frederiksberg		Denmark	2000
84	Pfizer Investigational Site	Helsinki		Finland	00120
85	Pfizer Investigational Site	Hyvinkaa		Finland	05800
86	Pfizer Investigational Site	Tampere		Finland	33520
87	Pfizer Investigational Site	Berlin		Germany	14059
88	Pfizer Investigational Site	Dresden		Germany	01067
89	Pfizer Investigational Site	Hamburg		Germany	22081
90	Pfizer Investigational Site	Leipzig		Germany	04103
91	Pfizer Investigational Site	Nuernberg		Germany	90429
92	Pfizer Investigational Site	Rheine		Germany	48431
93	Pfizer Investigational Site	Maroussi Athens		Greece	15126
94	Pfizer Investigational Site	Seremban	Negeri Sembilan	Malaysia	70300
95	Pfizer Investigational Site	Batu Caves	Selangor	Malaysia	68100
96	Pfizer Investigational Site	Subang Jaya	Selangor	Malaysia	47500
97	Pfizer Investigational Site	Putrajaya	Wilayah Persekutuan	Malaysia	62250
98	Pfizer Investigational Site	Torreon	Coahuila	Mexico	27000
99	Pfizer Investigational Site	Morelia	Michoacan	Mexico	58249
100	Pfizer Investigational Site	Cuernavaca	Morelos	Mexico	62270
101	Pfizer Investigational Site	Mexico	Queretaro	Mexico	76178
102	Pfizer Investigational Site	Merida	Yucatan	Mexico	97000
103	Pfizer Investigational Site	Bialystok		Poland	15-337
104	Pfizer Investigational Site	Bialystok		Poland	15-461
105	Pfizer Investigational Site	Koscian		Poland	64-000
106	Pfizer Investigational Site	Poznan		Poland	60-773
107	Pfizer Investigational Site	Torun		Poland	87-100
108	Pfizer Investigational Site	Moscow		Russian Federation	115093
109	Pfizer Investigational Site	Moscow		Russian Federation	115446
110	Pfizer Investigational Site	Petrozavodsk		Russian Federation	185019
111	Pfizer Investigational Site	Nove Zamky		Slovakia	94001
112	Pfizer Investigational Site	Poprad		Slovakia	058 01
113	Pfizer Investigational Site	Povazska Bystrica		Slovakia	017 01
114	Pfizer Investigational Site	Rimavska Sobota		Slovakia	979 01
115	Pfizer Investigational Site	Senica		Slovakia	905 01
116	Pfizer Investigational Site	Zilina		Slovakia	010 01
117	Pfizer Investigational Site	Santiago de Compostela	A Coruña	Spain	15705
118	Pfizer Investigational Site	A Coruña		Spain	15006
119	Pfizer Investigational Site	Madrid		Spain	28046
120	Pfizer Investigational Site	Malaga		Spain	29009
121	Pfizer Investigational Site	Sevilla		Spain	41013
122	Pfizer Investigational Site	Falun		Sweden	791 82
123	Pfizer Investigational Site	Goteborg		Sweden	413 46
124	Pfizer Investigational Site	Uppsala		Sweden	751 85
125	Pfizer Investigational Site	Rajathevee	Bangkok	Thailand	10400
126	Pfizer Investigational Site	Amphoe Muang	Chiang Mai	Thailand	50200
127	Pfizer Investigational Site	Muang District	Khonkaen	Thailand	40002
128	Pfizer Investigational Site	Wirral	Merseyside	United Kingdom	CH49 5PE
129	Pfizer Investigational Site	Cannock	Staffs	United Kingdom	WS11 2XY
130	Pfizer Investigational Site	Solihull	West Midlands	United Kingdom	B91 2JL
131	Pfizer Investigational Site	Newcastle Upon Tyne		United Kingdom	NE1 4LP
132	Pfizer Investigational Site	Caracas	DC/ Municipio Libertados	Venezuela	1040-A
133	Pfizer Investigational Site	Caracas	Distrito Capital	Venezuela	1010

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:

NCT00856544

Other Study ID Numbers:

A3921046

First Posted:

Mar 5, 2009

Last Update Posted:

Jan 10, 2013

Last Verified:

Dec 1, 2012

Keywords provided by Pfizer

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Tofacitinib

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Period Title: Overall Study
STARTED	318	318	79	80
Treated	315	318	79	80
COMPLETED	261	252	71	67
NOT COMPLETED	57	66	8	13

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	Total
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.	Total of all reporting groups
Overall Participants	315	318	79	80	792
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	52.7 (11.7)	51.9 (11.8)	50.8 (11.2)	53.3 (10.8)	52.3 (11.6)
Sex: Female, Male (Count of Participants)
Female	264 83.8%	258 81.1%	63 79.7%	60 75%	645 81.4%
Male	51 16.2%	60 18.9%	16 20.3%	20 25%	147 18.6%

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 percent (%) 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 (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	157
Number [percentage of participants]	52.73 16.7%	58.25 18.3%	31.21 39.5%

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 each dose 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	27.04
	Confidence Interval	(2-Sided) 95% 17.94 to 36.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of each dose 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	21.52
	Confidence Interval	(2-Sided) 95% 12.39 to 30.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score 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
FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here 'n' is 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	315	157
Baseline (n= 311, 315, 157)	1.44 (0.69)	1.43 (0.68)	1.35 (0.66)
Change at Month 3 (n= 292, 292, 147)	-0.45 (0.53)	-0.54 (0.60)	-0.16 (0.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 10 mg, Placebo
	Comments	Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a 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, 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	-0.35
	Confidence Interval	(2-Sided) 95% -0.44 to -0.26
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	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 treatments, visits and treatment-by-visit interaction as fixed effects and participants as a 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 comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and 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	-0.26
	Confidence Interval	(2-Sided) 95% -0.35 to -0.16
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.05
	Estimation Comments

3. Primary Outcome

Title	Percentage of Participants Achieving 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) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description
FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	263	270	148
Number [percentage of participants]	9.13 2.9%	13.33 4.2%	2.70 3.4%

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 each dose of CP-690,550 10 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. For the comparison of 10 mg to placebo to be statistically significant, the 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	10.63
	Confidence Interval	(2-Sided) 95% 5.80 to 15.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	CP-690,550 5 mg, Placebo
	Comments	Normal approximation to the binomial distribution was used to test the superiority of each dose 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	0.0038
	Comments	A step-down procedure was used to control for multiple comparisons. For comparison of 5 mg to placebo to be statistically significant, comparison of 10 mg to placebo and 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	6.42
	Confidence Interval	(2-Sided) 95% 2.07 to 10.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
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 HAQ); and CRP.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	157
Week 2	27.33 8.7%	32.25 10.1%	10.90 13.8%
Month 1	38.59 12.3%	48.54 15.3%	22.93 29%
Month 2	54.02 17.1%	64.40 20.3%	26.11 33.1%
Month 3	56.27 17.9%	64.72 20.4%	27.39 34.7%
Month 4.5	50.80 16.1%	57.93 18.2%	25.48 32.3%
Month 6	52.73 16.7%	58.25 18.3%	31.21 39.5%

5. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) 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 HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description
FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	79	78
Month 9	50.48 16%	62.14 19.5%	37.97 48.1%	34.62 43.3%
Month 12	51.45 16.3%	56.63 17.8%	31.65 40.1%	34.62 43.3%

6. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 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 HAQ); and CRP.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	157
Week 2	5.79 1.8%	8.14 2.6%	1.28 1.6%
Month 1	11.58 3.7%	18.12 5.7%	1.27 1.6%
Month 2	23.15 7.3%	29.77 9.4%	4.46 5.6%
Month 3	27.33 8.7%	33.98 10.7%	9.55 12.1%
Month 4.5	27.97 8.9%	33.33 10.5%	8.28 10.5%
Month 6	33.76 10.7%	36.57 11.5%	12.74 16.1%

7. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) 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 HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.

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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	79	78
Month 9	31.51 10%	43.04 13.5%	25.32 32.1%	26.92 33.7%
Month 12	33.44 10.6%	42.72 13.4%	24.05 30.4%	25.64 32.1%

8. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 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 HAQ); and CRP.
Time Frame	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	157
Week 2	0.32 0.1%	2.28 0.7%	0.00 0%
Month 1	3.54 1.1%	7.12 2.2%	0.00 0%
Month 2	9.00 2.9%	10.36 3.3%	1.27 1.6%
Month 3	8.36 2.7%	14.24 4.5%	1.91 2.4%
Month 4.5	11.90 3.8%	18.12 5.7%	3.18 4%
Month 6	13.18 4.2%	16.18 5.1%	3.18 4%

9. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) 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 HAQ); and CRP.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.

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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	309	79	78
Month 9	14.15 4.5%	25.24 7.9%	10.13 12.8%	11.54 14.4%
Month 12	19.29 6.1%	25.57 8%	13.92 17.6%	20.51 25.6%

10. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
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	Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	312	315	158
Baseline (n=312, 315, 158)	5.21 (0.92)	5.26 (0.96)	5.22 (0.92)
Week 2 (n=309, 304, 156)	4.41 (1.10)	4.18 (1.09)	4.92 (1.01)
Month 1 (n=304, 300, 151)	4.08 (1.13)	3.83 (1.12)	4.68 (1.09)
Month 2 (n=294, 300, 148)	3.70 (1.20)	3.49 (1.15)	4.59 (1.16)
Month 3 (n=293, 291, 147)	3.62 (1.22)	3.44 (1.15)	4.51 (1.15)
Month 4.5 (n=281,286,71)	3.46 (1.27)	3.15 (1.12)	3.92 (1.18)
Month 6 (n=279,278,68)	3.39 (1.21)	3.09 (1.13)	3.60 (1.12)

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 population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	267	263	72	68
Month 9	3.21 (1.14)	2.88 (1.05)	3.22 (1.05)	2.83 (0.93)
Month 12	3.08 (1.19)	2.81 (1.04)	3.03 (1.15)	2.99 (1.06)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	309	313	158
Baseline (n=309,313,158)	6.29 (0.96)	6.36 (1.01)	6.30 (0.92)
Month 3 (n=206,263,140)	4.41 (1.39)	4.20 (1.30)	5.32 (1.26)
Month 6 (n=241,248,62)	4.14 (1.34)	3.84 (1.26)	4.34 (1.19)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	220	226	63	62
Mean (Standard Deviation) [units on a scale]	3.82 (1.30)	3.50 (1.11)	3.76 (1.31)	3.62 (1.19)

14. Secondary Outcome

Title	Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Description	DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores 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, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12

Outcome Measure Data

Analysis Population Description
Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).

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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 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 the number of SJC and TJC using the 28 joints count and ESR (mm/hr). 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 3, 6, 12

Outcome Measure Data

Analysis Population Description
Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).

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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 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 Baseline, Week 2, Month 1, 2, 3, 4.5 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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	315	157
Baseline (n = 311, 315, 157)	1.44 (0.69)	1.43 (0.68)	1.35 (0.66)
Week 2 (n = 310, 305, 156)	1.24 (0.69)	1.14 (0.67)	1.28 (0.66)
Month 1 (n = 304, 303, 154)	1.12 (0.67)	1.01 (0.65)	1.20 (0.67)
Month 2 (n = 299, 300, 150)	1.03 (0.68)	0.93 (0.66)	1.20 (0.63)
Month 3 (n = 293, 292, 148)	0.98 (0.67)	0.88 (0.67)	1.16 (0.67)
Month 4.5 (n = 282, 289, 71)	0.97 (0.68)	0.84 (0.67)	0.95 (0.62)
Month 6 (n = 278, 279, 68)	0.91 (0.67)	0.81 (0.65)	0.93 (0.61)

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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time Frame	Month 9, Month 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	266	264	72	70
Month 9	0.89 (0.68)	0.71 (0.64)	0.85 (0.65)	0.70 (0.64)
Month 12	0.86 (0.68)	0.73 (0.64)	0.81 (0.68)	0.73 (0.69)

18. Secondary Outcome

Title	Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 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, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	315	158
Baseline (n = 311, 315, 158)	57.08 (23.82)	58.58 (22.19)	57.11 (22.84)
Week 2 (n = 310, 306, 156)	46.81 (22.82)	41.85 (22.49)	51.01 (24.45)
Month 1 (n = 304, 303, 154)	40.17 (23.20)	37.08 (22.14)	45.69 (25.00)
Month 2 (n = 299, 301, 150)	36.40 (22.63)	32.84 (21.71)	47.30 (24.29)
Month 3 (n = 294, 292, 148)	34.92 (23.03)	32.96 (23.10)	46.59 (27.14)
Month 4.5 (n = 284, 289, 71)	34.43 (22.68)	32.62 (21.74)	40.23 (24.44)
Month 6 (n = 279, 280, 68)	31.07 (21.84)	29.94 (21.53)	34.19 (21.69)

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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	267	264	72	70
Month 9	30.78 (22.28)	27.13 (20.77)	29.50 (21.34)	25.26 (21.96)
Month 12	30.18 (23.11)	25.43 (20.57)	28.20 (22.46)	25.39 (22.71)

20. Secondary Outcome

Title	Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 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 = very well and 100 = very poorly.
Time Frame	Baseline, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	315	158
Baseline (n=311,315,158)	59.03 (22.89)	60.22 (22.53)	57.92 (23.33)
Week 2 (n=310,306,156)	46.59 (22.52)	42.99 (22.16)	51.27 (23.97)
Month 1 (n=303,303,154)	40.50 (23.29)	36.53 (21.42)	46.25 (24.22)
Month 2 (n=299,301,150)	37.18 (22.52)	33.80 (22.21)	50.42 (23.56)
Month 3 (n=294,292,148)	36.27 (22.64)	33.43 (22.55)	47.09 (26.13)
Month 4.5 (n=284,289,71)	35.92 (22.69)	34.05 (22.09)	41.03 (23.75)
Month 6 (n=279,280,68)	33.75 (23.01)	31.31 (21.55)	35.47 (20.28)

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 = very well and 100 = very poorly.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	266	264	72	70
Month 9	32.06 (22.49)	28.01 (20.81)	28.97 (20.07)	28.56 (22.74)
Month 12	30.64 (22.03)	27.94 (20.39)	28.71 (23.05)	28.20 (24.29)

22. Secondary Outcome

Title	Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 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, Week 2, Month 1, 2, 3, 4.5, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	310	313	158
Baseline (n=310,313,158)	60.48 (17.83)	59.66 (17.03)	58.87 (16.52)
Week 2 (n=308,304,155)	46.41 (20.14)	43.79 (18.17)	49.08 (18.90)
Month 1 (n=302,303,154)	38.35 (19.92)	34.31 (18.70)	42.86 (20.13)
Month 2 (n=299,299,150)	32.54 (19.36)	29.40 (17.36)	41.25 (20.42)
Month 3 (n=293,292,148)	31.97 (20.25)	29.21 (19.31)	39.54 (21.09)
Month 4.5 (n=283,288,71)	29.45 (19.84)	26.11 (17.54)	33.04 (21.06)
Month 6 (n=278,280,68)	25.83 (17.29)	23.69 (16.62)	27.88 (19.10)

23. Secondary Outcome

Title	Physician Global Assessment (PGA) of Arthritis 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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	265	264	72	70
Month 9	24.36 (17.67)	20.09 (14.23)	22.70 (15.42)	20.63 (17.35)
Month 12	21.52 (17.14)	18.12 (14.50)	19.01 (15.01)	17.59 (15.21)

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 is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	312	315	158
Baseline:physical functioning(n=312,315,158)	32.53 (9.58)	31.74 (9.62)	32.76 (9.59)
Baseline:role physical(n=312,315,158)	33.73 (9.74)	33.15 (9.43)	33.91 (9.57)
Baseline:social functioning(n=312,315,158)	36.22 (11.15)	37.04 (10.27)	36.87 (11.63)
Baseline:bodily pain(n=312,315,158)	33.38 (7.25)	33.94 (7.28)	34.22 (7.47)
Baseline:mental health(n=312,315,158)	39.94 (12.52)	41.05 (10.54)	41.50 (11.38)
Baseline:role emotional(n=312,315,158)	35.51 (13.65)	34.91 (13.00)	35.36 (12.97)
Baseline:vitality(n=312,315,158)	40.84 (10.29)	40.87 (8.89)	41.33 (9.37)
Baseline:general health(n=312,315,158)	33.95 (9.14)	34.27 (8.58)	34.65 (8.32)
Baseline:mental component(n=312,315,158)	40.86 (12.59)	41.56 (11.14)	41.67 (11.57)
Baseline:physical component(n=312,315,158)	32.44 (7.82)	32.02 (7.46)	32.74 (7.60)
Month 1:physical functioning(n=303,302,154)	36.17 (10.33)	36.71 (10.08)	33.95 (9.72)
Month 1:role physical(n=303,301,154)	38.20 (10.33)	39.00 (9.60)	37.15 (9.41)
Month 1:social functioning(n=303,302,154)	40.25 (10.99)	41.96 (9.73)	39.29 (9.92)
Month 1:bodily pain(n=303,302,154)	39.02 (7.86)	40.70 (7.69)	36.87 (7.14)
Month 1:mental health(n=303,302,153)	43.40 (11.43)	44.70 (10.00)	42.79 (11.04)
Month 1:role emotional(n=303,301,154)	38.36 (12.79)	39.27 (11.91)	38.18 (12.97)
Month 1:vitality(n=303,302,153)	45.87 (10.17)	46.71 (8.76)	43.74 (9.00)
Month 1:general health(n=303,302,154)	37.86 (9.45)	38.81 (8.65)	36.39 (8.35)
Month 1:mental component(n=303,301,153)	44.04 (11.64)	45.32 (10.13)	43.80 (11.22)
Month 1:physical component(n=303,301,153)	37.12 (8.31)	37.94 (7.96)	34.86 (7.48)
Month 3:physical functioning(n=294,291,147)	37.15 (10.47)	38.29 (10.60)	34.35 (10.42)
Month 3:role physical(n=294,292,147)	39.25 (9.91)	40.57 (9.69)	36.50 (9.76)
Month 3:social functioning(n=294,292,147)	41.51 (10.46)	42.44 (9.92)	38.62 (11.04)
Month 3:bodily pain(n=294,292,147)	40.22 (8.24)	41.82 (8.70)	37.50 (8.26)
Month 3:mental health(n=294,292,147)	44.69 (10.45)	45.15 (10.28)	42.68 (10.88)
Month 3:role emotional(n=293,291,146)	38.36 (11.98)	39.81 (12.04)	37.42 (13.23)
Month 3:vitality(n=294,292,147)	47.05 (9.71)	47.22 (9.05)	43.84 (9.68)
Month 3:general health(n=294,291,147)	38.98 (9.69)	39.45 (9.19)	35.56 (9.37)
Month 3:mental component(n=293,290,146)	44.96 (10.75)	45.35 (10.26)	43.10 (11.12)
Month 3:physical component(n=293,290,146)	38.26 (8.46)	39.53 (8.58)	34.90 (8.37)
Month 6:physical functioning(n=279,280,68)	38.55 (10.60)	39.42 (10.38)	38.18 (9.63)
Month 6:role physical(n=279,279,68)	39.86 (9.82)	41.02 (9.41)	40.27 (8.86)
Month 6:social functioning(n=279,280,68)	41.97 (10.22)	43.36 (10.01)	43.67 (9.96)
Month 6:bodily pain(n=279,280,68)	41.01 (8.17)	42.12 (8.45)	41.91 (7.74)
Month 6:mental health(n=279,280,68)	44.43 (10.26)	45.01 (10.27)	44.12 (10.13)
Month 6:role emotional(n=279,279,68)	39.37 (12.11)	40.49 (11.79)	39.81 (12.38)
Month 6:vitality(n=279,280,68)	47.02 (9.82)	47.80 (9.55)	46.67 (8.93)
Month 6:general health(n=279,280,68)	40.03 (9.51)	39.71 (9.17)	38.10 (9.05)
Month 6:mental component(n=279,279,68)	44.73 (10.59)	45.63 (10.29)	45.13 (11.02)
Month 6:physical component(n=279,279,68)	39.49 (8.64)	40.24 (8.43)	39.24 (7.19)

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 is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time Frame	Month 9, 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	267	264	72	70
Month 9:physical functioning(n=267,263,72,70)	39.40 (10.60)	40.67 (10.12)	38.86 (10.47)	40.83 (9.76)
Month 9:role physical(n=267,263,72,70)	40.21 (9.99)	42.03 (9.05)	41.44 (9.70)	42.99 (9.18)
Month 9:social functioning(n=267,264,72,70)	42.43 (9.97)	43.67 (9.60)	43.26 (11.23)	44.11 (10.32)
Month 9:bodily pain(n=267,264,72,70)	41.83 (8.89)	43.37 (8.45)	42.31 (8.42)	44.03 (8.26)
Month 9:mental health(n=267,264,72,70)	45.49 (10.69)	46.03 (10.67)	46.12 (10.49)	45.11 (10.51)
Month 9:role emotional(n=267,264,72,70)	40.55 (11.54)	42.16 (11.43)	40.75 (12.67)	41.02 (11.46)
Month 9:vitality(n=267,264,72,70)	48.39 (9.53)	48.70 (9.41)	48.38 (8.71)	47.29 (10.43)
Month 9:general health(n=266,264,72,70)	39.77 (9.63)	40.57 (9.29)	40.38 (9.04)	40.08 (9.50)
Month 9:mental component(n=266,262,72,70)	45.97 (10.45)	46.61 (10.74)	46.42 (11.01)	45.22 (11.40)
Month 9:physical component(n=266,262,72,70)	39.79 (8.60)	41.15 (8.15)	40.07 (7.97)	42.05 (6.93)
Month 12:physical functioning(n=258, 250,70,67)	39.07 (11.18)	40.38 (10.24)	38.61 (11.38)	39.85 (10.97)
Month 12:role physical(n=258, 250,70,67)	40.51 (9.99)	42.11 (9.31)	42.51 (9.72)	43.16 (9.51)
Month 12:social functioning(n=258, 250,70,67)	42.69 (10.14)	43.63 (9.71)	44.27 (9.72)	44.36 (10.30)
Month 12:bodily pain(n=258, 250,70,67)	41.95 (8.77)	43.28 (8.70)	42.59 (9.07)	45.49 (8.11)
Month 12:mental health(n=258, 250,70,67)	44.86 (10.63)	45.52 (10.27)	46.10 (10.81)	45.65 (11.29)
Month 12:role emotional(n=258, 250,70,67)	40.02 (12.10)	41.37 (11.79)	42.92 (11.80)	42.40 (11.92)
Month 12:vitality(n=258, 250,70,67)	48.08 (9.83)	48.12 (9.22)	49.77 (9.52)	47.75 (10.45)
Month 12:general health(n=258, 250,70,67)	39.63 (9.64)	39.88 (8.88)	40.86 (9.34)	39.43 (10.35)
Month 12:mental component(n=258, 250,70,67)	45.39 (10.69)	45.92 (10.65)	47.84 (11.04)	46.33 (11.21)
Month 12:physical component(n=258, 250,70,67)	39.94 (8.83)	41.13 (8.13)	40.16 (9.14)	41.62 (8.16)

26. Secondary Outcome

Title	Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Description	Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	312	314	158
Baseline:overall sleep problem(n=312,313,158)	41.05 (20.68)	40.89 (18.47)	39.75 (18.25)
Baseline:sleep problem summary(n=312,314,158)	39.51 (21.22)	40.08 (19.02)	37.87 (18.37)
Baseline:somnolence(n=312,314,158)	34.38 (21.95)	36.09 (21.59)	34.94 (17.94)
Baseline:snoring(n=310,314,157)	32.26 (30.31)	31.27 (31.27)	33.76 (32.09)
Baseline:quantity(n=312,313,158)	6.88 (2.13)	6.72 (1.55)	6.82 (1.51)
Baseline:sleep disturbance(n=312,313,158)	44.39 (26.68)	41.58 (24.61)	41.20 (25.42)
Baseline:awaken short of breath(n=312,314,158)	18.91 (24.38)	19.81 (24.38)	17.34 (21.78)
Baseline:adequacy(n=312,314,158)	47.56 (28.78)	44.97 (26.89)	46.84 (25.69)
Month 1:overall sleep problem(n=301,301,154)	36.51 (19.94)	34.77 (17.79)	37.09 (18.02)
Month 1:sleep problem summary(n=301,301,154)	35.87 (20.50)	34.45 (17.94)	35.95 (18.32)
Month 1:somnolence(n=301,302,154)	31.58 (21.01)	30.49 (20.05)	33.33 (19.02)
Month 1:snoring(n=300,302,153)	29.87 (29.33)	28.74 (30.29)	32.03 (29.68)
Month 1:quantity(n=301,301,154)	6.90 (1.54)	7.02 (1.55)	6.81 (1.54)
Month 1:sleep disturbance(n=301,302,154)	38.43 (26.01)	34.64 (24.20)	37.42 (24.86)
Month 1:awaken short of breath(n=301,301,154)	18.34 (23.41)	17.21 (21.91)	14.94 (20.01)
Month 1:adequacy(n=301,302,154)	52.92 (27.91)	51.52 (26.23)	49.16 (23.51)
Month 3:overall sleep problem(n=292,292,146)	35.10 (18.58)	34.06 (17.33)	38.66 (17.32)
Month 3:sleep problem summary(n=292,292,146)	34.41 (19.04)	33.80 (17.65)	37.97 (17.21)
Month 3:somnolence(n=292,292,146)	30.07 (19.89)	28.90 (18.75)	35.43 (20.29)
Month 3:snoring(n=290,292,144)	31.31 (29.56)	31.78 (30.23)	31.81 (29.77)
Month 3:quantity(n=293,292,147)	6.87 (1.54)	6.96 (1.46)	6.76 (1.55)
Month 3:sleep disturbance(n=292,292,146)	36.67 (23.98)	33.69 (23.01)	37.77 (24.18)
Month 3:awaken short of breath(n=292,292,146)	19.38 (24.67)	17.26 (21.19)	18.08 (21.57)
Month 3:adequacy(n=292,292,146)	54.66 (27.42)	51.58 (26.71)	45.82 (25.54)
Month 6:overall sleep problem(n=277,280,68)	33.92 (19.36)	33.11 (16.94)	34.87 (18.29)
Month 6:sleep problem summary(n=277,280,68)	33.26 (19.87)	33.30 (17.17)	34.85 (18.81)
Month 6:somnolence(n=277,280,68)	31.12 (20.03)	29.81 (18.23)	30.29 (19.19)
Month 6:snoring(n=271,280,68)	31.14 (28.98)	32.07 (29.21)	31.47 (29.79)
Month 6:quantity(n=278,279,68)	6.86 (1.52)	6.94 (1.42)	6.82 (1.41)
Month 6:sleep disturbance(n=277,280,68)	34.48 (24.11)	31.33 (21.96)	34.78 (24.36)
Month 6:awaken short of breath(n=277,280,68)	17.62 (19.89)	17.57 (20.87)	17.06 (24.98)
Month 6:adequacy(n=277,280,68)	54.40 (28.34)	51.64 (26.36)	50.29 (26.76)

27. 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 population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	312	315	158
Baseline (n=312,315,158)	139 44.1%	139 43.7%	70 88.6%
Month 1 (n=305,303,155)	155 49.2%	145 45.6%	72 91.1%
Month 3 (n=294,292,147)	139 44.1%	152 47.8%	65 82.3%
Month 6 (n=278,280,145)	142 45.1%	143 45%	66 83.5%

28. Secondary Outcome

Title	Medical Outcome Study (MOS) Sleep Scale at Month 12
Description	Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	258	249	70	66
Overall sleep problem	34.17 (18.71)	32.24 (17.13)	31.74 (17.41)	33.58 (17.44)
Sleep problem summary	33.71 (19.11)	32.58 (17.42)	30.95 (17.09)	32.53 (17.89)
Somnolence	29.30 (19.09)	27.93 (17.70)	30.86 (21.18)	28.48 (15.45)
Snoring	30.32 (28.59)	32.37 (29.70)	31.43 (31.13)	31.38 (27.58)
Quantity	6.94 (1.51)	7.04 (1.30)	6.83 (1.36)	6.95 (1.42)
Sleep disturbance	34.78 (24.31)	31.75 (21.95)	29.41 (24.04)	35.63 (22.81)
Awaken short of breath	19.77 (24.38)	17.19 (21.25)	17.71 (19.42)	14.85 (17.30)
Adequacy	54.38 (26.14)	53.29 (25.26)	55.00 (25.01)	55.76 (26.37)

29. 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 population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	258	250	70	67
Number [participants]	134 42.5%	144 45.3%	37 46.8%	36 45%

30. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
Description	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame	Baseline, Month 1, 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	312	314	158
Baseline (n=312,314,158)	29.01 (11.01)	28.65 (9.49)	29.72 (8.97)
Month 1 (n=301,302,153)	33.16 (10.75)	33.94 (8.91)	31.78 (9.58)
Month 3 (n=294,292,147)	34.38 (10.07)	34.99 (9.20)	31.41 (9.95)
Month 6 (n=277,280,68)	35.14 (9.91)	35.01 (9.45)	35.24 (9.30)

31. Secondary Outcome

Title	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
Description	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	258	249	70	67
Mean (Standard Deviation) [units on a scale]	35.02 (9.83)	36.34 (9.15)	36.93 (9.19)	36.07 (9.64)

32. Secondary Outcome

Title	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 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 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	311	314	158
Baseline (n=311,314,158)	0.46 (0.31)	0.48 (0.29)	0.51 (0.27)
Month 3 (n=294,291,147)	0.63 (0.24)	0.68 (0.24)	0.56 (0.28)
Month 6 (n=277,280,68)	0.66 (0.23)	0.70 (0.21)	0.65 (0.20)

33. Secondary Outcome

Title	Euro Quality of Life (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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	258	249	70	67
Mean (Standard Deviation) [units on a scale]	0.68 (0.23)	0.70 (0.21)	0.66 (0.24)	0.69 (0.23)

34. Other Pre-specified Outcome

Title	Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Description	Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	51	54	33
Number [days]	3	3	3

35. Other Pre-specified Outcome

Title	Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
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	2 weeks

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	51	54	33
Number [days]	3	3	3

36. Secondary Outcome

Title	Work Limitations Questionnaire (WLQ) Score at Baseline, 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: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	164	163	90
Baseline:time management(n=152,149,80)	47.13 (27.40)	46.05 (27.83)	39.98 (24.44)
Baseline:physical demands(n=154,154,86)	48.08 (25.92)	50.83 (25.34)	51.88 (24.98)
Baseline:mental demands(n=158,154,83)	36.58 (26.35)	35.86 (25.72)	30.31 (24.19)
Baseline:output demands(n=153,149,79)	41.93 (27.66)	38.76 (28.34)	32.72 (25.35)
Baseline:work loss index(n=164,163,90)	11.25 (6.04)	10.76 (6.16)	9.22 (5.28)
Month 3:time management(n=139,131,69)	38.56 (30.11)	37.39 (30.53)	36.99 (28.24)
Month 3:physical demands(n=135, 32,66)	43.14 (26.03)	45.07 (30.63)	52.78 (24.73)
Month 3:mental demands(n=142,136,72)	30.43 (27.99)	31.60 (29.49)	28.15 (23.69)
Month 3:output demands(n=136,132,68)	32.23 (27.77)	33.43 (30.58)	27.33 (24.32)
Month 3:work loss index(n=145,138,73)	9.29 (6.32)	9.64 (7.10)	8.77 (5.47)
Month 6:time management(n=112,108,27)	34.43 (28.40)	35.73 (31.85)	33.77 (31.88)
Month 6:physical demands(n=114,110,24)	48.72 (29.30)	41.75 (30.91)	48.13 (32.45)
Month 6:mental demands(n=115,112,27)	25.94 (26.35)	27.98 (28.18)	22.34 (26.57)
Month 6:output demands(n=111,111,26)	28.92 (26.55)	28.98 (28.12)	29.52 (29.09)
Month 6:work loss index(n=116,114,28)	8.73 (6.26)	8.71 (6.64)	8.03 (6.64)

37. Secondary Outcome

Title	Work Limitations Questionnaire (WLQ) Score at 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: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	108	101	38	32
Time management(n=105,98,35,31)	37.01 (30.03)	35.29 (31.80)	30.82 (29.59)	36.57 (30.80)
Physical demands(n=105,97,36,28)	44.15 (27.91)	42.41 (31.59)	47.15 (30.40)	40.82 (30.86)
Mental demands(n=108,100,36,32)	27.27 (26.33)	27.42 (27.56)	20.70 (26.37)	33.05 (29.78)
Output demands(n=105,95,35,29)	26.75 (25.54)	25.67 (27.25)	22.54 (25.05)	28.43 (27.66)
Work loss index(n=108,101,38,32)	8.65 (6.12)	8.28 (6.59)	7.06 (5.81)	8.89 (6.29)

38. 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:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	307	313	154
Baseline:Seen any doctor(n=307,312,153)	1.13 (0.34)	1.11 (0.32)	1.16 (0.37)
Baseline:Treated in emergency room(n=307,313,154)	1.94 (0.24)	1.94 (0.23)	1.95 (0.22)
Baseline:Admitted for overnight stay(n=19,18,8)	0.16 (0.37)	0.22 (0.43)	0.50 (0.93)
Baseline:Hospitalization(n=307,313,154)	1.95 (0.22)	1.93 (0.26)	1.94 (0.24)
Baseline:Outpatient surgery(n=307,312,154)	1.97 (0.16)	1.98 (0.14)	1.94 (0.24)
Baseline:Non-study diagnostic test(n=307,312,154)	1.85 (0.35)	1.87 (0.33)	1.86 (0.35)
Baseline:In nursing home(n=307,312,154)	2.00 (0.06)	1.99 (0.08)	1.99 (0.11)
Baseline:Home healthcare services(n=307,312,154)	1.99 (0.10)	1.99 (0.11)	1.99 (0.11)
Baseline:Required aids/devices(n=307,311,154)	1.88 (0.33)	1.87 (0.34)	1.88 (0.33)
Baseline:Non-medical practitioner(n=307,312,154)	1.96 (0.20)	1.98 (0.14)	1.98 (0.14)
Baseline:Currently employed(n=307,312,154)	1.64 (0.48)	1.66 (0.47)	1.62 (0.49)
Baseline:Feel well enough to work(n=121,122,57)	1.88 (0.33)	1.89 (0.32)	1.79 (0.41)
Baseline:Unable to work due to RA(n=122,129,55)	1.34 (0.48)	1.25 (0.43)	1.42 (0.50)
Baseline:Lost job/retired early(n=121,116,54)	1.64 (0.48)	1.47 (0.50)	1.50 (0.50)
Baseline:Work disabled due to RA(n=126,120,53)	1.50 (0.50)	1.34 (0.48)	1.47 (0.50)
Baseline:Retired(n=132,133,59)	1.50 (0.50)	1.41 (0.49)	1.41 (0.50)
Baseline:Sick leave due to RA(n=286,278,145)	1.75 (0.43)	1.78 (0.41)	1.81 (0.39)
Baseline:Performed part time work(n=285,278,143)	1.89 (0.31)	1.89 (0.31)	1.92 (0.28)
Baseline:Performed paid work(n=287,277,144)	1.67 (0.47)	1.66 (0.47)	1.66 (0.48)
Baseline:Unable to do chores(n=305,307,153)	1.44 (0.50)	1.48 (0.50)	1.44 (0.50)
Baseline:Chores by housekeeper(n=306,312,154)	1.85 (0.36)	1.88 (0.32)	1.88 (0.32)
Baseline:Chores by family/friends(n=306,312,154)	1.49 (0.50)	1.49 (0.50)	1.48 (0.50)
Month 3:Seen any doctor(n=290,291,146)	1.38 (0.49)	1.41 (0.49)	1.36 (0.48)
Month 3:Treated in emergency room(n=290,291,146)	1.96 (0.20)	1.98 (0.15)	1.96 (0.20)
Month 3:Admitted for overnight stay(n=12,7,6)	0.25 (0.62)	0.14 (0.38)	0.33 (0.82)
Month 3:Hospitalization(n=288,291,146)	1.99 (0.12)	1.99 (0.12)	1.97 (0.16)
Month 3:Outpatient surgery(n=290,291,146)	1.98 (0.14)	1.98 (0.13)	1.96 (0.20)
Month 3:Non-study diagnostic test(n=288,291,146)	1.91 (0.29)	1.91 (0.29)	1.90 (0.30)
Month 3:In nursing home(n=290,291,146)	2.00 (0.06)	1.99 (0.08)	2.00 (0.00)
Month 3:Home healthcare services(n=289,291,146)	1.99 (0.08)	1.99 (0.12)	1.99 (0.12)
Month 3:Required aids/devices(n=288,291,146)	1.91 (0.28)	1.91 (0.29)	1.81 (0.40)
Month 3:Non-medical practitioner(n=290,291,146)	1.98 (0.14)	1.98 (0.14)	1.99 (0.08)
Month 3:Currently employed(n=289,291,146)	1.64 (0.48)	1.66 (0.48)	1.63 (0.48)
Month 3:Feel well enough to work(n=107,130,47)	1.81 (0.39)	1.75 (0.44)	1.79 (0.41)
Month 3:Unable to work due to RA(n=108,124,50)	1.43 (0.50)	1.49 (0.50)	1.46 (0.50)
Month 3:Lost job/retired early(n=109,125,49)	1.58 (0.50)	1.61 (0.49)	1.55 (0.50)
Month 3:Work disabled due to RA(n=108,123,47)	1.49 (0.50)	1.54 (0.50)	1.51 (0.51)
Month 3:Retired(n=132,129,57)	1.45 (0.50)	1.44 (0.50)	1.39 (0.49)
Month 3:Sick leave due to RA(n=265,266,139)	1.88 (0.32)	1.91 (0.28)	1.83 (0.38)
Month 3:Performed part time work(n=264,265,139)	1.94 (0.24)	1.96 (0.20)	1.94 (0.23)
Month 3:Performed paid work(n=265,266,139)	1.72 (0.45)	1.77 (0.42)	1.72 (0.45)
Month 3:Unable to do chores(n=284,286,147)	1.65 (0.48)	1.71 (0.46)	1.57 (0.50)
Month 3:Chores by housekeeper(n=289,290,146)	1.90 (0.31)	1.93 (0.25)	1.93 (0.25)
Month 3:Chores by family/friends(n=288,290,146)	1.65 (0.48)	1.68 (0.47)	1.59 (0.49)
Month 6:Seen any doctor(n=275,279,68)	1.40 (0.49)	1.37 (0.48)	1.43 (0.50)
Month 6:Treated in emergency room(n=275,279,68)	1.95 (0.21)	1.98 (0.15)	1.97 (0.17)
Month 6:Admitted for overnight stay (n=13,5,2)	0.62 (0.87)	0.40 (0.89)	0.00 (0.00)
Month 6:Hospitalization(n=274,279,68)	1.97 (0.17)	1.97 (0.16)	2.00 (0.00)
Month 6:Outpatient surgery(n=275,279,68)	1.98 (0.13)	1.98 (0.13)	1.93 (0.26)
Month 6:Non-study diagnostic test(n=274,279,68)	1.91 (0.29)	1.93 (0.25)	1.85 (0.36)
Month 6:In nursing home(n=275,279,68)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)
Month 6:Home healthcare services(n=273,278,68)	1.99 (0.09)	1.99 (0.08)	2.00 (0.00)
Month 6:Required aids/devices(n=274,278,68)	1.91 (0.28)	1.91 (0.29)	1.93 (0.26)
Month 6:Non-medical practitioner(n=275,279,68)	1.99 (0.10)	2.00 (0.06)	2.00 (0.00)
Month 6:Currently employed(n=274,279,68)	1.65 (0.48)	1.66 (0.47)	1.65 (0.48)
Month 6:Feel well enough to work(n=117,129,25)	1.80 (0.40)	1.71 (0.46)	1.72 (0.46)
Month 6:Unable to work due to RA(n=121,126,23)	1.45 (0.50)	1.49 (0.50)	1.43 (0.51)
Month 6:Lost job/retired early(n=118,125,23)	1.63 (0.49)	1.57 (0.50)	1.52 (0.51)
Month 6:Work disabled due to RA(n=117,125,23)	1.53 (0.50)	1.57 (0.50)	1.65 (0.49)
Month 6:Retired(n=129,136,30)	1.47 (0.50)	1.50 (0.50)	1.47 (0.51)
Month 6:Sick leave due to RA(n=250,255,59)	1.92 (0.28)	1.95 (0.23)	1.93 (0.52)
Month 6:Performed part time work(n=250,255,59)	1.97 (0.17)	1.97 (0.17)	1.98 (0.13)
Month 6:Performed paid work(n=249,255,59)	1.78 (0.41)	1.81 (0.39)	1.76 (0.43)
Month 6:Unable to do chores(n=269,276,67)	1.70 (0.46)	1.73 (0.45)	1.69 (0.47)
Month 6:Chores by housekeeper(n=275,277,68)	1.90 (0.30)	1.95 (0.22)	1.91 (0.29)
Month 6:Chores by family/friends(n=274,277,68)	1.71 (0.46)	1.75 (0.43)	1.79 (0.41)

39. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	254	246	70	66
Seen any doctor(n=254,243,70,66)	1.48 (0.50)	1.44 (0.50)	1.40 (0.49)	1.50 (0.50)
Treated in ER(n=254,246,70,67)	1.95 (0.22)	1.95 (0.22)	1.91 (0.28)	1.93 (0.26)
Admitted for overnight stay (n=13,12,6,5)	0.23 (0.60)	0.25 (0.62)	0.33 (0.82)	0.00 (0.00)
Hospitalization(n=254,246,70,67)	1.97 (0.17)	1.97 (0.16)	1.99 (0.16)	1.97 (0.12)
Had outpatient surgery(n=253,246,70,67)	1.97 (0.18)	1.98 (0.14)	1.97 (0.17)	1.97 (0.17)
Diagnostic test(n=253,246,70,67)	1.87 (0.33)	1.90 (0.30)	1.91 (0.28)	1.84 (0.37)
In nursing home(n=254,245,70,67)	1.98 (0.12)	2.00 (0.00)	2.00 (0.00)	2.00 (0.00)
Home healthcare services(n=252,246,70,67)	2.00 (0.06)	2.00 (0.06)	1.99 (0.12)	2.00 (0.00)
Required aids/devices(n=254,246,70,67)	1.92 (0.28)	1.93 (0.25)	1.94 (0.23)	1.93 (0.26)
Non-medical practitioner(n=254,246,70,67)	1.99 (0.09)	1.99 (0.11)	1.96 (0.20)	2.00 (0.00)
Currently employed(n=254,246,70,67)	1.66 (0.47)	1.65 (0.48)	1.50 (0.50)	1.63 (0.49)
Feel well enough to work(n=102,107,18,19)	1.74 (0.44)	1.64 (0.48)	1.72 (0.46)	1.74 (0.45)
Unable to work due to RA(n=100,107,19,19)	1.50 (0.50)	1.54 (0.50)	1.37 (0.50)	1.63 (0.50)
Lost job/retired early(n=99,103,18,19)	1.62 (0.49)	1.55 (0.50)	1.56 (0.51)	1.58 (0.51)
Work disabled due to RA(n=103,106,18,19)	1.57 (0.50)	1.56 (0.50)	1.39 (0.50)	1.58 (0.51)
Retired(n=114,117,22,22)	1.42 (0.50)	1.44 (0.50)	1.36 (0.49)	1.32 (0.48)
Sick leave due to RA(n=223,215,65,59)	1.93 (0.25)	1.94 (0.24)	1.98 (0.12)	1.93 (0.25)
Performed part time work(n=224,217,64,57)	1.96 (0.19)	1.97 (0.18)	1.98 (0.13)	1.96 (0.19)
Performed paid work(n=224,222,64,57)	1.78 (0.41)	1.76 (0.43)	1.72 (0.45)	1.75 (0.43)
Unable to do chores(n=250,246,69,66)	1.73 (0.44)	1.77 (0.42)	1.74 (0.44)	1.89 (0.31)
Chores by housekeeper(n=254,246,70,67)	1.91 (0.29)	1.96 (0.19)	2.00 (0.00)	1.93 (0.26)
Chores by family/friends(n=253,246,70,66)	1.75 (0.43)	1.80 (0.40)	1.79 (0.41)	1.82 (0.39)

40. 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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	266	280	130
Baseline:Doctor visit(n=266,280,130)	4.27 (3.99)	4.17 (3.58)	4.13 (3.80)
Baseline:RA related doctor visit(n=266,280,130)	1.33 (0.85)	1.32 (0.71)	1.25 (0.61)
Baseline:Hospital ER visit(n=19,18,8)	1.26 (0.81)	1.28 (0.67)	1.38 (0.74)
Baseline:RA related ER visit(n=19,18,8)	0.58 (0.77)	0.50 (0.51)	0.88 (0.83)
Baseline:Hospitalization(n=16,23,9)	1.50 (2.00)	1.26 (0.45)	1.22 (0.67)
Baseline:RA related hospitalization(n=16,23,9)	0.94 (0.68)	1.09 (0.90)	0.78 (0.67)
Baseline:Outpatient surgery(n=8,6,9)	1.13 (0.35)	1.17 (0.41)	1.33 (0.50)
Baseline:RA related outpatient surgery(n=8,5,9)	0.88 (0.64)	0.20 (0.45)	0.56 (0.88)
Baseline:Non-study diagnostic test(n=45,39,22)	1.64 (1.03)	2.13 (2.34)	1.64 (0.95)
Baseline:RA related diagnostic test(n=45,40,22)	0.80 (0.87)	0.90 (0.98)	0.73 (0.88)
Baseline:Non-medical practitioner visit(n=13,6,3)	8.08 (7.90)	2.83 (1.83)	8.00 (2.00)
Baseline:RA related non-medical visit(n=13,6,3)	1.23 (0.73)	1.00 (0.89)	1.33 (0.58)
Month 3:Doctor visit(n=183,174,94)	4.50 (4.18)	4.05 (3.77)	4.66 (4.94)
Month 3:RA related doctor visit(n=183,174,94)	1.06 (0.75)	0.97 (0.72)	1.03 (0.71)
Month 3:Hospital ER visit(n=11,7,6)	1.36 (0.92)	1.00 (0.00)	1.17 (0.41)
Month 3:RA related ER visit(n=12,7,6)	0.17 (0.39)	0.29 (0.76)	0.00 (0.00)
Month 3:Hospitalization(n=4,4,4)	1.00 (0.00)	1.00 (0.00)	0.75 (0.50)
Month 3:RA related hospitalization(n=4,4,4)	0.25 (0.50)	0.50 (0.58)	0.25 (0.50)
Month 3:Outpatient surgery(n=6,5,6)	2.17 (1.94)	1.00 (0.00)	1.00 (0.00)
Month 3:RA related outpatient surgery(n=6,5,6)	0.00 (0.00)	0.00 (0.00)	0.17 (0.41)
Month 3:Non-study diagnostic test(n=24,26,15)	1.63 (1.21)	1.35 (0.63)	1.33 (0.82)
Month 3:RA related diagnostic test(n=26,27,15)	0.23 (0.65)	0.22 (0.51)	0.47 (0.52)
Month 3:Non-medical practitioner visit(n=6,6,1)	4.00 (2.28)	3.00 (3.52)	40.00 (NA)
Month 3:RA related non-medical visit(n=6,6,1)	0.67 (1.03)	0.67 (0.52)	4.00 (NA)
Month 6:Doctor visit(n=168,178,39)	3.54 (3.87)	3.07 (2.73)	3.08 (3.96)
Month 6:RA related doctor visit(n=168,177,39)	0.91 (0.65)	0.97 (0.71)	0.74 (0.59)
Month 6:Hospital ER visit(n=13,4,2)	1.31 (0.63)	1.00 (0.00)	2.50 (2.12)
Month 6:RA related ER visit(n=13,6,2)	0.08 (0.28)	0.00 (0.00)	0.00 (0.00)
Month 6:Hospitalization(n=8,5,2)	1.13 (0.35)	1.00 (0.00)	1.00 (0.00)
Month 6:RA related hospitalization(n=8,7,2)	0.38 (0.74)	0.29 (0.76)	1.00 (0.00)
Month 6:Outpatient surgery(n=5,5,5)	1.00 (0.00)	1.40 (0.55)	1.00 (0.00)
Month 6:RA related outpatient surgery(n=5,5,5)	0.00 (0.00)	0.00 (0.00)	0.20 (0.45)
Month 6:Non-study diagnostic test(n=23,20,9)	2.04 (1.49)	1.60 (1.10)	1.11 (0.33)
Month 6:RA related diagnostic test(n=25,20,10)	0.28 (0.54)	0.35 (0.67)	0.20 (0.42)
Month 6:Non-medical practitioner visit(n=3,1,1)	12.67 (11.02)	12.00 (NA)	NA (NA)
Month 6:RA related non-medical visit(n=3,1,1)	0.33 (0.58)	4.00 (NA)	NA (NA)

41. 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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	136	139	42	34
Doctor visit(n=136,139,42,34)	3.17 (3.59)	2.58 (2.62)	3.19 (4.58)	2.62 (1.65)
RA related doctor visit (n=136,139,42,34)	0.89 (0.66)	0.74 (0.64)	1.05 (0.82)	0.79 (0.69)
Hospital ER visit(n=13,12,6,5)	1.15 (0.38)	1.17 (0.58)	1.67 (1.63)	1.00 (0.00)
RA related ER visit(n=13,12,6,5)	0.15 (0.55)	0.33 (0.65)	0.33 (0.82)	0.00 (0.00)
Hospitalization(n=7,8,1,2)	1.00 (0.00)	1.00 (0.00)	1.00 (NA)	1.50 (0.71)
RA related hospitalization(n=8,8,1,2)	0.50 (0.93)	0.63 (0.92)	0.00 (NA)	0.00 (0.00)
Outpatient surgery(n=4,5,2,2)	1.25 (0.50)	1.60 (1.34)	1.00 (0.00)	1.00 (0.00)
RA related outpatient surgery(n=8,5,2,2)	0.13 (0.35)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Non-study diagnostic test(n=30,25,6,9)	1.67 (0.88)	1.68 (1.44)	1.33 (0.52)	2.00 (0.87)
RA related diagnostic test(n=32,25,6,11)	0.34 (0.70)	0.12 (0.33)	0.00 (0.00)	0.09 (0.30)
Non-medical practitioner visit(n=2,2,3,0)	3.00 (1.41)	6.00 (2.83)	3.00 (2.65)	NA (NA)
RA related non-medical visit(n=2,3,3,0)	0.00 (0.00)	0.67 (0.58)	0.67 (0.58)	NA (NA)

42. 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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	154	158	78
Baseline:Hospital length of stay(n=16,23,8)	12.69 (6.05)	15.26 (13.03)	14.50 (15.97)
Baseline:Days in nursing home(n=1,2,1)	28.00 (NA)	14.50 (0.71)	21.00 (NA)
Baseline:Days aids/devices used(n=37,40,19)	84.92 (71.64)	100.78 (109.26)	65.37 (74.55)
Baseline:RA related aids used(n=37,42,19)	1.65 (1.18)	1.90 (1.36)	1.42 (0.84)
Baseline:Days of work per week(n=110,106,59)	5.02 (1.05)	5.01 (0.88)	4.86 (1.02)
Baseline:Days on sick leave due to RA(n=71,61,27)	27.06 (33.38)	30.26 (35.56)	31.41 (32.27)
Baseline:Days of part time work(n=30,29,12)	22.77 (28.95)	20.86 (29.44)	34.83 (34.89)
Baseline:Paid work, bothered by RA(n=94,93,48)	40.11 (30.69)	39.26 (29.85)	43.15 (32.11)
Baseline:Chores by housekeeper(n=46,37,18)	27.17 (35.34)	19.73 (28.01)	37.28 (38.31)
Baseline:Chores by family(n=154,158,79)	41.26 (38.38)	34.92 (33.94)	37.81 (35.78)
Month 3:Hospital length of stay(n=4,4,4)	7.00 (4.24)	8.25 (2.99)	3.75 (0.50)
Month 3:Days in nursing home(n=1,2,0)	10.00 (NA)	14.00 (9.90)	NA (NA)
Month 3:Days aids/devices used(n=24,28,28)	104.96 (87.40)	104.36 (128.12)	120.75 (152.78)
Month 3:RA related aids used(n=25,28,28)	1.68 (0.95)	1.68 (1.39)	1.79 (1.69)
Month 3:Days of work per week(n=104,99,52)	5.16 (1.01)	5.12 (1.08)	4.94 (1.00)
Month 3:Days on sick leave due to RA(n=31,22,24)	28.23 (34.67)	28.45 (39.07)	24.58 (33.18)
Month 3:Days of part time work(n=16,11,8)	20.06 (28.06)	36.91 (37.77)	36.13 (31.16)
Month 3:Paid work, bothered by RA(n=75,62,38)	31.25 (33.22)	33.15 (30.42)	42.32 (31.88)
Month 3:Chores by housekeeper(n=30,19,10)	26.87 (34.10)	16.58 (26.03)	21.40 (26.42)
Month 3:Chores by family(n=97,92,60)	34.23 (34.27)	30.51 (33.93)	41.92 (36.89)
Month 6:Hospital length of stay(n=8,7,2)	9.63 (7.76)	6.43 (5.03)	13.50 (0.71)
Month 6:Days in nursing home(n=0,0,0)	NA (NA)	NA (NA)	NA (NA)
Month 6:Days aids/devices used(n=23,26,5)	135.04 (104.11)	116.27 (130.92)	129.20 (42.11)
Month 6:RA related aids used(n=24,26,5)	1.79 (1.18)	1.85 (1.43)	1.80 (1.48)
Month 6:Days of work per week(n=92,95,24)	5.15 (1.04)	5.04 (0.94)	4.88 (0.99)
Month 6:Days on sick leave due to RA(n=21,14,4)	27.71 (36.77)	24.43 (31.00)	10.75 (13.45)
Month 6:Days of part time work(n=7,8,2)	35.43 (27.85)	28.00 (36.01)	7.50 (3.54)
Month 6:Paid work, bothered by RA(n=54,46,13)	30.80 (31.45)	31.74 (30.04)	33.31 (30.18)
Month 6:Chores by housekeeper(n=26,13,6)	22.42 (28.69)	20.92 (31.17)	43.50 (41.56)
Month 6:Chores by family(n=78,68,14)	29.53 (31.60)	24.90 (31.36)	33.93 (37.88)

43. 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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	86	84	34	23
Hospital length of stay(n=8,8,1,2)	8.88 (6.73)	12.38 (11.98)	2.00 (NA)	1.50 (0.71)
Days in nursing home(n=4,0,0,0)	19.50 (8.35)	NA (NA)	NA (NA)	NA (NA)
Days aids/devices used(n=19,15,4,5)	111.79 (84.57)	161.40 (382.20)	225.00 (155.88)	62.00 (75.38)
RA related aids used(n=21,16,4,5)	1.19 (1.21)	2.50 (4.76)	2.50 (1.73)	1.80 (1.30)
Days of work per week(n=86,84,34,23)	5.20 (1.03)	5.35 (0.74)	5.00 (1.10)	5.22 (0.80)
Days on sick leave due to RA(n=15,12,1,4)	36.40 (42.27)	13.58 (25.37)	20.00 (NA)	31.00 (41.49)
Days of part time work(n=8,7,1,2)	14.88 (30.48)	6.71 (3.15)	24.00 (NA)	52.50 (53.03)
Paid work, bothered by RA(n=49,53,18,14)	39.08 (35.44)	40.02 (33.50)	40.39 (34.19)	47.57 (39.16)
Chores by housekeeper(n=23,9,0,5)	32.17 (36.69)	17.22 (28.01)	NA (NA)	6.60 (3.29)
Chores by family(n=63,48,14,12)	26.67 (32.49)	24.98 (29.88)	26.43 (32.22)	26.00 (31.05)

44. 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, work done and work missed were reported.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	154	159	79
Baseline:Home healthcare services (n=3,4,2)	4.67 (6.35)	2.75 (2.36)	1.50 (0.71)
Baseline:RA related home HC services(n=3,4,2)	0.67 (0.58)	1.00 (0.82)	0.50 (0.71)
Baseline:Work done(n=110,106,59)	7.84 (2.85)	7.45 (2.27)	7.24 (1.89)
Baseline:Missed work due to RA(n=30,29,12)	4.30 (4.18)	6.24 (16.81)	7.33 (8.07)
Baseline:Chores by housekeeper(n=46,37,18)	4.61 (3.96)	4.62 (2.78)	5.17 (5.15)
Baseline:Chores by family(n=154,159,79)	4.27 (4.81)	3.86 (7.09)	4.30 (5.59)
Month 3:Home healthcare services(n=2,4,2)	1.50 (0.71)	3.25 (2.06)	1.50 (0.71)
Month 3:RA related home HC services(n=2,4,2)	0.00 (0.00)	0.25 (2.50)	1.00 (1.41)
Month 3:Work done(n=104,98,53)	8.99 (7.48)	7.64 (2.20)	8.06 (4.94)
Month 3:Missed work due to RA(n=16,11,8)	3.94 (1.88)	4.18 (2.14)	3.88 (1.13)
Month 3:Chores by housekeeper(n=30,19,10)	4.17 (2.68)	3.74 (3.74)	3.30 (2.00)
Month 3:Chores by family(n=98,89,59)	3.32 (3.30)	2.98 (3.35)	4.97 (5.77)
Month 6:Home healthcare services(n=2,2,0)	17.00 (9.90)	2.00 (1.41)	NA (NA)
Month 6:RA related home HC services(n=2,2,0)	1.00 (1.41)	2.00 (1.41)	NA (NA)
Month 6:Work done(n=92,95,24)	8.12 (1.89)	7.53 (1.72)	8.50 (5.34)
Month 6:Missed work due to RA(n=7,8,1)	4.43 (1.62)	3.38 (1.69)	2.00 (NA)
Month 6:Chores by housekeeper(n=25,13,6)	4.64 (3.01)	5.69 (6.45)	5.17 (3.13)
Month 6:Chores by family(n=77,66,14)	3.73 (3.58)	2.91 (3.30)	4.36 (2.68)

45. 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, work done and work missed were reported.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	85	85	34	24
Home healthcare services(n=1,1,1,0)	1.00 (NA)	2.00 (NA)	1.00 (NA)	NA (NA)
RA related healthcare services(n=1,1,1,0)	0.00 (NA)	2.00 (NA)	1.00 (NA)	NA (NA)
Work done(n=85,85,34,24)	8.60 (4.00)	7.67 (1.77)	8.79 (5.85)	7.38 (1.86)
Missed work due to RA(n=8,7,1,2)	5.00 (6.21)	3.29 (1.80)	0.00 (NA)	4.00 (1.41)
Chores by housekeeper(n=22,9,0,5)	4.86 (2.71)	3.89 (1.96)	NA (NA)	4.40 (2.30)
Chores by family(n=62,47,14,12)	3.24 (3.26)	2.70 (2.22)	2.50 (1.40)	5.92 (8.08)

46. 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 a 0 to 10-point scale, where higher score indicated lower work performance.
Time Frame	Baseline, Month 3, 6

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Arm/Group Title	CP-690,550 5 mg	CP-690,550 10 mg	Placebo
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
Measure Participants	239	238	124
Baseline (n=239, 238, 119)	5.03 (5.89)	4.72 (3.22)	4.55 (3.14)
Month 3 (n= 223, 229, 124)	3.74 (3.04)	3.18 (3.21)	3.97 (3.15)
Month 6 (n= 210, 224, 46)	3.40 (3.06)	2.66 (2.83)	3.24 (2.86)

47. 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 a 0 to 10-point scale, where higher score indicated lower work performance.
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description
FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were 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
Arm/Group Description	CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.	CP-690,550 10 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.	Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
Measure Participants	174	180	50	50
Mean (Standard Deviation) [units on a scale]	2.79 (2.67)	2.52 (2.74)	2.84 (2.13)	3.08 (2.60)

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)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Placebo, Then CP-690,550 5 mg (Month 3 to 6)		Placebo, Then CP-690,550 10 mg (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Placebo, Then CP-690,550 5 mg (Post Month 6)		Placebo, Then CP-690,550 10 mg (Post Month 6)
Time Frame
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)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Placebo, Then CP-690,550 5 mg (Month 3 to 6)		Placebo, Then CP-690,550 10 mg (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Placebo, Then CP-690,550 5 mg (Post Month 6)		Placebo, Then CP-690,550 10 mg (Post Month 6)
Arm/Group Description	CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.		CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.		Matching placebo Film-coated tablet orally twice daily up to Month 3.		CP-690,550 5 mg twice daily from Month 3 to 6.		CP-690,550 10 mg tablet twice daily from Month 3 to 6.		Matching placebo twice daily from Month 3 to 6.		Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.		Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.		CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.		CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.		Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.		Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.
All Cause Mortality
	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	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (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)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Placebo, Then CP-690,550 5 mg (Month 3 to 6)		Placebo, Then CP-690,550 10 mg (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Placebo, Then CP-690,550 5 mg (Post Month 6)		Placebo, Then CP-690,550 10 mg (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	Affected / at Risk (%)	# Events
Total	9/315 (2.9%)		8/318 (2.5%)		6/159 (3.8%)		5/315 (1.6%)		7/318 (2.2%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		7/315 (2.2%)		9/318 (2.8%)		2/79 (2.5%)		0/80 (0%)
Blood and lymphatic system disorders
Thrombocytopenia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Cardiac disorders
Angina pectoris	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Bradycardia	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Cardiac failure acute	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Atrial fibrillation	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Gastrointestinal disorders
Constipation	0/315 (0%)		1/318 (0.3%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Pancreatitis	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Colitis	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Duodenal ulcer haemorrhage	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Peritonitis	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Salivary gland calculus	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
General disorders
Chest pain	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		1/318 (0.3%)		1/79 (1.3%)		0/80 (0%)
Hepatobiliary disorders
Biliary dyskinesia	0/315 (0%)		0/318 (0%)		1/159 (0.6%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Cholecystitis	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Biliary colic	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Bile duct stone	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Cholelithiasis	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Infections and infestations
Bronchitis	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Diabetic foot infection	0/315 (0%)		1/318 (0.3%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Herpes zoster disseminated	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Pneumonia	0/315 (0%)		2/318 (0.6%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Bronchiectasis	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Pulmonary tuberculosis	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Pneumonia cryptococcal	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Injury, poisoning and procedural complications
Tendon rupture	0/315 (0%)		2/318 (0.6%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Foot fracture	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Joint dislocation	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Femur fracture	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Muscle injury	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Tendon injury	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		1/79 (1.3%)		0/80 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/315 (0%)		1/318 (0.3%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Type 2 diabetes mellitus	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/315 (0%)		0/318 (0%)		1/159 (0.6%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Rheumatoid arthritis	1/315 (0.3%)		0/318 (0%)		2/159 (1.3%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Arthralgia	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Fistula	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Foot deformity	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Fracture nonunion	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis	0/315 (0%)		1/318 (0.3%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Thyroid adenoma	0/315 (0%)		1/318 (0.3%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Breast cancer	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Nervous system disorders
Cerebrovascular accident	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Epilepsy	0/315 (0%)		0/318 (0%)		1/159 (0.6%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Amnesia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Syncope	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Transient ischaemic attack	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Reproductive system and breast disorders
Menorrhagia	0/315 (0%)		0/318 (0%)		1/159 (0.6%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Asthma	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		1/315 (0.3%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Pulmonary hypertension	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Respiratory failure	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		1/318 (0.3%)		0/79 (0%)		0/80 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Vascular disorders
Hypotension	1/315 (0.3%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Peripheral vascular disorder	0/315 (0%)		1/318 (0.3%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (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)		CP-690,550 5 mg (Month 3 to 6)		CP-690,550 10 mg (Month 3 to 6)		Placebo (Month 3 to 6)		Placebo, Then CP-690,550 5 mg (Month 3 to 6)		Placebo, Then CP-690,550 10 mg (Month 3 to 6)		CP-690,550 5 mg (Post Month 6)		CP-690,550 10 mg (Post Month 6)		Placebo, Then CP-690,550 5 mg (Post Month 6)		Placebo, Then CP-690,550 10 mg (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	Affected / at Risk (%)	# Events
Total	95/315 (30.2%)		89/318 (28%)		51/159 (32.1%)		69/315 (21.9%)		73/318 (23%)		12/81 (14.8%)		16/38 (42.1%)		18/40 (45%)		32/315 (10.2%)		47/318 (14.8%)		15/79 (19%)		17/80 (21.3%)
Blood and lymphatic system disorders
Anaemia	7/315 (2.2%)		2/318 (0.6%)		3/159 (1.9%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Lymphadenopathy	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		2/318 (0.6%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Leukopenia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		2/315 (0.6%)		1/318 (0.3%)		2/79 (2.5%)		0/80 (0%)
Neutropenia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		2/80 (2.5%)
Eye disorders
Visual impairment	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Gastrointestinal disorders
Diarrhoea	14/315 (4.4%)		10/318 (3.1%)		6/159 (3.8%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		6/315 (1.9%)		1/318 (0.3%)		2/79 (2.5%)		1/80 (1.3%)
Dyspepsia	4/315 (1.3%)		8/318 (2.5%)		2/159 (1.3%)		4/315 (1.3%)		1/318 (0.3%)		0/81 (0%)		1/38 (2.6%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Gastritis	8/315 (2.5%)		6/318 (1.9%)		3/159 (1.9%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Nausea	11/315 (3.5%)		8/318 (2.5%)		4/159 (2.5%)		6/315 (1.9%)		4/318 (1.3%)		1/81 (1.2%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Vomiting	7/315 (2.2%)		2/318 (0.6%)		3/159 (1.9%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Abdominal distension	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Abdominal pain	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		1/318 (0.3%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		2/315 (0.6%)		0/318 (0%)		0/79 (0%)		2/80 (2.5%)
Abdominal pain upper	0/315 (0%)		0/318 (0%)		0/159 (0%)		2/315 (0.6%)		1/318 (0.3%)		1/81 (1.2%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Dental caries	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Dry mouth	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Flatulence	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Gingivitis	0/315 (0%)		0/318 (0%)		0/159 (0%)		2/315 (0.6%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Oesophageal spasm	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
General disorders
Device connection issue	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Oedema peripheral	0/315 (0%)		0/318 (0%)		0/159 (0%)		4/315 (1.3%)		8/318 (2.5%)		1/81 (1.2%)		3/38 (7.9%)		0/40 (0%)		2/315 (0.6%)		2/318 (0.6%)		0/79 (0%)		2/80 (2.5%)
Pyrexia	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		1/318 (0.3%)		0/81 (0%)		3/38 (7.9%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Infections and infestations
Bronchitis	6/315 (1.9%)		3/318 (0.9%)		4/159 (2.5%)		3/315 (1%)		4/318 (1.3%)		3/81 (3.7%)		0/38 (0%)		1/40 (2.5%)		3/315 (1%)		6/318 (1.9%)		2/79 (2.5%)		2/80 (2.5%)
Nasopharyngitis	16/315 (5.1%)		7/318 (2.2%)		12/159 (7.5%)		6/315 (1.9%)		9/318 (2.8%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Pharyngitis	3/315 (1%)		5/318 (1.6%)		5/159 (3.1%)		1/315 (0.3%)		2/318 (0.6%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Upper respiratory tract infection	19/315 (6%)		23/318 (7.2%)		7/159 (4.4%)		13/315 (4.1%)		9/318 (2.8%)		0/81 (0%)		1/38 (2.6%)		3/40 (7.5%)		11/315 (3.5%)		18/318 (5.7%)		3/79 (3.8%)		3/80 (3.8%)
Abscess jaw	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Dermatitis infected	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Gastroenteritis	0/315 (0%)		0/318 (0%)		0/159 (0%)		7/315 (2.2%)		2/318 (0.6%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Genital herpes	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Herpes virus infection	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Oral herpes	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Sinusitis	0/315 (0%)		0/318 (0%)		0/159 (0%)		2/315 (0.6%)		3/318 (0.9%)		2/81 (2.5%)		0/38 (0%)		0/40 (0%)		5/315 (1.6%)		0/318 (0%)		0/79 (0%)		2/80 (2.5%)
Urinary tract infection	0/315 (0%)		0/318 (0%)		0/159 (0%)		5/315 (1.6%)		5/318 (1.6%)		1/81 (1.2%)		1/38 (2.6%)		2/40 (5%)		3/315 (1%)		7/318 (2.2%)		0/79 (0%)		3/80 (3.8%)
Injury, poisoning and procedural complications
Fall	0/315 (0%)		0/318 (0%)		0/159 (0%)		2/315 (0.6%)		3/318 (0.9%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Joint sprain	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		2/318 (0.6%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Overdose	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Procedural vomiting	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Investigations
Alanine aminotransferase increased	6/315 (1.9%)		6/318 (1.9%)		4/159 (2.5%)		1/315 (0.3%)		5/318 (1.6%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Blood creatine phosphokinase increased	0/315 (0%)		0/318 (0%)		0/159 (0%)		3/315 (1%)		5/318 (1.6%)		0/81 (0%)		1/38 (2.6%)		1/40 (2.5%)		3/315 (1%)		7/318 (2.2%)		0/79 (0%)		1/80 (1.3%)
Blood creatinine increased	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Blood potassium increased	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Blood urea increased	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Weight increased	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		0/318 (0%)		1/81 (1.2%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Metabolism and nutrition disorders
Hyperlipidaemia	0/315 (0%)		0/318 (0%)		0/159 (0%)		3/315 (1%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Musculoskeletal and connective tissue disorders
Back pain	4/315 (1.3%)		8/318 (2.5%)		0/159 (0%)		2/315 (0.6%)		3/318 (0.9%)		2/81 (2.5%)		0/38 (0%)		1/40 (2.5%)		3/315 (1%)		2/318 (0.6%)		3/79 (3.8%)		0/80 (0%)
Rheumatoid arthritis	2/315 (0.6%)		2/318 (0.6%)		5/159 (3.1%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Arthralgia	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		5/318 (1.6%)		0/81 (0%)		1/38 (2.6%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Bursitis	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Fibromyalgia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Musculoskeletal pain	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		3/318 (0.9%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Myalgia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Nervous system disorders
Headache	12/315 (3.8%)		10/318 (3.1%)		6/159 (3.8%)		2/315 (0.6%)		5/318 (1.6%)		2/81 (2.5%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		5/318 (1.6%)		2/79 (2.5%)		0/80 (0%)
Migraine	0/315 (0%)		0/318 (0%)		0/159 (0%)		2/315 (0.6%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Psychiatric disorders
Depression	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Insomnia	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	0/315 (0%)		0/318 (0%)		0/159 (0%)		1/315 (0.3%)		2/318 (0.6%)		0/81 (0%)		2/38 (5.3%)		2/40 (5%)		0/315 (0%)		3/318 (0.9%)		2/79 (2.5%)		1/80 (1.3%)
Dyspnoea exertional	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Nasal dryness	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Oropharyngeal pain	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Respiratory disorder	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		1/318 (0.3%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Skin and subcutaneous tissue disorders
Erythema	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Onychoclasis	0/315 (0%)		0/318 (0%)		0/159 (0%)		0/315 (0%)		0/318 (0%)		0/81 (0%)		0/38 (0%)		1/40 (2.5%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)
Rash	0/315 (0%)		0/318 (0%)		0/159 (0%)		3/315 (1%)		0/318 (0%)		2/81 (2.5%)		0/38 (0%)		2/40 (5%)		4/315 (1.3%)		4/318 (1.3%)		1/79 (1.3%)		2/80 (2.5%)
Vascular disorders
Hypertension	4/315 (1.3%)		7/318 (2.2%)		1/159 (0.6%)		3/315 (1%)		4/318 (1.3%)		1/81 (1.2%)		1/38 (2.6%)		0/40 (0%)		0/315 (0%)		0/318 (0%)		0/79 (0%)		0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT00856544

Other Study ID Numbers:

A3921046

First Posted:

Mar 5, 2009

Last Update Posted:

Jan 10, 2013

Last Verified:

Dec 1, 2012