A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The A... | NCT00853385 | Trialant
NCT00853385
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 18, 2013Estimated
Enrollment
717Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
CP 690,550
CP-690,550
Placebo
Placebo
Biologic TNFi
Countries
United States
Australia
Bosnia and Herzegovina
Bulgaria
Canada
Chile
Costa Rica
Croatia
Czechia
Denmark
Dominican Republic
Finland
Germany
Mexico
Philippines
Poland
Slovakia
South Korea
Spain
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00853385
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A3921064
Secondary IDs
Not provided
Brief Title
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Official Title
Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jan 2013
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
Mar 2011Actual
Completion Date
Mar 2011Actual
First Submitted Date
Feb 27, 2009
First Submission Date that Met QC Criteria
Feb 27, 2009
First Posted Date
Mar 2, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 4, 2012
Results First Submitted that Met QC Criteria
Dec 4, 2012
Results First Posted Date
Jan 9, 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
Jan 10, 2013
Last Update Posted Date
Jan 18, 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 is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
oral DMARD
JAK inhibitor
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
717Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
5mg
Experimental
Drug: CP 690,550
10 mg
Experimental
Drug: CP-690,550
Placebo Sequence 1
Placebo Comparator
Other: Placebo
Placebo Sequence 2
Placebo Comparator
Other: Placebo
adalimumab
Active Comparator
Biological: Biologic TNFi
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CP 690,550
Drug
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
5mg
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% 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 the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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 With 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) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.
Exclusion Criteria:
Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/L
History of any other autoimmune rheumatic disease other than Sjogren's syndrome
No malignancy or history of malignancy.
History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
Patients who have previously received adalimumab therapy for any reason.
Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
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.
CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
10 mg
Placebo
Other
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Placebo Sequence 1
Placebo
Other
tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
Placebo Sequence 2
Biologic TNFi
Biological
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
adalimumab
Humira (Adalimumab)
Month 6
Month 1, 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response 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 the HAQ); and CRP.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 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 the HAQ); and CRP.
Month 1, 3, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response 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 the HAQ); and CRP.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 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 the HAQ); and CRP.
Month 1, 3, 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response 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 the HAQ); and CRP.
Month 9, 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 1, 3, 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 1, 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 1, 3, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 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 9, 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 1, 3, 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 SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Baseline, Month 1, 3, 6, 9, 12
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Month 1, 3, 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; 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.
Month 9, 12
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 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, Month 1, 3, 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, Month 1, 3 and 6
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Baseline, Month 1, 3, 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 mm = very well and 100 mm = very poorly.
Month 9, 12
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 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, Month 1, 3, 6
Physician Global Assessment (PGA) of Arthritis Pain 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Month 9, 12
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Baseline, Month 1, 3, 6
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Month 12
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Baseline, Month 1, 3, 6
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Month 12
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
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
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 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 1, 3, 6
Euro Quality of Life-5 Dimension (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 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Month 3, 6
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
Baseline, 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: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Baseline, Month 3, 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
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, hours affected per day and average number of hours missed work per day 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, hours affected per day and average number of hours missed work per day 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 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 10-point scale, where higher score indicated lower work performance.
Month 12
Glendale
Arizona
85304
United States
Pfizer Investigational Site
Mesa
Arizona
85202
United States
Pfizer Investigational Site
Paradise Valley
Arizona
85253
United States
Pfizer Investigational Site
Phoenix
Arizona
85037
United States
Pfizer Investigational Site
Jonesboro
Arkansas
72401
United States
Pfizer Investigational Site
Fair Oaks
California
95628
United States
Pfizer Investigational Site
San Diego
California
92108
United States
Pfizer Investigational Site
Boulder
Colorado
80304
United States
Pfizer Investigational Site
Largo
Florida
33777
United States
Pfizer Investigational Site
Naples
Florida
34102
United States
Pfizer Investigational Site
Palm Harbor
Florida
34684
United States
Pfizer Investigational Site
Pinellas Park
Florida
33782
United States
Pfizer Investigational Site
Plantation
Florida
33324
United States
Pfizer Investigational Site
St. Petersburg
Florida
33710
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
Rockford
Illinois
61107
United States
Pfizer Investigational Site
Evansville
Indiana
47714
United States
Pfizer Investigational Site
Wichita
Kansas
67203
United States
Pfizer Investigational Site
Lexington
Kentucky
40504
United States
Pfizer Investigational Site
Lexington
Kentucky
40515
United States
Pfizer Investigational Site
Baton Rouge
Louisiana
70809
United States
Pfizer Investigational Site
Haverhill
Massachusetts
01830
United States
Pfizer Investigational Site
Worcester
Massachusetts
01610
United States
Pfizer Investigational Site
Grand Rapids
Michigan
49546
United States
Pfizer Investigational Site
Cincinnati
Ohio
45219
United States
Pfizer Investigational Site
Oklahoma City
Oklahoma
73112
United States
Pfizer Investigational Site
Greenville
South Carolina
29601
United States
Pfizer Investigational Site
Austin
Texas
78705
United States
Pfizer Investigational Site
Dallas
Texas
75231
United States
Pfizer Investigational Site
Houston
Texas
77034
United States
Pfizer Investigational Site
Lubbock
Texas
79424
United States
Pfizer Investigational Site
Mesquite
Texas
75150
United States
Pfizer Investigational Site
Seattle
Washington
98104
United States
Pfizer Investigational Site
Seattle
Washington
98122
United States
Pfizer Investigational Site
Clarksburg
West Virginia
26301
United States
Pfizer Investigational Site
St Leonards
New South Wales
2065
Australia
Pfizer Investigational Site
Cairns
Queensland
4870
Australia
Pfizer Investigational Site
Maroochydore
Queensland
4558
Australia
Pfizer Investigational Site
Malvern East
Victoria
3145
Australia
Pfizer Investigational Site
Sarajevo
71000
Bosnia and Herzegovina
Pfizer Investigational Site
Pleven
5800
Bulgaria
Pfizer Investigational Site
Plovdiv
4000
Bulgaria
Pfizer Investigational Site
Plovdiv
4002
Bulgaria
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Sevlievo
5400
Bulgaria
Pfizer Investigational Site
Sofia
1606
Bulgaria
Pfizer Investigational Site
Sofia
1709
Bulgaria
Pfizer Investigational Site
Vancouver
British Columbia
V5Z 1L7
Canada
Pfizer Investigational Site
Lunenburg
Nova Scotia
B0J 2C0
Canada
Pfizer Investigational Site
London
Ontario
N6A 4V2
Canada
Pfizer Investigational Site
Mississauga
Ontario
L5M 2V8
Canada
Pfizer Investigational Site
Toronto
Ontario
M5T 2S8
Canada
Pfizer Investigational Site
Québec
Quebec
G1W 4R4
Canada
Pfizer Investigational Site
Trois-Rivières
Quebec
G8Z 1Y2
Canada
Pfizer Investigational Site
Saskatoon
Saskatchewan
S7N 0W8
Canada
Pfizer Investigational Site
Rancagua
Región del Libertador General Bernardo O’Higgins
2841959
Chile
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
Cartago
Cartago Province
Costa Rica
Pfizer Investigational Site
San José
Provincia de San José
00
Costa Rica
Pfizer Investigational Site
San José
Provincia de San José
Costa Rica
Pfizer Investigational Site
Osijek
31000
Croatia
Pfizer Investigational Site
Split
21000
Croatia
Pfizer Investigational Site
Zagreb
10000
Croatia
Pfizer Investigational Site
Brno
60200
Czechia
Pfizer Investigational Site
Brno
656 91
Czechia
Pfizer Investigational Site
Brno
65691
Czechia
Pfizer Investigational Site
Brno-Židenice
615 00
Czechia
Pfizer Investigational Site
Hlučín
748 01
Czechia
Pfizer Investigational Site
Pardubice
530 02
Czechia
Pfizer Investigational Site
Prague
128 50
Czechia
Pfizer Investigational Site
Prague
140 00
Czechia
Pfizer Investigational Site
Prague
14800
Czechia
Pfizer Investigational Site
Praha 11 - Chodov
148 00
Czechia
Pfizer Investigational Site
Zlín
760 01
Czechia
Pfizer Investigational Site
Frederiksberg
2000
Denmark
Pfizer Investigational Site
Randers NOE
8930
Denmark
Pfizer Investigational Site
Santo Domingo
Santo Domingo Province
00000
Dominican Republic
Pfizer Investigational Site
Hyvinkää
05800
Finland
Pfizer Investigational Site
Aachen
52064
Germany
Pfizer Investigational Site
Berlin
14059
Germany
Pfizer Investigational Site
Frankfurt am Main
60590
Germany
Pfizer Investigational Site
Halle
06108
Germany
Pfizer Investigational Site
Halle
06128
Germany
Pfizer Investigational Site
Herne
44652
Germany
Pfizer Investigational Site
Ratingen
40882
Germany
Pfizer Investigational Site
Würzburg
97080
Germany
Pfizer Investigational Site
Guadalajara
Jalisco
44620
Mexico
Pfizer Investigational Site
Mexico City
Mexico City
10700
Mexico
Pfizer Investigational Site
Morelia
Michoacán
58249
Mexico
Pfizer Investigational Site
San Luis Potosí City
San Luis Potosí
78240
Mexico
Pfizer Investigational Site
Lipa City
Batangas
4217
Philippines
Pfizer Investigational Site
Angeles City
Pampanga
2009
Philippines
Pfizer Investigational Site
Cebu City
6000
Philippines
Pfizer Investigational Site
Bialystok
15-337
Poland
Pfizer Investigational Site
Cieszyn
43-400
Poland
Pfizer Investigational Site
Kościan
64-000
Poland
Pfizer Investigational Site
Krakow
31-501
Poland
Pfizer Investigational Site
Sopot
81-759
Poland
Pfizer Investigational Site
Torun
87-100
Poland
Pfizer Investigational Site
Warsaw
02-118
Poland
Pfizer Investigational Site
Bratislava
82606
Slovakia
Pfizer Investigational Site
Dunajská Streda
92901
Slovakia
Pfizer Investigational Site
Košice
040 01
Slovakia
Pfizer Investigational Site
Nové Zámky
94001
Slovakia
Pfizer Investigational Site
Povazska Dystrica
017 01
Slovakia
Pfizer Investigational Site
Žilina
010 01
Slovakia
Pfizer Investigational Site
Daegu
705-718
South Korea
Pfizer Investigational Site
Gwangju
501-757
South Korea
Pfizer Investigational Site
Seoul
110-744
South Korea
Pfizer Investigational Site
Seoul
133-792
South Korea
Pfizer Investigational Site
A Coruña
A Coruña
15006
Spain
Pfizer Investigational Site
Santiago de Compostela
A Coruña
15705
Spain
Pfizer Investigational Site
Madrid
Madrid
28041
Spain
Pfizer Investigational Site
Vigo
Pontevedra
36200
Spain
Pfizer Investigational Site
Seville
Sevilla
41009
Spain
Pfizer Investigational Site
Valencia
Valencia
46026
Spain
Pfizer Investigational Site
Rajathevee
Bangkok
10400
Thailand
Pfizer Investigational Site
Amphoe Muang
Chiang Mai
50200
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
Dudley, West Midlands
DY1 2HQ
United Kingdom
Derived
Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
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.
Citera G, Jain R, Irazoque F, Madariaga H, Gruben D, Wang L, Stockert L, Santana K, Ebrahim A, Ponce de Leon D. Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials. Rheumatol Ther. 2024 Feb;11(1):35-50. doi: 10.1007/s40744-023-00612-7. Epub 2023 Nov 5.
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.
Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
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.
Bergman M, Tundia N, Yang M, Orvis E, Clewell J, Bensimon A. Economic Benefit from Improvements in Quality of Life with Upadacitinib: Comparisons with Tofacitinib and Methotrexate in Patients with Rheumatoid Arthritis. Adv Ther. 2021 Dec;38(12):5649-5661. doi: 10.1007/s12325-021-01930-4. Epub 2021 Oct 12.
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.
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.
van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.
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.
Genovese MC, van Vollenhoven RF, Wilkinson B, Wang L, Zwillich SH, Gruben D, Biswas P, Riese R, Takiya L, Jones TV. Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis. Arthritis Res Ther. 2016 Jun 23;18:145. doi: 10.1186/s13075-016-1049-3.
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.
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, Garcia Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B; ORAL Standard Investigators. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):508-19. doi: 10.1056/NEJMoa1112072.
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
FG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
FG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
FG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
FG000204 subjects
FG001201 subjects
FG00256 subjects
FG00352 subjects
FG004204 subjects
COMPLETED
FG000150 subjects
FG001158 subjects
FG00247 subjects
FG00339 subjects
FG004162 subjects
NOT COMPLETED
FG00054 subjects
FG00143 subjects
FG0029 subjects
FG00313 subjects
FG00442 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Adverse Event
FG00024 subjects
FG00124 subjects
FG0022 subjects
FG0035 subjects
FG004
Lack of Efficacy
FG0006 subjects
FG0017 subjects
FG0023 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG00018 subjects
FG0019 subjects
FG0024 subjects
FG0034 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
BG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
BG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
BG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
BG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000204
BG001201
BG00256
BG00352
BG004204
BG005717
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
BG00053.0± 11.9
BG00152.9± 11.8
BG00255.5± 13.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000174
BG001168
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% 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: all randomized participants who received >=1 dose and had >=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.
Posted
Number
percentage of participants
Month 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG002106
OG003
Title
Denominators
Categories
Title
Measurements
OG00051.53
OG00152.55
OG00228.30
OG003
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 for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.
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
24.24
2-Sided
95
13.18
35.31
No
Superiority or Other
Primary
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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.
Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Primary
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).
Posted
Number
percentage of participants
Month 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
ACR20 response: >=20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Posted
Number
percentage of participants
Month 1, 3
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response 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 the HAQ); and CRP.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Posted
Number
percentage of participants
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 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 the HAQ); and CRP.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Posted
Number
percentage of participants
Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response 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 the HAQ); and CRP.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Posted
Number
percentage of participants
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 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 the HAQ); and CRP.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Posted
Number
percentage of participants
Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response 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 the HAQ); and CRP.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
Posted
Number
percentage of participants
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
DAS28-4 [CRP] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.
Posted
Baseline, Month 1, 3, 6, 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.
Posted
Baseline, Month 1, 3, 6, 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
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; 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.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Secondary
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
mm
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
mm
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
mm
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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 mm = very well and 100 mm = very poorly.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
mm
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
mm
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Physician Global Assessment (PGA) of Arthritis Pain 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
mm
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 9, 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Secondary
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
Secondary
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Number
participants
Baseline, Month 1, 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
Posted
Number
participants
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Euro Quality of Life-5 Dimension (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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Secondary
Work Limitations Questionnaire (WLQ) Score at 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 [no loss] to 100 [complete loss of work]).
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
events
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
events
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
days
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
days
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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, hours affected per day and average number of hours missed work per day were reported.
FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
hours per day
Baseline, Month 3, 6
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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, hours affected per day and average number of hours missed work per day were reported.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
hours per day
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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 10-point scale, where higher score indicated lower work performance.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
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 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
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 10-point scale, where higher score indicated lower work performance.
FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Posted
Mean
Standard Deviation
units on a scale
Month 12
ID
Title
Description
OG000
CP-690,550 5 mg
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG001
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
Time Frame
Baseline Through Month 12
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 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
12
204
51
204
EG001
CP-690,550 10 mg (Up To Month 3)
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
10
201
44
201
EG002
Placebo (Up To Month 3)
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
2
108
18
108
EG003
Adalimumab (Up To Month 3)
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
5
204
50
204
EG004
CP-690,550 5 mg (Month 3 to 6)
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
10
232
18
232
EG005
CP-690,550 10 mg (Month 3 to 6)
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
7
222
8
222
EG006
Placebo (Month 3 to 6)
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
2
59
3
59
EG007
Adalimumab (Month 3 to 6)
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
6
204
18
204
EG008
CP-690,550 5 mg (Post Month 6)
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
11
260
36
260
EG009
CP-690,550 10 mg (Post Month 6)
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
10
253
44
253
EG010
Adalimumab (Post Month 6)
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
7
204
24
204
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG0031 affected204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
Atrioventricular block complete
Cardiac disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0021 affected108 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Anal polyp
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Salivary gland calculus
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0021 affected108 at risk
EG003
Impaired healing
General disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Cellulitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0002 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Herpes zoster
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Labyrinthitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0021 affected108 at risk
EG003
Tooth abscess
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Hair follicle tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Metastatic renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Ovarian germ cell teratoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Dysarthria
Nervous system disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0021 affected108 at risk
EG003
IgA nephropathy
Renal and urinary disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Hypertension
Vascular disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0011 affected201 at risk
EG0020 affected108 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Retinal detachment
Eye disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Pyrexia
General disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Breast abscess
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Clostridial infection
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Erysipelas
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Gallbladder empyema
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Localised infection
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Septic shock
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Scapula fracture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Benign salivary gland neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cholesteatoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cervix disorder
Reproductive system and breast disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Ovarian torsion
Reproductive system and breast disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Chest pain
General disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Lung abscess
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Pneumonia
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Salpingo-oophoritis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Headache
Nervous system disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Pulmonary sarcoidosis
Respiratory, thoracic and mediastinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain upper
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0004 affected204 at risk
EG0012 affected201 at risk
EG0021 affected108 at risk
EG0033 affected204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0097 affected253 at risk
EG0100 affected204 at risk
Diarrhoea
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0005 affected204 at risk
EG0012 affected201 at risk
EG0020 affected108 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0004 affected204 at risk
EG0013 affected201 at risk
EG0022 affected108 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0004 affected204 at risk
EG0010 affected201 at risk
EG0021 affected108 at risk
EG003
Oedema peripheral
General disorders
MedDRAv13.1
Non-systematic Assessment
EG0003 affected204 at risk
EG0014 affected201 at risk
EG0023 affected108 at risk
EG003
Bronchitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0002 affected204 at risk
EG0013 affected201 at risk
EG0021 affected108 at risk
EG003
Herpes zoster
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0015 affected201 at risk
EG0020 affected108 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0008 affected204 at risk
EG0014 affected201 at risk
EG0020 affected108 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0009 affected204 at risk
EG0017 affected201 at risk
EG0021 affected108 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0005 affected204 at risk
EG0012 affected201 at risk
EG0020 affected108 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRAv13.1
Non-systematic Assessment
EG0003 affected204 at risk
EG0014 affected201 at risk
EG0020 affected108 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0014 affected201 at risk
EG0021 affected108 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0002 affected204 at risk
EG0011 affected201 at risk
EG0021 affected108 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0004 affected204 at risk
EG0010 affected201 at risk
EG0022 affected108 at risk
EG003
Headache
Nervous system disorders
MedDRAv13.1
Non-systematic Assessment
EG0008 affected204 at risk
EG0016 affected201 at risk
EG0022 affected108 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0012 affected201 at risk
EG0023 affected108 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0001 affected204 at risk
EG0013 affected201 at risk
EG0021 affected108 at risk
EG003
Hypertension
Vascular disorders
MedDRAv13.1
Non-systematic Assessment
EG0002 affected204 at risk
EG0015 affected201 at risk
EG0022 affected108 at risk
EG003
Pharyngitis
Infections and infestations
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRAv13.1
Non-systematic Assessment
EG0000 affected204 at risk
EG0010 affected201 at risk
EG0020 affected108 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
Ancestor Terms
ID
Term
D001168
Arthritis
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
D000068879
Adalimumab
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
22 subjects
6 subjects
0 subjects
1 subjects
12 subjects
51.9
± 13.7
BG00452.5± 11.7
BG00552.9± 12.1
43
BG00339
BG004162
BG005586
Male
BG00030
BG00133
BG00213
BG00313
BG00442
BG005131
199
47.24
OG000
OG002
Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
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
23.22
2-Sided
95
12.16
34.29
No
Superiority or Other
OG002
OG003
Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
Normal approximation
0.0007
Statistical testing was done at 5% significance level (2-sided).
Percent difference
18.93
2-Sided
95
7.90
29.96
No
Superiority or Other
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000201
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=201, 199, 106, 201)
Title
Measurements
OG0001.50± 0.64
OG0011.53± 0.63
OG0021.42± 0.68
OG0031.50± 0.59
Month 3 (n=188, 185, 98, 190)
Title
Measurements
OG000-0.49± 0.59
OG001-0.59± 0.58
OG002-0.17± 0.56
OG003
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 (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
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 in this measure, the comparison of 10 mg to placebo in ACR20 had to be significant.
LS mean difference
-0.38
Standard Error of the Mean
0.06
2-Sided
95
-0.50
-0.25
No
Superiority or Other
OG000
OG002
LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
Mixed Models Analysis
<0.0001
Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as the comparison of 5 mg to placebo in ACR20 had to be statistically significant.
LS mean difference
-0.31
2-Sided
95
-0.43
-0.19
No
Superiority or Other
OG002
OG003
LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.
Mixed Models Analysis
<0.0001
Statistical testing was done at 5% significance level (2-sided).
LS mean difference
-0.25
2-Sided
95
-0.37
-0.13
No
Superiority or Other
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000177
OG001176
OG00292
OG003178
Title
Denominators
Categories
Title
Measurements
OG0006.21
OG00112.50
OG0021.09
OG0036.74
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 CP-690,550 10 mg to placebo and two-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 comparison of 10 mg to placebo to be statistically significant in this measure, comparison of 10 mg to placebo in HAQ-DI had to be significant.
Percent difference
11.41
2-Sided
95
6.08
16.73
No
Superiority or Other
OG000
OG002
Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
Normal approximation
0.0151
Step-down procedure: For the comparison of 5 mg to placebo to be statistically significant in this measure, the comparison of 10 mg to placebo as well as comparison of 5 mg to placebo in HAQ-DI had to be statistically significant.
Percent difference
5.12
2-Sided
95
0.98
9.26
No
Superiority or Other
OG002
OG003
Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.
Normal approximation
0.0091
Statistical testing was done at 5% significance level (2-sided).
Percent difference
5.65
2-Sided
95
1.40
9.90
No
Superiority or Other
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG002106
OG003199
Title
Denominators
Categories
Month 1
Title
Measurements
OG00041.24
OG00145.92
OG00216.04
OG00337.88
Month 3
Title
Measurements
OG00060.71
OG00158.67
OG00226.42
OG003
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG00256
OG00350
OG004199
Title
Denominators
Categories
Month 9
Title
Measurements
OG00049.49
OG00150.51
OG00230.36
OG00336.00
OG00447.24
Month 12
Title
Measurements
OG00049.49
OG00149.49
OG00233.93
OG003
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG002106
OG003199
Title
Denominators
Categories
Month 1
Title
Measurements
OG00014.95
OG00116.33
OG0024.72
OG00312.12
Month 3
Title
Measurements
OG00034.18
OG00127.55
OG0026.60
OG003
Month 6
Title
Measurements
OG00036.73
OG00134.69
OG00212.26
OG003
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG00256
OG00350
OG004199
Title
Denominators
Categories
Month 9
Title
Measurements
OG00035.71
OG00137.24
OG00217.86
OG00326.00
OG00429.15
Month 12
Title
Measurements
OG00036.73
OG00135.71
OG00221.43
OG003
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG002106
OG003199
Title
Denominators
Categories
Month 1
Title
Measurements
OG0002.58
OG0014.08
OG0020.94
OG0033.03
Month 3
Title
Measurements
OG00012.24
OG00114.80
OG0021.89
OG003
Month 6
Title
Measurements
OG00019.90
OG00121.94
OG0021.89
OG003
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000196
OG001196
OG00256
OG00350
OG004199
Title
Denominators
Categories
Month 9
Title
Measurements
OG00018.37
OG00121.94
OG0028.93
OG00310.00
OG00411.06
Month 12
Title
Measurements
OG00022.96
OG00123.47
OG00210.71
OG003
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000200
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=200, 199, 106, 201)
Title
Measurements
OG0005.43± 0.89
OG0015.43± 0.83
OG0025.44± 0.88
OG0035.33± 0.92
Month 1 (n=193, 196, 104, 197)
Title
Measurements
OG0004.26± 1.09
OG0014.21± 1.05
OG0025.09± 1.15
OG003
Month 3 (n=187, 184, 99, 190)
Title
Measurements
OG0003.78± 1.21
OG0013.77± 1.21
OG0024.83± 1.25
OG003
Month 6 (n=174, 180, 46, 181)
Title
Measurements
OG0003.51± 1.27
OG0013.29± 1.22
OG0023.85± 1.14
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000160
OG001167
OG00249
OG00341
OG004171
Title
Denominators
Categories
Month 9 (n=160, 167, 49, 41, 171)
Title
Measurements
OG0003.13± 1.11
OG0013.20± 1.20
OG0023.11± 1.11
OG0033.03± 1.10
OG0043.46± 1.21
Month 12 (n=149, 150, 48, 37, 160)
Title
Measurements
OG0003.05± 1.13
OG0013.00± 1.18
OG0023.12± 0.96
OG003
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000195
OG001194
OG002103
OG003194
Title
Denominators
Categories
Baseline (n=195, 194, 103, 194)
Title
Measurements
OG0006.56± 0.93
OG0016.48± 0.89
OG0026.45± 0.90
OG0036.36± 0.93
Month 1 (n=172, 175, 90, 176)
Title
Measurements
OG0005.23± 1.19
OG0015.14± 1.26
OG0025.93± 1.22
OG003
Month 3 (n=170, 166, 87, 167)
Title
Measurements
OG0004.64± 1.33
OG0014.66± 1.39
OG0025.60± 1.31
OG003
Month 6 (n=155, 162, 41, 158)
Title
Measurements
OG0004.40± 1.38
OG0014.21± 1.38
OG0024.61± 1.17
OG003
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000140
OG001151
OG00245
OG00335
OG004149
Title
Denominators
Categories
Month 9 (n=140, 151, 45, 35, 149)
Title
Measurements
OG0004.00± 1.21
OG0014.08± 1.33
OG0023.99± 1.25
OG0033.93± 1.17
OG0044.20± 1.39
Month 12 (n=134, 136, 44, 32, 139)
Title
Measurements
OG0003.85± 1.22
OG0013.88± 1.35
OG0024.00± 0.95
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000194
OG001196
OG002106
OG003198
Title
Denominators
Categories
Month 1 (n=194, 196, 106, 198)
Title
Measurements
OG0001.15± 0.66
OG0011.11± 0.67
OG0021.32± 0.69
OG0031.12± 0.64
Month 3 (n=188, 185, 99, 190)
Title
Measurements
OG0001.00± 0.72
OG0010.94± 0.75
OG0021.25± 0.67
OG003
Month 6 (n=174, 181, 46, 180)
Title
Measurements
OG0000.92± 0.72
OG0010.89± 0.69
OG0021.15± 0.71
OG003
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000158
OG001167
OG00249
OG00341
OG004171
Title
Denominators
Categories
Month 9 (n=158, 167, 49, 41, 171)
Title
Measurements
OG0000.86± 0.66
OG0010.85± 0.66
OG0020.89± 0.69
OG0030.90± 0.64
OG0040.97± 0.67
Month 12 (n=149, 149, 49, 38, 159)
Title
Measurements
OG0000.83± 0.68
OG0010.81± 0.71
OG0020.88± 0.71
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000201
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=201, 199, 106, 201)
Title
Measurements
OG00059.29± 20.95
OG00159.01± 22.18
OG00255.20± 21.27
OG00356.46± 21.92
Month 1 (n=194, 196, 106, 198)
Title
Measurements
OG00039.71± 22.60
OG00136.77± 22.63
OG00249.92± 23.94
OG003
Month 3 (n=188, 185, 99, 190)
Title
Measurements
OG00032.98± 23.09
OG00131.27± 22.39
OG00248.53± 23.42
OG003
Month 6 (n=174, 181, 46, 179)
Title
Measurements
OG00030.40± 23.26
OG00128.36± 22.52
OG00235.04± 20.95
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000158
OG001167
OG00249
OG00341
OG004171
Title
Denominators
Categories
Month 9 (n=158, 167, 49, 41, 171)
Title
Measurements
OG00027.04± 21.35
OG00127.99± 22.97
OG00231.31± 22.66
OG00324.93± 19.38
OG00432.70± 24.18
Month 12 (n=150, 150, 49, 38, 160)
Title
Measurements
OG00026.99± 21.97
OG00124.55± 20.68
OG00228.23± 17.86
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000201
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=201, 199, 106, 201)
Title
Measurements
OG00059.86± 21.38
OG00156.55± 23.83
OG00254.46± 21.27
OG00357.22± 22.22
Month 1 (n=194, 196, 105, 197)
Title
Measurements
OG00041.85± 23.02
OG00136.61± 23.51
OG00250.70± 24.24
OG003
Month 3 (n=188, 185, 99, 190)
Title
Measurements
OG00035.56± 23.81
OG00131.25± 22.23
OG00249.84± 22.45
OG003
Month 6 (n=174, 181, 46, 180)
Title
Measurements
OG00032.79± 25.56
OG00129.74± 22.41
OG00237.76± 20.86
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000158
OG001167
OG00249
OG00341
OG004171
Title
Denominators
Categories
Month 9 (n=158, 167, 49, 41, 171)
Title
Measurements
OG00028.39± 22.31
OG00129.47± 21.99
OG00231.78± 20.75
OG00330.00± 20.31
OG00434.38± 24.93
Month 12 (n=149, 150, 49, 37, 160)
Title
Measurements
OG00026.86± 22.44
OG00127.70± 22.09
OG00230.78± 17.65
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000199
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=199, 199, 106, 201)
Title
Measurements
OG00059.92± 16.77
OG00159.56± 16.70
OG00260.28± 16.55
OG00358.64± 15.98
Month 1 (n=193, 195, 106, 197)
Title
Measurements
OG00038.90± 18.56
OG00136.16± 19.27
OG00250.73± 22.08
OG003
Month 3 (n=186, 185, 99, 189)
Title
Measurements
OG00030.28± 20.71
OG00129.91± 21.04
OG00245.12± 22.77
OG003
Month 6 (n=174, 180, 46, 178)
Title
Measurements
OG00024.97± 19.26
OG00124.46± 19.78
OG00229.76± 20.43
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000160
OG001167
OG00249
OG00341
OG004170
Title
Denominators
Categories
Month 9 (n=160, 167, 49, 41, 170)
Title
Measurements
OG00019.93± 16.20
OG00121.92± 17.87
OG00225.82± 20.32
OG00323.78± 15.54
OG00425.45± 19.94
Month 12 (n=149, 150, 48, 38, 157)
Title
Measurements
OG00018.67± 16.18
OG00118.87± 16.05
OG00219.77± 13.88
OG003
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Month 12: Social functioning (n=150,150,49,38,160)
Title
Measurements
OG00043.14± 10.46
OG00144.07± 10.44
OG00243.78± 9.97
OG003
Month 12: Bodily pain (n=150,150,49,38,160)
Title
Measurements
OG00043.44± 9.48
OG00144.02± 10.02
OG00243.90± 8.28
OG003
Month 12: Mental health (n=150,149,49,38,159)
Title
Measurements
OG00044.83± 10.02
OG00145.06± 10.49
OG00244.09± 9.20
OG003
Month 12:Role emotional (n=150,150,49,38,159)
Title
Measurements
OG00040.18± 11.46
OG00142.25± 11.68
OG00240.23± 10.79
OG003
Month 12: Vitality (n=150,149,49,38,159)
Title
Measurements
OG00047.60± 9.01
OG00149.12± 9.95
OG00247.31± 9.13
OG003
Month 12:General health (n=150,150,49,38,160)
Title
Measurements
OG00041.07± 9.85
OG00142.33± 9.05
OG00240.47± 9.44
OG003
Month 12:Mental component (n=149,149,49,38,158)
Title
Measurements
OG00045.02± 10.14
OG00146.29± 10.56
OG00245.02± 9.29
OG003
Month 12: Physical component(n=149,149,49,38,158)
Title
Measurements
OG00041.44± 8.81
OG00141.96± 9.40
OG00240.82± 8.01
OG003
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000201
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=201, 199, 106, 201)
Title
Measurements
OG00028.18± 10.48
OG00128.56± 10.84
OG00230.49± 10.23
OG00327.95± 10.07
Month 1 (n=192, 196, 106, 198)
Title
Measurements
OG00032.54± 9.94
OG00133.95± 10.54
OG00231.66± 10.09
OG003
Month 3 (n=187, 185, 99, 190)
Title
Measurements
OG00033.86± 10.18
OG00135.12± 11.07
OG00230.96± 10.21
OG003
Month 6 (n=173, 181, 46, 180)
Title
Measurements
OG00034.58± 10.53
OG00136.09± 10.07
OG00232.37± 8.92
OG003
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000150
OG001151
OG00249
OG00338
OG004159
Title
Denominators
Categories
Title
Measurements
OG00035.76± 9.53
OG00137.53± 10.41
OG00236.71± 7.81
OG00335.71± 9.65
OG00434.30± 9.83
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000199
OG001198
OG002105
OG003200
Title
Denominators
Categories
Baseline: SPS (n=199, 198, 105, 200)
Title
Measurements
OG00042.13± 20.58
OG00140.20± 19.48
OG00239.14± 19.04
OG00340.90± 19.68
Baseline: OSP (n=199, 198, 105, 200)
Title
Measurements
OG00043.24± 19.91
OG00142.27± 19.32
OG00241.27± 19.47
OG003
Baseline: Ade (n=200, 198, 105, 200)
Title
Measurements
OG00042.95± 27.92
OG00144.04± 28.21
OG00247.43± 26.06
OG003
Baseline: ASOB (n=200, 198, 105, 200)
Title
Measurements
OG00019.10± 24.91
OG00115.96± 21.70
OG00218.67± 24.54
OG003
Baseline: SD (n=200, 198, 105, 200)
Title
Measurements
OG00045.46± 26.30
OG00144.67± 25.96
OG00243.95± 27.40
OG003
Baseline: Qua (n=200, 198, 104, 199)
Title
Measurements
OG0006.46± 1.36
OG0016.61± 1.70
OG0026.70± 1.51
OG003
Baseline: Sno (n=198, 197, 105, 199)
Title
Measurements
OG00036.06± 31.78
OG00134.62± 31.71
OG00230.10± 28.16
OG003
Baseline: Som (n=199, 198, 105, 199)
Title
Measurements
OG00036.52± 21.22
OG00135.66± 22.28
OG00236.70± 20.55
OG003
Month 1: SPS (n=194, 195, 105, 198)
Title
Measurements
OG00036.25± 19.19
OG00134.03± 18.74
OG00237.62± 18.83
OG003
Month 1: OSP (n=194, 195, 105, 198)
Title
Measurements
OG00036.70± 18.13
OG00134.81± 18.64
OG00238.77± 18.45
OG003
Month 1: Ade (n=194, 195, 105, 198)
Title
Measurements
OG00048.97± 27.11
OG00152.62± 27.62
OG00249.81± 25.87
OG003
Month 1: ASOB (n=194, 195, 105, 198)
Title
Measurements
OG00018.35± 22.52
OG00114.56± 20.13
OG00219.81± 23.78
OG003
Month 1: SD (n=194, 195, 105, 198)
Title
Measurements
OG00036.52± 23.48
OG00135.46± 24.25
OG00240.43± 26.13
OG003
Month 1: Qua (n=193, 195, 105, 197)
Title
Measurements
OG0006.70± 1.38
OG0016.97± 1.49
OG0026.74± 1.49
OG003
Month 1: Sno (n=194, 193, 104, 196)
Title
Measurements
OG00036.08± 32.53
OG00134.30± 29.56
OG00231.35± 27.13
OG003
Month 1: Som (n=194, 195, 105, 198)
Title
Measurements
OG00031.68± 21.26
OG00131.04± 22.02
OG00233.90± 21.80
OG003
Month 3: SPS (n=186, 185, 99, 190)
Title
Measurements
OG00035.39± 18.66
OG00132.86± 20.91
OG00237.54± 19.18
OG003
Month 3: OSP (n=186, 185, 99, 190)
Title
Measurements
OG00035.74± 18.30
OG00133.44± 20.23
OG00238.55± 18.97
OG003
Month 3: Ade (n=187, 185, 99, 190)
Title
Measurements
OG00050.59± 27.67
OG00153.24± 28.90
OG00248.99± 28.16
OG003
Month 3: ASOB (n=187, 185, 99, 190)
Title
Measurements
OG00018.18± 22.12
OG00114.81± 20.62
OG00218.59± 20.85
OG003
Month 3: SD (n=186, 185, 99, 190)
Title
Measurements
OG00035.93± 24.29
OG00132.86± 25.10
OG00238.66± 26.24
OG003
Month 3: Qua (n=188, 185, 99, 190)
Title
Measurements
OG0006.82± 1.32
OG0017.03± 1.45
OG0026.51± 1.56
OG003
Month 3: Sno (n=186, 184, 99, 189)
Title
Measurements
OG00033.66± 30.78
OG00134.35± 30.06
OG00230.10± 22.92
OG003
Month 3: Som (n=187, 185, 99, 190)
Title
Measurements
OG00029.41± 19.66
OG00130.74± 22.65
OG00236.50± 20.10
OG003
Month 6: SPS (n=173, 181, 46, 179)
Title
Measurements
OG00032.66± 18.60
OG00131.79± 18.64
OG00236.52± 19.89
OG003
Month 6: OSP (n=173, 181, 46, 179)
Title
Measurements
OG00033.28± 17.93
OG00132.46± 18.50
OG00236.87± 18.51
OG003
Month 6: Ade (n=173, 181, 46, 179)
Title
Measurements
OG00053.12± 28.85
OG00153.76± 27.87
OG00250.00± 26.83
OG003
Month 6: ASOB (n=173, 181, 46, 179)
Title
Measurements
OG00016.65± 22.00
OG00113.48± 20.21
OG00216.52± 20.79
OG003
Month 6: SD (n=173, 181, 46, 179)
Title
Measurements
OG00032.95± 23.76
OG00132.00± 24.30
OG00237.31± 24.73
OG003
Month 6: Qua (n=173, 181, 45, 178)
Title
Measurements
OG0006.86± 1.18
OG0017.10± 1.60
OG0026.71± 1.50
OG003
Month 6: Sno (n=171, 180, 46, 179)
Title
Measurements
OG00031.46± 31.43
OG00135.00± 29.13
OG00223.91± 23.33
OG003
Month 6: Som (n=173, 181, 46, 179)
Title
Measurements
OG00028.17± 17.55
OG00130.39± 22.37
OG00233.62± 17.72
OG003
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000148
OG001150
OG00249
OG00337
OG004158
Title
Denominators
Categories
SPS (n=148, 150, 49, 37, 159)
Title
Measurements
OG00034.62± 18.58
OG00130.64± 18.42
OG00234.69± 19.10
OG00334.68± 21.32
OG00435.72± 20.25
OSP (n=148, 150, 49, 37, 158)
Title
Measurements
OG00034.86± 17.87
OG00131.49± 17.90
OG00236.00± 17.63
OG003
Ade (n=149, 150, 49, 37, 159)
Title
Measurements
OG00051.21± 26.96
OG00157.20± 28.48
OG00254.29± 27.84
OG003
ASOB (n=149, 150, 49, 37, 159)
Title
Measurements
OG00016.78± 19.74
OG00114.13± 20.67
OG00221.22± 22.14
OG003
SD (n=149, 150, 49, 37, 159)
Title
Measurements
OG00034.82± 23.95
OG00132.32± 22.41
OG00237.12± 23.55
OG003
Qua (n=148, 150, 49, 37, 158)
Title
Measurements
OG0006.78± 1.19
OG0017.03± 1.47
OG0026.86± 1.34
OG003
Sno (n=148, 150, 48, 37, 159)
Title
Measurements
OG00033.78± 29.95
OG00130.53± 27.29
OG00227.50± 22.83
OG003
Som (n=148, 150, 49, 37, 158)
Title
Measurements
OG00029.41± 18.95
OG00127.07± 19.36
OG00232.38± 17.53
OG003
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000201
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=201, 199, 106, 201)
Title
Measurements
OG00094
OG00194
OG00249
OG00388
Month 1 (n=194, 196, 106, 198)
Title
Measurements
OG00093
OG001107
OG00255
OG003
Month 3 (n=188, 185, 99, 190)
Title
Measurements
OG000100
OG001110
OG00237
OG003
Month 6 (n=174, 181, 94, 182)
Title
Measurements
OG000100
OG001100
OG00246
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000150
OG001151
OG00249
OG00338
OG004160
Title
Denominators
Categories
Title
Measurements
OG00080
OG00184
OG00228
OG00319
OG00475
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000200
OG001199
OG002106
OG003201
Title
Denominators
Categories
Baseline (n=200, 199, 106, 201)
Title
Measurements
OG0000.43± 0.32
OG0010.43± 0.32
OG0020.50± 0.28
OG0030.45± 0.29
Month 1 (n=192, 195, 106, 198)
Title
Measurements
OG0000.61± 0.23
OG0010.60± 0.25
OG0020.56± 0.25
OG003
Month 3 (n=187, 184, 99, 189)
Title
Measurements
OG0000.62± 0.28
OG0010.64± 0.28
OG0020.55± 0.27
OG003
Month 6 (n=172, 180, 46, 178)
Title
Measurements
OG0000.66± 0.26
OG0010.65± 0.25
OG0020.58± 0.28
OG003
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000147
OG001151
OG00249
OG00338
OG004159
Title
Denominators
Categories
Title
Measurements
OG0000.69± 0.22
OG0010.69± 0.22
OG0020.68± 0.20
OG0030.66± 0.19
OG0040.66± 0.27
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG00085
OG00181
OG00242
OG00378
Title
Denominators
Categories
Baseline: TMS (n=79, 77, 40, 76)
Title
Measurements
OG00041.46± 23.42
OG00142.09± 28.98
OG00237.65± 23.69
OG00346.43± 25.94
Baseline: PDS (n=85, 76, 40, 77)
Title
Measurements
OG00049.99± 23.16
OG00152.14± 24.22
OG00253.24± 23.62
OG003
Baseline: MIDS (n=82, 79, 41, 77)
Title
Measurements
OG00026.80± 22.80
OG00127.30± 22.32
OG00224.85± 28.33
OG003
Baseline: ODS (n=80, 74, 40, 77)
Title
Measurements
OG00036.34± 26.55
OG00137.29± 28.16
OG00229.28± 26.41
OG003
Baseline: WLI (n=85, 81, 42, 81)
Title
Measurements
OG0009.76± 5.34
OG0019.85± 5.67
OG0028.83± 5.90
OG003
Month 3: TMS (n=74, 68, 40, 70)
Title
Measurements
OG00031.31± 25.50
OG00121.97± 25.52
OG00234.26± 26.40
OG003
Month 3: PDS (n=77, 72, 39, 76)
Title
Measurements
OG00053.03± 26.21
OG00147.04± 33.97
OG00255.57± 27.38
OG003
Month 3: MIDS (n=78, 72, 41, 73)
Title
Measurements
OG00021.45± 22.03
OG00115.14± 20.53
OG00223.20± 26.04
OG003
Month 3: ODS (n=75, 70, 39, 76)
Title
Measurements
OG00026.64± 23.61
OG00119.31± 23.89
OG00227.44± 25.18
OG003
Month 3: WLI (n=80, 74, 41, 78)
Title
Measurements
OG0007.89± 5.12
OG0015.92± 5.17
OG0028.39± 5.73
OG003
Month 6: PDS (n=66, 65, 15, 71)
Title
Measurements
OG00055.62± 30.05
OG00153.57± 36.13
OG00255.03± 29.84
OG003
Month 6: TMS (n=68, 65, 16, 67)
Title
Measurements
OG00029.87± 26.81
OG00121.30± 27.67
OG00224.53± 24.19
OG003
Month 6: MIDS (n=70, 68, 16, 71)
Title
Measurements
OG00017.50± 21.18
OG00112.87± 22.77
OG00218.26± 23.15
OG003
Month 6: ODS (n=67, 67, 16, 69)
Title
Measurements
OG00023.18± 25.53
OG00116.44± 23.79
OG00219.69± 20.77
OG003
Month 6: WLI (n= 70, 69, 16, 73)
Title
Measurements
OG0007.32± 5.47
OG0015.69± 5.54
OG0026.89± 4.90
OG003
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG00057
OG00155
OG00221
OG00314
OG00460
Title
Denominators
Categories
TMS (n=55, 53, 20, 14, 57)
Title
Measurements
OG00025.59± 25.10
OG00120.77± 28.68
OG00232.69± 29.07
OG00328.75± 28.26
OG00426.57± 26.68
PDS (n=55, 52, 18, 14, 58)
Title
Measurements
OG00054.35± 32.96
OG00155.69± 38.22
OG00251.81± 32.57
OG003
MIDS (n=55, 51, 21, 14, 58)
Title
Measurements
OG00014.72± 19.96
OG00113.96± 23.76
OG00221.46± 27.11
OG003
ODS (n=57, 50, 19, 14, 58)
Title
Measurements
OG00020.51± 23.13
OG00117.35± 27.77
OG00227.11± 27.29
OG003
WLI (n=57, 55, 21, 14, 60)
Title
Measurements
OG0006.61± 5.07
OG0015.78± 5.59
OG0027.75± 6.53
OG003
OG002
Placebo
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Baseline: Seen NM practitioner (n=201,199,106,201)
Title
Measurements
OG0001.99± 0.12
OG0011.97± 0.17
OG0021.98± 0.14
OG003
Baseline: Currently employed (n=201,199,106,201)
Title
Measurements
OG0001.64± 0.48
OG0011.65± 0.48
OG0021.64± 0.48
OG003
Baseline: Feel well enough to work (n=73,83,39,81)
Title
Measurements
OG0001.90± 0.30
OG0011.89± 0.31
OG0021.82± 0.39
OG003
Baseline: Retired (n=80,88,45,89)
Title
Measurements
OG0001.41± 0.50
OG0011.41± 0.49
OG0021.40± 0.50
OG003
Baseline: Lost job/retired early(n=66,82,39,81)
Title
Measurements
OG0001.50± 0.50
OG0011.70± 0.46
OG0021.74± 0.44
OG003
Baseline: Unable to work due to RA (n=76,84,40,78)
Title
Measurements
OG0001.36± 0.48
OG0011.37± 0.49
OG0021.45± 0.50
OG003
Baseline: Work disabled due to RA (n=66,82,40,79)
Title
Measurements
OG0001.56± 0.50
OG0011.70± 0.46
OG0021.70± 0.46
OG003
Baseline: Sick leave due to RA (n=167,166,92,167)
Title
Measurements
OG0001.85± 0.36
OG0011.86± 0.35
OG0021.84± 0.37
OG003
Baseline: Part time work (n=169,166,92,167)
Title
Measurements
OG0001.92± 0.27
OG0011.92± 0.27
OG0021.93± 0.25
OG003
Baseline: Performed paid work(n=169,166,91,167)
Title
Measurements
OG0001.69± 0.46
OG0011.70± 0.46
OG0021.66± 0.48
OG003
Baseline: Unable to do chores (n=201,199,105,198)
Title
Measurements
OG0001.41± 0.49
OG0011.46± 0.50
OG0021.53± 0.50
OG003
Baseline: Chores by housekeeper(n=201,199,106,201)
Title
Measurements
OG0001.89± 0.32
OG0011.90± 0.29
OG0021.93± 0.25
OG003
Baseline: Chores by family (n=200,199,106,201)
Title
Measurements
OG0001.50± 0.50
OG0011.48± 0.50
OG0021.62± 0.49
OG003
Month 3: Seen any doctor (n=186,185,99,190)
Title
Measurements
OG0001.27± 0.45
OG0011.28± 0.45
OG0021.22± 0.42
OG003
Month 3: Treated in ER (n=186,185,99,190)
Title
Measurements
OG0001.96± 0.20
OG0011.96± 0.19
OG0021.96± 0.20
OG003
Month 3: Admitted overnight stay (n=8,8,4,9)
Title
Measurements
OG0000.25± 0.46
OG0010.88± 0.99
OG0020.00± 0.00
OG003
Month 3: Hospitalization (n=185,185,99,190)
Title
Measurements
OG0001.98± 0.15
OG0011.97± 0.16
OG0021.99± 0.10
OG003
Month 3: Outpatient surgeries (n=185,185,99,190)
Title
Measurements
OG0001.98± 0.13
OG0011.98± 0.15
OG0021.96± 0.20
OG003
Month 3: Diagnostic tests (n=184,185,99,190)
Title
Measurements
OG0001.90± 0.30
OG0011.87± 0.34
OG0021.91± 0.29
OG003
Month 3: In nursing home (n=185,185,99,190)
Title
Measurements
OG0001.99± 0.07
OG0012.00± 0.00
OG0022.00± 0.00
OG003
Month 3: Home HC services (n=184,185,99,190)
Title
Measurements
OG0001.99± 0.07
OG0012.00± 0.00
OG0022.00± 0.00
OG003
Month 3: Required aids/devices (n=185,185,99,190)
Title
Measurements
OG0001.94± 0.25
OG0011.91± 0.29
OG0021.92± 0.27
OG003
Month 3: Seen NM practitioner (n=185,185,99,190)
Title
Measurements
OG0001.97± 0.16
OG0012.00± 0.00
OG0021.98± 0.14
OG003
Month 3: Currently employed (n=185,185,99,190)
Title
Measurements
OG0001.62± 0.49
OG0011.64± 0.48
OG0021.63± 0.49
OG003
Month 3: Feel well enough to work (n=74,79,41,80)
Title
Measurements
OG0001.70± 0.46
OG0011.73± 0.44
OG0021.93± 0.26
OG003
Month 3: Retired (n=80,86,47,86)
Title
Measurements
OG0001.39± 0.49
OG0011.34± 0.48
OG0021.38± 0.49
OG003
Month 3: Lost job/retired early(n=73,78,40,79)
Title
Measurements
OG0001.55± 0.50
OG0011.59± 0.50
OG0021.75± 0.44
OG003
Month 3: Unable to work due to RA (n=76,83,44,77)
Title
Measurements
OG0001.42± 0.50
OG0011.46± 0.50
OG0021.45± 0.50
OG003
Month 3: Work disabled due to RA (n=71,82,41,73)
Title
Measurements
OG0001.63± 0.49
OG0011.68± 0.47
OG0021.61± 0.49
OG003
Month 3: Sick leave due to RA (n=153,146,85,157)
Title
Measurements
OG0001.93± 0.26
OG0011.94± 0.24
OG0021.81± 0.39
OG003
Month 3: Part time work (n=153,145,85,155)
Title
Measurements
OG0001.95± 0.21
OG0011.97± 0.16
OG0021.94± 0.24
OG003
Month 3: Performed paid work(n=153,145,85,157)
Title
Measurements
OG0001.73± 0.45
OG0011.81± 0.39
OG0021.68± 0.47
OG003
Month 3: Unable to do chores(n=182,182,99,189)
Title
Measurements
OG0001.62± 0.49
OG0011.71± 0.46
OG0021.59± 0.50
OG003
Month 3: Chores by housekeeper (n=184,183,99,190)
Title
Measurements
OG0001.91± 0.29
OG0011.94± 0.24
OG0021.93± 0.26
OG003
Month 3: Chores by family (n=183,183,99,190)
Title
Measurements
OG0001.67± 0.47
OG0011.74± 0.44
OG0021.66± 0.48
OG003
Month 6: Seen any doctor (n=173,180,45,179)
Title
Measurements
OG0001.25± 0.43
OG0011.28± 0.45
OG0021.27± 0.45
OG003
Month 6: Treated in ER (n=173,180,46,179)
Title
Measurements
OG0001.93± 0.25
OG0011.97± 0.18
OG0021.91± 0.28
OG003
Month 6: Admitted overnight stay (n=12,6,4,3)
Title
Measurements
OG0000.58± 0.67
OG0010.17± 0.41
OG0020.00± 0.00
OG003
Month 6: Hospitalization (n=172,180,46,179)
Title
Measurements
OG0001.95± 0.22
OG0011.97± 0.16
OG0021.96± 0.21
OG003
Month 6: Outpatient surgeries (n=173,180,46,178)
Title
Measurements
OG0001.98± 0.15
OG0011.96± 0.19
OG0021.98± 0.15
OG003
Month 6: Diagnostic tests (n=173,180,46,178)
Title
Measurements
OG0001.87± 0.33
OG0011.86± 0.35
OG0021.89± 0.31
OG003
Month 6: In nursing home (n=173,180,46,178)
Title
Measurements
OG0001.99± 0.11
OG0012.00± 0.00
OG0022.00± 0.00
OG003
Month 6: Home HC services (n=173,180,46,177)
Title
Measurements
OG0001.99± 0.11
OG0011.99± 0.11
OG0022.00± 0.00
OG003
Month 6: Required aids/devices (n=173,180,46,178)
Title
Measurements
OG0001.91± 0.28
OG0011.91± 0.29
OG0021.87± 0.34
OG003
Month 6: Seen NM practitioner (n=173,180,45,178)
Title
Measurements
OG0002.00± 0.00
OG0011.98± 0.13
OG0022.00± 0.00
OG003
Month 6: Currently employed (n=173,180,46,179)
Title
Measurements
OG0001.62± 0.49
OG0011.66± 0.48
OG0021.63± 0.49
OG003
Month 6: Feel well enough to work (72,81,23,76)
Title
Measurements
OG0001.75± 0.44
OG0011.77± 0.43
OG0021.83± 0.39
OG003
Month 6: Retired (n=77,87,22,82)
Title
Measurements
OG0001.32± 0.47
OG0011.30± 0.46
OG0021.32± 0.48
OG003
Month 6: Lost job/retired early (n=70,82,22,72)
Title
Measurements
OG0001.57± 0.50
OG0011.66± 0.48
OG0021.68± 0.48
OG003
Month 6: Unable to work due to RA (n=73,83,23,74)
Title
Measurements
OG0001.51± 0.50
OG0011.54± 0.50
OG0021.48± 0.51
OG003
Month 6: Work disabled due to RA (n=67,80,22,72)
Title
Measurements
OG0001.72± 0.45
OG0011.70± 0.46
OG0021.73± 0.46
OG003
Month 6: Sick leave due to RA (n=138,134,38,144)
Title
Measurements
OG0001.93± 0.25
OG0011.93± 0.25
OG0021.92± 0.27
OG003
Month 6: Part time work (n=135,134,37,142)
Title
Measurements
OG0001.94± 0.24
OG0011.96± 0.21
OG0021.97± 0.16
OG003
Month 6: Performed paid work (n=136,136,38,142)
Title
Measurements
OG0001.75± 0.43
OG0011.80± 0.40
OG0021.74± 0.45
OG003
Month 6: Unable to do chores(n=171,178,45,175)
Title
Measurements
OG0001.70± 0.46
OG0011.74± 0.44
OG0021.62± 0.49
OG003
Month 6: Chores by housekeeper (n=172,180,45,180)
Title
Measurements
OG0001.92± 0.27
OG0011.94± 0.23
OG0021.93± 0.25
OG003
Month 6: Chores by family (n=172,180,46,180)
Title
Measurements
OG0001.72± 0.45
OG0011.74± 0.44
OG0021.67± 0.47
OG003
OG002
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000148
OG001151
OG00249
OG00338
OG004160
Title
Denominators
Categories
Seen any doctor (n=148,151,49,38,160)
Title
Measurements
OG0001.31± 0.46
OG0011.27± 0.45
OG0021.24± 0.43
OG0031.24± 0.43
OG0041.23± 0.42
Treated in ER (n=149,151,49,38,160)
Title
Measurements
OG0001.98± 0.14
OG0011.97± 0.18
OG0022.00± 0.00
OG003
Admitted overnight stay (n=3,5,0,1,6)
Title
Measurements
OG0000.33± 0.58
OG0010.20± 0.45
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Hospitalization (n=148,151,49,38,160)
Title
Measurements
OG0001.98± 0.14
OG0011.97± 0.18
OG0021.98± 0.14
OG003
Outpatient surgeries (n=148,151,49,38,160)
Title
Measurements
OG0001.97± 0.18
OG0011.99± 0.11
OG0022.00± 0.00
OG003
Diagnostic tests (n=149,151,49,38,159)
Title
Measurements
OG0001.94± 0.24
OG0011.87± 0.33
OG0021.88± 0.33
OG003
In nursing home (n=149,151,49,38,159)
Title
Measurements
OG0001.99± 0.12
OG0012.00± 0.00
OG0022.00± 0.00
OG003
Home HC services (n=148,151,49,38,159)
Title
Measurements
OG0002.00± 0.00
OG0012.00± 0.00
OG0022.00± 0.00
OG003
Required aids/devices (n=148,151,49,38,160)
Title
Measurements
OG0001.93± 0.26
OG0011.92± 0.27
OG0021.94± 0.24
OG003
Seen NM practitioner(n=149,151,49,38,160)
Title
Measurements
OG0001.98± 0.14
OG0011.97± 0.16
OG0021.98± 0.14
OG003
Currently employed (n=148,151,49,38,160)
Title
Measurements
OG0001.59± 0.49
OG0011.68± 0.47
OG0021.61± 0.49
OG003
Feel well enough to work (n=61,79,19,19,76)
Title
Measurements
OG0001.72± 0.45
OG0011.75± 0.44
OG0021.84± 0.37
OG003
Retired (n=64,84,21,19,80)
Title
Measurements
OG0001.25± 0.44
OG0011.31± 0.47
OG0021.19± 0.40
OG003
Lost job/retired early (n=58,75,19,18,75)
Title
Measurements
OG0001.53± 0.50
OG0011.72± 0.45
OG0021.68± 0.48
OG003
Unable to work due to RA (n=59,77,19,19,77)
Title
Measurements
OG0001.56± 0.50
OG0011.61± 0.49
OG0021.58± 0.51
OG003
Work disabled due to RA (n=58,76,19,18,75)
Title
Measurements
OG0001.64± 0.48
OG0011.75± 0.44
OG0021.79± 0.42
OG003
Sick leave due to RA (n=118,112,37,30,124)
Title
Measurements
OG0001.96± 0.20
OG0011.96± 0.19
OG0021.95± 0.23
OG003
Part time work (n=117,112,37,30,123)
Title
Measurements
OG0001.95± 0.22
OG0011.99± 0.09
OG0022.00± 0.00
OG003
Performed paid work (n=118,114,37,31,123)
Title
Measurements
OG0001.83± 0.38
OG0011.82± 0.39
OG0021.78± 0.42
OG003
Unable to do chores (n=146,150,47,38,154)
Title
Measurements
OG0001.81± 0.40
OG0011.75± 0.44
OG0021.79± 0.41
OG003
Chores by housekeeper (n=148,151,49,38,160)
Title
Measurements
OG0001.94± 0.24
OG0011.97± 0.16
OG0021.96± 0.20
OG003
Chores by family (n=145,151,49,38,160)
Title
Measurements
OG0001.76± 0.43
OG0011.80± 0.40
OG0021.84± 0.37
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000168
OG001174
OG00290
OG003172
Title
Denominators
Categories
Baseline: Doctor visits (n=168,174,90,172)
Title
Measurements
OG0004.26± 3.51
OG0014.06± 3.57
OG0024.50± 5.32
OG0033.87± 3.74
Baseline: NM practitioners visits (n=3,6,2,6)
Title
Measurements
OG0001.33± 0.58
OG0013.00± 1.79
OG0024.50± 4.95
OG003
Baseline: Hospital ER visits (n=12,14,7,12)
Title
Measurements
OG0001.08± 0.51
OG0011.93± 1.59
OG0021.57± 0.79
OG003
Baseline: Number visits hospitalized(n=11,5,7,11)
Title
Measurements
OG0002.82± 5.71
OG0011.00± 0.00
OG0021.00± 0.00
OG003
Baseline:Number of outpatient surgeries(n=8,6,2,7)
Month 6: RA related doctor visit(n=132,131,33,129)
Title
Measurements
OG0000.81± 0.63
OG0010.96± 0.74
OG0020.88± 0.86
OG003
Month 6: RA related ER visit (n=12,6,4,3)
Title
Measurements
OG0000.25± 0.62
OG0010.67± 0.82
OG0020.00± 0.00
OG003
Month 6: RA-diagnostic tests (n=21,25,5,19)
Title
Measurements
OG0000.18± 0.50
OG0010.16± 0.37
OG0020.20± 0.45
OG003
Month 6: RA related hospitalization (n=9,5,2,1)
Title
Measurements
OG0000.22± 0.67
OG0010.40± 0.89
OG0020.00± 0.00
OG003
Month 6: RA related outpatient surgery (n=4,7,1,2)
Title
Measurements
OG0000.00± 0.00
OG0010.43± 0.79
OG0020.00± NAStandard deviation was not estimable since only 1 participant were evaluable.
OG003
Month 6: RA related NM visit (n=1,3,0,1)
Title
Measurements
OG0000.00± NAStandard deviation was not estimable since only 1 participant were evaluable.
OG0010.67± 1.15
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000104
OG001111
OG00237
OG00330
OG004125
Title
Denominators
Categories
Doctor visit (n=102,111,37,30,125)
Title
Measurements
OG0002.73± 2.78
OG0012.80± 2.46
OG0023.92± 5.97
OG0033.50± 3.34
OG0042.94± 3.93
NM practitioners visits (n=3,4,1,2,0)
Title
Measurements
OG00010.67± 11.72
OG0019.75± 10.97
OG002192.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Hospital ER visits (n=3,5,0,1,6)
Title
Measurements
OG0001.00± 0.00
OG0012.40± 1.34
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Number of visits hospitalized (n=3,5,1,1,3)
Title
Measurements
OG0001.00± 0.00
OG0011.00± 0.00
OG0021.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Number of outpatient surgeries (n=5,2,0,2,5)
Title
Measurements
OG0001.40± 0.89
OG0011.50± 0.71
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Non-study diagnostic tests (n=8,19,6,6,22)
Title
Measurements
OG0001.13± 0.35
OG0011.95± 1.31
OG0023.17± 2.64
OG003
RA related doctor visit (n=104,111,37,30,125)
Title
Measurements
OG0000.82± 0.59
OG0010.93± 0.57
OG0020.89± 0.52
OG003
RA related ER visits (n=3,5,0,1,6)
Title
Measurements
OG0000.33± 0.58
OG0010.00± 0.00
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
RA-diagnostic tests (n=9,19,6,6,22)
Title
Measurements
OG0000.11± 0.33
OG0010.21± 0.42
OG0020.17± 0.41
OG003
RA related hospitalization (n=3,5,1,1,3)
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG0020.00± NAStandard deviation was not estimable since only 1 participant were evaluable.
OG003
RA related outpatient surgery (n=5,2,0,2,5)
Title
Measurements
OG0000.00± 0.00
OG0010.00± 0.00
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
RA related NM visits (n=3,4,1,2,0)
Title
Measurements
OG0000.00± 0.00
OG0010.50± 1.00
OG0020.00± NAStandard deviation was not estimable as only 1 participant was evaluable.
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000101
OG001102
OG00239
OG00397
Title
Denominators
Categories
Baseline: Hospital length of stay (n=11,6,7,11)
Title
Measurements
OG00013.64± 12.91
OG00110.83± 9.89
OG00213.43± 9.78
OG00312.82± 10.93
Baseline: Days in nursing home (n=3,0,0,4)
Title
Measurements
OG00019.33± 17.56
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Baseline: Days devices/aids used (n=17,28,8,16)
Title
Measurements
OG000133.88± 111.17
OG00167.32± 61.88
OG002172.75± 94.28
OG003
Baseline: Days of work per week (n=71,69,38,70)
Title
Measurements
OG0004.94± 1.18
OG0014.80± 1.05
OG0024.95± 0.98
OG003
Baseline: Chores by housekeeper (n=23,19,6,18)
Title
Measurements
OG00015.57± 25.73
OG00114.95± 27.24
OG00238.83± 41.44
OG003
Baseline: Chores by family (n=101,102,39,97)
Title
Measurements
OG00024.06± 29.27
OG00126.57± 31.02
OG00226.95± 32.87
OG003
Baseline: Days on sick leave (n=24,24,15,29)
Title
Measurements
OG00019.58± 27.78
OG00116.33± 27.21
OG00229.60± 34.88
OG003
Baseline: Days of part time work (n=13,13,6,10)
Title
Measurements
OG00013.31± 18.94
OG00125.31± 61.19
OG0025.33± 3.44
OG003
Baseline: Paid work, bothered by RA(n=51,47,31,53)
Title
Measurements
OG00029.10± 27.47
OG00129.45± 31.37
OG00228.74± 28.76
OG003
Baseline: RA related devices/aids (n=17,28,9,17)
Title
Measurements
OG0001.76± 1.15
OG0011.39± 0.69
OG0022.33± 1.66
OG003
Month 3: Hospital length of stay (n=4,6,1,3)
Title
Measurements
OG0006.25± 4.03
OG00110.00± 10.75
OG0022.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Month 3: Days in nursing home (n=0,0,0,2)
Title
Measurements
OG000NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
Month 3: Days devices/aids used (n=11,17,6,15)
Title
Measurements
OG000117.91± 112.91
OG00160.41± 88.79
OG002163.83± 153.63
OG003
Month 3: Days of work per week (n=70,66,38,68)
Title
Measurements
OG0004.83± 0.95
OG0014.68± 1.18
OG0024.95± 0.80
OG003
Month 3: Chores by housekeeper (n=17,11,7,12)
Title
Measurements
OG00012.59± 23.15
OG0016.00± 8.63
OG0028.00± 12.54
OG003
Month 3: Chores by family (n=60,47,34,58)
Title
Measurements
OG00024.10± 32.38
OG00118.32± 24.03
OG00224.97± 31.72
OG003
Month 3: Days on sick leave (n=11,9,17,15)
Title
Measurements
OG00024.27± 33.73
OG00118.44± 29.37
OG00227.12± 31.42
OG003
Month 3: Days of part time work (n=7,4,6,10)
Title
Measurements
OG00013.29± 13.76
OG00125.50± 27.77
OG0025.50± 3.27
OG003
Month 3: Paid work, bothered by RA (n=39,28,28,44)
Title
Measurements
OG00016.08± 21.77
OG00126.57± 32.41
OG00219.93± 20.79
OG003
Month 3: RA related devices/aids (n=12,17,8,16)
Title
Measurements
OG0001.75± 1.22
OG0011.12± 1.36
OG0022.38± 1.60
OG003
Month 6: Hospital length of stay (n=9,5,2,1)
Title
Measurements
OG00010.00± 8.20
OG00112.80± 16.71
OG0028.50± 2.12
OG003
Month 6: Days in nursing home (n=2,0,0,0)
Title
Measurements
OG00027.00± 18.38
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Month 6: Days devices/aids used (n=14,16,5,14)
Title
Measurements
OG000102.29± 115.01
OG001126.25± 134.08
OG00280.20± 73.45
OG003
Month 6: Days of work per week (n=65,61,17,66)
Title
Measurements
OG0004.94± 0.85
OG0014.70± 1.09
OG0025.35± 0.93
OG003
Month 6: Chores by housekeeper (n=11,10,3,7)
Title
Measurements
OG0007.73± 8.25
OG00115.80± 22.73
OG00244.00± 42.57
OG003
Month 6: Chores by family (n=46,46,15,50)
Title
Measurements
OG00013.59± 16.95
OG00129.09± 35.16
OG00235.53± 39.39
OG003
Month 6: Days on sick leave (n=7,9,3,9)
Title
Measurements
OG00029.57± 41.48
OG00112.44± 14.60
OG0023.00± 2.00
OG003
Month 6: Days of part time work (n=7,6,1,7)
Title
Measurements
OG0007.57± 6.80
OG00124.67± 33.07
OG0024.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Month 6: Paid work, bothered by RA (n=31,25,10,33)
Title
Measurements
OG00014.71± 18.47
OG00120.40± 25.93
OG00211.00± 9.13
OG003
Month 6: RA related devices/aids (n=15,16,6,14)
Title
Measurements
OG0002.00± 1.73
OG0011.56± 1.46
OG0022.17± 1.83
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG00060
OG00149
OG00219
OG00315
OG00458
Title
Denominators
Categories
Hospital length of stay (n=3,5,1,1,3)
Title
Measurements
OG0008.00± 6.93
OG0015.60± 2.70
OG00215.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG0031.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG00415.33± 4.51
Days in nursing home (n=2,0,0,0,1)
Title
Measurements
OG00024.50± 4.95
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Days devices/aids used (n=11,12,3,2,15)
Title
Measurements
OG000144.55± 258.85
OG00151.75± 41.51
OG002163.67± 173.70
OG003
Days of work per week (n=60,49,19,15,58)
Title
Measurements
OG0004.83± 1.04
OG0015.04± 0.93
OG0025.16± 0.90
OG003
Chores by housekeeper (n=9,4,1,2,10)
Title
Measurements
OG0004.44± 3.40
OG0017.75± 5.06
OG00290.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Chores by family (n=35,30,8,10,45)
Title
Measurements
OG00022.06± 27.84
OG00113.13± 12.28
OG00251.88± 40.91
OG003
Days on sick leave (n=5,3,2,0,4)
Title
Measurements
OG00010.40± 11.41
OG00136.00± 45.97
OG00250.00± 56.57
OG003
Days of part time work (n=6,1,0,0,1)
Title
Measurements
OG00011.33± 12.55
OG00133.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Paid work, bothered by RA (n=20,20,7,9,22)
Title
Measurements
OG00024.10± 30.75
OG00120.40± 27.90
OG00211.43± 8.60
OG003
RA related devices/aids used (n=11,12,3,3,15)
Title
Measurements
OG0002.18± 2.79
OG0010.75± 0.62
OG0022.33± 1.53
OG003
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000101
OG001102
OG00239
OG00395
Title
Denominators
Categories
Baseline: Home HC services (n=2,2,1,2)
Title
Measurements
OG0003.00± 2.83
OG0011.50± 0.71
OG0022.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG0031.00± 0.00
Baseline: Work done (n=72,69,38,70)
Title
Measurements
OG0007.76± 2.40
OG0017.54± 2.25
OG0027.79± 1.76
OG003
Baseline: Chores by housekeeper (n=22,19,7,18)
Title
Measurements
OG0005.23± 4.60
OG0015.53± 5.36
OG0028.00± 7.55
OG003
Baseline: Chores by family (n=101,102,39,95)
Title
Measurements
OG0004.24± 4.75
OG0013.31± 2.76
OG0024.21± 4.71
OG003
Baseline: Missed work due to RA (n=13,13,6,10)
Title
Measurements
OG0006.38± 7.22
OG0015.00± 5.85
OG0024.00± 1.26
OG003
Baseline: RA related home HC services (n=2,2,1,3)
Title
Measurements
OG0000.50± 0.71
OG0011.00± 0.00
OG0021.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Month 3: Home HC services (n=1,0,0,0)
Title
Measurements
OG0001.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Month 3: Work done (n=70,66,38,68)
Title
Measurements
OG0008.06± 3.59
OG0017.53± 1.92
OG0028.53± 5.62
OG003
Month 3: Chores by housekeeper (n=17,11,7,12)
Title
Measurements
OG0004.00± 2.12
OG0015.73± 2.61
OG0025.00± 2.00
OG003
Month 3: Chores by family (n=59,46,34,59)
Title
Measurements
OG0003.46± 3.67
OG0013.28± 2.60
OG0023.41± 2.72
OG003
Month 3: Missed work due to RA (n=7,4,6,9)
Title
Measurements
OG0004.57± 5.03
OG00120.75± 39.51
OG0025.50± 5.01
OG003
Month 3: RA related home HC services (n=1,0,0,0)
Title
Measurements
OG0001.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
Month 6: Home HC services (n=2,2,0,0)
Title
Measurements
OG0002.50± 2.12
OG00116.00± 5.66
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Month 6: Work done (n=65,61,17,66)
Title
Measurements
OG0008.35± 4.46
OG0017.72± 2.24
OG0029.71± 7.59
OG003
Month 6: Chores by housekeeper (n=11,10,3,7)
Title
Measurements
OG0003.36± 2.58
OG0015.40± 2.50
OG0025.33± 1.53
OG003
Month 6: Chores by family (n=47,45,13,51)
Title
Measurements
OG0003.30± 2.69
OG0012.91± 2.00
OG0023.69± 2.32
OG003
Month 6: Missed work due to RA (n=7,6,1,7)
Title
Measurements
OG0004.57± 5.19
OG0013.17± 2.32
OG0025.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Month 6: RA related home HC services (n=2,2,0,0)
Title
Measurements
OG0001.00± 1.41
OG0010.50± 0.71
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG00060
OG00149
OG00219
OG00315
OG00458
Title
Denominators
Categories
Home HC services (n=0,0,0,0,1)
Title
Measurements
OG000NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG0041.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
Work done (n=60,49,19,15,58)
Title
Measurements
OG0007.52± 2.27
OG0017.82± 1.60
OG0029.53± 7.65
OG003
Chores by housekeeper (n=8,4,1,2,10)
Title
Measurements
OG0004.63± 3.16
OG0014.75± 0.96
OG0023.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
Chores by family (n=34,30,8,10,44)
Title
Measurements
OG0002.65± 1.95
OG0014.00± 4.11
OG0022.88± 2.17
OG003
Missed work due to RA (n=6,1,0,0,1)
Title
Measurements
OG0002.00± 1.67
OG0014.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
RA related home HC services (n=0,0,0,0,1)
Title
Measurements
OG000NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG001NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG002NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
OG003
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000139
OG001141
OG00283
OG003142
Title
Denominators
Categories
Baseline (n=139,141,83,142)
Title
Measurements
OG0004.16± 3.05
OG0014.16± 3.33
OG0024.08± 3.32
OG0034.19± 3.09
Month 3 (n=137,129,76,139)
Title
Measurements
OG0002.68± 2.75
OG0012.81± 2.89
OG0023.38± 2.84
OG003
Month 6 (n=125,125,35,127)
Title
Measurements
OG0002.31± 2.51
OG0012.39± 2.84
OG0022.17± 2.64
OG003
OG003
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
OG004
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
Units
Counts
Participants
OG000101
OG001101
OG00232
OG00330
OG004107
Title
Denominators
Categories
Title
Measurements
OG0002.18± 2.65
OG0011.92± 2.50
OG0022.69± 2.66
OG0032.23± 3.02
OG0041.93± 2.45
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0061 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0061 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0092 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0081 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0091 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0042 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
2 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
3 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
3 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
4 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0087 affected260 at risk
EG00910 affected253 at risk
EG0104 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0083 affected260 at risk
EG0096 affected253 at risk
EG0104 affected204 at risk
7 affected
204 at risk
EG0045 affected232 at risk
EG0052 affected222 at risk
EG0061 affected59 at risk
EG0073 affected204 at risk
EG0088 affected260 at risk
EG0093 affected253 at risk
EG0105 affected204 at risk
7 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0089 affected260 at risk
EG0096 affected253 at risk
EG0104 affected204 at risk
7 affected
204 at risk
EG0045 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0076 affected204 at risk
EG0082 affected260 at risk
EG0094 affected253 at risk
EG0105 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0083 affected260 at risk
EG0095 affected253 at risk
EG0101 affected204 at risk
1 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
4 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0097 affected253 at risk
EG0101 affected204 at risk
1 affected
204 at risk
EG0043 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
5 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
4 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
4 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0040 affected232 at risk
EG0050 affected222 at risk
EG0060 affected59 at risk
EG0070 affected204 at risk
EG0087 affected260 at risk
EG0093 affected253 at risk
EG0102 affected204 at risk
0 affected
204 at risk
EG0041 affected232 at risk
EG0051 affected222 at risk
EG0060 affected59 at risk
EG0074 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
0 affected
204 at risk
EG0043 affected232 at risk
EG0052 affected222 at risk
EG0060 affected59 at risk
EG0075 affected204 at risk
EG0082 affected260 at risk
EG0093 affected253 at risk
EG0101 affected204 at risk
0 affected
204 at risk
EG0044 affected232 at risk
EG0052 affected222 at risk
EG0062 affected59 at risk
EG0071 affected204 at risk
EG0080 affected260 at risk
EG0090 affected253 at risk
EG0100 affected204 at risk
-0.45
± 0.52
56.28
34.00
OG00449.25
23.62
27.64
28.00
OG00433.67
8.54
9.05
14.00
OG00416.58
4.27
± 1.06
3.88
± 1.15
3.63
± 1.19
3.02
± 1.28
OG0043.18± 1.25
5.13
± 1.21
4.66
± 1.28
4.37
± 1.30
3.70
± 1.24
OG0043.95± 1.48
1.05
± 0.64
0.98
± 0.65
0.91
± 0.72
OG0040.90± 0.67
39.27
± 24.29
36.27
± 25.67
32.78
± 22.57
29.37
± 20.57
OG00427.94± 22.70
39.32
± 23.83
36.97
± 25.28
33.50
± 21.97
29.70
± 20.69
OG00430.33± 24.46
38.81
± 20.08
32.40
± 21.08
27.77
± 18.36
20.68
± 14.51
OG00420.44± 16.94
34.79
± 8.69
36.23
± 11.52
33.14
± 7.33
39.64
± 11.19
35.54
± 12.05
39.95
± 9.54
35.18
± 7.96
40.58
± 11.64
32.74
± 6.83
35.38
± 9.79
38.37
± 9.06
40.98
± 10.41
39.58
± 8.36
42.83
± 10.93
39.10
± 11.55
44.44
± 10.00
38.35
± 8.43
44.05
± 10.79
37.08
± 7.88
36.56
± 10.24
39.51
± 8.89
40.84
± 10.92
40.60
± 9.54
43.05
± 10.45
39.24
± 11.53
45.57
± 9.76
39.33
± 9.32
43.90
± 10.84
38.58
± 8.36
37.29
± 10.40
39.99
± 9.14
42.36
± 10.43
41.59
± 8.95
43.13
± 11.35
39.54
± 11.85
45.93
± 9.88
39.91
± 8.72
44.24
± 11.69
39.36
± 8.39
39.75
± 9.20
OG00441.12± 9.44
42.76
± 9.78
OG00442.03± 11.55
42.26
± 7.77
OG00441.81± 9.73
43.70
± 10.16
OG00443.44± 12.04
41.46
± 11.81
OG00440.07± 12.15
46.41
± 10.03
OG00446.11± 10.28
40.57
± 9.34
OG00440.12± 9.58
45.23
± 11.22
OG00444.08± 11.45
39.73
± 7.73
OG00440.35± 8.31
40.42
± 9.84
OG00439.21± 10.63
41.18
± 9.30
OG00441.07± 9.29
44.94
± 9.78
OG00442.96± 10.92
43.18
± 7.76
OG00442.73± 9.77
45.28
± 10.94
OG00444.23± 10.93
41.03
± 12.67
OG00439.89± 11.63
48.17
± 9.36
OG00446.27± 9.65
40.77
± 8.31
OG00440.40± 9.13
46.12
± 11.75
OG00444.42± 10.70
41.12
± 6.49
OG00440.72± 8.84
31.94
± 10.48
32.72
± 10.27
33.69
± 10.58
43.12
± 19.50
44.25
± 27.83
20.00
± 24.31
46.55
± 26.31
6.65
± 1.82
34.77
± 30.50
33.47
± 19.68
38.16
± 20.30
39.18
± 19.67
46.87
± 27.30
18.69
± 25.26
39.41
± 25.42
6.89
± 1.55
32.76
± 28.19
33.91
± 19.60
37.21
± 20.47
38.32
± 20.05
49.21
± 28.65
18.42
± 24.42
39.95
± 25.83
6.83
± 1.47
34.60
± 27.80
31.05
± 20.26
36.31
± 19.25
36.73
± 19.04
50.22
± 27.33
19.22
± 22.37
36.39
± 24.20
6.81
± 1.36
33.18
± 27.32
31.84
± 20.38
35.38
± 20.40
OG00436.52± 19.68
50.00
± 30.18
OG00449.81± 27.20
18.38
± 18.49
OG00417.48± 21.79
34.86
± 23.94
OG00437.36± 25.19
6.84
± 1.34
OG0046.72± 1.31
32.43
± 26.81
OG00434.47± 30.01
29.37
± 22.25
OG00430.00± 21.21
95
93
93
0.58
± 0.27
0.61
± 0.26
0.64
± 0.24
44.51
± 21.15
28.45
± 23.77
36.82
± 22.71
9.92
± 5.01
35.73
± 28.50
54.38
± 28.15
22.64
± 21.97
26.57
± 22.50
8.23
± 5.47
52.17
± 28.69
29.70
± 25.24
22.61
± 22.38
25.82
± 22.93
7.84
± 5.04
59.02
± 36.59
OG00450.41± 33.98
19.44
± 24.29
OG00417.99± 20.10
25.36
± 29.64
OG00421.55± 22.63
8.06
± 6.01
OG0046.85± 5.21
1.94
± 0.25
0.08
± 0.29
1.95
± 0.23
1.97
± 0.18
1.82
± 0.39
1.98
± 0.14
1.99
± 0.12
1.91
± 0.29
1.97
± 0.17
1.65
± 0.48
1.80
± 0.40
1.39
± 0.49
1.57
± 0.50
1.37
± 0.49
1.65
± 0.48
1.83
± 0.38
1.94
± 0.24
1.67
± 0.47
1.41
± 0.49
1.91
± 0.29
1.51
± 0.50
1.29
± 0.45
1.95
± 0.22
0.22
± 0.44
1.98
± 0.12
1.97
± 0.18
1.89
± 0.31
1.99
± 0.10
2.00
± 0.00
1.92
± 0.28
1.98
± 0.12
1.64
± 0.48
1.74
± 0.44
1.38
± 0.49
1.65
± 0.48
1.58
± 0.50
1.74
± 0.44
1.90
± 0.29
1.94
± 0.25
1.70
± 0.46
1.66
± 0.47
1.94
± 0.24
1.68
± 0.47
1.31
± 0.46
1.98
± 0.15
0.00
± 0.00
1.99
± 0.07
1.99
± 0.11
1.89
± 0.31
2.00
± 0.00
2.00
± 0.00
1.92
± 0.27
1.99
± 0.07
1.63
± 0.48
1.71
± 0.46
1.35
± 0.48
1.67
± 0.47
1.57
± 0.50
1.72
± 0.45
1.94
± 0.24
1.95
± 0.22
1.76
± 0.43
1.67
± 0.47
1.96
± 0.19
1.71
± 0.45
1.97
± 0.16
OG0041.96± 0.19
0.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
OG0040.17± 0.41
1.97
± 0.16
OG0041.98± 0.14
1.95
± 0.23
OG0041.97± 0.17
1.84
± 0.37
OG0041.86± 0.35
2.00
± 0.00
OG0041.99± 0.08
2.00
± 0.00
OG0041.99± 0.08
1.92
± 0.27
OG0041.91± 0.29
1.95
± 0.23
OG0042.00± 0.00
1.61
± 0.50
OG0041.64± 0.48
1.84
± 0.37
OG0041.68± 0.47
1.53
± 0.51
OG0041.35± 0.48
1.78
± 0.43
OG0041.67± 0.47
1.58
± 0.51
OG0041.57± 0.50
1.67
± 0.49
OG0041.67± 0.47
2.00
± 0.00
OG0041.97± 0.18
2.00
± 0.00
OG0041.99± 0.09
1.71
± 0.46
OG0041.82± 0.38
1.84
± 0.37
OG0041.73± 0.45
1.95
± 0.23
OG0041.93± 0.25
1.71
± 0.46
OG0041.71± 0.45
10.00
± 10.51
1.58
± 1.73
1.27
± 0.90
2.57
± 4.16
1.64
± 1.10
1.19
± 0.73
0.25
± 0.45
0.84
± 0.73
0.82
± 0.60
0.43
± 0.79
1.00
± 0.63
3.05
± 2.87
7.50
± 9.19
1.90
± 1.10
1.00
± 0.00
1.33
± 0.52
1.45
± 0.83
0.93
± 0.65
0.00
± 0.00
0.24
± 0.44
0.67
± 1.15
0.00
± 0.00
0.50
± 0.71
2.73
± 2.96
14.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
1.75
± 0.96
1.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
1.50
± 0.71
1.53
± 0.61
1.00
± 0.56
0.00
± 0.00
0.11
± 0.32
0.00
± NA
Standard deviation was not estimable since only 1 participant were evaluable.
1.00
± 1.41
0.00
± NA
Standard deviation was not estimable as only 1 participant was evaluable.
10.50
± 6.36
OG004NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
3.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
OG0041.00± 0.00
1.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
OG0041.00± 0.00
1.00
± 0.00
OG0042.20± 2.17
1.33
± 0.82
OG0041.64± 0.90
0.87
± 0.68
OG0040.84± 0.80
0.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
OG0040.17± 0.41
0.00
± 0.00
OG0040.05± 0.21
0.00
± NA
Standard deviation was not estimable since only 1 participant were evaluable.
OG0040.67± 0.58
0.00
± 0.00
OG0040.00± 0.00
0.00
± 0.00
OG004NA± NAData not available as no participant was evaluable for the treatment arm at the given time point.
14.25
± 9.95
66.13
± 65.33
5.01
± 1.04
6.94
± 6.86
29.80
± 32.91
16.31
± 26.05
18.50
± 26.88
42.74
± 31.81
1.65
± 1.06
10.33
± 8.14
OG003
17.50
± 4.95
91.80
± 95.18
4.75
± 1.25
10.50
± 16.08
25.41
± 30.46
5.13
± 4.60
14.90
± 27.04
33.61
± 30.31
1.81
± 0.98
6.00
± NA
Standard deviation was not estimable since only 1 participant was evaluable.
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
94.21
± 76.92
4.95
± 0.92
7.29
± 3.82
22.64
± 29.51
8.67
± 13.13
9.29
± 8.67
24.55
± 26.88
2.07
± 1.27
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
OG00410.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
321.50
± 327.39
OG00479.33± 74.00
4.93
± 0.70
OG0044.95± 1.07
24.00
± 16.97
OG0044.90± 3.78
28.40
± 33.88
OG00423.49± 28.68
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
OG00418.25± 14.06
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
OG00430.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
12.33
± 12.32
OG00422.86± 24.20
3.00
± 2.65
OG0041.53± 0.74
8.16
± 2.85
3.89
± 2.37
2.82
± 1.79
4.00
± 4.11
0.33
± 0.58
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
8.38
± 4.89
4.17
± 1.99
3.68
± 3.72
3.56
± 1.59
OG003
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
8.00
± 4.27
6.29
± 7.95
3.33
± 3.55
3.29
± 1.70
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
7.73
± 2.40
OG0047.93± 3.12
6.00
± 1.41
OG0044.10± 2.08
2.70
± 2.26
OG0042.55± 1.81
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
OG0044.00± NAStandard deviation was not estimable since only 1 participant was evaluable.
OG003
NA
± NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
OG0041.00± NAStandard deviation was not estimable since only 1 participant was evaluable.