A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For T... | NCT00856544 | Trialant
NCT00856544
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 10, 2013Estimated
Enrollment
795Actual
Phase
Phase 3
Conditions
Arthritis, Rheumatoid
Interventions
CP-690,550
CP-690,550
Placebo
Placebo
Countries
United States
Australia
Chile
China
Colombia
Croatia
Denmark
Finland
Germany
Greece
Malaysia
Mexico
Poland
Russia
Slovakia
Spain
Sweden
Thailand
United Kingdom
Venezuela
Protocol Section
Identification Module
NCT ID
NCT00856544
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A3921046
Secondary IDs
Not provided
Brief Title
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
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
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2009
Primary Completion Date
Jan 2011Actual
Completion Date
Jan 2011Actual
First Submitted Date
Mar 3, 2009
First Submission Date that Met QC Criteria
Mar 3, 2009
First Posted Date
Mar 5, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 6, 2012
Results First Submitted that Met QC Criteria
Dec 6, 2012
Results First Posted Date
Jan 10, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 5, 2012
Certification/Extension First Submitted that Passed QC Review
Nov 5, 2012
Certification/Extension First Posted Date
Nov 7, 2012Estimated
Last Update Submitted Date
Dec 6, 2012
Last Update Posted Date
Jan 10, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Arthritis, Rheumatoid
Keywords
Arthritis
Rheumatoid
Antirheumatic Agents
Clinical Trial
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
795Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Active 5 mg
Experimental
Drug: CP-690,550
Active 10 mg
Experimental
Drug: CP-690,550
Placebo Sequence 1
Placebo Comparator
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
Placebo Sequence 2
Placebo Comparator
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CP-690,550
Drug
Film coated tablet, 5 mg PO BID, 1 year
Active 5 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 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.
Month 6
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Baseline, Month 3
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
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 Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 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.
Other Outcomes
Measure
Description
Time Frame
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
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.
2 weeks
Eligibility Module
Eligibility Criteria
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.
Strand V, Schulze-Koops H, Al-Emadi S, Kinch CD, Gruben D, Germino R, Connell CA, Mysler E. Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension trials. BMJ Open. 2025 Dec 24;15(12):e082366. doi: 10.1136/bmjopen-2023-082366.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 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.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 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.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 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.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 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.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 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.
Month 9, 12
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
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.
Week 2, Month 1, 2, 3, 4.5, 6
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 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.
Month 9, 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 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.
Baseline, Month 3, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at 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.
Month 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
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.
Baseline, Month 3, 6, 12
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 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.
Month 9, Month 12
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Assessment of Arthritis Pain at Month 9 and 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.
Month 9, 12
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 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.
Month 9, 12
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment (PGA) of Arthritis at Month 9 and 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.
Month 9, 12
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 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.
Baseline, Month 1, 3, 6
36-Item Short-Form Health Survey (SF-36) at Month 9 and 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.
Month 9, 12
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 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.
Baseline, Month 1, 3, 6
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 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.
Baseline, Month 1, 3, 6
Medical Outcome Study (MOS) Sleep Scale at 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.
Month 12
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at 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.
Month 12
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 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.
Baseline, Month 1, 3, 6
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at 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.
Month 12
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 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.
Baseline, Month 3, 6
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at 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.
Month 12
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 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]).
Baseline, Month 3, 6
Work Limitations Questionnaire (WLQ) Score at 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]).
Month 12
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, 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.
Baseline, Month 3, 6
Work Productivity and Healthcare Resource Utilization (HCRU) at 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.
Month 12
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Baseline, Month 3, 6
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at 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.
Month 12
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Baseline, Month 3, 6
Number of Days as Assessed Using RA-HCRU at 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.
Month 12
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of 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.
Baseline, Month 3, 6
Number of Hours Per Day as Assessed RA-HCRU at 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.
Month 12
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 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.
Baseline, Month 3, 6
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at 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.
Month 12
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
2 weeks
Jonesboro
Arkansas
72401
United States
Pfizer Investigational Site
Palo Alto
California
94304
United States
Pfizer Investigational Site
Stanford
California
94305
United States
Pfizer Investigational Site
Boulder
Colorado
80304
United States
Pfizer Investigational Site
Denver
Colorado
80206
United States
Pfizer Investigational Site
Danbury
Connecticut
06810
United States
Pfizer Investigational Site
Hamden
Connecticut
06518
United States
Pfizer Investigational Site
Trumbull
Connecticut
06611
United States
Pfizer Investigational Site
New Port Richey
Florida
34652
United States
Pfizer Investigational Site
Ocala
Florida
34474
United States
Pfizer Investigational Site
Plantation
Florida
33324
United States
Pfizer Investigational Site
Port Richey
Florida
34668
United States
Pfizer Investigational Site
Tamarac
Florida
33321
United States
Pfizer Investigational Site
Tampa
Florida
33613
United States
Pfizer Investigational Site
Decatur
Georgia
30033
United States
Pfizer Investigational Site
Marietta
Georgia
30060
United States
Pfizer Investigational Site
Maywood
Illinois
60153
United States
Pfizer Investigational Site
Oakbrook Terrace
Illinois
60181
United States
Pfizer Investigational Site
Rockford
Illinois
61103-3692
United States
Pfizer Investigational Site
Springfield
Illinois
62702
United States
Pfizer Investigational Site
Springfield
Illinois
62703
United States
Pfizer Investigational Site
Vernon Hills
Illinois
60061
United States
Pfizer Investigational Site
Evansville
Indiana
47714
United States
Pfizer Investigational Site
Indianapolis
Indiana
46227
United States
Pfizer Investigational Site
Wichita
Kansas
67203
United States
Pfizer Investigational Site
Lexington
Kentucky
40505
United States
Pfizer Investigational Site
Leominster
Massachusetts
01453
United States
Pfizer Investigational Site
Worcester
Massachusetts
01605
United States
Pfizer Investigational Site
Edina
Minnesota
55435
United States
Pfizer Investigational Site
Lincoln
Nebraska
68516
United States
Pfizer Investigational Site
Albany
New York
12206
United States
Pfizer Investigational Site
Orchard Park
New York
14127
United States
Pfizer Investigational Site
Rochester
New York
14618
United States
Pfizer Investigational Site
Asheville
North Carolina
28801
United States
Pfizer Investigational Site
Charlotte
North Carolina
28210
United States
Pfizer Investigational Site
Bethlehem
Pennsylvania
18015
United States
Pfizer Investigational Site
Wyomissing
Pennsylvania
19610
United States
Pfizer Investigational Site
Greenville
South Carolina
29601
United States
Pfizer Investigational Site
Knoxville
Tennessee
37909
United States
Pfizer Investigational Site
Austin
Texas
78705
United States
Pfizer Investigational Site
Dallas
Texas
75235
United States
Pfizer Investigational Site
Seattle
Washington
98133
United States
Pfizer Investigational Site
Tacoma
Washington
98405-2308
United States
Pfizer Investigational Site
Tacoma
Washington
98405
United States
Pfizer Investigational Site
Clarksburg
West Virginia
26301
United States
Pfizer Investigational Site
Campsie
New South Wales
2194
Australia
Pfizer Investigational Site
Cairns
Queensland
4870
Australia
Pfizer Investigational Site
Maroochydore
Queensland
4558
Australia
Pfizer Investigational Site
Woodville
South Australia
5011
Australia
Pfizer Investigational Site
Malvern East
Victoria
3145
Australia
Pfizer Investigational Site
Shenton Park
Western Australia
6008
Australia
Pfizer Investigational Site
Santiago
RM
7510186
Chile
Pfizer Investigational Site
Santiago
RM
8360156
Chile
Pfizer Investigational Site
Providencia
Santiago, RM
7530206
Chile
Pfizer Investigational Site
Viña del Mar
Valparaiso
2570017
Chile
Pfizer Investigational Site
Viña del Mar
2570017
Chile
Pfizer Investigational Site
Hefei
Anhui
230001
China
Pfizer Investigational Site
Hefei
Anhui
230022
China
Pfizer Investigational Site
Guangzhou
Guangdong
510260
China
Pfizer Investigational Site
Guangzhou
Guangdong
510630
China
Pfizer Investigational Site
Wuhan
Hubei
430030
China
Pfizer Investigational Site
Changsha
Hunan
410008
China
Pfizer Investigational Site
Nanjing
Jiangsu
210029
China
Pfizer Investigational Site
Suzhou
Jiangsu
215006
China
Pfizer Investigational Site
Jinan
Shandong
250012
China
Pfizer Investigational Site
Qingdao
Shandong
266011
China
Pfizer Investigational Site
Xi’an
Shanxi
710032
China
Pfizer Investigational Site
Chengdu
Sichuan
610041
China
Pfizer Investigational Site
Hangzhou
Zhejiang
310009
China
Pfizer Investigational Site
Beijing
100020
China
Pfizer Investigational Site
Beijing
100044
China
Pfizer Investigational Site
Beijing
100853
China
Pfizer Investigational Site
Shanghai
200001
China
Pfizer Investigational Site
Shanghai
200003
China
Pfizer Investigational Site
Shanghai
200433
China
Pfizer Investigational Site
Tianjin
300052
China
Pfizer Investigational Site
Barranquilla
Atlántico
0000
Colombia
Pfizer Investigational Site
Bogota
Cundinamarca
Colombia
Pfizer Investigational Site
Bucaramanga
Santander Department
Colombia
Pfizer Investigational Site
Opatija
51410
Croatia
Pfizer Investigational Site
Zagreb
10000
Croatia
Pfizer Investigational Site
Frederiksberg
2000
Denmark
Pfizer Investigational Site
Helsinki
00120
Finland
Pfizer Investigational Site
Hyvinkää
05800
Finland
Pfizer Investigational Site
Tampere
33520
Finland
Pfizer Investigational Site
Berlin
14059
Germany
Pfizer Investigational Site
Dresden
01067
Germany
Pfizer Investigational Site
Hamburg
22081
Germany
Pfizer Investigational Site
Leipzig
04103
Germany
Pfizer Investigational Site
Nuremberg
90429
Germany
Pfizer Investigational Site
Rheine
48431
Germany
Pfizer Investigational Site
Maroussi Athens
15126
Greece
Pfizer Investigational Site
Putrajaya
Kuala Lumpur
62250
Malaysia
Pfizer Investigational Site
Seremban
Negeri Sembilan
70300
Malaysia
Pfizer Investigational Site
Batu Caves
Selangor
68100
Malaysia
Pfizer Investigational Site
Subang Jaya
Selangor
47500
Malaysia
Pfizer Investigational Site
Torreón
Coahuila
27000
Mexico
Pfizer Investigational Site
Morelia
Michoacán
58249
Mexico
Pfizer Investigational Site
Cuernavaca
Morelos
62270
Mexico
Pfizer Investigational Site
México
Querétaro
76178
Mexico
Pfizer Investigational Site
Mérida
Yucatán
97000
Mexico
Pfizer Investigational Site
Bialystok
15-337
Poland
Pfizer Investigational Site
Bialystok
15-461
Poland
Pfizer Investigational Site
Kościan
64-000
Poland
Pfizer Investigational Site
Poznan
60-773
Poland
Pfizer Investigational Site
Torun
87-100
Poland
Pfizer Investigational Site
Moscow
115093
Russia
Pfizer Investigational Site
Moscow
115446
Russia
Pfizer Investigational Site
Petrozavodsk
185019
Russia
Pfizer Investigational Site
Nové Zámky
94001
Slovakia
Pfizer Investigational Site
Poprad
058 01
Slovakia
Pfizer Investigational Site
Považská Bystrica
017 01
Slovakia
Pfizer Investigational Site
Rimavská Sobota
979 01
Slovakia
Pfizer Investigational Site
Senica
905 01
Slovakia
Pfizer Investigational Site
Žilina
010 01
Slovakia
Pfizer Investigational Site
A Coruña
A Coruña
15006
Spain
Pfizer Investigational Site
Santiago de Compostela
A Coruña
15705
Spain
Pfizer Investigational Site
Madrid
Madrid
28046
Spain
Pfizer Investigational Site
Málaga
Malaga
29009
Spain
Pfizer Investigational Site
Seville
Sevilla
41013
Spain
Pfizer Investigational Site
Falun
791 82
Sweden
Pfizer Investigational Site
Gothenburg
413 46
Sweden
Pfizer Investigational Site
Uppsala
751 85
Sweden
Pfizer Investigational Site
Rajathevee
Bangkok
10400
Thailand
Pfizer Investigational Site
Amphoe Muang
Chiang Mai
50200
Thailand
Pfizer Investigational Site
Muang District
Khonkaen
40002
Thailand
Pfizer Investigational Site
Metropolitan Borough of Wirral
Merseyside
CH49 5PE
United Kingdom
Pfizer Investigational Site
Cannock
Staffs
WS11 2XY
United Kingdom
Pfizer Investigational Site
Solihull
West Midlands
B91 2JL
United Kingdom
Pfizer Investigational Site
Newcastle upon Tyne
NE1 4LP
United Kingdom
Pfizer Investigational Site
Caracas
DC/ Municipio Libertados
1040-A
Venezuela
Pfizer Investigational Site
Caracas
Distrito Federal
1010
Venezuela
Derived
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Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.
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Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.
Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
Dougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478.
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Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x.
Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157.
Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.
Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
Strand V, Kremer JM, Gruben D, Krishnaswami S, Zwillich SH, Wallenstein GV. Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Apr;69(4):592-598. doi: 10.1002/acr.23004.
Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14.
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FG002
Placebo Then CP-690,550 5 mg
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.
FG003
Placebo Then CP-690,550 10 mg
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.
FG000318 subjects
FG001318 subjects
FG00279 subjects
FG00380 subjects
Treated
FG000315 subjects
FG001318 subjects
FG00279 subjects
FG00380 subjects
COMPLETED
FG000261 subjects
FG001252 subjects
FG00271 subjects
FG00367 subjects
NOT COMPLETED
FG00057 subjects
FG00166 subjects
FG0028 subjects
FG00313 subjects
Type
Comment
Reasons
Randomized but not treated
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Death
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Adverse Event
FG00020 subjects
FG00129 subjects
FG0022 subjects
FG0033 subjects
Lack of Efficacy
FG00016 subjects
FG00112 subjects
FG0023 subjects
FG0033 subjects
Other
FG0009 subjects
FG00116 subjects
FG0021 subjects
FG0036 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
Withdrawal by Subject
FG0008 subjects
FG0015 subjects
FG0020 subjects
FG0031 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
BG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
BG002
Placebo Then CP-690,550 5 mg
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.
BG003
Placebo Then CP-690,550 10 mg
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.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000315
BG001318
BG00279
BG00380
BG004792
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00052.7± 11.7
BG00151.9± 11.8
BG00250.8± 11.2
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000264
BG001258
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 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.
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.
Posted
Number
percentage of participants
Month 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Units
Counts
Participants
OG000311
OG001309
OG002157
Title
Denominators
Categories
Title
Measurements
OG00052.73
OG00158.25
OG00231.21
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
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.
Normal approximation
<0.0001
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.
Percent difference
27.04
2-Sided
95
17.94
36.13
No
Superiority or Other
Primary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Primary
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
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.
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.
Posted
Number
percentage of participants
Month 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 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.
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.
Posted
Number
percentage of participants
Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 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.
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.
Posted
Number
percentage of participants
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 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.
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.
Posted
Number
percentage of participants
Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 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.
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.
Posted
Number
percentage of participants
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 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.
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.
Posted
Number
percentage of participants
Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 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.
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.
Posted
Number
percentage of participants
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
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
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.
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.
Posted
Mean
Standard Deviation
units on a scale
Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
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.
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).
Posted
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
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.
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).
Posted
Baseline, Month 3, 6, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 9, Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 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.
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.
Posted
Mean
Standard Deviation
mm
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Patient Assessment of Arthritis Pain at Month 9 and 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.
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.
Posted
Mean
Standard Deviation
mm
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
OG003
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
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.
Posted
Mean
Standard Deviation
mm
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 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.
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.
Posted
Mean
Standard Deviation
mm
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
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.
Posted
Mean
Standard Deviation
mm
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Physician Global Assessment (PGA) of Arthritis at Month 9 and 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.
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.
Posted
Mean
Standard Deviation
mm
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
OG003
Secondary
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
36-Item Short-Form Health Survey (SF-36) at Month 9 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 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.
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.
Posted
Number
participants
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Medical Outcome Study (MOS) Sleep Scale at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at 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.
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.
Posted
Number
participants
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Other Pre-specified
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
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.
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.
Posted
Number
days
2 weeks
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Other Pre-specified
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
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.
Posted
Number
days
2 weeks
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 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]).
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Secondary
Work Limitations Questionnaire (WLQ) Score at 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]).
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
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.
Posted
Mean
Standard Deviation
events
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at 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.
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.
Posted
Mean
Standard Deviation
events
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
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.
Posted
Mean
Standard Deviation
days
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Number of Days as Assessed Using RA-HCRU at 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.
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.
Posted
Mean
Standard Deviation
days
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of 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.
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.
Posted
Mean
Standard Deviation
hours per day
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Number of Hours Per Day as Assessed RA-HCRU at 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.
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.
Posted
Mean
Standard Deviation
hours per day
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo
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.
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at 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.
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.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 12.
OG002
Placebo Then CP-690,550 5 mg
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.
Time Frame
Not provided
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CP-690,550 5 mg (Up To Month 3)
CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.
9
315
95
315
EG001
CP-690,550 10 mg (Up To Month 3)
CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.
8
318
89
318
EG002
Placebo (Up To Month 3)
Matching placebo Film-coated tablet orally twice daily up to Month 3.
6
159
51
159
EG003
CP-690,550 5 mg (Month 3 to 6)
CP-690,550 5 mg twice daily from Month 3 to 6.
5
315
69
315
EG004
CP-690,550 10 mg (Month 3 to 6)
CP-690,550 10 mg tablet twice daily from Month 3 to 6.
7
318
73
318
EG005
Placebo (Month 3 to 6)
Matching placebo twice daily from Month 3 to 6.
0
81
12
81
EG006
Placebo, Then CP-690,550 5 mg (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.
0
38
16
38
EG007
Placebo, Then CP-690,550 10 mg (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.
0
40
18
40
EG008
CP-690,550 5 mg (Post Month 6)
CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
7
315
32
315
EG009
CP-690,550 10 mg (Post Month 6)
CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.
9
318
47
318
EG010
Placebo, Then CP-690,550 5 mg (Post Month 6)
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.
2
79
15
79
EG011
Placebo, Then CP-690,550 10 mg (Post Month 6)
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.
0
80
17
80
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG0030 affected315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
Bradycardia
Cardiac disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0011 affected318 at risk
EG0020 affected159 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Chest pain
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Biliary dyskinesia
Hepatobiliary disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0021 affected159 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Diabetic foot infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0011 affected318 at risk
EG0020 affected159 at risk
EG003
Herpes zoster disseminated
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0012 affected318 at risk
EG0020 affected159 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0012 affected318 at risk
EG0020 affected159 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0011 affected318 at risk
EG0020 affected159 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0021 affected159 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0022 affected159 at risk
EG003
Metastasis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0011 affected318 at risk
EG0020 affected159 at risk
EG003
Thyroid adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0011 affected318 at risk
EG0020 affected159 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0021 affected159 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0021 affected159 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.1
Non-systematic Assessment
EG0001 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0011 affected318 at risk
EG0020 affected159 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Biliary colic
Hepatobiliary disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Bronchiectasis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Fracture nonunion
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Syncope
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Salivary gland calculus
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Pneumonia cryptococcal
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Muscle injury
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0007 affected315 at risk
EG0012 affected318 at risk
EG0023 affected159 at risk
EG0030 affected315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG00014 affected315 at risk
EG00110 affected318 at risk
EG0026 affected159 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0004 affected315 at risk
EG0018 affected318 at risk
EG0022 affected159 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0008 affected315 at risk
EG0016 affected318 at risk
EG0023 affected159 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG00011 affected315 at risk
EG0018 affected318 at risk
EG0024 affected159 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0007 affected315 at risk
EG0012 affected318 at risk
EG0023 affected159 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0006 affected315 at risk
EG0013 affected318 at risk
EG0024 affected159 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG00016 affected315 at risk
EG0017 affected318 at risk
EG00212 affected159 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0003 affected315 at risk
EG0015 affected318 at risk
EG0025 affected159 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG00019 affected315 at risk
EG00123 affected318 at risk
EG0027 affected159 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0006 affected315 at risk
EG0016 affected318 at risk
EG0024 affected159 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0004 affected315 at risk
EG0018 affected318 at risk
EG0020 affected159 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0002 affected315 at risk
EG0012 affected318 at risk
EG0025 affected159 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG00012 affected315 at risk
EG00110 affected318 at risk
EG0026 affected159 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Non-systematic Assessment
EG0004 affected315 at risk
EG0017 affected318 at risk
EG0021 affected159 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Visual impairment
Eye disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Oesophageal spasm
Gastrointestinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Device connection issue
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Oedema peripheral
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Pyrexia
General disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Abscess jaw
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Dermatitis infected
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Blood potassium increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Blood urea increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Weight increased
Investigations
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Migraine
Nervous system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Depression
Psychiatric disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 13.1
Non-systematic Assessment
EG0000 affected315 at risk
EG0010 affected318 at risk
EG0020 affected159 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D001172
Arthritis, Rheumatoid
D001168
Arthritis
Ancestor Terms
ID
Term
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C479163
tofacitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
53.3
± 10.8
BG00452.3± 11.6
63
BG00360
BG004645
Male
BG00051
BG00160
BG00216
BG00320
BG004147
OG000
OG002
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.
Normal Approximation
<0.0001
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.
Percent Difference
21.52
2-Sided
95
12.39
30.65
No
Superiority or Other
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.
Units
Counts
Participants
OG000311
OG001315
OG002157
Title
Denominators
Categories
Baseline (n= 311, 315, 157)
Title
Measurements
OG0001.44± 0.69
OG0011.43± 0.68
OG0021.35± 0.66
Change at Month 3 (n= 292, 292, 147)
Title
Measurements
OG000-0.45± 0.53
OG001-0.54± 0.60
OG002-0.16± 0.54
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
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.
Mixed Models Analysis
<0.0001
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.
LS mean difference
-0.35
Standard Error of the Mean
0.05
2-Sided
95
-0.44
-0.26
No
Superiority or Other
OG000
OG002
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.
Mixed Models Analysis
<0.0001
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.
LS mean difference
-0.26
Standard Error of the Mean
0.05
2-Sided
95
-0.35
-0.16
No
Superiority or Other
Placebo
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.
Units
Counts
Participants
OG000263
OG001270
OG002148
Title
Denominators
Categories
Title
Measurements
OG0009.13
OG00113.33
OG0022.70
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
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.
Normal Approximation
<0.0001
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.
Percent difference
10.63
2-Sided
95
5.80
15.45
No
Superiority or Other
OG000
OG002
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.
Normal Approximation
0.0038
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.
Percent difference
6.42
2-Sided
95
2.07
10.77
No
Superiority or Other
Units
Counts
Participants
OG000311
OG001309
OG002157
Title
Denominators
Categories
Week 2
Title
Measurements
OG00027.33
OG00132.25
OG00210.90
Month 1
Title
Measurements
OG00038.59
OG00148.54
OG00222.93
Month 2
Title
Measurements
OG00054.02
OG00164.40
OG00226.11
Month 3
Title
Measurements
OG00056.27
OG00164.72
OG00227.39
Month 4.5
Title
Measurements
OG00050.80
OG00157.93
OG00225.48
Month 6
Title
Measurements
OG00052.73
OG00158.25
OG00231.21
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000311
OG001309
OG00279
OG00378
Title
Denominators
Categories
Month 9
Title
Measurements
OG00050.48
OG00162.14
OG00237.97
OG00334.62
Month 12
Title
Measurements
OG00051.45
OG00156.63
OG00231.65
OG003
Units
Counts
Participants
OG000311
OG001309
OG002157
Title
Denominators
Categories
Week 2
Title
Measurements
OG0005.79
OG0018.14
OG0021.28
Month 1
Title
Measurements
OG00011.58
OG00118.12
OG0021.27
Month 2
Title
Measurements
OG00023.15
OG00129.77
OG0024.46
Month 3
Title
Measurements
OG00027.33
OG00133.98
OG0029.55
Month 4.5
Title
Measurements
OG00027.97
OG00133.33
OG0028.28
Month 6
Title
Measurements
OG00033.76
OG00136.57
OG00212.74
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000311
OG001309
OG00279
OG00378
Title
Denominators
Categories
Month 9
Title
Measurements
OG00031.51
OG00143.04
OG00225.32
OG00326.92
Month 12
Title
Measurements
OG00033.44
OG00142.72
OG00224.05
OG003
Units
Counts
Participants
OG000311
OG001309
OG002157
Title
Denominators
Categories
Week 2
Title
Measurements
OG0000.32
OG0012.28
OG0020.00
Month 1
Title
Measurements
OG0003.54
OG0017.12
OG0020.00
Month 2
Title
Measurements
OG0009.00
OG00110.36
OG0021.27
Month 3
Title
Measurements
OG0008.36
OG00114.24
OG0021.91
Month 4.5
Title
Measurements
OG00011.90
OG00118.12
OG0023.18
Month 6
Title
Measurements
OG00013.18
OG00116.18
OG0023.18
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000311
OG001309
OG00279
OG00378
Title
Denominators
Categories
Month 9
Title
Measurements
OG00014.15
OG00125.24
OG00210.13
OG00311.54
Month 12
Title
Measurements
OG00019.29
OG00125.57
OG00213.92
OG003
Units
Counts
Participants
OG000312
OG001315
OG002158
Title
Denominators
Categories
Baseline (n=312, 315, 158)
Title
Measurements
OG0005.21± 0.92
OG0015.26± 0.96
OG0025.22± 0.92
Week 2 (n=309, 304, 156)
Title
Measurements
OG0004.41± 1.10
OG0014.18± 1.09
OG0024.92± 1.01
Month 1 (n=304, 300, 151)
Title
Measurements
OG0004.08± 1.13
OG0013.83± 1.12
OG0024.68± 1.09
Month 2 (n=294, 300, 148)
Title
Measurements
OG0003.70± 1.20
OG0013.49± 1.15
OG0024.59± 1.16
Month 3 (n=293, 291, 147)
Title
Measurements
OG0003.62± 1.22
OG0013.44± 1.15
OG0024.51± 1.15
Month 4.5 (n=281,286,71)
Title
Measurements
OG0003.46± 1.27
OG0013.15± 1.12
OG0023.92± 1.18
Month 6 (n=279,278,68)
Title
Measurements
OG0003.39± 1.21
OG0013.09± 1.13
OG0023.60± 1.12
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000267
OG001263
OG00272
OG00368
Title
Denominators
Categories
Month 9
Title
Measurements
OG0003.21± 1.14
OG0012.88± 1.05
OG0023.22± 1.05
OG0032.83± 0.93
Month 12
Title
Measurements
OG0003.08± 1.19
OG0012.81± 1.04
OG0023.03± 1.15
OG003
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.
Units
Counts
Participants
OG000309
OG001313
OG002158
Title
Denominators
Categories
Baseline (n=309,313,158)
Title
Measurements
OG0006.29± 0.96
OG0016.36± 1.01
OG0026.30± 0.92
Month 3 (n=206,263,140)
Title
Measurements
OG0004.41± 1.39
OG0014.20± 1.30
OG0025.32± 1.26
Month 6 (n=241,248,62)
Title
Measurements
OG0004.14± 1.34
OG0013.84± 1.26
OG0024.34± 1.19
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000220
OG001226
OG00263
OG00362
Title
Denominators
Categories
Title
Measurements
OG0003.82± 1.30
OG0013.50± 1.11
OG0023.76± 1.31
OG0033.62± 1.19
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Units
Counts
Participants
OG000311
OG001315
OG002157
Title
Denominators
Categories
Baseline (n = 311, 315, 157)
Title
Measurements
OG0001.44± 0.69
OG0011.43± 0.68
OG0021.35± 0.66
Week 2 (n = 310, 305, 156)
Title
Measurements
OG0001.24± 0.69
OG0011.14± 0.67
OG0021.28± 0.66
Month 1 (n = 304, 303, 154)
Title
Measurements
OG0001.12± 0.67
OG0011.01± 0.65
OG0021.20± 0.67
Month 2 (n = 299, 300, 150)
Title
Measurements
OG0001.03± 0.68
OG0010.93± 0.66
OG0021.20± 0.63
Month 3 (n = 293, 292, 148)
Title
Measurements
OG0000.98± 0.67
OG0010.88± 0.67
OG0021.16± 0.67
Month 4.5 (n = 282, 289, 71)
Title
Measurements
OG0000.97± 0.68
OG0010.84± 0.67
OG0020.95± 0.62
Month 6 (n = 278, 279, 68)
Title
Measurements
OG0000.91± 0.67
OG0010.81± 0.65
OG0020.93± 0.61
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000266
OG001264
OG00272
OG00370
Title
Denominators
Categories
Month 9
Title
Measurements
OG0000.89± 0.68
OG0010.71± 0.64
OG0020.85± 0.65
OG0030.70± 0.64
Month 12
Title
Measurements
OG0000.86± 0.68
OG0010.73± 0.64
OG0020.81± 0.68
OG003
Units
Counts
Participants
OG000311
OG001315
OG002158
Title
Denominators
Categories
Baseline (n = 311, 315, 158)
Title
Measurements
OG00057.08± 23.82
OG00158.58± 22.19
OG00257.11± 22.84
Week 2 (n = 310, 306, 156)
Title
Measurements
OG00046.81± 22.82
OG00141.85± 22.49
OG00251.01± 24.45
Month 1 (n = 304, 303, 154)
Title
Measurements
OG00040.17± 23.20
OG00137.08± 22.14
OG00245.69± 25.00
Month 2 (n = 299, 301, 150)
Title
Measurements
OG00036.40± 22.63
OG00132.84± 21.71
OG00247.30± 24.29
Month 3 (n = 294, 292, 148)
Title
Measurements
OG00034.92± 23.03
OG00132.96± 23.10
OG00246.59± 27.14
Month 4.5 (n = 284, 289, 71)
Title
Measurements
OG00034.43± 22.68
OG00132.62± 21.74
OG00240.23± 24.44
Month 6 (n = 279, 280, 68)
Title
Measurements
OG00031.07± 21.84
OG00129.94± 21.53
OG00234.19± 21.69
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000267
OG001264
OG00272
OG00370
Title
Denominators
Categories
Month 9
Title
Measurements
OG00030.78± 22.28
OG00127.13± 20.77
OG00229.50± 21.34
OG00325.26± 21.96
Month 12
Title
Measurements
OG00030.18± 23.11
OG00125.43± 20.57
OG00228.20± 22.46
OG003
Units
Counts
Participants
OG000311
OG001315
OG002158
Title
Denominators
Categories
Baseline (n=311,315,158)
Title
Measurements
OG00059.03± 22.89
OG00160.22± 22.53
OG00257.92± 23.33
Week 2 (n=310,306,156)
Title
Measurements
OG00046.59± 22.52
OG00142.99± 22.16
OG00251.27± 23.97
Month 1 (n=303,303,154)
Title
Measurements
OG00040.50± 23.29
OG00136.53± 21.42
OG00246.25± 24.22
Month 2 (n=299,301,150)
Title
Measurements
OG00037.18± 22.52
OG00133.80± 22.21
OG00250.42± 23.56
Month 3 (n=294,292,148)
Title
Measurements
OG00036.27± 22.64
OG00133.43± 22.55
OG00247.09± 26.13
Month 4.5 (n=284,289,71)
Title
Measurements
OG00035.92± 22.69
OG00134.05± 22.09
OG00241.03± 23.75
Month 6 (n=279,280,68)
Title
Measurements
OG00033.75± 23.01
OG00131.31± 21.55
OG00235.47± 20.28
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000266
OG001264
OG00272
OG00370
Title
Denominators
Categories
Month 9
Title
Measurements
OG00032.06± 22.49
OG00128.01± 20.81
OG00228.97± 20.07
OG00328.56± 22.74
Month 12
Title
Measurements
OG00030.64± 22.03
OG00127.94± 20.39
OG00228.71± 23.05
OG003
Units
Counts
Participants
OG000310
OG001313
OG002158
Title
Denominators
Categories
Baseline (n=310,313,158)
Title
Measurements
OG00060.48± 17.83
OG00159.66± 17.03
OG00258.87± 16.52
Week 2 (n=308,304,155)
Title
Measurements
OG00046.41± 20.14
OG00143.79± 18.17
OG00249.08± 18.90
Month 1 (n=302,303,154)
Title
Measurements
OG00038.35± 19.92
OG00134.31± 18.70
OG00242.86± 20.13
Month 2 (n=299,299,150)
Title
Measurements
OG00032.54± 19.36
OG00129.40± 17.36
OG00241.25± 20.42
Month 3 (n=293,292,148)
Title
Measurements
OG00031.97± 20.25
OG00129.21± 19.31
OG00239.54± 21.09
Month 4.5 (n=283,288,71)
Title
Measurements
OG00029.45± 19.84
OG00126.11± 17.54
OG00233.04± 21.06
Month 6 (n=278,280,68)
Title
Measurements
OG00025.83± 17.29
OG00123.69± 16.62
OG00227.88± 19.10
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000265
OG001264
OG00272
OG00370
Title
Denominators
Categories
Month 9
Title
Measurements
OG00024.36± 17.67
OG00120.09± 14.23
OG00222.70± 15.42
OG00320.63± 17.35
Month 12
Title
Measurements
OG00021.52± 17.14
OG00118.12± 14.50
OG00219.01± 15.01
OG003
Units
Counts
Participants
OG000312
OG001315
OG002158
Title
Denominators
Categories
Baseline:physical functioning(n=312,315,158)
Title
Measurements
OG00032.53± 9.58
OG00131.74± 9.62
OG00232.76± 9.59
Baseline:role physical(n=312,315,158)
Title
Measurements
OG00033.73± 9.74
OG00133.15± 9.43
OG00233.91± 9.57
Baseline:social functioning(n=312,315,158)
Title
Measurements
OG00036.22± 11.15
OG00137.04± 10.27
OG00236.87± 11.63
Baseline:bodily pain(n=312,315,158)
Title
Measurements
OG00033.38± 7.25
OG00133.94± 7.28
OG00234.22± 7.47
Baseline:mental health(n=312,315,158)
Title
Measurements
OG00039.94± 12.52
OG00141.05± 10.54
OG00241.50± 11.38
Baseline:role emotional(n=312,315,158)
Title
Measurements
OG00035.51± 13.65
OG00134.91± 13.00
OG00235.36± 12.97
Baseline:vitality(n=312,315,158)
Title
Measurements
OG00040.84± 10.29
OG00140.87± 8.89
OG00241.33± 9.37
Baseline:general health(n=312,315,158)
Title
Measurements
OG00033.95± 9.14
OG00134.27± 8.58
OG00234.65± 8.32
Baseline:mental component(n=312,315,158)
Title
Measurements
OG00040.86± 12.59
OG00141.56± 11.14
OG00241.67± 11.57
Baseline:physical component(n=312,315,158)
Title
Measurements
OG00032.44± 7.82
OG00132.02± 7.46
OG00232.74± 7.60
Month 1:physical functioning(n=303,302,154)
Title
Measurements
OG00036.17± 10.33
OG00136.71± 10.08
OG00233.95± 9.72
Month 1:role physical(n=303,301,154)
Title
Measurements
OG00038.20± 10.33
OG00139.00± 9.60
OG00237.15± 9.41
Month 1:social functioning(n=303,302,154)
Title
Measurements
OG00040.25± 10.99
OG00141.96± 9.73
OG00239.29± 9.92
Month 1:bodily pain(n=303,302,154)
Title
Measurements
OG00039.02± 7.86
OG00140.70± 7.69
OG00236.87± 7.14
Month 1:mental health(n=303,302,153)
Title
Measurements
OG00043.40± 11.43
OG00144.70± 10.00
OG00242.79± 11.04
Month 1:role emotional(n=303,301,154)
Title
Measurements
OG00038.36± 12.79
OG00139.27± 11.91
OG00238.18± 12.97
Month 1:vitality(n=303,302,153)
Title
Measurements
OG00045.87± 10.17
OG00146.71± 8.76
OG00243.74± 9.00
Month 1:general health(n=303,302,154)
Title
Measurements
OG00037.86± 9.45
OG00138.81± 8.65
OG00236.39± 8.35
Month 1:mental component(n=303,301,153)
Title
Measurements
OG00044.04± 11.64
OG00145.32± 10.13
OG00243.80± 11.22
Month 1:physical component(n=303,301,153)
Title
Measurements
OG00037.12± 8.31
OG00137.94± 7.96
OG00234.86± 7.48
Month 3:physical functioning(n=294,291,147)
Title
Measurements
OG00037.15± 10.47
OG00138.29± 10.60
OG00234.35± 10.42
Month 3:role physical(n=294,292,147)
Title
Measurements
OG00039.25± 9.91
OG00140.57± 9.69
OG00236.50± 9.76
Month 3:social functioning(n=294,292,147)
Title
Measurements
OG00041.51± 10.46
OG00142.44± 9.92
OG00238.62± 11.04
Month 3:bodily pain(n=294,292,147)
Title
Measurements
OG00040.22± 8.24
OG00141.82± 8.70
OG00237.50± 8.26
Month 3:mental health(n=294,292,147)
Title
Measurements
OG00044.69± 10.45
OG00145.15± 10.28
OG00242.68± 10.88
Month 3:role emotional(n=293,291,146)
Title
Measurements
OG00038.36± 11.98
OG00139.81± 12.04
OG00237.42± 13.23
Month 3:vitality(n=294,292,147)
Title
Measurements
OG00047.05± 9.71
OG00147.22± 9.05
OG00243.84± 9.68
Month 3:general health(n=294,291,147)
Title
Measurements
OG00038.98± 9.69
OG00139.45± 9.19
OG00235.56± 9.37
Month 3:mental component(n=293,290,146)
Title
Measurements
OG00044.96± 10.75
OG00145.35± 10.26
OG00243.10± 11.12
Month 3:physical component(n=293,290,146)
Title
Measurements
OG00038.26± 8.46
OG00139.53± 8.58
OG00234.90± 8.37
Month 6:physical functioning(n=279,280,68)
Title
Measurements
OG00038.55± 10.60
OG00139.42± 10.38
OG00238.18± 9.63
Month 6:role physical(n=279,279,68)
Title
Measurements
OG00039.86± 9.82
OG00141.02± 9.41
OG00240.27± 8.86
Month 6:social functioning(n=279,280,68)
Title
Measurements
OG00041.97± 10.22
OG00143.36± 10.01
OG00243.67± 9.96
Month 6:bodily pain(n=279,280,68)
Title
Measurements
OG00041.01± 8.17
OG00142.12± 8.45
OG00241.91± 7.74
Month 6:mental health(n=279,280,68)
Title
Measurements
OG00044.43± 10.26
OG00145.01± 10.27
OG00244.12± 10.13
Month 6:role emotional(n=279,279,68)
Title
Measurements
OG00039.37± 12.11
OG00140.49± 11.79
OG00239.81± 12.38
Month 6:vitality(n=279,280,68)
Title
Measurements
OG00047.02± 9.82
OG00147.80± 9.55
OG00246.67± 8.93
Month 6:general health(n=279,280,68)
Title
Measurements
OG00040.03± 9.51
OG00139.71± 9.17
OG00238.10± 9.05
Month 6:mental component(n=279,279,68)
Title
Measurements
OG00044.73± 10.59
OG00145.63± 10.29
OG00245.13± 11.02
Month 6:physical component(n=279,279,68)
Title
Measurements
OG00039.49± 8.64
OG00140.24± 8.43
OG00239.24± 7.19
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.
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000267
OG001264
OG00272
OG00370
Title
Denominators
Categories
Month 9:physical functioning(n=267,263,72,70)
Title
Measurements
OG00039.40± 10.60
OG00140.67± 10.12
OG00238.86± 10.47
OG00340.83± 9.76
Month 9:role physical(n=267,263,72,70)
Title
Measurements
OG00040.21± 9.99
OG00142.03± 9.05
OG00241.44± 9.70
OG003
Month 9:social functioning(n=267,264,72,70)
Title
Measurements
OG00042.43± 9.97
OG00143.67± 9.60
OG00243.26± 11.23
OG003
Month 9:bodily pain(n=267,264,72,70)
Title
Measurements
OG00041.83± 8.89
OG00143.37± 8.45
OG00242.31± 8.42
OG003
Month 9:mental health(n=267,264,72,70)
Title
Measurements
OG00045.49± 10.69
OG00146.03± 10.67
OG00246.12± 10.49
OG003
Month 9:role emotional(n=267,264,72,70)
Title
Measurements
OG00040.55± 11.54
OG00142.16± 11.43
OG00240.75± 12.67
OG003
Month 9:vitality(n=267,264,72,70)
Title
Measurements
OG00048.39± 9.53
OG00148.70± 9.41
OG00248.38± 8.71
OG003
Month 9:general health(n=266,264,72,70)
Title
Measurements
OG00039.77± 9.63
OG00140.57± 9.29
OG00240.38± 9.04
OG003
Month 9:mental component(n=266,262,72,70)
Title
Measurements
OG00045.97± 10.45
OG00146.61± 10.74
OG00246.42± 11.01
OG003
Month 9:physical component(n=266,262,72,70)
Title
Measurements
OG00039.79± 8.60
OG00141.15± 8.15
OG00240.07± 7.97
OG003
Month 12:physical functioning(n=258, 250,70,67)
Title
Measurements
OG00039.07± 11.18
OG00140.38± 10.24
OG00238.61± 11.38
OG003
Month 12:role physical(n=258, 250,70,67)
Title
Measurements
OG00040.51± 9.99
OG00142.11± 9.31
OG00242.51± 9.72
OG003
Month 12:social functioning(n=258, 250,70,67)
Title
Measurements
OG00042.69± 10.14
OG00143.63± 9.71
OG00244.27± 9.72
OG003
Month 12:bodily pain(n=258, 250,70,67)
Title
Measurements
OG00041.95± 8.77
OG00143.28± 8.70
OG00242.59± 9.07
OG003
Month 12:mental health(n=258, 250,70,67)
Title
Measurements
OG00044.86± 10.63
OG00145.52± 10.27
OG00246.10± 10.81
OG003
Month 12:role emotional(n=258, 250,70,67)
Title
Measurements
OG00040.02± 12.10
OG00141.37± 11.79
OG00242.92± 11.80
OG003
Month 12:vitality(n=258, 250,70,67)
Title
Measurements
OG00048.08± 9.83
OG00148.12± 9.22
OG00249.77± 9.52
OG003
Month 12:general health(n=258, 250,70,67)
Title
Measurements
OG00039.63± 9.64
OG00139.88± 8.88
OG00240.86± 9.34
OG003
Month 12:mental component(n=258, 250,70,67)
Title
Measurements
OG00045.39± 10.69
OG00145.92± 10.65
OG00247.84± 11.04
OG003
Month 12:physical component(n=258, 250,70,67)
Title
Measurements
OG00039.94± 8.83
OG00141.13± 8.13
OG00240.16± 9.14
OG003
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.
Units
Counts
Participants
OG000312
OG001314
OG002158
Title
Denominators
Categories
Baseline:overall sleep problem(n=312,313,158)
Title
Measurements
OG00041.05± 20.68
OG00140.89± 18.47
OG00239.75± 18.25
Baseline:sleep problem summary(n=312,314,158)
Title
Measurements
OG00039.51± 21.22
OG00140.08± 19.02
OG00237.87± 18.37
Baseline:somnolence(n=312,314,158)
Title
Measurements
OG00034.38± 21.95
OG00136.09± 21.59
OG00234.94± 17.94
Baseline:snoring(n=310,314,157)
Title
Measurements
OG00032.26± 30.31
OG00131.27± 31.27
OG00233.76± 32.09
Baseline:quantity(n=312,313,158)
Title
Measurements
OG0006.88± 2.13
OG0016.72± 1.55
OG0026.82± 1.51
Baseline:sleep disturbance(n=312,313,158)
Title
Measurements
OG00044.39± 26.68
OG00141.58± 24.61
OG00241.20± 25.42
Baseline:awaken short of breath(n=312,314,158)
Title
Measurements
OG00018.91± 24.38
OG00119.81± 24.38
OG00217.34± 21.78
Baseline:adequacy(n=312,314,158)
Title
Measurements
OG00047.56± 28.78
OG00144.97± 26.89
OG00246.84± 25.69
Month 1:overall sleep problem(n=301,301,154)
Title
Measurements
OG00036.51± 19.94
OG00134.77± 17.79
OG00237.09± 18.02
Month 1:sleep problem summary(n=301,301,154)
Title
Measurements
OG00035.87± 20.50
OG00134.45± 17.94
OG00235.95± 18.32
Month 1:somnolence(n=301,302,154)
Title
Measurements
OG00031.58± 21.01
OG00130.49± 20.05
OG00233.33± 19.02
Month 1:snoring(n=300,302,153)
Title
Measurements
OG00029.87± 29.33
OG00128.74± 30.29
OG00232.03± 29.68
Month 1:quantity(n=301,301,154)
Title
Measurements
OG0006.90± 1.54
OG0017.02± 1.55
OG0026.81± 1.54
Month 1:sleep disturbance(n=301,302,154)
Title
Measurements
OG00038.43± 26.01
OG00134.64± 24.20
OG00237.42± 24.86
Month 1:awaken short of breath(n=301,301,154)
Title
Measurements
OG00018.34± 23.41
OG00117.21± 21.91
OG00214.94± 20.01
Month 1:adequacy(n=301,302,154)
Title
Measurements
OG00052.92± 27.91
OG00151.52± 26.23
OG00249.16± 23.51
Month 3:overall sleep problem(n=292,292,146)
Title
Measurements
OG00035.10± 18.58
OG00134.06± 17.33
OG00238.66± 17.32
Month 3:sleep problem summary(n=292,292,146)
Title
Measurements
OG00034.41± 19.04
OG00133.80± 17.65
OG00237.97± 17.21
Month 3:somnolence(n=292,292,146)
Title
Measurements
OG00030.07± 19.89
OG00128.90± 18.75
OG00235.43± 20.29
Month 3:snoring(n=290,292,144)
Title
Measurements
OG00031.31± 29.56
OG00131.78± 30.23
OG00231.81± 29.77
Month 3:quantity(n=293,292,147)
Title
Measurements
OG0006.87± 1.54
OG0016.96± 1.46
OG0026.76± 1.55
Month 3:sleep disturbance(n=292,292,146)
Title
Measurements
OG00036.67± 23.98
OG00133.69± 23.01
OG00237.77± 24.18
Month 3:awaken short of breath(n=292,292,146)
Title
Measurements
OG00019.38± 24.67
OG00117.26± 21.19
OG00218.08± 21.57
Month 3:adequacy(n=292,292,146)
Title
Measurements
OG00054.66± 27.42
OG00151.58± 26.71
OG00245.82± 25.54
Month 6:overall sleep problem(n=277,280,68)
Title
Measurements
OG00033.92± 19.36
OG00133.11± 16.94
OG00234.87± 18.29
Month 6:sleep problem summary(n=277,280,68)
Title
Measurements
OG00033.26± 19.87
OG00133.30± 17.17
OG00234.85± 18.81
Month 6:somnolence(n=277,280,68)
Title
Measurements
OG00031.12± 20.03
OG00129.81± 18.23
OG00230.29± 19.19
Month 6:snoring(n=271,280,68)
Title
Measurements
OG00031.14± 28.98
OG00132.07± 29.21
OG00231.47± 29.79
Month 6:quantity(n=278,279,68)
Title
Measurements
OG0006.86± 1.52
OG0016.94± 1.42
OG0026.82± 1.41
Month 6:sleep disturbance(n=277,280,68)
Title
Measurements
OG00034.48± 24.11
OG00131.33± 21.96
OG00234.78± 24.36
Month 6:awaken short of breath(n=277,280,68)
Title
Measurements
OG00017.62± 19.89
OG00117.57± 20.87
OG00217.06± 24.98
Month 6:adequacy(n=277,280,68)
Title
Measurements
OG00054.40± 28.34
OG00151.64± 26.36
OG00250.29± 26.76
Units
Counts
Participants
OG000312
OG001315
OG002158
Title
Denominators
Categories
Baseline (n=312,315,158)
Title
Measurements
OG000139
OG001139
OG00270
Month 1 (n=305,303,155)
Title
Measurements
OG000155
OG001145
OG00272
Month 3 (n=294,292,147)
Title
Measurements
OG000139
OG001152
OG00265
Month 6 (n=278,280,145)
Title
Measurements
OG000142
OG001143
OG00266
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000258
OG001249
OG00270
OG00366
Title
Denominators
Categories
Overall sleep problem
Title
Measurements
OG00034.17± 18.71
OG00132.24± 17.13
OG00231.74± 17.41
OG00333.58± 17.44
Sleep problem summary
Title
Measurements
OG00033.71± 19.11
OG00132.58± 17.42
OG00230.95± 17.09
OG003
Somnolence
Title
Measurements
OG00029.30± 19.09
OG00127.93± 17.70
OG00230.86± 21.18
OG003
Snoring
Title
Measurements
OG00030.32± 28.59
OG00132.37± 29.70
OG00231.43± 31.13
OG003
Quantity
Title
Measurements
OG0006.94± 1.51
OG0017.04± 1.30
OG0026.83± 1.36
OG003
Sleep disturbance
Title
Measurements
OG00034.78± 24.31
OG00131.75± 21.95
OG00229.41± 24.04
OG003
Awaken short of breath
Title
Measurements
OG00019.77± 24.38
OG00117.19± 21.25
OG00217.71± 19.42
OG003
Adequacy
Title
Measurements
OG00054.38± 26.14
OG00153.29± 25.26
OG00255.00± 25.01
OG003
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000258
OG001250
OG00270
OG00367
Title
Denominators
Categories
Title
Measurements
OG000134
OG001144
OG00237
OG00336
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.
Units
Counts
Participants
OG000312
OG001314
OG002158
Title
Denominators
Categories
Baseline (n=312,314,158)
Title
Measurements
OG00029.01± 11.01
OG00128.65± 9.49
OG00229.72± 8.97
Month 1 (n=301,302,153)
Title
Measurements
OG00033.16± 10.75
OG00133.94± 8.91
OG00231.78± 9.58
Month 3 (n=294,292,147)
Title
Measurements
OG00034.38± 10.07
OG00134.99± 9.20
OG00231.41± 9.95
Month 6 (n=277,280,68)
Title
Measurements
OG00035.14± 9.91
OG00135.01± 9.45
OG00235.24± 9.30
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000258
OG001249
OG00270
OG00367
Title
Denominators
Categories
Title
Measurements
OG00035.02± 9.83
OG00136.34± 9.15
OG00236.93± 9.19
OG00336.07± 9.64
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.
Units
Counts
Participants
OG000311
OG001314
OG002158
Title
Denominators
Categories
Baseline (n=311,314,158)
Title
Measurements
OG0000.46± 0.31
OG0010.48± 0.29
OG0020.51± 0.27
Month 3 (n=294,291,147)
Title
Measurements
OG0000.63± 0.24
OG0010.68± 0.24
OG0020.56± 0.28
Month 6 (n=277,280,68)
Title
Measurements
OG0000.66± 0.23
OG0010.70± 0.21
OG0020.65± 0.20
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000258
OG001249
OG00270
OG00367
Title
Denominators
Categories
Title
Measurements
OG0000.68± 0.23
OG0010.70± 0.21
OG0020.66± 0.24
OG0030.69± 0.23
Units
Counts
Participants
OG00051
OG00154
OG00233
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
Units
Counts
Participants
OG00051
OG00154
OG00233
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0023
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.
Units
Counts
Participants
OG000164
OG001163
OG00290
Title
Denominators
Categories
Baseline:time management(n=152,149,80)
Title
Measurements
OG00047.13± 27.40
OG00146.05± 27.83
OG00239.98± 24.44
Baseline:physical demands(n=154,154,86)
Title
Measurements
OG00048.08± 25.92
OG00150.83± 25.34
OG00251.88± 24.98
Baseline:mental demands(n=158,154,83)
Title
Measurements
OG00036.58± 26.35
OG00135.86± 25.72
OG00230.31± 24.19
Baseline:output demands(n=153,149,79)
Title
Measurements
OG00041.93± 27.66
OG00138.76± 28.34
OG00232.72± 25.35
Baseline:work loss index(n=164,163,90)
Title
Measurements
OG00011.25± 6.04
OG00110.76± 6.16
OG0029.22± 5.28
Month 3:time management(n=139,131,69)
Title
Measurements
OG00038.56± 30.11
OG00137.39± 30.53
OG00236.99± 28.24
Month 3:physical demands(n=135, 32,66)
Title
Measurements
OG00043.14± 26.03
OG00145.07± 30.63
OG00252.78± 24.73
Month 3:mental demands(n=142,136,72)
Title
Measurements
OG00030.43± 27.99
OG00131.60± 29.49
OG00228.15± 23.69
Month 3:output demands(n=136,132,68)
Title
Measurements
OG00032.23± 27.77
OG00133.43± 30.58
OG00227.33± 24.32
Month 3:work loss index(n=145,138,73)
Title
Measurements
OG0009.29± 6.32
OG0019.64± 7.10
OG0028.77± 5.47
Month 6:time management(n=112,108,27)
Title
Measurements
OG00034.43± 28.40
OG00135.73± 31.85
OG00233.77± 31.88
Month 6:physical demands(n=114,110,24)
Title
Measurements
OG00048.72± 29.30
OG00141.75± 30.91
OG00248.13± 32.45
Month 6:mental demands(n=115,112,27)
Title
Measurements
OG00025.94± 26.35
OG00127.98± 28.18
OG00222.34± 26.57
Month 6:output demands(n=111,111,26)
Title
Measurements
OG00028.92± 26.55
OG00128.98± 28.12
OG00229.52± 29.09
Month 6:work loss index(n=116,114,28)
Title
Measurements
OG0008.73± 6.26
OG0018.71± 6.64
OG0028.03± 6.64
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.
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000108
OG001101
OG00238
OG00332
Title
Denominators
Categories
Time management(n=105,98,35,31)
Title
Measurements
OG00037.01± 30.03
OG00135.29± 31.80
OG00230.82± 29.59
OG00336.57± 30.80
Physical demands(n=105,97,36,28)
Title
Measurements
OG00044.15± 27.91
OG00142.41± 31.59
OG00247.15± 30.40
OG003
Mental demands(n=108,100,36,32)
Title
Measurements
OG00027.27± 26.33
OG00127.42± 27.56
OG00220.70± 26.37
OG003
Output demands(n=105,95,35,29)
Title
Measurements
OG00026.75± 25.54
OG00125.67± 27.25
OG00222.54± 25.05
OG003
Work loss index(n=108,101,38,32)
Title
Measurements
OG0008.65± 6.12
OG0018.28± 6.59
OG0027.06± 5.81
OG003
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.
Units
Counts
Participants
OG000307
OG001313
OG002154
Title
Denominators
Categories
Baseline:Seen any doctor(n=307,312,153)
Title
Measurements
OG0001.13± 0.34
OG0011.11± 0.32
OG0021.16± 0.37
Baseline:Treated in emergency room(n=307,313,154)
Title
Measurements
OG0001.94± 0.24
OG0011.94± 0.23
OG0021.95± 0.22
Baseline:Admitted for overnight stay(n=19,18,8)
Title
Measurements
OG0000.16± 0.37
OG0010.22± 0.43
OG0020.50± 0.93
Baseline:Hospitalization(n=307,313,154)
Title
Measurements
OG0001.95± 0.22
OG0011.93± 0.26
OG0021.94± 0.24
Baseline:Outpatient surgery(n=307,312,154)
Title
Measurements
OG0001.97± 0.16
OG0011.98± 0.14
OG0021.94± 0.24
Baseline:Non-study diagnostic test(n=307,312,154)
Title
Measurements
OG0001.85± 0.35
OG0011.87± 0.33
OG0021.86± 0.35
Baseline:In nursing home(n=307,312,154)
Title
Measurements
OG0002.00± 0.06
OG0011.99± 0.08
OG0021.99± 0.11
Baseline:Home healthcare services(n=307,312,154)
Title
Measurements
OG0001.99± 0.10
OG0011.99± 0.11
OG0021.99± 0.11
Baseline:Required aids/devices(n=307,311,154)
Title
Measurements
OG0001.88± 0.33
OG0011.87± 0.34
OG0021.88± 0.33
Baseline:Non-medical practitioner(n=307,312,154)
Title
Measurements
OG0001.96± 0.20
OG0011.98± 0.14
OG0021.98± 0.14
Baseline:Currently employed(n=307,312,154)
Title
Measurements
OG0001.64± 0.48
OG0011.66± 0.47
OG0021.62± 0.49
Baseline:Feel well enough to work(n=121,122,57)
Title
Measurements
OG0001.88± 0.33
OG0011.89± 0.32
OG0021.79± 0.41
Baseline:Unable to work due to RA(n=122,129,55)
Title
Measurements
OG0001.34± 0.48
OG0011.25± 0.43
OG0021.42± 0.50
Baseline:Lost job/retired early(n=121,116,54)
Title
Measurements
OG0001.64± 0.48
OG0011.47± 0.50
OG0021.50± 0.50
Baseline:Work disabled due to RA(n=126,120,53)
Title
Measurements
OG0001.50± 0.50
OG0011.34± 0.48
OG0021.47± 0.50
Baseline:Retired(n=132,133,59)
Title
Measurements
OG0001.50± 0.50
OG0011.41± 0.49
OG0021.41± 0.50
Baseline:Sick leave due to RA(n=286,278,145)
Title
Measurements
OG0001.75± 0.43
OG0011.78± 0.41
OG0021.81± 0.39
Baseline:Performed part time work(n=285,278,143)
Title
Measurements
OG0001.89± 0.31
OG0011.89± 0.31
OG0021.92± 0.28
Baseline:Performed paid work(n=287,277,144)
Title
Measurements
OG0001.67± 0.47
OG0011.66± 0.47
OG0021.66± 0.48
Baseline:Unable to do chores(n=305,307,153)
Title
Measurements
OG0001.44± 0.50
OG0011.48± 0.50
OG0021.44± 0.50
Baseline:Chores by housekeeper(n=306,312,154)
Title
Measurements
OG0001.85± 0.36
OG0011.88± 0.32
OG0021.88± 0.32
Baseline:Chores by family/friends(n=306,312,154)
Title
Measurements
OG0001.49± 0.50
OG0011.49± 0.50
OG0021.48± 0.50
Month 3:Seen any doctor(n=290,291,146)
Title
Measurements
OG0001.38± 0.49
OG0011.41± 0.49
OG0021.36± 0.48
Month 3:Treated in emergency room(n=290,291,146)
Title
Measurements
OG0001.96± 0.20
OG0011.98± 0.15
OG0021.96± 0.20
Month 3:Admitted for overnight stay(n=12,7,6)
Title
Measurements
OG0000.25± 0.62
OG0010.14± 0.38
OG0020.33± 0.82
Month 3:Hospitalization(n=288,291,146)
Title
Measurements
OG0001.99± 0.12
OG0011.99± 0.12
OG0021.97± 0.16
Month 3:Outpatient surgery(n=290,291,146)
Title
Measurements
OG0001.98± 0.14
OG0011.98± 0.13
OG0021.96± 0.20
Month 3:Non-study diagnostic test(n=288,291,146)
Title
Measurements
OG0001.91± 0.29
OG0011.91± 0.29
OG0021.90± 0.30
Month 3:In nursing home(n=290,291,146)
Title
Measurements
OG0002.00± 0.06
OG0011.99± 0.08
OG0022.00± 0.00
Month 3:Home healthcare services(n=289,291,146)
Title
Measurements
OG0001.99± 0.08
OG0011.99± 0.12
OG0021.99± 0.12
Month 3:Required aids/devices(n=288,291,146)
Title
Measurements
OG0001.91± 0.28
OG0011.91± 0.29
OG0021.81± 0.40
Month 3:Non-medical practitioner(n=290,291,146)
Title
Measurements
OG0001.98± 0.14
OG0011.98± 0.14
OG0021.99± 0.08
Month 3:Currently employed(n=289,291,146)
Title
Measurements
OG0001.64± 0.48
OG0011.66± 0.48
OG0021.63± 0.48
Month 3:Feel well enough to work(n=107,130,47)
Title
Measurements
OG0001.81± 0.39
OG0011.75± 0.44
OG0021.79± 0.41
Month 3:Unable to work due to RA(n=108,124,50)
Title
Measurements
OG0001.43± 0.50
OG0011.49± 0.50
OG0021.46± 0.50
Month 3:Lost job/retired early(n=109,125,49)
Title
Measurements
OG0001.58± 0.50
OG0011.61± 0.49
OG0021.55± 0.50
Month 3:Work disabled due to RA(n=108,123,47)
Title
Measurements
OG0001.49± 0.50
OG0011.54± 0.50
OG0021.51± 0.51
Month 3:Retired(n=132,129,57)
Title
Measurements
OG0001.45± 0.50
OG0011.44± 0.50
OG0021.39± 0.49
Month 3:Sick leave due to RA(n=265,266,139)
Title
Measurements
OG0001.88± 0.32
OG0011.91± 0.28
OG0021.83± 0.38
Month 3:Performed part time work(n=264,265,139)
Title
Measurements
OG0001.94± 0.24
OG0011.96± 0.20
OG0021.94± 0.23
Month 3:Performed paid work(n=265,266,139)
Title
Measurements
OG0001.72± 0.45
OG0011.77± 0.42
OG0021.72± 0.45
Month 3:Unable to do chores(n=284,286,147)
Title
Measurements
OG0001.65± 0.48
OG0011.71± 0.46
OG0021.57± 0.50
Month 3:Chores by housekeeper(n=289,290,146)
Title
Measurements
OG0001.90± 0.31
OG0011.93± 0.25
OG0021.93± 0.25
Month 3:Chores by family/friends(n=288,290,146)
Title
Measurements
OG0001.65± 0.48
OG0011.68± 0.47
OG0021.59± 0.49
Month 6:Seen any doctor(n=275,279,68)
Title
Measurements
OG0001.40± 0.49
OG0011.37± 0.48
OG0021.43± 0.50
Month 6:Treated in emergency room(n=275,279,68)
Title
Measurements
OG0001.95± 0.21
OG0011.98± 0.15
OG0021.97± 0.17
Month 6:Admitted for overnight stay (n=13,5,2)
Title
Measurements
OG0000.62± 0.87
OG0010.40± 0.89
OG0020.00± 0.00
Month 6:Hospitalization(n=274,279,68)
Title
Measurements
OG0001.97± 0.17
OG0011.97± 0.16
OG0022.00± 0.00
Month 6:Outpatient surgery(n=275,279,68)
Title
Measurements
OG0001.98± 0.13
OG0011.98± 0.13
OG0021.93± 0.26
Month 6:Non-study diagnostic test(n=274,279,68)
Title
Measurements
OG0001.91± 0.29
OG0011.93± 0.25
OG0021.85± 0.36
Month 6:In nursing home(n=275,279,68)
Title
Measurements
OG0002.00± 0.00
OG0012.00± 0.00
OG0022.00± 0.00
Month 6:Home healthcare services(n=273,278,68)
Title
Measurements
OG0001.99± 0.09
OG0011.99± 0.08
OG0022.00± 0.00
Month 6:Required aids/devices(n=274,278,68)
Title
Measurements
OG0001.91± 0.28
OG0011.91± 0.29
OG0021.93± 0.26
Month 6:Non-medical practitioner(n=275,279,68)
Title
Measurements
OG0001.99± 0.10
OG0012.00± 0.06
OG0022.00± 0.00
Month 6:Currently employed(n=274,279,68)
Title
Measurements
OG0001.65± 0.48
OG0011.66± 0.47
OG0021.65± 0.48
Month 6:Feel well enough to work(n=117,129,25)
Title
Measurements
OG0001.80± 0.40
OG0011.71± 0.46
OG0021.72± 0.46
Month 6:Unable to work due to RA(n=121,126,23)
Title
Measurements
OG0001.45± 0.50
OG0011.49± 0.50
OG0021.43± 0.51
Month 6:Lost job/retired early(n=118,125,23)
Title
Measurements
OG0001.63± 0.49
OG0011.57± 0.50
OG0021.52± 0.51
Month 6:Work disabled due to RA(n=117,125,23)
Title
Measurements
OG0001.53± 0.50
OG0011.57± 0.50
OG0021.65± 0.49
Month 6:Retired(n=129,136,30)
Title
Measurements
OG0001.47± 0.50
OG0011.50± 0.50
OG0021.47± 0.51
Month 6:Sick leave due to RA(n=250,255,59)
Title
Measurements
OG0001.92± 0.28
OG0011.95± 0.23
OG0021.93± 0.52
Month 6:Performed part time work(n=250,255,59)
Title
Measurements
OG0001.97± 0.17
OG0011.97± 0.17
OG0021.98± 0.13
Month 6:Performed paid work(n=249,255,59)
Title
Measurements
OG0001.78± 0.41
OG0011.81± 0.39
OG0021.76± 0.43
Month 6:Unable to do chores(n=269,276,67)
Title
Measurements
OG0001.70± 0.46
OG0011.73± 0.45
OG0021.69± 0.47
Month 6:Chores by housekeeper(n=275,277,68)
Title
Measurements
OG0001.90± 0.30
OG0011.95± 0.22
OG0021.91± 0.29
Month 6:Chores by family/friends(n=274,277,68)
Title
Measurements
OG0001.71± 0.46
OG0011.75± 0.43
OG0021.79± 0.41
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.
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000254
OG001246
OG00270
OG00366
Title
Denominators
Categories
Seen any doctor(n=254,243,70,66)
Title
Measurements
OG0001.48± 0.50
OG0011.44± 0.50
OG0021.40± 0.49
OG0031.50± 0.50
Treated in ER(n=254,246,70,67)
Title
Measurements
OG0001.95± 0.22
OG0011.95± 0.22
OG0021.91± 0.28
OG003
Admitted for overnight stay (n=13,12,6,5)
Title
Measurements
OG0000.23± 0.60
OG0010.25± 0.62
OG0020.33± 0.82
OG003
Hospitalization(n=254,246,70,67)
Title
Measurements
OG0001.97± 0.17
OG0011.97± 0.16
OG0021.99± 0.16
OG003
Had outpatient surgery(n=253,246,70,67)
Title
Measurements
OG0001.97± 0.18
OG0011.98± 0.14
OG0021.97± 0.17
OG003
Diagnostic test(n=253,246,70,67)
Title
Measurements
OG0001.87± 0.33
OG0011.90± 0.30
OG0021.91± 0.28
OG003
In nursing home(n=254,245,70,67)
Title
Measurements
OG0001.98± 0.12
OG0012.00± 0.00
OG0022.00± 0.00
OG003
Home healthcare services(n=252,246,70,67)
Title
Measurements
OG0002.00± 0.06
OG0012.00± 0.06
OG0021.99± 0.12
OG003
Required aids/devices(n=254,246,70,67)
Title
Measurements
OG0001.92± 0.28
OG0011.93± 0.25
OG0021.94± 0.23
OG003
Non-medical practitioner(n=254,246,70,67)
Title
Measurements
OG0001.99± 0.09
OG0011.99± 0.11
OG0021.96± 0.20
OG003
Currently employed(n=254,246,70,67)
Title
Measurements
OG0001.66± 0.47
OG0011.65± 0.48
OG0021.50± 0.50
OG003
Feel well enough to work(n=102,107,18,19)
Title
Measurements
OG0001.74± 0.44
OG0011.64± 0.48
OG0021.72± 0.46
OG003
Unable to work due to RA(n=100,107,19,19)
Title
Measurements
OG0001.50± 0.50
OG0011.54± 0.50
OG0021.37± 0.50
OG003
Lost job/retired early(n=99,103,18,19)
Title
Measurements
OG0001.62± 0.49
OG0011.55± 0.50
OG0021.56± 0.51
OG003
Work disabled due to RA(n=103,106,18,19)
Title
Measurements
OG0001.57± 0.50
OG0011.56± 0.50
OG0021.39± 0.50
OG003
Retired(n=114,117,22,22)
Title
Measurements
OG0001.42± 0.50
OG0011.44± 0.50
OG0021.36± 0.49
OG003
Sick leave due to RA(n=223,215,65,59)
Title
Measurements
OG0001.93± 0.25
OG0011.94± 0.24
OG0021.98± 0.12
OG003
Performed part time work(n=224,217,64,57)
Title
Measurements
OG0001.96± 0.19
OG0011.97± 0.18
OG0021.98± 0.13
OG003
Performed paid work(n=224,222,64,57)
Title
Measurements
OG0001.78± 0.41
OG0011.76± 0.43
OG0021.72± 0.45
OG003
Unable to do chores(n=250,246,69,66)
Title
Measurements
OG0001.73± 0.44
OG0011.77± 0.42
OG0021.74± 0.44
OG003
Chores by housekeeper(n=254,246,70,67)
Title
Measurements
OG0001.91± 0.29
OG0011.96± 0.19
OG0022.00± 0.00
OG003
Chores by family/friends(n=253,246,70,66)
Title
Measurements
OG0001.75± 0.43
OG0011.80± 0.40
OG0021.79± 0.41
OG003
Units
Counts
Participants
OG000266
OG001280
OG002130
Title
Denominators
Categories
Baseline:Doctor visit(n=266,280,130)
Title
Measurements
OG0004.27± 3.99
OG0014.17± 3.58
OG0024.13± 3.80
Baseline:RA related doctor visit(n=266,280,130)
Title
Measurements
OG0001.33± 0.85
OG0011.32± 0.71
OG0021.25± 0.61
Baseline:Hospital ER visit(n=19,18,8)
Title
Measurements
OG0001.26± 0.81
OG0011.28± 0.67
OG0021.38± 0.74
Baseline:RA related ER visit(n=19,18,8)
Title
Measurements
OG0000.58± 0.77
OG0010.50± 0.51
OG0020.88± 0.83
Baseline:Hospitalization(n=16,23,9)
Title
Measurements
OG0001.50± 2.00
OG0011.26± 0.45
OG0021.22± 0.67
Baseline:RA related hospitalization(n=16,23,9)
Title
Measurements
OG0000.94± 0.68
OG0011.09± 0.90
OG0020.78± 0.67
Baseline:Outpatient surgery(n=8,6,9)
Title
Measurements
OG0001.13± 0.35
OG0011.17± 0.41
OG0021.33± 0.50
Baseline:RA related outpatient surgery(n=8,5,9)
Title
Measurements
OG0000.88± 0.64
OG0010.20± 0.45
OG0020.56± 0.88
Baseline:Non-study diagnostic test(n=45,39,22)
Title
Measurements
OG0001.64± 1.03
OG0012.13± 2.34
OG0021.64± 0.95
Baseline:RA related diagnostic test(n=45,40,22)
Title
Measurements
OG0000.80± 0.87
OG0010.90± 0.98
OG0020.73± 0.88
Baseline:Non-medical practitioner visit(n=13,6,3)
Title
Measurements
OG0008.08± 7.90
OG0012.83± 1.83
OG0028.00± 2.00
Baseline:RA related non-medical visit(n=13,6,3)
Title
Measurements
OG0001.23± 0.73
OG0011.00± 0.89
OG0021.33± 0.58
Month 3:Doctor visit(n=183,174,94)
Title
Measurements
OG0004.50± 4.18
OG0014.05± 3.77
OG0024.66± 4.94
Month 3:RA related doctor visit(n=183,174,94)
Title
Measurements
OG0001.06± 0.75
OG0010.97± 0.72
OG0021.03± 0.71
Month 3:Hospital ER visit(n=11,7,6)
Title
Measurements
OG0001.36± 0.92
OG0011.00± 0.00
OG0021.17± 0.41
Month 3:RA related ER visit(n=12,7,6)
Title
Measurements
OG0000.17± 0.39
OG0010.29± 0.76
OG0020.00± 0.00
Month 3:Hospitalization(n=4,4,4)
Title
Measurements
OG0001.00± 0.00
OG0011.00± 0.00
OG0020.75± 0.50
Month 3:RA related hospitalization(n=4,4,4)
Title
Measurements
OG0000.25± 0.50
OG0010.50± 0.58
OG0020.25± 0.50
Month 3:Outpatient surgery(n=6,5,6)
Title
Measurements
OG0002.17± 1.94
OG0011.00± 0.00
OG0021.00± 0.00
Month 3:RA related outpatient surgery(n=6,5,6)
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.17± 0.41
Month 3:Non-study diagnostic test(n=24,26,15)
Title
Measurements
OG0001.63± 1.21
OG0011.35± 0.63
OG0021.33± 0.82
Month 3:RA related diagnostic test(n=26,27,15)
Title
Measurements
OG0000.23± 0.65
OG0010.22± 0.51
OG0020.47± 0.52
Month 3:Non-medical practitioner visit(n=6,6,1)
Title
Measurements
OG0004.00± 2.28
OG0013.00± 3.52
OG00240.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
Month 3:RA related non-medical visit(n=6,6,1)
Title
Measurements
OG0000.67± 1.03
OG0010.67± 0.52
OG0024.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
Month 6:Doctor visit(n=168,178,39)
Title
Measurements
OG0003.54± 3.87
OG0013.07± 2.73
OG0023.08± 3.96
Month 6:RA related doctor visit(n=168,177,39)
Title
Measurements
OG0000.91± 0.65
OG0010.97± 0.71
OG0020.74± 0.59
Month 6:Hospital ER visit(n=13,4,2)
Title
Measurements
OG0001.31± 0.63
OG0011.00± 0.00
OG0022.50± 2.12
Month 6:RA related ER visit(n=13,6,2)
Title
Measurements
OG0000.08± 0.28
OG0010.00± 0.00
OG0020.00± 0.00
Month 6:Hospitalization(n=8,5,2)
Title
Measurements
OG0001.13± 0.35
OG0011.00± 0.00
OG0021.00± 0.00
Month 6:RA related hospitalization(n=8,7,2)
Title
Measurements
OG0000.38± 0.74
OG0010.29± 0.76
OG0021.00± 0.00
Month 6:Outpatient surgery(n=5,5,5)
Title
Measurements
OG0001.00± 0.00
OG0011.40± 0.55
OG0021.00± 0.00
Month 6:RA related outpatient surgery(n=5,5,5)
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.20± 0.45
Month 6:Non-study diagnostic test(n=23,20,9)
Title
Measurements
OG0002.04± 1.49
OG0011.60± 1.10
OG0021.11± 0.33
Month 6:RA related diagnostic test(n=25,20,10)
Title
Measurements
OG0000.28± 0.54
OG0010.35± 0.67
OG0020.20± 0.42
Month 6:Non-medical practitioner visit(n=3,1,1)
Title
Measurements
OG00012.67± 11.02
OG00112.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter
Month 6:RA related non-medical visit(n=3,1,1)
Title
Measurements
OG0000.33± 0.58
OG0014.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000136
OG001139
OG00242
OG00334
Title
Denominators
Categories
Doctor visit(n=136,139,42,34)
Title
Measurements
OG0003.17± 3.59
OG0012.58± 2.62
OG0023.19± 4.58
OG0032.62± 1.65
RA related doctor visit (n=136,139,42,34)
Title
Measurements
OG0000.89± 0.66
OG0010.74± 0.64
OG0021.05± 0.82
OG003
Hospital ER visit(n=13,12,6,5)
Title
Measurements
OG0001.15± 0.38
OG0011.17± 0.58
OG0021.67± 1.63
OG003
RA related ER visit(n=13,12,6,5)
Title
Measurements
OG0000.15± 0.55
OG0010.33± 0.65
OG0020.33± 0.82
OG003
Hospitalization(n=7,8,1,2)
Title
Measurements
OG0001.00± 0.00
OG0011.00± 0.00
OG0021.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
RA related hospitalization(n=8,8,1,2)
Title
Measurements
OG0000.50± 0.93
OG0010.63± 0.92
OG0020.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
Outpatient surgery(n=4,5,2,2)
Title
Measurements
OG0001.25± 0.50
OG0011.60± 1.34
OG0021.00± 0.00
OG003
RA related outpatient surgery(n=8,5,2,2)
Title
Measurements
OG0000.13± 0.35
OG0010.00± 0.00
OG0020.00± 0.00
OG003
Non-study diagnostic test(n=30,25,6,9)
Title
Measurements
OG0001.67± 0.88
OG0011.68± 1.44
OG0021.33± 0.52
OG003
RA related diagnostic test(n=32,25,6,11)
Title
Measurements
OG0000.34± 0.70
OG0010.12± 0.33
OG0020.00± 0.00
OG003
Non-medical practitioner visit(n=2,2,3,0)
Title
Measurements
OG0003.00± 1.41
OG0016.00± 2.83
OG0023.00± 2.65
OG003
RA related non-medical visit(n=2,3,3,0)
Title
Measurements
OG0000.00± 0.00
OG0010.67± 0.58
OG0020.67± 0.58
OG003
Units
Counts
Participants
OG000154
OG001158
OG00278
Title
Denominators
Categories
Baseline:Hospital length of stay(n=16,23,8)
Title
Measurements
OG00012.69± 6.05
OG00115.26± 13.03
OG00214.50± 15.97
Baseline:Days in nursing home(n=1,2,1)
Title
Measurements
OG00028.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG00114.50± 0.71
OG00221.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
Baseline:Days aids/devices used(n=37,40,19)
Title
Measurements
OG00084.92± 71.64
OG001100.78± 109.26
OG00265.37± 74.55
Baseline:RA related aids used(n=37,42,19)
Title
Measurements
OG0001.65± 1.18
OG0011.90± 1.36
OG0021.42± 0.84
Baseline:Days of work per week(n=110,106,59)
Title
Measurements
OG0005.02± 1.05
OG0015.01± 0.88
OG0024.86± 1.02
Baseline:Days on sick leave due to RA(n=71,61,27)
Title
Measurements
OG00027.06± 33.38
OG00130.26± 35.56
OG00231.41± 32.27
Baseline:Days of part time work(n=30,29,12)
Title
Measurements
OG00022.77± 28.95
OG00120.86± 29.44
OG00234.83± 34.89
Baseline:Paid work, bothered by RA(n=94,93,48)
Title
Measurements
OG00040.11± 30.69
OG00139.26± 29.85
OG00243.15± 32.11
Baseline:Chores by housekeeper(n=46,37,18)
Title
Measurements
OG00027.17± 35.34
OG00119.73± 28.01
OG00237.28± 38.31
Baseline:Chores by family(n=154,158,79)
Title
Measurements
OG00041.26± 38.38
OG00134.92± 33.94
OG00237.81± 35.78
Month 3:Hospital length of stay(n=4,4,4)
Title
Measurements
OG0007.00± 4.24
OG0018.25± 2.99
OG0023.75± 0.50
Month 3:Days in nursing home(n=1,2,0)
Title
Measurements
OG00010.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG00114.00± 9.90
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
Month 3:Days aids/devices used(n=24,28,28)
Title
Measurements
OG000104.96± 87.40
OG001104.36± 128.12
OG002120.75± 152.78
Month 3:RA related aids used(n=25,28,28)
Title
Measurements
OG0001.68± 0.95
OG0011.68± 1.39
OG0021.79± 1.69
Month 3:Days of work per week(n=104,99,52)
Title
Measurements
OG0005.16± 1.01
OG0015.12± 1.08
OG0024.94± 1.00
Month 3:Days on sick leave due to RA(n=31,22,24)
Title
Measurements
OG00028.23± 34.67
OG00128.45± 39.07
OG00224.58± 33.18
Month 3:Days of part time work(n=16,11,8)
Title
Measurements
OG00020.06± 28.06
OG00136.91± 37.77
OG00236.13± 31.16
Month 3:Paid work, bothered by RA(n=75,62,38)
Title
Measurements
OG00031.25± 33.22
OG00133.15± 30.42
OG00242.32± 31.88
Month 3:Chores by housekeeper(n=30,19,10)
Title
Measurements
OG00026.87± 34.10
OG00116.58± 26.03
OG00221.40± 26.42
Month 3:Chores by family(n=97,92,60)
Title
Measurements
OG00034.23± 34.27
OG00130.51± 33.93
OG00241.92± 36.89
Month 6:Hospital length of stay(n=8,7,2)
Title
Measurements
OG0009.63± 7.76
OG0016.43± 5.03
OG00213.50± 0.71
Month 6:Days in nursing home(n=0,0,0)
Title
Measurements
OG000NA± NAData was not analyzed as no participant was evaluable for this parameter.
OG001NA± NAData was not analyzed as no participant was evaluable for this parameter.
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
Month 6:Days aids/devices used(n=23,26,5)
Title
Measurements
OG000135.04± 104.11
OG001116.27± 130.92
OG002129.20± 42.11
Month 6:RA related aids used(n=24,26,5)
Title
Measurements
OG0001.79± 1.18
OG0011.85± 1.43
OG0021.80± 1.48
Month 6:Days of work per week(n=92,95,24)
Title
Measurements
OG0005.15± 1.04
OG0015.04± 0.94
OG0024.88± 0.99
Month 6:Days on sick leave due to RA(n=21,14,4)
Title
Measurements
OG00027.71± 36.77
OG00124.43± 31.00
OG00210.75± 13.45
Month 6:Days of part time work(n=7,8,2)
Title
Measurements
OG00035.43± 27.85
OG00128.00± 36.01
OG0027.50± 3.54
Month 6:Paid work, bothered by RA(n=54,46,13)
Title
Measurements
OG00030.80± 31.45
OG00131.74± 30.04
OG00233.31± 30.18
Month 6:Chores by housekeeper(n=26,13,6)
Title
Measurements
OG00022.42± 28.69
OG00120.92± 31.17
OG00243.50± 41.56
Month 6:Chores by family(n=78,68,14)
Title
Measurements
OG00029.53± 31.60
OG00124.90± 31.36
OG00233.93± 37.88
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG00086
OG00184
OG00234
OG00323
Title
Denominators
Categories
Hospital length of stay(n=8,8,1,2)
Title
Measurements
OG0008.88± 6.73
OG00112.38± 11.98
OG0022.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG0031.50± 0.71
Days in nursing home(n=4,0,0,0)
Title
Measurements
OG00019.50± 8.35
OG001NA± NAData was not analyzed as no participant was evaluable for this parameter.
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
OG003
Days aids/devices used(n=19,15,4,5)
Title
Measurements
OG000111.79± 84.57
OG001161.40± 382.20
OG002225.00± 155.88
OG003
RA related aids used(n=21,16,4,5)
Title
Measurements
OG0001.19± 1.21
OG0012.50± 4.76
OG0022.50± 1.73
OG003
Days of work per week(n=86,84,34,23)
Title
Measurements
OG0005.20± 1.03
OG0015.35± 0.74
OG0025.00± 1.10
OG003
Days on sick leave due to RA(n=15,12,1,4)
Title
Measurements
OG00036.40± 42.27
OG00113.58± 25.37
OG00220.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
Days of part time work(n=8,7,1,2)
Title
Measurements
OG00014.88± 30.48
OG0016.71± 3.15
OG00224.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
Paid work, bothered by RA(n=49,53,18,14)
Title
Measurements
OG00039.08± 35.44
OG00140.02± 33.50
OG00240.39± 34.19
OG003
Chores by housekeeper(n=23,9,0,5)
Title
Measurements
OG00032.17± 36.69
OG00117.22± 28.01
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
OG003
Chores by family(n=63,48,14,12)
Title
Measurements
OG00026.67± 32.49
OG00124.98± 29.88
OG00226.43± 32.22
OG003
Units
Counts
Participants
OG000154
OG001159
OG00279
Title
Denominators
Categories
Baseline:Home healthcare services (n=3,4,2)
Title
Measurements
OG0004.67± 6.35
OG0012.75± 2.36
OG0021.50± 0.71
Baseline:RA related home HC services(n=3,4,2)
Title
Measurements
OG0000.67± 0.58
OG0011.00± 0.82
OG0020.50± 0.71
Baseline:Work done(n=110,106,59)
Title
Measurements
OG0007.84± 2.85
OG0017.45± 2.27
OG0027.24± 1.89
Baseline:Missed work due to RA(n=30,29,12)
Title
Measurements
OG0004.30± 4.18
OG0016.24± 16.81
OG0027.33± 8.07
Baseline:Chores by housekeeper(n=46,37,18)
Title
Measurements
OG0004.61± 3.96
OG0014.62± 2.78
OG0025.17± 5.15
Baseline:Chores by family(n=154,159,79)
Title
Measurements
OG0004.27± 4.81
OG0013.86± 7.09
OG0024.30± 5.59
Month 3:Home healthcare services(n=2,4,2)
Title
Measurements
OG0001.50± 0.71
OG0013.25± 2.06
OG0021.50± 0.71
Month 3:RA related home HC services(n=2,4,2)
Title
Measurements
OG0000.00± 0.00
OG0010.25± 2.50
OG0021.00± 1.41
Month 3:Work done(n=104,98,53)
Title
Measurements
OG0008.99± 7.48
OG0017.64± 2.20
OG0028.06± 4.94
Month 3:Missed work due to RA(n=16,11,8)
Title
Measurements
OG0003.94± 1.88
OG0014.18± 2.14
OG0023.88± 1.13
Month 3:Chores by housekeeper(n=30,19,10)
Title
Measurements
OG0004.17± 2.68
OG0013.74± 3.74
OG0023.30± 2.00
Month 3:Chores by family(n=98,89,59)
Title
Measurements
OG0003.32± 3.30
OG0012.98± 3.35
OG0024.97± 5.77
Month 6:Home healthcare services(n=2,2,0)
Title
Measurements
OG00017.00± 9.90
OG0012.00± 1.41
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
Month 6:RA related home HC services(n=2,2,0)
Title
Measurements
OG0001.00± 1.41
OG0012.00± 1.41
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
Month 6:Work done(n=92,95,24)
Title
Measurements
OG0008.12± 1.89
OG0017.53± 1.72
OG0028.50± 5.34
Month 6:Missed work due to RA(n=7,8,1)
Title
Measurements
OG0004.43± 1.62
OG0013.38± 1.69
OG0022.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
Month 6:Chores by housekeeper(n=25,13,6)
Title
Measurements
OG0004.64± 3.01
OG0015.69± 6.45
OG0025.17± 3.13
Month 6:Chores by family(n=77,66,14)
Title
Measurements
OG0003.73± 3.58
OG0012.91± 3.30
OG0024.36± 2.68
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG00085
OG00185
OG00234
OG00324
Title
Denominators
Categories
Home healthcare services(n=1,1,1,0)
Title
Measurements
OG0001.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG0012.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG0021.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003NA± NAData was not analyzed as no participant was evaluable for this parameter.
RA related healthcare services(n=1,1,1,0)
Title
Measurements
OG0000.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG0012.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG0021.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
Work done(n=85,85,34,24)
Title
Measurements
OG0008.60± 4.00
OG0017.67± 1.77
OG0028.79± 5.85
OG003
Missed work due to RA(n=8,7,1,2)
Title
Measurements
OG0005.00± 6.21
OG0013.29± 1.80
OG0020.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
Chores by housekeeper(n=22,9,0,5)
Title
Measurements
OG0004.86± 2.71
OG0013.89± 1.96
OG002NA± NAData was not analyzed as no participant was evaluable for this parameter.
OG003
Chores by family(n=62,47,14,12)
Title
Measurements
OG0003.24± 3.26
OG0012.70± 2.22
OG0022.50± 1.40
OG003
Units
Counts
Participants
OG000239
OG001238
OG002124
Title
Denominators
Categories
Baseline (n=239, 238, 119)
Title
Measurements
OG0005.03± 5.89
OG0014.72± 3.22
OG0024.55± 3.14
Month 3 (n= 223, 229, 124)
Title
Measurements
OG0003.74± 3.04
OG0013.18± 3.21
OG0023.97± 3.15
Month 6 (n= 210, 224, 46)
Title
Measurements
OG0003.40± 3.06
OG0012.66± 2.83
OG0023.24± 2.86
OG003
Placebo Then CP-690,550 10 mg
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.
Units
Counts
Participants
OG000174
OG001180
OG00250
OG00350
Title
Denominators
Categories
Title
Measurements
OG0002.79± 2.67
OG0012.52± 2.74
OG0022.84± 2.13
OG0033.08± 2.60
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0091 affected318 at risk
EG0101 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0101 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0081 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0091 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0086 affected315 at risk
EG0091 affected318 at risk
EG0102 affected79 at risk
EG0111 affected80 at risk
4 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
6 affected
315 at risk
EG0044 affected318 at risk
EG0051 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
3 affected
315 at risk
EG0044 affected318 at risk
EG0053 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0083 affected315 at risk
EG0096 affected318 at risk
EG0102 affected79 at risk
EG0112 affected80 at risk
6 affected
315 at risk
EG0049 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0042 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
13 affected
315 at risk
EG0049 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0073 affected40 at risk
EG00811 affected315 at risk
EG00918 affected318 at risk
EG0103 affected79 at risk
EG0113 affected80 at risk
1 affected
315 at risk
EG0045 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
2 affected
315 at risk
EG0043 affected318 at risk
EG0052 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0083 affected315 at risk
EG0092 affected318 at risk
EG0103 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
2 affected
315 at risk
EG0045 affected318 at risk
EG0052 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0095 affected318 at risk
EG0102 affected79 at risk
EG0110 affected80 at risk
3 affected
315 at risk
EG0044 affected318 at risk
EG0051 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0042 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0082 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0112 affected80 at risk
2 affected
315 at risk
EG0041 affected318 at risk
EG0051 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
2 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
4 affected
315 at risk
EG0048 affected318 at risk
EG0051 affected81 at risk
EG0063 affected38 at risk
EG0070 affected40 at risk
EG0082 affected315 at risk
EG0092 affected318 at risk
EG0100 affected79 at risk
EG0112 affected80 at risk
1 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0063 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
7 affected
315 at risk
EG0042 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
2 affected
315 at risk
EG0043 affected318 at risk
EG0052 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0085 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0112 affected80 at risk
5 affected
315 at risk
EG0045 affected318 at risk
EG0051 affected81 at risk
EG0061 affected38 at risk
EG0072 affected40 at risk
EG0083 affected315 at risk
EG0097 affected318 at risk
EG0100 affected79 at risk
EG0113 affected80 at risk
2 affected
315 at risk
EG0043 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0042 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
3 affected
315 at risk
EG0045 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0071 affected40 at risk
EG0083 affected315 at risk
EG0097 affected318 at risk
EG0100 affected79 at risk
EG0111 affected80 at risk
1 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0040 affected318 at risk
EG0051 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
3 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0045 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0043 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
2 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
1 affected
315 at risk
EG0042 affected318 at risk
EG0050 affected81 at risk
EG0062 affected38 at risk
EG0072 affected40 at risk
EG0080 affected315 at risk
EG0093 affected318 at risk
EG0102 affected79 at risk
EG0111 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0061 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0041 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0071 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0110 affected80 at risk
3 affected
315 at risk
EG0040 affected318 at risk
EG0052 affected81 at risk
EG0060 affected38 at risk
EG0072 affected40 at risk
EG0084 affected315 at risk
EG0094 affected318 at risk
EG0101 affected79 at risk
EG0112 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0082 affected315 at risk
EG0091 affected318 at risk
EG0102 affected79 at risk
EG0110 affected80 at risk
0 affected
315 at risk
EG0040 affected318 at risk
EG0050 affected81 at risk
EG0060 affected38 at risk
EG0070 affected40 at risk
EG0080 affected315 at risk
EG0090 affected318 at risk
EG0100 affected79 at risk
EG0112 affected80 at risk
34.62
25.64
20.51
2.99
± 1.06
0.73
± 0.69
25.39
± 22.71
28.20
± 24.29
17.59
± 15.21
42.99
± 9.18
44.11
± 10.32
44.03
± 8.26
45.11
± 10.51
41.02
± 11.46
47.29
± 10.43
40.08
± 9.50
45.22
± 11.40
42.05
± 6.93
39.85
± 10.97
43.16
± 9.51
44.36
± 10.30
45.49
± 8.11
45.65
± 11.29
42.40
± 11.92
47.75
± 10.45
39.43
± 10.35
46.33
± 11.21
41.62
± 8.16
32.53
± 17.89
28.48
± 15.45
31.38
± 27.58
6.95
± 1.42
35.63
± 22.81
14.85
± 17.30
55.76
± 26.37
40.82
± 30.86
33.05
± 29.78
28.43
± 27.66
8.89
± 6.29
1.93
± 0.26
0.00
± 0.00
1.97
± 0.12
1.97
± 0.17
1.84
± 0.37
2.00
± 0.00
2.00
± 0.00
1.93
± 0.26
2.00
± 0.00
1.63
± 0.49
1.74
± 0.45
1.63
± 0.50
1.58
± 0.51
1.58
± 0.51
1.32
± 0.48
1.93
± 0.25
1.96
± 0.19
1.75
± 0.43
1.89
± 0.31
1.93
± 0.26
1.82
± 0.39
0.79
± 0.69
1.00
± 0.00
0.00
± 0.00
1.50
± 0.71
0.00
± 0.00
1.00
± 0.00
0.00
± 0.00
2.00
± 0.87
0.09
± 0.30
NA
± NA
Data was not analyzed as no participant was evaluable for this parameter.
NA
± NA
Data was not analyzed as no participant was evaluable for this parameter.
NA
± NA
Data was not analyzed as no participant was evaluable for this parameter.
62.00
± 75.38
1.80
± 1.30
5.22
± 0.80
31.00
± 41.49
52.50
± 53.03
47.57
± 39.16
6.60
± 3.29
26.00
± 31.05
NA
± NA
Data was not analyzed as no participant was evaluable for this parameter.