Arthritis, Rheumatoid
Conditions
Keywords
double-blind placebo-controlled investigational drug oral therapy safety and efficacy hand and feet x-rays
Brief summary
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
Interventions
DRUGCP-690,550
Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
DRUGPlacebo
Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate
Exclusion criteria
* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | Month 6 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=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 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. |
| Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | Month 6 | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (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, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline, Month 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores 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. |
| Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Baseline, Month 6 | mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12, 18, 24 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12, 18, 24 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12, 18, 24 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline, Month 1, 3, 6 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24 | Month 12, 18, 24 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24 | Month 12, 18, 24 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]). |
| Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12, 18, 24 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]). |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family, friends or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12, 18, 24 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12, 18, 24 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 1, 3, 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 1, 3, 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12, 18, 24 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 1, 3, 6 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12, 18, 24 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 1, 3 | ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 1, 3, 6 | ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 1, 3, 6 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | 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 indicated low disease activity, \>3.2 to 5.1 indicated moderate to high disease activity and \<2.6 = remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24 | DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP \[mg/L\] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 \[CRP\] \<=3.2 implied low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 implied moderate to high disease activity and DAS28 \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24 | DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Modified Total Sharp Scores (mTSS) at Baseline | Baseline | mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Modified Total Sharp Scores (mTSS) at Month 12 and 24 | Month 12, 24 | mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty. |
| Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Baseline, Month 1, 3, 6 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. |
| Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1, 3, 6 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| 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 1, 3 and 6 | Month 1, 3, 6 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| 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 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1, 3, 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | 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. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 1, 3, 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 9, 12, 15, 18, 21, 24 | 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. |
| Association Between Genomic and Metabonomic Variation | Month 24 | — |
| Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart. |
| Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline, Month 9, 12, 15, 18, 21, 24 | BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart. |
| Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24 | Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24 | — |
| Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24 | Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24 | — |
| Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | Baseline through Month 12, Month 24 | 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. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12. |
| Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | Baseline through Month 12, Month 24 | 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. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12. |
| Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | Baseline through Month 12, Month 24 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12. |
| Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | Baseline through Month 12, Month 24 | ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12. |
| Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | Baseline through Month 12, Month 24 | ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12. |
Countries
Australia, Brazil, Bulgaria, Canada, Colombia, Czechia, Greece, India, Japan, Mexico, Poland, South Korea, Taiwan, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24. | 321 |
| CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 24. | 316 |
| Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24. | 81 |
| Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24. | 79 |
| Total | 797 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 36 | 26 | 5 | 6 |
| Overall Study | Death | 1 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 7 | 3 | 3 | 1 |
| Overall Study | Lost to Follow-up | 5 | 0 | 0 | 3 |
| Overall Study | Ongoing at cut-off date | 250 | 265 | 64 | 64 |
| Overall Study | Other | 1 | 1 | 2 | 0 |
| Overall Study | Participant moved | 4 | 1 | 0 | 0 |
| Overall Study | Pregnancy | 1 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 6 | 6 | 3 | 1 |
| Overall Study | Randomized, but not treated | 0 | 3 | 0 | 0 |
| Overall Study | Site closure | 1 | 0 | 0 | 1 |
| Overall Study | Sponsor request | 0 | 1 | 0 | 0 |
| Overall Study | Study terminated by Sponsor | 1 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 11 | 2 | 2 |
Baseline characteristics
| Characteristic | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 11.6 | 52.0 years STANDARD_DEVIATION 11.4 | 53.2 years STANDARD_DEVIATION 11.5 | 52.1 years STANDARD_DEVIATION 11.8 | 52.8 years STANDARD_DEVIATION 11.5 |
| Sex: Female, Male Female | 269 Participants | 273 Participants | 65 Participants | 72 Participants | 679 Participants |
| Sex: Female, Male Male | 52 Participants | 43 Participants | 16 Participants | 7 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 70 / 321 | 49 / 316 | 21 / 160 | 33 / 363 | 27 / 353 | 4 / 81 | 66 / 402 | 79 / 395 |
| serious Total, serious adverse events | 12 / 321 | 10 / 316 | 5 / 160 | 18 / 363 | 8 / 353 | 5 / 81 | 14 / 402 | 13 / 395 |
Outcome results
Primary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline | 1.41 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 | -0.3 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline | 1.39 units on a scale | Standard Deviation 0.66 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 | -0.4 units on a scale | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline | 1.31 units on a scale | Standard Deviation 0.68 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 | -0.1 units on a scale | Standard Deviation 0.38 |
Comparison: Change at Month 3: Least squares mean difference and corresponding 95% confidence interval (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.p-value: <0.000195% CI: [-0.49, -0.31]Mixed Models Analysis
Comparison: Change at Month 3: Least squares 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.p-value: 0.000295% CI: [-0.34, -0.16]Mixed Models Analysis
Primary
Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6
mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time frame: Baseline, Month 6
Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Baseline | 28.66 units on a scale | Standard Error 2.98 |
| CP-690,550 5 mg | Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Change at Month 6 | 0.12 units on a scale | Standard Error 0.12 |
| CP-690,550 10 mg | Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Baseline | 34.66 units on a scale | Standard Error 2.95 |
| CP-690,550 10 mg | Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Change at Month 6 | 0.06 units on a scale | Standard Error 0.11 |
| Placebo | Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Baseline | 29.53 units on a scale | Standard Error 4.25 |
| Placebo | Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 | Change at Month 6 | 0.47 units on a scale | Standard Error 0.16 |
Comparison: Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.p-value: 0.037695% CI: [-0.79, -0.02]Mixed Models Analysis
Comparison: Change at Month 6: Linear mixed model with treatment effect and site location as fixed effects and baseline value as covariate was used for the analysis.p-value: 0.079295% CI: [-0.73, 0.04]Mixed Models Analysis
Primary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=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 Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time frame: Month 6
Population: Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 51.46 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 61.81 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 25.32 percentage of participants |
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.p-value: <0.000195% CI: [27.73, 45.23]Normal approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.p-value: <0.000195% CI: [17.28, 34.97]Normal approximation
Primary
Percentage of Participant 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 swollen joint count (SJC) and tender/painful joint count (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, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 7.17 percentage of participants |
| CP-690,550 10 mg | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 15.95 percentage of participants |
| Placebo | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 1.55 percentage of participants |
Comparison: 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.p-value: <0.000195% CI: [9.44, 19.36]Normal approximation
Comparison: 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.p-value: 0.003495% CI: [1.85, 9.38]Normal approximation
Secondary
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical functioning(n=295,300,146) | 36.40 units on a scale | Standard Deviation 10.51 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:vitality(n=283,285,62) | 46.58 units on a scale | Standard Deviation 10.11 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role emotional(n=295,300,146) | 39.52 units on a scale | Standard Deviation 12.64 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental component(n=294,300,146) | 45.22 units on a scale | Standard Deviation 11.69 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:general health(n=283,285,62) | 40.40 units on a scale | Standard Deviation 9.14 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:general health(n=294,300,146) | 39.76 units on a scale | Standard Deviation 9.31 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role physical(n=295,300,146) | 39.83 units on a scale | Standard Deviation 10.11 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental component(n=282,284,62) | 45.39 units on a scale | Standard Deviation 11.86 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role physical(n=307,308,153) | 39.21 units on a scale | Standard Deviation 10.04 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:social functioning(n=295,300,146) | 42.73 units on a scale | Standard Deviation 10.6 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical component(n=282,284,62) | 39.69 units on a scale | Standard Deviation 8.39 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental health(n=283,285,62) | 44.46 units on a scale | Standard Deviation 11.86 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:social functioning(n=308,308,153) | 41.70 units on a scale | Standard Deviation 10.44 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental component(n=315,309,156) | 41.01 units on a scale | Standard Deviation 11.54 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical component(n=307,308,153) | 36.99 units on a scale | Standard Deviation 8.24 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role physical(n=282,284,62) | 41.46 units on a scale | Standard Deviation 10.16 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:vitality(n=315,309,156) | 40.62 units on a scale | Standard Deviation 9.9 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:bodily pain(n=308,308,153) | 39.75 units on a scale | Standard Deviation 8.08 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:social functioning(n=283,285,62) | 42.99 units on a scale | Standard Deviation 10.58 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:vitality(n=295,300,146) | 46.72 units on a scale | Standard Deviation 10.31 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical component(n=315,309,156) | 33.05 units on a scale | Standard Deviation 7.94 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:bodily pain(n=283,285,62) | 41.90 units on a scale | Standard Deviation 8.81 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental health(n=308,308,153) | 43.70 units on a scale | Standard Deviation 11.76 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:general health(n=308,308,153) | 38.49 units on a scale | Standard Deviation 9.28 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role emotional(n=315,309,156) | 35.64 units on a scale | Standard Deviation 12.67 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical component(n=294,300,146) | 38.65 units on a scale | Standard Deviation 8.62 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental component(n=307,308,153) | 44.90 units on a scale | Standard Deviation 11.74 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical functioning(n=315,309,156) | 32.16 units on a scale | Standard Deviation 9.98 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role emotional(n=282,284,62) | 40.58 units on a scale | Standard Deviation 12.54 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role emotional(n=307,308,153) | 39.06 units on a scale | Standard Deviation 12.34 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role physical(n=315,309,156) | 34.61 units on a scale | Standard Deviation 9.4 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:bodily pain(n=295,300,146) | 41.30 units on a scale | Standard Deviation 9.23 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:general health(n=315,309,156) | 35.16 units on a scale | Standard Deviation 9.07 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:social functioning(n=315,309,156) | 37.16 units on a scale | Standard Deviation 11.05 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:vitality(n=308,308,153) | 45.33 units on a scale | Standard Deviation 10.33 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical functioning(n=283,284,62) | 37.33 units on a scale | Standard Deviation 10.51 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:bodily pain(n=315,309,156) | 34.01 units on a scale | Standard Deviation 7.52 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical functioning(n=308,308,153) | 34.61 units on a scale | Standard Deviation 9.96 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental health(n=295,300,146) | 43.84 units on a scale | Standard Deviation 11.82 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental health(n=315,309,156) | 39.94 units on a scale | Standard Deviation 11.3 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical component(n=294,300,146) | 41.30 units on a scale | Standard Deviation 8.49 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role emotional(n=315,309,156) | 36.25 units on a scale | Standard Deviation 13.37 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:vitality(n=315,309,156) | 42.53 units on a scale | Standard Deviation 9.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role emotional(n=295,300,146) | 43.12 units on a scale | Standard Deviation 11.97 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:general health(n=315,309,156) | 36.03 units on a scale | Standard Deviation 8.79 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental component(n=315,309,156) | 42.24 units on a scale | Standard Deviation 11.52 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical component(n=315,309,156) | 33.75 units on a scale | Standard Deviation 7.77 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:vitality(n=295,300,146) | 48.60 units on a scale | Standard Deviation 9.52 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental component(n=307,308,153) | 46.28 units on a scale | Standard Deviation 10.7 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical functioning(n=308,308,153) | 36.72 units on a scale | Standard Deviation 10.01 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role physical(n=307,308,153) | 41.02 units on a scale | Standard Deviation 9.81 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:social functioning(n=308,308,153) | 43.54 units on a scale | Standard Deviation 10.06 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental health(n=283,285,62) | 45.60 units on a scale | Standard Deviation 11.34 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:bodily pain(n=308,308,153) | 42.02 units on a scale | Standard Deviation 8.41 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:general health(n=294,300,146) | 41.20 units on a scale | Standard Deviation 8.84 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental health(n=308,308,153) | 44.88 units on a scale | Standard Deviation 10.82 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role emotional(n=307,308,153) | 41.13 units on a scale | Standard Deviation 12.03 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role emotional(n=282,284,62) | 42.71 units on a scale | Standard Deviation 11.69 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:vitality(n=308,308,153) | 46.84 units on a scale | Standard Deviation 9.77 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical component(n=307,308,153) | 38.96 units on a scale | Standard Deviation 8.07 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:vitality(n=283,285,62) | 48.52 units on a scale | Standard Deviation 9.42 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:general health(n=283,285,62) | 41.78 units on a scale | Standard Deviation 9.24 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental component(n=282,284,62) | 46.82 units on a scale | Standard Deviation 10.85 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role physical(n=295,300,146) | 42.82 units on a scale | Standard Deviation 9.98 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical component(n=282,284,62) | 41.78 units on a scale | Standard Deviation 8.56 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical functioning(n=295,300,146) | 39.34 units on a scale | Standard Deviation 10.66 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical functioning(n=283,284,62) | 39.76 units on a scale | Standard Deviation 10.71 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role physical(n=282,284,62) | 43.37 units on a scale | Standard Deviation 9.62 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental component(n=294,300,146) | 47.05 units on a scale | Standard Deviation 10.27 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:social functioning(n=283,285,62) | 44.87 units on a scale | Standard Deviation 10.53 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:social functioning(n=295,300,146) | 44.50 units on a scale | Standard Deviation 10.27 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:bodily pain(n=283,285,62) | 44.18 units on a scale | Standard Deviation 9.37 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:general health(n=308,308,153) | 39.91 units on a scale | Standard Deviation 9 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical functioning(n=315,309,156) | 32.61 units on a scale | Standard Deviation 9.86 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental health(n=315,309,156) | 40.45 units on a scale | Standard Deviation 11.15 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role physical(n=315,309,156) | 35.41 units on a scale | Standard Deviation 9.73 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:bodily pain(n=295,300,146) | 44.43 units on a scale | Standard Deviation 9.02 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:social functioning(n=315,309,156) | 39.17 units on a scale | Standard Deviation 11.42 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:bodily pain(n=315,309,156) | 34.64 units on a scale | Standard Deviation 7.89 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental health(n=295,300,146) | 45.52 units on a scale | Standard Deviation 10.5 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:vitality(n=308,308,153) | 43.82 units on a scale | Standard Deviation 10.4 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical component(n=307,308,153) | 36.25 units on a scale | Standard Deviation 8.24 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical functioning(n=295,300,146) | 35.39 units on a scale | Standard Deviation 10.66 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:social functioning(n=295,300,146) | 40.86 units on a scale | Standard Deviation 11.23 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:bodily pain(n=295,300,146) | 38.17 units on a scale | Standard Deviation 9.16 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:general health(n=294,300,146) | 38.24 units on a scale | Standard Deviation 8.79 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role physical(n=295,300,146) | 38.37 units on a scale | Standard Deviation 10.65 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:bodily pain(n=283,285,62) | 40.70 units on a scale | Standard Deviation 8.06 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental component(n=294,300,146) | 43.70 units on a scale | Standard Deviation 11.68 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical component(n=294,300,146) | 36.79 units on a scale | Standard Deviation 8.39 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental health(n=295,300,146) | 42.80 units on a scale | Standard Deviation 11.47 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role emotional(n=295,300,146) | 38.20 units on a scale | Standard Deviation 13.46 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:vitality(n=295,300,146) | 44.24 units on a scale | Standard Deviation 10.15 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental health(n=283,285,62) | 43.37 units on a scale | Standard Deviation 8.46 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role emotional(n=282,284,62) | 41.88 units on a scale | Standard Deviation 10.8 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:vitality(n=283,285,62) | 46.31 units on a scale | Standard Deviation 9.14 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:general health(n=283,285,62) | 39.90 units on a scale | Standard Deviation 7.03 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental component(n=282,284,62) | 45.42 units on a scale | Standard Deviation 9.35 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical component(n=282,284,62) | 39.21 units on a scale | Standard Deviation 6.99 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical functioning(n=283,284,62) | 37.60 units on a scale | Standard Deviation 8.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role physical(n=282,284,62) | 41.38 units on a scale | Standard Deviation 8.78 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:social functioning(n=283,285,62) | 42.79 units on a scale | Standard Deviation 9.48 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:general health(n=308,308,153) | 37.70 units on a scale | Standard Deviation 8.85 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical functioning(n=315,309,156) | 33.50 units on a scale | Standard Deviation 10.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role physical(n=315,309,156) | 36.69 units on a scale | Standard Deviation 10.54 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:social functioning(n=315,309,156) | 39.37 units on a scale | Standard Deviation 11.54 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:bodily pain(n=315,309,156) | 35.57 units on a scale | Standard Deviation 8.05 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental health(n=315,309,156) | 42.03 units on a scale | Standard Deviation 11.28 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role emotional(n=315,309,156) | 37.43 units on a scale | Standard Deviation 13.82 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:vitality(n=315,309,156) | 42.97 units on a scale | Standard Deviation 9.95 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:general health(n=315,309,156) | 36.82 units on a scale | Standard Deviation 8.11 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental component(n=315,309,156) | 43.21 units on a scale | Standard Deviation 11.9 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical component(n=315,309,156) | 34.51 units on a scale | Standard Deviation 8.03 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental component(n=307,308,153) | 43.86 units on a scale | Standard Deviation 11.9 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical functioning(n=308,308,153) | 35.27 units on a scale | Standard Deviation 10.48 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role physical(n=307,308,153) | 38.30 units on a scale | Standard Deviation 10.24 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:social functioning(n=308,308,153) | 41.01 units on a scale | Standard Deviation 11.57 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:bodily pain(n=308,308,153) | 37.31 units on a scale | Standard Deviation 8.93 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental health(n=308,308,153) | 42.70 units on a scale | Standard Deviation 11.98 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role emotional(n=307,308,153) | 38.53 units on a scale | Standard Deviation 12.47 |
Secondary
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:vitality | 47.50 units on a scale | Standard Deviation 10.28 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:bodily pain | 42.24 units on a scale | Standard Deviation 8.9 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:social functioning | 44.16 units on a scale | Standard Deviation 10.13 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical functioning | 38.42 units on a scale | Standard Deviation 10.83 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:bodily pain | 42.83 units on a scale | Standard Deviation 8.85 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical component | 39.79 units on a scale | Standard Deviation 8.38 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental health | 44.73 units on a scale | Standard Deviation 10.78 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical component | 40.23 units on a scale | Standard Deviation 8.61 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental component | 45.82 units on a scale | Standard Deviation 11.23 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role emotional | 41.09 units on a scale | Standard Deviation 12.73 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:social functioning | 43.48 units on a scale | Standard Deviation 10.56 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:general health | 40.35 units on a scale | Standard Deviation 9.31 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role emotional | 41.66 units on a scale | Standard Deviation 12.56 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:vitality | 47.54 units on a scale | Standard Deviation 10.15 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental health | 45.02 units on a scale | Standard Deviation 11.18 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical functioning | 37.94 units on a scale | Standard Deviation 10.38 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role physical | 41.37 units on a scale | Standard Deviation 10.19 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental component | 46.53 units on a scale | Standard Deviation 11.5 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:general health | 40.61 units on a scale | Standard Deviation 9.16 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role physical | 41.41 units on a scale | Standard Deviation 10.3 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role physical | 43.96 units on a scale | Standard Deviation 9.86 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role emotional | 42.80 units on a scale | Standard Deviation 11.44 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical functioning | 40.66 units on a scale | Standard Deviation 10.7 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:social functioning | 45.20 units on a scale | Standard Deviation 10.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:bodily pain | 44.17 units on a scale | Standard Deviation 9.45 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:vitality | 47.94 units on a scale | Standard Deviation 9.81 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:general health | 42.02 units on a scale | Standard Deviation 9.57 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental health | 45.05 units on a scale | Standard Deviation 11.75 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role emotional | 43.01 units on a scale | Standard Deviation 11.72 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental component | 46.38 units on a scale | Standard Deviation 11.16 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:vitality | 48.12 units on a scale | Standard Deviation 9.96 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:general health | 41.65 units on a scale | Standard Deviation 9.38 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental component | 46.49 units on a scale | Standard Deviation 10.61 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical component | 42.02 units on a scale | Standard Deviation 8.82 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical component | 42.49 units on a scale | Standard Deviation 8.75 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical functioning | 40.01 units on a scale | Standard Deviation 11.03 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role physical | 43.59 units on a scale | Standard Deviation 9.93 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:social functioning | 45.18 units on a scale | Standard Deviation 10.54 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:bodily pain | 44.18 units on a scale | Standard Deviation 9.59 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental health | 45.07 units on a scale | Standard Deviation 11.22 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical functioning | 38.31 units on a scale | Standard Deviation 10.62 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:vitality | 47.08 units on a scale | Standard Deviation 11.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental health | 44.52 units on a scale | Standard Deviation 11.29 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role physical | 42.31 units on a scale | Standard Deviation 10.62 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental component | 45.70 units on a scale | Standard Deviation 11.01 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical functioning | 39.43 units on a scale | Standard Deviation 10.51 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role emotional | 41.27 units on a scale | Standard Deviation 12.59 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:general health | 40.48 units on a scale | Standard Deviation 9.38 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:social functioning | 44.28 units on a scale | Standard Deviation 10.48 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental component | 45.55 units on a scale | Standard Deviation 12.12 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental health | 44.66 units on a scale | Standard Deviation 12.07 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:bodily pain | 43.60 units on a scale | Standard Deviation 8.21 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical component | 41.22 units on a scale | Standard Deviation 8.29 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:social functioning | 43.70 units on a scale | Standard Deviation 10.1 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role physical | 41.48 units on a scale | Standard Deviation 9.87 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role emotional | 41.85 units on a scale | Standard Deviation 11.43 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:vitality | 46.23 units on a scale | Standard Deviation 10.02 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical component | 40.52 units on a scale | Standard Deviation 8.47 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:general health | 40.79 units on a scale | Standard Deviation 8.64 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:bodily pain | 43.88 units on a scale | Standard Deviation 8.56 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role emotional | 45.28 units on a scale | Standard Deviation 11.54 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:bodily pain | 47.17 units on a scale | Standard Deviation 9.99 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental component | 49.07 units on a scale | Standard Deviation 10.98 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical component | 43.44 units on a scale | Standard Deviation 10.11 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role physical | 45.15 units on a scale | Standard Deviation 10.12 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:mental health | 48.35 units on a scale | Standard Deviation 11.68 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:role emotional | 44.38 units on a scale | Standard Deviation 12.34 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:social functioning | 47.18 units on a scale | Standard Deviation 10.29 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:role physical | 44.96 units on a scale | Standard Deviation 10.21 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical component | 43.92 units on a scale | Standard Deviation 9.2 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:general health | 43.98 units on a scale | Standard Deviation 9.96 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:vitality | 49.20 units on a scale | Standard Deviation 10.33 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:social functioning | 45.90 units on a scale | Standard Deviation 11.4 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:physical functioning | 42.27 units on a scale | Standard Deviation 11.02 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:vitality | 50.10 units on a scale | Standard Deviation 9.83 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:general health | 43.83 units on a scale | Standard Deviation 9.53 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental health | 46.81 units on a scale | Standard Deviation 11.48 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:bodily pain | 45.78 units on a scale | Standard Deviation 9.89 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 9:physical functioning | 41.29 units on a scale | Standard Deviation 11.8 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 | Month 12:mental component | 47.95 units on a scale | Standard Deviation 10.79 |
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 (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 5.22 units on a scale | Standard Deviation 0.88 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,152) | 4.04 units on a scale | Standard Deviation 1.14 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=294,299,145) | 3.62 units on a scale | Standard Deviation 1.13 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 3.33 units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 2.96 units on a scale | Standard Deviation 1.09 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 5.20 units on a scale | Standard Deviation 0.87 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=294,299,145) | 3.29 units on a scale | Standard Deviation 1.14 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,152) | 3.84 units on a scale | Standard Deviation 1.09 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 3.79 units on a scale | Standard Deviation 1.06 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,152) | 4.73 units on a scale | Standard Deviation 1.1 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=294,299,145) | 4.54 units on a scale | Standard Deviation 1.18 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 5.16 units on a scale | Standard Deviation 0.87 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24
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 indicated low disease activity, \>3.2 to 5.1 indicated moderate to high disease activity and \<2.6 = remission.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 3.11 units on a scale | Standard Deviation 1.17 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 3.07 units on a scale | Standard Deviation 1.23 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 2.75 units on a scale | Standard Deviation 1.14 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 2.88 units on a scale | Standard Deviation 1.2 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 3.05 units on a scale | Standard Deviation 1.18 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 2.99 units on a scale | Standard Deviation 1.11 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 2.91 units on a scale | Standard Deviation 1.05 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 3.03 units on a scale | Standard Deviation 1.06 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP \[mg/L\] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 \[CRP\] \<=3.2 implied low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 implied moderate to high disease activity and DAS28 \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Population: Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Population: Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).
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.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=316,306,154) | 6.34 units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=258,250,127) | 5.12 units on a scale | Standard Deviation 1.32 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=249,248,122) | 4.58 units on a scale | Standard Deviation 1.29 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=239,236,49) | 4.34 units on a scale | Standard Deviation 1.24 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=239,236,49) | 3.90 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=316,306,154) | 6.25 units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=249,248,122) | 4.19 units on a scale | Standard Deviation 1.34 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=258,250,127) | 4.84 units on a scale | Standard Deviation 1.28 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=239,236,49) | 4.81 units on a scale | Standard Deviation 1.21 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=258,250,127) | 5.83 units on a scale | Standard Deviation 1.17 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=249,248,122) | 5.57 units on a scale | Standard Deviation 1.23 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=316,306,154) | 6.27 units on a scale | Standard Deviation 1.01 |
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 4.12 units on a scale | Standard Deviation 1.26 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 4.09 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 3.79 units on a scale | Standard Deviation 1.34 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 3.84 units on a scale | Standard Deviation 1.35 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 4.04 units on a scale | Standard Deviation 1.33 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 4.20 units on a scale | Standard Deviation 1.41 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 3.87 units on a scale | Standard Deviation 1.3 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 3.84 units on a scale | Standard Deviation 1.35 |
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Month 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 6 (n=283,285,62) | 0.62 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline (n=313,309,153) | 0.43 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 3 (n=261,262,125) | 0.60 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 6 (n=283,285,62) | 0.69 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline (n=313,309,153) | 0.47 units on a scale | Standard Deviation 0.31 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 3 (n=261,262,125) | 0.67 units on a scale | Standard Deviation 0.22 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 6 (n=283,285,62) | 0.59 units on a scale | Standard Deviation 0.24 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 3 (n=261,262,125) | 0.52 units on a scale | Standard Deviation 0.3 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline (n=313,309,153) | 0.47 units on a scale | Standard Deviation 0.3 |
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24 | 0.64 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24 | 0.69 units on a scale | Standard Deviation 0.26 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24 | 0.63 units on a scale | Standard Deviation 0.3 |
| Placebo, Then CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24 | 0.74 units on a scale | Standard Deviation 0.22 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline (n=315,307,155) | 28.59 units on a scale | Standard Deviation 10.62 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 1 (n=309,306,150) | 33.13 units on a scale | Standard Deviation 10.47 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 3 (n=295,300,146) | 34.19 units on a scale | Standard Deviation 10.29 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 6 (n=283,284,61) | 34.36 units on a scale | Standard Deviation 9.95 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 6 (n=283,284,61) | 36.47 units on a scale | Standard Deviation 9.76 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline (n=315,307,155) | 29.49 units on a scale | Standard Deviation 10.62 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 3 (n=295,300,146) | 36.14 units on a scale | Standard Deviation 9.53 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 1 (n=309,306,150) | 34.31 units on a scale | Standard Deviation 10.19 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 6 (n=283,284,61) | 33.69 units on a scale | Standard Deviation 9.06 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 1 (n=309,306,150) | 31.52 units on a scale | Standard Deviation 10.63 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 3 (n=295,300,146) | 31.51 units on a scale | Standard Deviation 11.1 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline (n=315,307,155) | 31.07 units on a scale | Standard Deviation 11.06 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24 | 35.06 units on a scale | Standard Deviation 10 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24 | 35.88 units on a scale | Standard Deviation 10.04 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24 | 35.58 units on a scale | Standard Deviation 10.65 |
| Placebo, Then CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24 | 37.29 units on a scale | Standard Deviation 9.98 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, 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; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Baseline (n=315,309,156) | 1.41 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,153) | 1.16 units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 1.00 units on a scale | Standard Deviation 0.65 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 0.94 units on a scale | Standard Deviation 0.62 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 0.79 units on a scale | Standard Deviation 0.64 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Baseline (n=315,309,156) | 1.39 units on a scale | Standard Deviation 0.66 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 0.84 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,153) | 1.02 units on a scale | Standard Deviation 0.65 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 1.09 units on a scale | Standard Deviation 0.62 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,153) | 1.25 units on a scale | Standard Deviation 0.67 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 1.19 units on a scale | Standard Deviation 0.69 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 | Baseline (n=315,309,156) | 1.31 units on a scale | Standard Deviation 0.68 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 0.91 units on a scale | Standard Deviation 0.65 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 0.90 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 0.76 units on a scale | Standard Deviation 0.68 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 0.75 units on a scale | Standard Deviation 0.64 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 0.95 units on a scale | Standard Deviation 0.66 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 0.84 units on a scale | Standard Deviation 0.66 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 0.74 units on a scale | Standard Deviation 0.67 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 0.74 units on a scale | Standard Deviation 0.68 |
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep problem summary(n=295,300,146) | 33.49 units on a scale | Standard Deviation 20.9 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep disturbance(n=295,300,146) | 34.43 units on a scale | Standard Deviation 26.15 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:quantity(n=295,300,146) | 6.69 units on a scale | Standard Deviation 1.51 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:snoring(n=283,285,62) | 31.87 units on a scale | Standard Deviation 29.85 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:awaken short of breath(n=295,300,146) | 16.61 units on a scale | Standard Deviation 24.68 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep disturbance(n=282,285,62) | 31.76 units on a scale | Standard Deviation 23.72 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:adequacy(n=295,300,146) | 52.88 units on a scale | Standard Deviation 29.21 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:overall sleep problem(n=282,285,62) | 33.10 units on a scale | Standard Deviation 19.14 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep problem summary(n=282,285,62) | 32.67 units on a scale | Standard Deviation 20.38 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:somnolence(n=283,285,62) | 30.60 units on a scale | Standard Deviation 21.25 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:overall sleep problem(n=314,309,156) | 40.19 units on a scale | Standard Deviation 20.12 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:quantity(n=283,285,62) | 6.66 units on a scale | Standard Deviation 1.46 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep problem summary(n=307,307,151) | 33.55 units on a scale | Standard Deviation 20.86 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:awaken short of breath(n=283,285,62) | 15.90 units on a scale | Standard Deviation 25.21 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:adequacy(n=283,285,62) | 53.14 units on a scale | Standard Deviation 27.54 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep problem summary(n=314,309,156) | 38.65 units on a scale | Standard Deviation 20.7 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:snoring(n=312,309,156) | 34.36 units on a scale | Standard Deviation 32.74 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:snoring(n=308,306,151) | 31.36 units on a scale | Standard Deviation 31.13 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:quantity(n=315,308,155) | 6.46 units on a scale | Standard Deviation 1.44 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep disturbance(n=314,309,156) | 41.04 units on a scale | Standard Deviation 27.04 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:awaken short of breath(n=308,307,151) | 15.26 units on a scale | Standard Deviation 24.95 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:awaken short of breath(n=314,309,156) | 17.90 units on a scale | Standard Deviation 25.82 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:adequacy(n=314,309,156) | 46.66 units on a scale | Standard Deviation 28.23 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:adequacy(n=308,307,151) | 51.23 units on a scale | Standard Deviation 28.31 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:somnolence(n=307,307,151) | 32.18 units on a scale | Standard Deviation 21.27 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:quantity(n=307,306,153) | 6.60 units on a scale | Standard Deviation 1.51 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:somnolence(n=314,309,156) | 36.75 units on a scale | Standard Deviation 22.74 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep disturbance(n=308,307,151) | 34.04 units on a scale | Standard Deviation 27.26 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:overall sleep problem(n=295,300,146) | 34.67 units on a scale | Standard Deviation 20.37 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:overall sleep problem(n=307,307,151) | 34.74 units on a scale | Standard Deviation 20.68 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:somnolence(n=295,300,146) | 31.86 units on a scale | Standard Deviation 21.52 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:snoring(n=295,299,146) | 33.49 units on a scale | Standard Deviation 31.36 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep problem summary(n=314,309,156) | 38.47 units on a scale | Standard Deviation 19.62 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:snoring(n=295,299,146) | 28.90 units on a scale | Standard Deviation 29.81 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:awaken short of breath(n=314,309,156) | 15.15 units on a scale | Standard Deviation 23.6 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep problem summary(n=295,300,146) | 33.30 units on a scale | Standard Deviation 19.97 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:quantity(n=295,300,146) | 6.67 units on a scale | Standard Deviation 1.34 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:snoring(n=312,309,156) | 29.71 units on a scale | Standard Deviation 31.28 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep disturbance(n=295,300,146) | 34.32 units on a scale | Standard Deviation 26.81 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:snoring(n=283,285,62) | 31.51 units on a scale | Standard Deviation 30.29 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep disturbance(n=308,307,151) | 33.07 units on a scale | Standard Deviation 24.86 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:awaken short of breath(n=295,300,146) | 14.13 units on a scale | Standard Deviation 21.52 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:somnolence(n=307,307,151) | 30.38 units on a scale | Standard Deviation 20.22 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:quantity(n=315,308,155) | 6.42 units on a scale | Standard Deviation 1.41 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:adequacy(n=295,300,146) | 50.93 units on a scale | Standard Deviation 27.31 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep disturbance(n=282,285,62) | 32.10 units on a scale | Standard Deviation 24.14 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:snoring(n=308,306,151) | 30.20 units on a scale | Standard Deviation 31.25 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:overall sleep problem(n=282,285,62) | 32.67 units on a scale | Standard Deviation 18.56 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:overall sleep problem(n=307,307,151) | 33.90 units on a scale | Standard Deviation 18.55 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:adequacy(n=308,307,151) | 49.61 units on a scale | Standard Deviation 27.28 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep problem summary(n=282,285,62) | 32.07 units on a scale | Standard Deviation 18.84 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:somnolence(n=314,309,156) | 34.63 units on a scale | Standard Deviation 22.05 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep disturbance(n=314,309,156) | 40.60 units on a scale | Standard Deviation 26.64 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:somnolence(n=283,285,62) | 28.16 units on a scale | Standard Deviation 20.17 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:somnolence(n=295,300,146) | 28.64 units on a scale | Standard Deviation 20.43 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:overall sleep problem(n=314,309,156) | 39.70 units on a scale | Standard Deviation 19.48 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:quantity(n=307,306,153) | 6.69 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:quantity(n=283,285,62) | 6.66 units on a scale | Standard Deviation 1.41 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:overall sleep problem(n=295,300,146) | 34.10 units on a scale | Standard Deviation 19.56 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:adequacy(n=314,309,156) | 45.83 units on a scale | Standard Deviation 27.37 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:awaken short of breath(n=283,285,62) | 13.47 units on a scale | Standard Deviation 21.19 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:awaken short of breath(n=308,307,151) | 11.60 units on a scale | Standard Deviation 19.7 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:adequacy(n=283,285,62) | 52.32 units on a scale | Standard Deviation 26.99 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep problem summary(n=307,307,151) | 33.33 units on a scale | Standard Deviation 18.97 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:adequacy(n=283,285,62) | 51.77 units on a scale | Standard Deviation 26.64 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:awaken short of breath(n=314,309,156) | 14.74 units on a scale | Standard Deviation 21.8 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:overall sleep problem(n=307,307,151) | 35.80 units on a scale | Standard Deviation 19.12 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:somnolence(n=307,307,151) | 32.80 units on a scale | Standard Deviation 23.78 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:adequacy(n=308,307,151) | 47.48 units on a scale | Standard Deviation 26.79 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:overall sleep problem(n=295,300,146) | 35.45 units on a scale | Standard Deviation 18.16 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep disturbance(n=282,285,62) | 31.61 units on a scale | Standard Deviation 21.56 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:awaken short of breath(n=283,285,62) | 13.23 units on a scale | Standard Deviation 20.47 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:overall sleep problem(n=314,309,156) | 37.30 units on a scale | Standard Deviation 18.32 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:somnolence(n=314,309,156) | 33.72 units on a scale | Standard Deviation 21.13 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:snoring(n=312,309,156) | 29.36 units on a scale | Standard Deviation 27.02 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:quantity(n=315,308,155) | 6.46 units on a scale | Standard Deviation 1.39 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep disturbance(n=314,309,156) | 36.49 units on a scale | Standard Deviation 26.76 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:adequacy(n=314,309,156) | 46.92 units on a scale | Standard Deviation 26.14 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep problem summary(n=307,307,151) | 35.36 units on a scale | Standard Deviation 19.46 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:snoring(n=308,306,151) | 29.80 units on a scale | Standard Deviation 28.92 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:quantity(n=307,306,153) | 6.38 units on a scale | Standard Deviation 1.46 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep disturbance(n=308,307,151) | 33.73 units on a scale | Standard Deviation 26.06 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:awaken short of breath(n=308,307,151) | 14.97 units on a scale | Standard Deviation 23.8 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep problem summary(n=295,300,146) | 35.16 units on a scale | Standard Deviation 19.04 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:somnolence(n=295,300,146) | 32.65 units on a scale | Standard Deviation 22.57 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:snoring(n=295,299,146) | 30.27 units on a scale | Standard Deviation 30.01 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:quantity(n=295,300,146) | 6.59 units on a scale | Standard Deviation 1.43 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep disturbance(n=295,300,146) | 33.15 units on a scale | Standard Deviation 25.49 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:awaken short of breath(n=295,300,146) | 15.75 units on a scale | Standard Deviation 22.56 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:adequacy(n=295,300,146) | 48.84 units on a scale | Standard Deviation 25.74 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:overall sleep problem(n=282,285,62) | 32.40 units on a scale | Standard Deviation 13.97 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep problem summary(n=282,285,62) | 31.56 units on a scale | Standard Deviation 15.05 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:somnolence(n=283,285,62) | 27.74 units on a scale | Standard Deviation 18.31 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:snoring(n=283,285,62) | 29.03 units on a scale | Standard Deviation 29.12 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:quantity(n=283,285,62) | 6.65 units on a scale | Standard Deviation 1.32 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep problem summary(n=314,309,156) | 36.39 units on a scale | Standard Deviation 18.5 |
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute.
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep problem summary | 31.69 units on a scale | Standard Deviation 18.69 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:overall sleep problem | 32.50 units on a scale | Standard Deviation 18.21 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:awaken short of breath | 14.19 units on a scale | Standard Deviation 22.23 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep disturbance | 30.72 units on a scale | Standard Deviation 23.45 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:quantity | 6.73 units on a scale | Standard Deviation 1.2 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:adequacy | 53.35 units on a scale | Standard Deviation 27.11 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:snoring | 31.77 units on a scale | Standard Deviation 30.75 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:somnolence | 30.53 units on a scale | Standard Deviation 20.71 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep problem summary | 31.97 units on a scale | Standard Deviation 19.21 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:adequacy | 52.16 units on a scale | Standard Deviation 26.33 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:overall sleep problem | 32.68 units on a scale | Standard Deviation 19.05 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:somnolence | 29.75 units on a scale | Standard Deviation 21.78 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:snoring | 30.91 units on a scale | Standard Deviation 31.14 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:quantity | 6.67 units on a scale | Standard Deviation 1.26 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep disturbance | 31.43 units on a scale | Standard Deviation 24.09 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:awaken short of breath | 13.48 units on a scale | Standard Deviation 20.86 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:somnolence | 28.96 units on a scale | Standard Deviation 20.81 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:awaken short of breath | 15.82 units on a scale | Standard Deviation 20.16 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep disturbance | 29.35 units on a scale | Standard Deviation 23.07 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:overall sleep problem | 30.92 units on a scale | Standard Deviation 17.24 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:quantity | 6.73 units on a scale | Standard Deviation 1.46 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:snoring | 31.64 units on a scale | Standard Deviation 30.18 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep problem summary | 31.69 units on a scale | Standard Deviation 18.18 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:adequacy | 55.37 units on a scale | Standard Deviation 25.66 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep problem summary | 28.73 units on a scale | Standard Deviation 17.96 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:sleep disturbance | 24.01 units on a scale | Standard Deviation 24.02 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:somnolence | 25.40 units on a scale | Standard Deviation 18.62 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:awaken short of breath | 13.33 units on a scale | Standard Deviation 22.14 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:quantity | 6.71 units on a scale | Standard Deviation 1.52 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:snoring | 25.71 units on a scale | Standard Deviation 25.25 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:overall sleep problem | 28.34 units on a scale | Standard Deviation 17.87 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | Month 12:adequacy | 53.02 units on a scale | Standard Deviation 28.77 |
Secondary
Modified Total Sharp Scores (mTSS) at Baseline
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Modified Total Sharp Scores (mTSS) at Baseline | 31.1 units on a scale | Standard Deviation 47.71 |
| CP-690,550 10 mg | Modified Total Sharp Scores (mTSS) at Baseline | 37.3 units on a scale | Standard Deviation 54.1 |
| Placebo | Modified Total Sharp Scores (mTSS) at Baseline | 32.6 units on a scale | Standard Deviation 41.8 |
Secondary
Modified Total Sharp Scores (mTSS) at Month 12 and 24
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 12, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Modified Total Sharp Scores (mTSS) at Month 12 and 24 | 31.4 units on a scale | Standard Deviation 47.88 |
| CP-690,550 10 mg | Modified Total Sharp Scores (mTSS) at Month 12 and 24 | 37.3 units on a scale | Standard Deviation 54.03 |
| Placebo | Modified Total Sharp Scores (mTSS) at Month 12 and 24 | 36.1 units on a scale | Standard Deviation 43.59 |
| Placebo, Then CP-690,550 10 mg | Modified Total Sharp Scores (mTSS) at Month 12 and 24 | 30.9 units on a scale | Standard Deviation 41.18 |
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.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related aids used(n=23,24,14) | 1.78 days | Standard Deviation 1.04 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of part time work(n=30,29,12) | 9.07 days | Standard Deviation 12.62 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of work per week(n=98,117,18) | 5.02 days | Standard Deviation 1.16 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Paid work, bothered by RA(n=52,48,27) | 20.60 days | Standard Deviation 27.99 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days on sick leave due to RA(n=41,44,29) | 13.17 days | Standard Deviation 21.61 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days on sick leave due to RA(n=15,11,4) | 14.93 days | Standard Deviation 24.05 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days in nursing home(n=3,3,2) | 14.33 days | Standard Deviation 12.1 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of work per week(n=109,121,59) | 5.01 days | Standard Deviation 1.14 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of part time work(n=8,12,3) | 11.88 days | Standard Deviation 14.99 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days aids/devices used(n=23,22,13) | 107.22 days | Standard Deviation 102.77 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related aids used(n=42,29,14) | 1.93 days | Standard Deviation 1.24 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Paid work, bothered by RA(n=46,52,13) | 18.87 days | Standard Deviation 25.75 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=25,21,12) | 17.00 days | Standard Deviation 20.88 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=85,66,15) | 29.41 days | Standard Deviation 33.22 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=30,24,6) | 15.90 days | Standard Deviation 22.43 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days on sick leave due to RA(n=19,15,16) | 12.16 days | Standard Deviation 20.51 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days in nursing home(n=0,1,0) | NA days | — |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=84,70,57) | 31.37 days | Standard Deviation 34.32 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of work per week(n=97,113,48) | 5.03 days | Standard Deviation 1.03 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital length of stay(n=9,4,1) | 5.67 days | Standard Deviation 4.95 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital length of stay(n=3,3,4) | 12.67 days | Standard Deviation 9.07 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital length of stay(n=18,18,5) | 10.94 days | Standard Deviation 9.12 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=158,152,73) | 36.28 days | Standard Deviation 34.4 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days in nursing home(n=3,0,0) | 24.00 days | Standard Deviation 3.61 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of part time work(n=16,12,12) | 9.44 days | Standard Deviation 11.51 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=50,44,15) | 19.06 days | Standard Deviation 23.91 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days aids/devices used(n=27,17,2) | 93.44 days | Standard Deviation 104.39 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days aids/devices used(n=41,25,14) | 109.63 days | Standard Deviation 108.88 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Paid work, bothered by RA(n=92,88,48) | 29.13 days | Standard Deviation 30.81 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related aids used(n=28,18,2) | 1.36 days | Standard Deviation 1.06 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=30,24,6) | 18.08 days | Standard Deviation 26.29 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of work per week(n=97,113,48) | 5.25 days | Standard Deviation 0.92 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days on sick leave due to RA(n=19,15,16) | 8.20 days | Standard Deviation 19.95 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of part time work(n=16,12,12) | 9.42 days | Standard Deviation 13.17 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Paid work, bothered by RA(n=52,48,27) | 17.42 days | Standard Deviation 21.52 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=25,21,12) | 6.05 days | Standard Deviation 33.69 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=84,70,57) | 21.46 days | Standard Deviation 29.48 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital length of stay(n=3,3,4) | 8.33 days | Standard Deviation 6.66 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days in nursing home(n=3,0,0) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days aids/devices used(n=27,17,2) | 87.12 days | Standard Deviation 61.54 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related aids used(n=28,18,2) | 1.56 days | Standard Deviation 1.2 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of work per week(n=98,117,18) | 5.29 days | Standard Deviation 0.78 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days on sick leave due to RA(n=15,11,4) | 14.18 days | Standard Deviation 25.86 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of part time work(n=8,12,3) | 11.33 days | Standard Deviation 11.44 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Paid work, bothered by RA(n=46,52,13) | 18.67 days | Standard Deviation 19.85 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related aids used(n=23,24,14) | 1.21 days | Standard Deviation 0.51 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=85,66,15) | 29.65 days | Standard Deviation 33.02 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days on sick leave due to RA(n=41,44,29) | 16.84 days | Standard Deviation 27.67 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days aids/devices used(n=41,25,14) | 74.08 days | Standard Deviation 66.11 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related aids used(n=42,29,14) | 1.59 days | Standard Deviation 1.02 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of work per week(n=109,121,59) | 5.14 days | Standard Deviation 0.92 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of part time work(n=30,29,12) | 12.07 days | Standard Deviation 16.5 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Paid work, bothered by RA(n=92,88,48) | 31.59 days | Standard Deviation 30.12 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=50,44,15) | 20.89 days | Standard Deviation 33.69 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=158,152,73) | 30.39 days | Standard Deviation 34 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital length of stay(n=9,4,1) | 16.25 days | Standard Deviation 26.51 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days in nursing home(n=0,1,0) | 28.00 days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days aids/devices used(n=23,22,13) | 69.36 days | Standard Deviation 60.36 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital length of stay(n=18,18,5) | 20.22 days | Standard Deviation 19.7 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days in nursing home(n=3,3,2) | 17.67 days | Standard Deviation 3.51 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days on sick leave due to RA(n=41,44,29) | 15.45 days | Standard Deviation 25.69 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related aids used(n=28,18,2) | 2.00 days | Standard Deviation 0 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days aids/devices used(n=23,22,13) | 85.00 days | Standard Deviation 57.64 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of part time work(n=30,29,12) | 26.92 days | Standard Deviation 32.2 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days aids/devices used(n=27,17,2) | 110.00 days | Standard Deviation 98.99 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of part time work(n=16,12,12) | 15.67 days | Standard Deviation 26.6 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Paid work, bothered by RA(n=92,88,48) | 31.90 days | Standard Deviation 31.61 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days in nursing home(n=3,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days on sick leave due to RA(n=19,15,16) | 11.13 days | Standard Deviation 21.56 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=50,44,15) | 17.87 days | Standard Deviation 18.71 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital length of stay(n=3,3,4) | 9.25 days | Standard Deviation 2.5 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days in nursing home(n=3,3,2) | 15.50 days | Standard Deviation 7.78 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=158,152,73) | 37.11 days | Standard Deviation 34.99 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=84,70,57) | 27.53 days | Standard Deviation 33.51 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital length of stay(n=18,18,5) | 22.20 days | Standard Deviation 15.37 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital length of stay(n=9,4,1) | 32.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=30,24,6) | 44.00 days | Standard Deviation 40.99 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Paid work, bothered by RA(n=46,52,13) | 12.85 days | Standard Deviation 15.66 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=25,21,12) | 21.75 days | Standard Deviation 18.71 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=85,66,15) | 34.87 days | Standard Deviation 40.65 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of work per week(n=97,113,48) | 4.88 days | Standard Deviation 1.21 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days in nursing home(n=0,1,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days aids/devices used(n=41,25,14) | 102.21 days | Standard Deviation 75.87 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of part time work(n=8,12,3) | 4.33 days | Standard Deviation 1.15 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Paid work, bothered by RA(n=52,48,27) | 34.59 days | Standard Deviation 33.28 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related aids used(n=42,29,14) | 1.64 days | Standard Deviation 0.5 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days on sick leave due to RA(n=15,11,4) | 24.25 days | Standard Deviation 43.84 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related aids used(n=23,24,14) | 1.21 days | Standard Deviation 0.7 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of work per week(n=109,121,59) | 4.93 days | Standard Deviation 1.39 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of work per week(n=98,117,18) | 4.94 days | Standard Deviation 1 |
Secondary
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Month 12, 18, 24
Population: FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital length of stay(n=8,4,2,1) | 10.13 days | Standard Deviation 6.58 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days in nursing home(n=2,0,0,0) | 11.50 days | Standard Deviation 2.12 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days aids/devices used(n=25,14,4,1) | 85.68 days | Standard Deviation 95.83 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related aids used(n=26,16,4,1) | 1.62 days | Standard Deviation 1.06 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of work per week(n=94,114,23,31) | 5.01 days | Standard Deviation 1.15 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days on sick leave due to RA(n=11,15,1,5) | 32.27 days | Standard Deviation 39.24 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of part time work(n=3,7,0,3) | 16.33 days | Standard Deviation 17.9 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Paid work, bothered by RA(n=38,38,10,12) | 20.89 days | Standard Deviation 24.78 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=18,18,4,0) | 14.06 days | Standard Deviation 20.23 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 30.15 days | Standard Deviation 33.03 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days aids/devices used(n=25,14,4,1) | 138.21 days | Standard Deviation 110.42 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=18,18,4,0) | 10.11 days | Standard Deviation 11.2 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related aids used(n=26,16,4,1) | 1.94 days | Standard Deviation 1.69 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of work per week(n=94,114,23,31) | 5.20 days | Standard Deviation 0.75 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days on sick leave due to RA(n=11,15,1,5) | 5.13 days | Standard Deviation 4.42 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of part time work(n=3,7,0,3) | 15.57 days | Standard Deviation 21.19 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 23.77 days | Standard Deviation 31.8 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Paid work, bothered by RA(n=38,38,10,12) | 18.58 days | Standard Deviation 24.28 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital length of stay(n=8,4,2,1) | 7.00 days | Standard Deviation 5.35 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days in nursing home(n=2,0,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Paid work, bothered by RA(n=38,38,10,12) | 23.80 days | Standard Deviation 28.35 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of part time work(n=3,7,0,3) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital length of stay(n=8,4,2,1) | 2.50 days | Standard Deviation 2.12 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 38.38 days | Standard Deviation 39.32 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related aids used(n=26,16,4,1) | 1.00 days | Standard Deviation 0.82 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days on sick leave due to RA(n=11,15,1,5) | 1.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=18,18,4,0) | 24.50 days | Standard Deviation 43.68 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days in nursing home(n=2,0,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of work per week(n=94,114,23,31) | 4.65 days | Standard Deviation 1.15 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days aids/devices used(n=25,14,4,1) | 100.50 days | Standard Deviation 57.63 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of work per week(n=94,114,23,31) | 4.87 days | Standard Deviation 1.26 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Paid work, bothered by RA(n=38,38,10,12) | 28.17 days | Standard Deviation 35.51 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days on sick leave due to RA(n=11,15,1,5) | 5.60 days | Standard Deviation 4.51 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 16.77 days | Standard Deviation 24.59 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days of part time work(n=3,7,0,3) | 31.67 days | Standard Deviation 51.39 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days in nursing home(n=2,0,0,0) | NA days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Days aids/devices used(n=25,14,4,1) | 180.00 days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related aids used(n=26,16,4,1) | 2.00 days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital length of stay(n=8,4,2,1) | 3.00 days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=18,18,4,0) | NA days | — |
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.
Time frame: Baseline, Month 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=3,3,4) | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital ER visit(n=14,11,4) | 1.29 events | Standard Deviation 0.61 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related ER visit(n=16,12,4) | 0.25 events | Standard Deviation 0.58 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=18,18,5) | 1.17 events | Standard Deviation 0.51 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Doctor visit(n=273,262,132) | 3.78 events | Standard Deviation 4.24 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital ER visit(n=15,12,4) | 1.27 events | Standard Deviation 0.59 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related hospitalization(n=18,19,5) | 1.11 events | Standard Deviation 0.58 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related ER visit(n=14,13,4) | 0.29 events | Standard Deviation 0.73 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related doctor visit(n=225,224,43) | 0.87 events | Standard Deviation 0.56 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related non-medical visit(n=6,8,3) | 1.50 events | Standard Deviation 1.52 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related non-medical visit(n=4,8,3) | 0.50 events | Standard Deviation 1 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=56,51,22) | 1.80 events | Standard Deviation 1.18 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner visit(n=4,8,3) | 7.50 events | Standard Deviation 11.03 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related diagnostic test(n=57,53,23) | 0.74 events | Standard Deviation 1.09 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related diagnostic test(n=37,44,14) | 0.14 events | Standard Deviation 0.35 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=9,4,1) | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=32,43,13) | 1.41 events | Standard Deviation 0.71 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related non-medical visit(n=11,18,7) | 1.00 events | Standard Deviation 0.77 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner visit(n=6,8,2) | 15.00 events | Standard Deviation 17.34 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related doctor visit(n=181,180,89) | 0.92 events | Standard Deviation 0.63 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related outpatient surgery(n=8,5,1) | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=8,5,1) | 1.25 events | Standard Deviation 0.46 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related outpatient surgery(n=8,14,5) | 0.38 events | Standard Deviation 0.52 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related hospitalization(n=9,4,1) | 0.11 events | Standard Deviation 0.33 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related doctor visit(n=271,262,131) | 1.16 events | Standard Deviation 0.7 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Doctor visit(n=226,225,43) | 3.00 events | Standard Deviation 2.89 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related ER visit(n=23,12,9) | 0.74 events | Standard Deviation 0.81 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related hospitalization(n=3,3,4) | 0.33 events | Standard Deviation 0.58 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner visit(n=10,17,7) | 12.50 events | Standard Deviation 12.29 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=58,41,11) | 1.78 events | Standard Deviation 1.83 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Doctor visit(n=181,181,89) | 2.85 events | Standard Deviation 1.79 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related diagnostic test(n=60,44,11) | 0.25 events | Standard Deviation 0.68 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=8,13,5) | 1.13 events | Standard Deviation 0.35 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=12,2,3) | 1.33 events | Standard Deviation 0.89 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital ER visit(n=19,11,9) | 1.42 events | Standard Deviation 0.77 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related outpatient surgery(n=12,3,3) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=12,2,3) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Doctor visit(n=273,262,132) | 4.00 events | Standard Deviation 5.07 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=8,13,5) | 1.85 events | Standard Deviation 2.76 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=56,51,22) | 1.67 events | Standard Deviation 1.16 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related diagnostic test(n=57,53,23) | 0.77 events | Standard Deviation 1.19 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Doctor visit(n=181,181,89) | 3.08 events | Standard Deviation 2.76 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related ER visit(n=14,13,4) | 0.15 events | Standard Deviation 0.55 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=9,4,1) | 1.25 events | Standard Deviation 0.5 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=32,43,13) | 1.56 events | Standard Deviation 1.35 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related diagnostic test(n=37,44,14) | 0.07 events | Standard Deviation 0.25 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related doctor visit(n=225,224,43) | 0.86 events | Standard Deviation 0.56 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related hospitalization(n=3,3,4) | 0.33 events | Standard Deviation 0.58 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related outpatient surgery(n=12,3,3) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=58,41,11) | 1.73 events | Standard Deviation 1.4 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related doctor visit(n=271,262,131) | 1.20 events | Standard Deviation 0.8 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital ER visit(n=19,11,9) | 1.73 events | Standard Deviation 1.27 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related ER visit(n=23,12,9) | 0.83 events | Standard Deviation 1.34 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=18,18,5) | 1.17 events | Standard Deviation 0.38 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related hospitalization(n=18,19,5) | 1.32 events | Standard Deviation 1.34 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related outpatient surgery(n=8,14,5) | 0.43 events | Standard Deviation 0.85 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner visit(n=10,17,7) | 10.88 events | Standard Deviation 13.09 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related non-medical visit(n=11,18,7) | 1.00 events | Standard Deviation 0.84 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related doctor visit(n=181,180,89) | 0.79 events | Standard Deviation 0.54 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital ER visit(n=14,11,4) | 1.45 events | Standard Deviation 0.93 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related hospitalization(n=9,4,1) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=8,5,1) | 1.20 events | Standard Deviation 0.45 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related outpatient surgery(n=8,5,1) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner visit(n=4,8,3) | 3.63 events | Standard Deviation 1.51 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related non-medical visit(n=4,8,3) | 0.38 events | Standard Deviation 0.52 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Doctor visit(n=226,225,43) | 2.72 events | Standard Deviation 2.28 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital ER visit(n=15,12,4) | 1.33 events | Standard Deviation 0.49 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related ER visit(n=16,12,4) | 0.33 events | Standard Deviation 0.78 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=3,3,4) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related diagnostic test(n=60,44,11) | 0.25 events | Standard Deviation 0.69 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner visit(n=6,8,2) | 6.13 events | Standard Deviation 4.55 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related non-medical visit(n=6,8,3) | 0.25 events | Standard Deviation 0.46 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related diagnostic test(n=37,44,14) | 0.14 events | Standard Deviation 0.36 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=56,51,22) | 1.73 events | Standard Deviation 1.12 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=58,41,11) | 2.00 events | Standard Deviation 1 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner visit(n=4,8,3) | 22.33 events | Standard Deviation 11.24 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related outpatient surgery(n=8,14,5) | 0.40 events | Standard Deviation 0.55 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Doctor visit(n=273,262,132) | 4.80 events | Standard Deviation 5.61 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related non-medical visit(n=4,8,3) | 0.67 events | Standard Deviation 0.58 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related diagnostic test(n=60,44,11) | 0.09 events | Standard Deviation 0.3 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Doctor visit(n=226,225,43) | 4.51 events | Standard Deviation 6.05 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related hospitalization(n=18,19,5) | 1.40 events | Standard Deviation 0.55 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related doctor visit(n=225,224,43) | 0.91 events | Standard Deviation 0.61 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=18,18,5) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=8,13,5) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital ER visit(n=15,12,4) | 2.25 events | Standard Deviation 2.5 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related ER visit(n=23,12,9) | 0.56 events | Standard Deviation 0.73 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related non-medical visit(n=6,8,3) | 1.67 events | Standard Deviation 0.58 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related ER visit(n=16,12,4) | 0.50 events | Standard Deviation 1 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital ER visit(n=19,11,9) | 1.22 events | Standard Deviation 0.67 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner visit(n=6,8,2) | 25.00 events | Standard Deviation 7.07 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=3,3,4) | 1.25 events | Standard Deviation 0.5 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related hospitalization(n=3,3,4) | 0.50 events | Standard Deviation 1 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related doctor visit(n=271,262,131) | 1.25 events | Standard Deviation 0.67 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital ER visit(n=14,11,4) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=12,2,3) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=9,4,1) | 2.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related ER visit(n=14,13,4) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Doctor visit(n=181,181,89) | 3.27 events | Standard Deviation 3.73 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related hospitalization(n=9,4,1) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related doctor visit(n=181,180,89) | 0.87 events | Standard Deviation 0.61 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related outpatient surgery(n=12,3,3) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=8,5,1) | 1.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related non-medical visit(n=11,18,7) | 1.57 events | Standard Deviation 1.27 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related outpatient surgery(n=8,5,1) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner visit(n=10,17,7) | 12.57 events | Standard Deviation 13.23 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=32,43,13) | 1.46 events | Standard Deviation 0.97 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related diagnostic test(n=57,53,23) | 0.83 events | Standard Deviation 1.15 |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Month 12, 18, 24
Population: FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related diagnostic test(n=52,50,9,9) | 0.27 events | Standard Deviation 0.56 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related ER visit(n=18,11,4,3) | 0.11 events | Standard Deviation 0.32 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospitalization(n=8,4,2,1) | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related hospitalization(n=8,4,2,1) | 0.50 events | Standard Deviation 0.76 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-study diagnostic test(n=50,47,9,8) | 1.98 events | Standard Deviation 1.49 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related outpatient surgery(n=13,4,1,1) | 0.46 events | Standard Deviation 0.66 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Doctor visit(n=197,221,56,52) | 2.70 events | Standard Deviation 2.74 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-medical practitioner visit(n=4,6,4,1) | 12.00 events | Standard Deviation 5.86 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related doctor visit (n=197,220,56,52) | 0.92 events | Standard Deviation 0.52 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related non-medical visit(n=4,6,4,1) | 1.25 events | Standard Deviation 0.96 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital ER visit(n=18,11,4,3) | 1.61 events | Standard Deviation 1.58 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=13,4,1,1) | 2.31 events | Standard Deviation 2.39 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related hospitalization(n=8,4,2,1) | 0.50 events | Standard Deviation 0.58 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related doctor visit (n=197,220,56,52) | 0.89 events | Standard Deviation 0.43 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related ER visit(n=18,11,4,3) | 0.09 events | Standard Deviation 0.3 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=13,4,1,1) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-study diagnostic test(n=50,47,9,8) | 1.55 events | Standard Deviation 1.14 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Doctor visit(n=197,221,56,52) | 2.43 events | Standard Deviation 2.26 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospitalization(n=8,4,2,1) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related non-medical visit(n=4,6,4,1) | 0.17 events | Standard Deviation 0.41 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital ER visit(n=18,11,4,3) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-medical practitioner visit(n=4,6,4,1) | 9.83 events | Standard Deviation 15.03 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related diagnostic test(n=52,50,9,9) | 0.24 events | Standard Deviation 0.48 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related outpatient surgery(n=13,4,1,1) | 0.25 events | Standard Deviation 0.5 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related non-medical visit(n=4,6,4,1) | 0.75 events | Standard Deviation 0.96 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related hospitalization(n=8,4,2,1) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=13,4,1,1) | 1.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related outpatient surgery(n=13,4,1,1) | 2.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Doctor visit(n=197,221,56,52) | 3.27 events | Standard Deviation 4.02 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related doctor visit (n=197,220,56,52) | 0.93 events | Standard Deviation 0.6 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital ER visit(n=18,11,4,3) | 1.25 events | Standard Deviation 0.5 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related ER visit(n=18,11,4,3) | 0.25 events | Standard Deviation 0.5 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospitalization(n=8,4,2,1) | 1.50 events | Standard Deviation 0.71 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-study diagnostic test(n=50,47,9,8) | 2.00 events | Standard Deviation 1 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related diagnostic test(n=52,50,9,9) | 0.22 events | Standard Deviation 0.67 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-medical practitioner visit(n=4,6,4,1) | 10.00 events | Standard Deviation 7.12 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-study diagnostic test(n=50,47,9,8) | 1.88 events | Standard Deviation 0.83 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospital ER visit(n=18,11,4,3) | 1.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related doctor visit (n=197,220,56,52) | 0.88 events | Standard Deviation 0.47 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related non-medical visit(n=4,6,4,1) | 0.00 events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related diagnostic test(n=52,50,9,9) | 0.11 events | Standard Deviation 0.33 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Doctor visit(n=197,221,56,52) | 2.81 events | Standard Deviation 3.91 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=13,4,1,1) | 2.00 events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related outpatient surgery(n=13,4,1,1) | 0.00 events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Non-medical practitioner visit(n=4,6,4,1) | 9.00 events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:Hospitalization(n=8,4,2,1) | 1.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related ER visit(n=18,11,4,3) | 0.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 | Month 12:RA related hospitalization(n=8,4,2,1) | 0.00 events | — |
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related home HC services(n=5,2,1) | 1.20 hours per day | Standard Deviation 0.84 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related home HC services(n=5,1,0) | 0.80 hours per day | Standard Deviation 0.84 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related home HC services(n=8,4,3) | 1.00 hours per day | Standard Deviation 0.76 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=5,2,1) | 2.20 hours per day | Standard Deviation 2.17 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Work done(n=97,113,48) | 7.71 hours per day | Standard Deviation 4.83 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=83,67,15) | 3.13 hours per day | Standard Deviation 2.39 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=83,70,56) | 4.31 hours per day | Standard Deviation 9.29 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Missed work due to RA(n=16,12,12) | 9.94 hours per day | Standard Deviation 16.85 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Missed work due to RA(n=30,30,12) | 7.03 hours per day | Standard Deviation 9.98 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=25,21,12) | 4.84 hours per day | Standard Deviation 4.59 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=6,2,3) | 1.50 hours per day | Standard Deviation 0.84 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=30,23,6) | 4.97 hours per day | Standard Deviation 3 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=51,44,14) | 4.27 hours per day | Standard Deviation 2.19 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=5,1,0) | 1.20 hours per day | Standard Deviation 0.45 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Missed work due to RA(n=8,12,3) | 2.38 hours per day | Standard Deviation 1.6 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=158,152,71) | 3.95 hours per day | Standard Deviation 4.33 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Work done(n=108,121,59) | 8.01 hours per day | Standard Deviation 4.05 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Work done(n=98,117,18) | 8.15 hours per day | Standard Deviation 4.15 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=5,1,0) | 4.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=6,2,3) | 3.00 hours per day | Standard Deviation 1.41 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related home HC services(n=8,4,3) | 1.50 hours per day | Standard Deviation 1 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Work done(n=108,121,59) | 8.22 hours per day | Standard Deviation 4.41 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Missed work due to RA(n=30,30,12) | 5.33 hours per day | Standard Deviation 4.47 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=51,44,14) | 4.98 hours per day | Standard Deviation 2.76 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=158,152,71) | 3.66 hours per day | Standard Deviation 3.87 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related home HC services(n=5,1,0) | 3.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Work done(n=97,113,48) | 8.25 hours per day | Standard Deviation 3.6 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Missed work due to RA(n=16,12,12) | 3.17 hours per day | Standard Deviation 2.92 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=25,21,12) | 4.48 hours per day | Standard Deviation 2.18 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=83,70,56) | 3.64 hours per day | Standard Deviation 4.73 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=5,2,1) | 3.00 hours per day | Standard Deviation 2.83 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related home HC services(n=5,2,1) | 1.50 hours per day | Standard Deviation 2.12 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Work done(n=98,117,18) | 7.90 hours per day | Standard Deviation 1.85 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Missed work due to RA(n=8,12,3) | 2.50 hours per day | Standard Deviation 1.62 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=30,23,6) | 4.87 hours per day | Standard Deviation 2.32 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=83,67,15) | 3.25 hours per day | Standard Deviation 4.09 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=5,2,1) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=5,1,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Work done(n=108,121,59) | 8.12 hours per day | Standard Deviation 5.25 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related home HC services(n=5,2,1) | 0.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=158,152,71) | 3.49 hours per day | Standard Deviation 4.16 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=6,2,3) | 1.33 hours per day | Standard Deviation 0.58 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Work done(n=98,117,18) | 7.56 hours per day | Standard Deviation 3.05 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=51,44,14) | 4.21 hours per day | Standard Deviation 2.22 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=83,67,15) | 2.93 hours per day | Standard Deviation 1.79 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Missed work due to RA(n=8,12,3) | 1.00 hours per day | Standard Deviation 1.73 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Missed work due to RA(n=16,12,12) | 5.42 hours per day | Standard Deviation 6.16 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Missed work due to RA(n=30,30,12) | 4.33 hours per day | Standard Deviation 6.29 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=25,21,12) | 4.83 hours per day | Standard Deviation 2.62 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Work done(n=97,113,48) | 7.42 hours per day | Standard Deviation 2.47 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related home HC services(n=8,4,3) | 0.67 hours per day | Standard Deviation 1.15 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=83,70,56) | 4.04 hours per day | Standard Deviation 4.45 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related home HC services(n=5,1,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=30,23,6) | 2.67 hours per day | Standard Deviation 1.21 |
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Month 12, 18, 24
Population: FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Home healthcare services(n=2,1,0,0) | 20.50 hours per day | Standard Deviation 27.58 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:RA related home HC services(n=2,1,0,0) | 0.50 hours per day | Standard Deviation 0.71 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Work done(n=95,114,23,31) | 7.78 hours per day | Standard Deviation 3.81 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Missed work due to RA(n=3,7,0,3) | 1.33 hours per day | Standard Deviation 1.15 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=17,17,4,0) | 4.47 hours per day | Standard Deviation 2.27 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 3.31 hours per day | Standard Deviation 2.36 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 3.20 hours per day | Standard Deviation 2.16 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Missed work due to RA(n=3,7,0,3) | 8.71 hours per day | Standard Deviation 12.42 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Home healthcare services(n=2,1,0,0) | 4.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Work done(n=95,114,23,31) | 7.92 hours per day | Standard Deviation 1.88 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:RA related home HC services(n=2,1,0,0) | 3.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=17,17,4,0) | 4.53 hours per day | Standard Deviation 1.7 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:RA related home HC services(n=2,1,0,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Work done(n=95,114,23,31) | 7.48 hours per day | Standard Deviation 2.02 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Missed work due to RA(n=3,7,0,3) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 3.75 hours per day | Standard Deviation 2.38 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Home healthcare services(n=2,1,0,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=17,17,4,0) | 5.25 hours per day | Standard Deviation 3.4 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by family(n=62,56,16,13) | 2.31 hours per day | Standard Deviation 0.95 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=17,17,4,0) | NA hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:RA related home HC services(n=2,1,0,0) | NA hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Missed work due to RA(n=3,7,0,3) | 2.67 hours per day | Standard Deviation 1.53 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Home healthcare services(n=2,1,0,0) | NA hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 | Month 12:Work done(n=95,114,23,31) | 8.03 hours per day | Standard Deviation 2.09 |
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.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline (n=315,309,156) | 140 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,309,153) | 144 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 140 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,139) | 132 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,139) | 140 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline (n=315,309,156) | 132 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 150 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,309,153) | 156 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,139) | 64 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1 (n=309,309,153) | 67 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 71 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline (n=315,309,156) | 70 participants |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | 131 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | 134 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | 36 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 | 28 participants |
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.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 58.39 mm | Standard Deviation 23.08 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,153) | 41.61 mm | Standard Deviation 24.08 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 34.47 mm | Standard Deviation 23.49 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 32.79 mm | Standard Deviation 22.9 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 29.05 mm | Standard Deviation 22.71 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 57.62 mm | Standard Deviation 24.1 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 29.23 mm | Standard Deviation 21.95 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,153) | 33.91 mm | Standard Deviation 22.3 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=283,285,62) | 36.76 mm | Standard Deviation 22.14 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,153) | 49.22 mm | Standard Deviation 24.51 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=295,300,146) | 46.96 mm | Standard Deviation 24.02 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 55.01 mm | Standard Deviation 23.87 |
Secondary
Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 31.59 mm | Standard Deviation 23.13 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 30.54 mm | Standard Deviation 23 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 27.45 mm | Standard Deviation 24.56 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 27.14 mm | Standard Deviation 23.1 |
| Placebo | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 31.74 mm | Standard Deviation 23.26 |
| Placebo | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 27.99 mm | Standard Deviation 23.55 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 27.54 mm | Standard Deviation 23.12 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 29.41 mm | Standard Deviation 26.22 |
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 = very well and 100 = very poorly.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 1 (n=309,308,153) | 41.26 mm | Standard Deviation 23.69 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Baseline (n=316,308,156) | 58.06 mm | Standard Deviation 23.62 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 3 (n=295,300,146) | 35.07 mm | Standard Deviation 22.68 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 6 (n=283,285,62) | 33.48 mm | Standard Deviation 22.39 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 6 (n=283,285,62) | 29.03 mm | Standard Deviation 22.68 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 3 (n=295,300,146) | 29.11 mm | Standard Deviation 20.54 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Baseline (n=316,308,156) | 56.45 mm | Standard Deviation 22.96 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 1 (n=309,308,153) | 34.95 mm | Standard Deviation 21.43 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Baseline (n=316,308,156) | 54.11 mm | Standard Deviation 22.87 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 1 (n=309,308,153) | 48.30 mm | Standard Deviation 24.47 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 3 (n=295,300,146) | 46.96 mm | Standard Deviation 24.09 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 | Month 6 (n=283,285,62) | 38.87 mm | Standard Deviation 23.17 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 31.19 mm | Standard Deviation 22.1 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 31.77 mm | Standard Deviation 22.55 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 29.12 mm | Standard Deviation 24.06 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 28.05 mm | Standard Deviation 22.46 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 31.46 mm | Standard Deviation 23.22 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 29.60 mm | Standard Deviation 23.15 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 27.41 mm | Standard Deviation 23.22 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 28.11 mm | Standard Deviation 24.09 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 1 | 41.42 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 3 | 56.31 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 1 | 52.10 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 3 | 66.34 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 1 | 16.34 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 | Month 3 | 27.27 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 47.90 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 48.54 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 56.96 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 62.46 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 32.91 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 30.38 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 29.33 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 33.33 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6
ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 3 | 28.80 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 1 | 16.83 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 6 | 32.36 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 3 | 36.25 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 1 | 18.45 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 6 | 43.69 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 1 | 1.31 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 6 | 8.44 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 | Month 3 | 7.79 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24
ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 32.69 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 32.69 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 41.10 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 44.01 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 22.78 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 21.52 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 20.00 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 16.00 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) 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 HAQ); and CRP.
Time frame: Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 3 | 10.68 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 1 | 3.88 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 6 | 14.56 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 3 | 17.15 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 1 | 3.56 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 6 | 22.33 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 1 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 6 | 1.30 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 | Month 3 | 2.60 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 18.45 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 18.77 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 27.51 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 28.48 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 8.86 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 10.13 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 12.00 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 12.00 percentage of participants |
Secondary
Physician Global Assessment (PGA) of Arthritis 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.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 59.44 mm | Standard Deviation 15.87 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,152) | 37.97 mm | Standard Deviation 18.58 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 3 (n=294,300,146) | 30.12 mm | Standard Deviation 18.61 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 6 (n=283,284,61) | 25.47 mm | Standard Deviation 18.62 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 6 (n=283,284,61) | 20.44 mm | Standard Deviation 15.75 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 58.42 mm | Standard Deviation 17.08 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 3 (n=294,300,146) | 24.47 mm | Standard Deviation 17.51 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,152) | 35.19 mm | Standard Deviation 19.29 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 6 (n=283,284,61) | 26.61 mm | Standard Deviation 17.73 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 1 (n=309,308,152) | 45.50 mm | Standard Deviation 19.57 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Month 3 (n=294,300,146) | 43.29 mm | Standard Deviation 22.25 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 | Baseline (n=316,309,156) | 55.90 mm | Standard Deviation 17.37 |
Secondary
Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 21.68 mm | Standard Deviation 16.14 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 20.40 mm | Standard Deviation 15.71 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 17.97 mm | Standard Deviation 15.08 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 18.90 mm | Standard Deviation 15.89 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 19.92 mm | Standard Deviation 17.59 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 20.42 mm | Standard Deviation 16.63 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 19.29 mm | Standard Deviation 15.53 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 18.79 mm | Standard Deviation 15.42 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]).
Time frame: Baseline, Month 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:work loss index(n=155,157,87) | 11.13 units on a scale | Standard Deviation 5.71 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:mental demands(n=151,151,86) | 33.91 units on a scale | Standard Deviation 25.41 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:mental demands(n=111,124,55 | 27.92 units on a scale | Standard Deviation 27.18 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:output demands(n=149,147,83) | 38.81 units on a scale | Standard Deviation 26.66 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:time management(n=107,116,52) | 45.18 units on a scale | Standard Deviation 31.06 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:mental demands(n=103,117,18) | 25.30 units on a scale | Standard Deviation 29.75 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:physical demands(n=106,124,55) | 47.11 units on a scale | Standard Deviation 29.37 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:physical demands(n=104,116,19) | 48.00 units on a scale | Standard Deviation 29.47 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:time management(n=97,116,19) | 37.90 units on a scale | Standard Deviation 30.57 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:work loss index(n=111,127,55) | 9.77 units on a scale | Standard Deviation 6.29 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:work loss index(n=105,123,19) | 8.78 units on a scale | Standard Deviation 6.75 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:time management(n=147,146,81) | 49.74 units on a scale | Standard Deviation 25.59 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:output demands(n=101,117,18) | 29.43 units on a scale | Standard Deviation 29.61 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:output demands(n=108,119,54) | 32.71 units on a scale | Standard Deviation 27.67 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:physical demands(n=149,152,86) | 50.17 units on a scale | Standard Deviation 24.18 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:time management(n=97,116,19) | 34.33 units on a scale | Standard Deviation 33.47 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:output demands(n=149,147,83) | 36.85 units on a scale | Standard Deviation 25.95 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:work loss index(n=155,157,87) | 9.98 units on a scale | Standard Deviation 5.66 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:time management(n=147,146,81) | 41.93 units on a scale | Standard Deviation 26.9 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:physical demands(n=149,152,86) | 50.11 units on a scale | Standard Deviation 24.19 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:mental demands(n=151,151,86) | 29.28 units on a scale | Standard Deviation 24.47 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:time management(n=107,116,52) | 35.87 units on a scale | Standard Deviation 33.78 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:physical demands(n=106,124,55) | 44.06 units on a scale | Standard Deviation 32.26 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:mental demands(n=111,124,55 | 23.52 units on a scale | Standard Deviation 27.09 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:output demands(n=108,119,54) | 25.48 units on a scale | Standard Deviation 28.69 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:work loss index(n=111,127,55) | 7.86 units on a scale | Standard Deviation 6.44 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:physical demands(n=104,116,19) | 43.01 units on a scale | Standard Deviation 34.57 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:mental demands(n=103,117,18) | 21.95 units on a scale | Standard Deviation 28.4 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:output demands(n=101,117,18) | 24.26 units on a scale | Standard Deviation 29.3 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:work loss index(n=105,123,19) | 7.47 units on a scale | Standard Deviation 6.57 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:output demands(n=101,117,18) | 35.56 units on a scale | Standard Deviation 26.78 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:mental demands(n=103,117,18) | 32.43 units on a scale | Standard Deviation 30.69 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:work loss index(n=111,127,55) | 10.89 units on a scale | Standard Deviation 6.4 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:time management(n=97,116,19) | 40.53 units on a scale | Standard Deviation 32.7 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:physical demands(n=149,152,86) | 49.96 units on a scale | Standard Deviation 26.67 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:mental demands(n=111,124,55 | 34.24 units on a scale | Standard Deviation 27.87 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:output demands(n=149,147,83) | 40.57 units on a scale | Standard Deviation 29.38 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:time management(n=107,116,52) | 41.11 units on a scale | Standard Deviation 27.36 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:physical demands(n=104,116,19) | 43.90 units on a scale | Standard Deviation 31.26 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:physical demands(n=106,124,55) | 46.02 units on a scale | Standard Deviation 25.36 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:mental demands(n=151,151,86) | 33.13 units on a scale | Standard Deviation 27.93 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:work loss index(n=155,157,87) | 10.99 units on a scale | Standard Deviation 6.78 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:time management(n=147,146,81) | 44.02 units on a scale | Standard Deviation 28.39 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:work loss index(n=105,123,19) | 10.05 units on a scale | Standard Deviation 6.54 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:output demands(n=108,119,54) | 39.23 units on a scale | Standard Deviation 28.44 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]).
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:output demands(n=93,107,23,31) | 23.71 units on a scale | Standard Deviation 26.59 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:work loss index(n=94,118,23,33) | 7.78 units on a scale | Standard Deviation 5.94 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:mental demands(n=93,115,23,33) | 21.24 units on a scale | Standard Deviation 25.05 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:physical demands(n=91,110,22,33) | 45.64 units on a scale | Standard Deviation 33.67 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:time management(n=92,108,22,32) | 35.82 units on a scale | Standard Deviation 31.75 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:work loss index(n=94,118,23,33) | 6.88 units on a scale | Standard Deviation 5.98 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:physical demands(n=91,110,22,33) | 46.16 units on a scale | Standard Deviation 33.53 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:mental demands(n=93,115,23,33) | 20.42 units on a scale | Standard Deviation 25.99 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:time management(n=92,108,22,32) | 31.30 units on a scale | Standard Deviation 31.68 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:output demands(n=93,107,23,31) | 21.18 units on a scale | Standard Deviation 26.52 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:time management(n=92,108,22,32) | 43.69 units on a scale | Standard Deviation 32.76 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:mental demands(n=93,115,23,33) | 39.29 units on a scale | Standard Deviation 35.39 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:output demands(n=93,107,23,31) | 37.12 units on a scale | Standard Deviation 34.59 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:physical demands(n=91,110,22,33) | 47.01 units on a scale | Standard Deviation 32.96 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:work loss index(n=94,118,23,33) | 11.33 units on a scale | Standard Deviation 7.64 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:output demands(n=93,107,23,31) | 33.67 units on a scale | Standard Deviation 34.78 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:mental demands(n=93,115,23,33) | 27.70 units on a scale | Standard Deviation 33.57 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:time management(n=92,108,22,32) | 37.58 units on a scale | Standard Deviation 36.88 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:work loss index(n=94,118,23,33) | 9.24 units on a scale | Standard Deviation 7.91 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 | Month 12:physical demands(n=91,110,22,33) | 41.10 units on a scale | Standard Deviation 35.89 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3 (n=151,176,81) | 3.81 units on a scale | Standard Deviation 3.11 |
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline (n=204,202,104) | 5.29 units on a scale | Standard Deviation 3.09 |
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6 (n=160,185,29) | 3.73 units on a scale | Standard Deviation 3.18 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3 (n=151,176,81) | 3.11 units on a scale | Standard Deviation 2.67 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline (n=204,202,104) | 4.88 units on a scale | Standard Deviation 3.03 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6 (n=160,185,29) | 2.99 units on a scale | Standard Deviation 2.94 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline (n=204,202,104) | 4.68 units on a scale | Standard Deviation 3.03 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6 (n=160,185,29) | 3.41 units on a scale | Standard Deviation 2.85 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3 (n=151,176,81) | 4.40 units on a scale | Standard Deviation 2.87 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24 | 3.19 units on a scale | Standard Deviation 3.13 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24 | 2.66 units on a scale | Standard Deviation 2.8 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24 | 2.51 units on a scale | Standard Deviation 2.54 |
| Placebo, Then CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24 | 2.66 units on a scale | Standard Deviation 2.72 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family, friends or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Baseline, Month 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed paid work(n=174,197,88) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Sick leave due to RA(n=236,236,123) | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=282,284,61) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed part time work(n=176,196,89) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed part time work(n=235,236,121) | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Admitted for overnight stay (n=22,12,9) | 0.27 units on a scale | Standard Deviation 0.63 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Sick leave due to RA(n=175,200,89) | 1.89 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed paid work(n=235,235,122) | 1.60 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Retired(n=178,157,41) | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Work disabled due to RA(n=174,154,38) | 1.52 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen any doctor (n=315, 305, 154) | 1.14 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=315,305,155) | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Lost job/retired early(n=173,158,38) | 1.69 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Retired(n=150,142,70) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by family/friends(n=315,305,155) | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by family/friends(n=281,285,61) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Lost job/retired early(n=148,139,67) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Seen any doctor(n=259,260,121) | 1.31 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Treated in emergency room(n=315,306,155) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to work due to RA(n=148,139,67) | 1.44 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Treated in emergency room(n=259,260,121) | 1.95 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed paid work(n=193,216,37) | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Feel well enough to work(n=147,140,68) | 1.78 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Admitted for overnight stay (n=14,12,4) | 0.64 units on a scale | Standard Deviation 0.84 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to work due to RA(n=177,155,40) | 1.47 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Currently employed(n=259,260,121) | 1.63 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=259,260,121) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to do chores(n=312,302,152) | 1.38 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Required aids/devices(n=259,260,121) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=259,260,121) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Feel well enough to work(n=176,154,38) | 1.77 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=257,260,121) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=259,260,121) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=315,306,155) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:In nursing home(n=259,260,121) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=315,305,155) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Currently employed(n=283,285,61) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed part time work(n=193,215,37) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner(n=283,285,61) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=315,306,155) | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner(n=259,260,121) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Required aids/devices(n=283,285,61) | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:In nursing home(n=315,306,155) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to do chores(n=281,284,61) | 1.63 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=315,306,154) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner(n=315,306,155) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=282,284,61) | 1.79 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices(n=315,306,155) | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Work disabled due to RA(n=150,140,68) | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=283,285,61) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=281,285,61) | 1.89 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Admitted for overnight stay (n=17,12,4) | 0.12 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Currently employed(n=314,306,155) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Lost job/retired early(n=184,169,86) | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Treated in emergency room(n=283,285,61) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Feel well enough to work(n=182,166,89) | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Seen any doctor(n=282,285,61) | 1.21 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to work due to RA(n=185,169,88) | 1.37 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Sick leave due to RA(n=195,216,37) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by family/friends(n=257,259,121) | 1.67 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=257,259,121) | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Work disabled due to RA(n=186,168,88) | 1.52 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=283,285,61) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to do chores(n=257,256,121) | 1.60 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Retired(n=193,171,92) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:In nursing home(n=283,285,61) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Retired(n=150,142,70) | 1.42 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen any doctor (n=315, 305, 154) | 1.15 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Feel well enough to work(n=182,166,89) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Lost job/retired early(n=184,169,86) | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Required aids/devices(n=259,260,121) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Currently employed(n=259,260,121) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to work due to RA(n=148,139,67) | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Sick leave due to RA(n=175,200,89) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=257,259,121) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to work due to RA(n=177,155,40) | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Treated in emergency room(n=315,306,155) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Admitted for overnight stay (n=22,12,9) | 0.25 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=315,306,155) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=315,305,155) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=315,306,155) | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:In nursing home(n=315,306,155) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=315,306,154) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices(n=315,306,155) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner(n=315,306,155) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Currently employed(n=314,306,155) | 1.60 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to work due to RA(n=185,169,88) | 1.37 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Work disabled due to RA(n=186,168,88) | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Retired(n=193,171,92) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Sick leave due to RA(n=236,236,123) | 1.81 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed part time work(n=235,236,121) | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed paid work(n=235,235,122) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to do chores(n=312,302,152) | 1.43 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=315,305,155) | 1.85 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by family/friends(n=315,305,155) | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Seen any doctor(n=259,260,121) | 1.31 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Treated in emergency room(n=259,260,121) | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Admitted for overnight stay (n=14,12,4) | 0.08 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=259,260,121) | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=259,260,121) | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=259,260,121) | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:In nursing home(n=259,260,121) | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=257,260,121) | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner(n=259,260,121) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Feel well enough to work(n=147,140,68) | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Lost job/retired early(n=148,139,67) | 1.63 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Work disabled due to RA(n=150,140,68) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed part time work(n=176,196,89) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed paid work(n=174,197,88) | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to do chores(n=257,256,121) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by family/friends(n=257,259,121) | 1.73 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Seen any doctor(n=282,285,61) | 1.21 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Treated in emergency room(n=283,285,61) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Admitted for overnight stay (n=17,12,4) | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=283,285,61) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=283,285,61) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=282,284,61) | 1.85 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:In nursing home(n=283,285,61) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=282,284,61) | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Required aids/devices(n=283,285,61) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner(n=283,285,61) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Currently employed(n=283,285,61) | 1.59 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Feel well enough to work(n=176,154,38) | 1.73 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Lost job/retired early(n=173,158,38) | 1.63 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Work disabled due to RA(n=174,154,38) | 1.66 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Retired(n=178,157,41) | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Sick leave due to RA(n=195,216,37) | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed part time work(n=193,215,37) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed paid work(n=193,216,37) | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to do chores(n=281,284,61) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=281,285,61) | 1.92 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by family/friends(n=281,285,61) | 1.76 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed paid work(n=174,197,88) | 1.69 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Work disabled due to RA(n=186,168,88) | 1.52 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen any doctor (n=315, 305, 154) | 1.16 units on a scale | Standard Deviation 0.36 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to do chores(n=257,256,121) | 1.52 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Lost job/retired early(n=184,169,86) | 1.67 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=257,259,121) | 1.90 units on a scale | Standard Deviation 0.3 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to work due to RA(n=185,169,88) | 1.32 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Lost job/retired early(n=173,158,38) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by family/friends(n=257,259,121) | 1.53 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Feel well enough to work(n=182,166,89) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Retired(n=178,157,41) | 1.61 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Currently employed(n=314,306,155) | 1.62 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed paid work(n=193,216,37) | 1.65 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Treated in emergency room(n=283,285,61) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner(n=315,306,155) | 1.95 units on a scale | Standard Deviation 0.21 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Work disabled due to RA(n=174,154,38) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Admitted for overnight stay (n=17,12,4) | 1.00 units on a scale | Standard Deviation 0.15 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices(n=315,306,155) | 1.90 units on a scale | Standard Deviation 0.3 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to work due to RA(n=177,155,40) | 1.43 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=283,285,61) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:In nursing home(n=315,306,155) | 1.99 units on a scale | Standard Deviation 0.11 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=283,285,61) | 1.95 units on a scale | Standard Deviation 0.22 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=315,306,154) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Seen any doctor(n=282,285,61) | 1.31 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=282,284,61) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by family/friends(n=281,285,61) | 1.75 units on a scale | Standard Deviation 0.43 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:In nursing home(n=283,285,61) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Sick leave due to RA(n=195,216,37) | 1.89 units on a scale | Standard Deviation 0.31 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=282,284,61) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=315,306,155) | 1.85 units on a scale | Standard Deviation 0.36 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Required aids/devices(n=259,260,121) | 1.89 units on a scale | Standard Deviation 0.31 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Required aids/devices(n=283,285,61) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=315,305,155) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to do chores(n=281,284,61) | 1.64 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner(n=283,285,61) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=259,260,121) | 1.88 units on a scale | Standard Deviation 0.32 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=315,306,155) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:In nursing home(n=259,260,121) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=259,260,121) | 1.99 units on a scale | Standard Deviation 0.09 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed part time work(n=193,215,37) | 1.92 units on a scale | Standard Deviation 0.28 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=257,260,121) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=259,260,121) | 1.99 units on a scale | Standard Deviation 0.09 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Currently employed(n=283,285,61) | 1.70 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner(n=259,260,121) | 1.98 units on a scale | Standard Deviation 0.16 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Admitted for overnight stay (n=14,12,4) | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Currently employed(n=259,260,121) | 1.60 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Treated in emergency room(n=259,260,121) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Admitted for overnight stay (n=22,12,9) | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Feel well enough to work(n=147,140,68) | 1.82 units on a scale | Standard Deviation 0.38 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Seen any doctor(n=259,260,121) | 1.28 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to work due to RA(n=148,139,67) | 1.39 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by family/friends(n=315,305,155) | 1.53 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed paid work(n=235,235,122) | 1.61 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Lost job/retired early(n=148,139,67) | 1.57 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Feel well enough to work(n=176,154,38) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Work disabled due to RA(n=150,140,68) | 1.57 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=315,305,155) | 1.90 units on a scale | Standard Deviation 0.3 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to do chores(n=312,302,152) | 1.43 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Retired(n=150,142,70) | 1.63 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed part time work(n=235,236,121) | 1.90 units on a scale | Standard Deviation 0.3 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Sick leave due to RA(n=175,200,89) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Sick leave due to RA(n=236,236,123) | 1.76 units on a scale | Standard Deviation 0.43 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Treated in emergency room(n=315,306,155) | 1.94 units on a scale | Standard Deviation 0.23 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed part time work(n=176,196,89) | 1.87 units on a scale | Standard Deviation 0.34 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Retired(n=193,171,92) | 1.52 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=281,285,61) | 1.90 units on a scale | Standard Deviation 0.3 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time frame: Month 12, 18, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by family/friends(n=249,264,67,63) | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Seen any doctor(n=250,265,67,63) | 1.21 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Feel well enough to work(n=151,141,41,29) | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:In nursing home(n=250,265,67,63) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Treated in ER(n=250,265,67,63) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Hospitalization(n=250,265,67,63) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=250,265,67,63) | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Diagnostic test(n=250,265,67,63) | 1.79 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Lost job/retired early(n=151,143,41,29) | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Admitted for overnight stay(n=18,11,4,3) | 0.17 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to work due to RA(n=150,141,41,29) | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Work disabled due to RA(n=151,143,42,30) | 1.60 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Non-medical practitioner(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Retired(n=154,140,42,30) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Sick leave due to RA(n=168,200,46,48) | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Required aids/devices(n=250,265,67,63) | 1.90 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed part time work(n=167,199,46,48) | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=249,264,67,63) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed paid work(n=168,200,46,48) | 1.77 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Currently employed(n=250,265,67,63) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Home healthcare services(n=249,264,67,63) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to do chores(n=246,265,67,63) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed paid work(n=168,200,46,48) | 1.81 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed part time work(n=167,199,46,48) | 1.96 units on a scale | Standard Deviation 0.18 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:In nursing home(n=250,265,67,63) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to do chores(n=246,265,67,63) | 1.78 units on a scale | Standard Deviation 0.42 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Seen any doctor(n=250,265,67,63) | 1.18 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Work disabled due to RA(n=151,143,42,30) | 1.66 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Currently employed(n=250,265,67,63) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Home healthcare services(n=249,264,67,63) | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Treated in ER(n=250,265,67,63) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Admitted for overnight stay(n=18,11,4,3) | 0.18 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to work due to RA(n=150,141,41,29) | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Diagnostic test(n=250,265,67,63) | 1.81 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Non-medical practitioner(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Hospitalization(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Required aids/devices(n=250,265,67,63) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Feel well enough to work(n=151,141,41,29) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Retired(n=154,140,42,30) | 1.44 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by family/friends(n=249,264,67,63) | 1.79 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Sick leave due to RA(n=168,200,46,48) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Lost job/retired early(n=151,143,41,29) | 1.69 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=249,264,67,63) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Diagnostic test(n=250,265,67,63) | 1.87 units on a scale | Standard Deviation 0.34 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:In nursing home(n=250,265,67,63) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Required aids/devices(n=250,265,67,63) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Non-medical practitioner(n=250,265,67,63) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Currently employed(n=250,265,67,63) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to work due to RA(n=150,141,41,29) | 1.49 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Lost job/retired early(n=151,143,41,29) | 1.68 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Work disabled due to RA(n=151,143,42,30) | 1.57 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Retired(n=154,140,42,30) | 1.52 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Sick leave due to RA(n=168,200,46,48) | 1.98 units on a scale | Standard Deviation 0.15 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed part time work(n=167,199,46,48) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed paid work(n=168,200,46,48) | 1.78 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to do chores(n=246,265,67,63) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=249,264,67,63) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by family/friends(n=249,264,67,63) | 1.76 units on a scale | Standard Deviation 0.43 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Seen any doctor(n=250,265,67,63) | 1.16 units on a scale | Standard Deviation 0.37 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Admitted for overnight stay(n=18,11,4,3) | 0.25 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Hospitalization(n=250,265,67,63) | 1.97 units on a scale | Standard Deviation 0.17 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=250,265,67,63) | 1.99 units on a scale | Standard Deviation 0.12 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Treated in ER(n=250,265,67,63) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Home healthcare services(n=249,264,67,63) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Feel well enough to work(n=151,141,41,29) | 1.80 units on a scale | Standard Deviation 0.4 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Diagnostic test(n=250,265,67,63) | 1.86 units on a scale | Standard Deviation 0.35 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Seen any doctor(n=250,265,67,63) | 1.17 units on a scale | Standard Deviation 0.38 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by family/friends(n=249,264,67,63) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:In nursing home(n=250,265,67,63) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed paid work(n=168,200,46,48) | 1.75 units on a scale | Standard Deviation 0.44 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Performed part time work(n=167,199,46,48) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Treated in ER(n=250,265,67,63) | 1.95 units on a scale | Standard Deviation 0.21 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Home healthcare services(n=249,264,67,63) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Sick leave due to RA(n=168,200,46,48) | 1.90 units on a scale | Standard Deviation 0.31 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Retired(n=154,140,42,30) | 1.57 units on a scale | Standard Deviation 0.5 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Required aids/devices(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Feel well enough to work(n=151,141,41,29) | 1.62 units on a scale | Standard Deviation 0.49 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Lost job/retired early(n=151,143,41,29) | 1.83 units on a scale | Standard Deviation 0.38 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Work disabled due to RA(n=151,143,42,30) | 1.77 units on a scale | Standard Deviation 0.43 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to work due to RA(n=150,141,41,29) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Currently employed(n=250,265,67,63) | 1.51 units on a scale | Standard Deviation 0.5 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Unable to do chores(n=246,265,67,63) | 1.75 units on a scale | Standard Deviation 0.44 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Non-medical practitioner(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Hospitalization(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Outpatient surgery(n=250,265,67,63) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Admitted for overnight stay(n=18,11,4,3) | 0.33 units on a scale | Standard Deviation 0.58 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12, 18 and 24 | Month 12:Chores by housekeeper(n=249,264,67,63) | 2.00 units on a scale | Standard Deviation 0 |
Other Pre-specified
Association Between Genomic and Metabonomic Variation
Time frame: Month 24
Other Pre-specified
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time frame: Baseline, Month 1, 3, 6
Population: Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline:systolic BP(n=316,309,156) | 125.85 millimeters of mercury (mmHg) | Standard Deviation 13.23 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline:diastolic BP(n=316,309,156) | 77.27 millimeters of mercury (mmHg) | Standard Deviation 8.41 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 1:systolic BP(n=309,308,153) | -1.6 millimeters of mercury (mmHg) | Standard Deviation 11.87 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 1:diastolic BP(n=309,308,153) | -0.1 millimeters of mercury (mmHg) | Standard Deviation 8.06 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 3:systolic BP(n=295,299,146) | -1.2 millimeters of mercury (mmHg) | Standard Deviation 12.33 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 3:diastolic BP(n=295,299,146) | 1.0 millimeters of mercury (mmHg) | Standard Deviation 8.76 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 6:systolic BP(n=283,285,62) | -0.5 millimeters of mercury (mmHg) | Standard Deviation 13.57 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 6:diastolic BP(n=283,285,62) | 0.2 millimeters of mercury (mmHg) | Standard Deviation 8.63 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 1:systolic BP(n=309,308,153) | 0.5 millimeters of mercury (mmHg) | Standard Deviation 12.4 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 6:systolic BP(n=283,285,62) | 1.1 millimeters of mercury (mmHg) | Standard Deviation 13.15 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 1:diastolic BP(n=309,308,153) | 0.1 millimeters of mercury (mmHg) | Standard Deviation 7.99 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 3:systolic BP(n=295,299,146) | 0.6 millimeters of mercury (mmHg) | Standard Deviation 13.55 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 3:diastolic BP(n=295,299,146) | 0.5 millimeters of mercury (mmHg) | Standard Deviation 8.61 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline:systolic BP(n=316,309,156) | 123.95 millimeters of mercury (mmHg) | Standard Deviation 15.05 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline:diastolic BP(n=316,309,156) | 77.25 millimeters of mercury (mmHg) | Standard Deviation 9.34 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 6:diastolic BP(n=283,285,62) | 0.8 millimeters of mercury (mmHg) | Standard Deviation 8.45 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 1:systolic BP(n=309,308,153) | 0.5 millimeters of mercury (mmHg) | Standard Deviation 11.96 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline:diastolic BP(n=316,309,156) | 76.81 millimeters of mercury (mmHg) | Standard Deviation 8.7 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Baseline:systolic BP(n=316,309,156) | 123.87 millimeters of mercury (mmHg) | Standard Deviation 14.32 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 1:diastolic BP(n=309,308,153) | 0.5 millimeters of mercury (mmHg) | Standard Deviation 7.19 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 6:systolic BP(n=283,285,62) | -0.6 millimeters of mercury (mmHg) | Standard Deviation 11.63 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 3:diastolic BP(n=295,299,146) | -0.0 millimeters of mercury (mmHg) | Standard Deviation 8.63 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 3:systolic BP(n=295,299,146) | 0.7 millimeters of mercury (mmHg) | Standard Deviation 11.75 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 | Change at Month 6:diastolic BP(n=283,285,62) | -0.4 millimeters of mercury (mmHg) | Standard Deviation 7.74 |
Other Pre-specified
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time frame: Baseline, Month 9, 12, 15, 18, 21, 24
Population: Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:systolic BP(n=316,309,79,77) | 125.83 mmHg | Standard Deviation 13.23 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:diastolic BP(n=316,309,79,77) | 77.27 mmHg | Standard Deviation 8.41 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:systolic BP(n=265,278,69,63) | -0.4 mmHg | Standard Deviation 13.51 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:diastolic BP(n=265,278,69,63) | 0.1 mmHg | Standard Deviation 8.92 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:systolic BP(n=251,265,67,63) | -1.3 mmHg | Standard Deviation 13.93 |
| CP-690,550 5 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:diastolic BP(n=251,265,67,63) | -0.9 mmHg | Standard Deviation 9.37 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:diastolic BP(n=251,265,67,63) | 0.6 mmHg | Standard Deviation 8.94 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:diastolic BP(n=265,278,69,63) | 1.3 mmHg | Standard Deviation 8.78 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:systolic BP(n=316,309,79,77) | 123.95 mmHg | Standard Deviation 15.05 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:systolic BP(n=265,278,69,63) | 1.8 mmHg | Standard Deviation 14.21 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:diastolic BP(n=316,309,79,77) | 77.25 mmHg | Standard Deviation 9.34 |
| CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:systolic BP(n=251,265,67,63) | 1.1 mmHg | Standard Deviation 14.28 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:diastolic BP(n=316,309,79,77) | 77.11 mmHg | Standard Deviation 8.62 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:systolic BP(n=265,278,69,63) | -1.1 mmHg | Standard Deviation 12.44 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:diastolic BP(n=265,278,69,63) | -0.0 mmHg | Standard Deviation 7.96 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:diastolic BP(n=251,265,67,63) | 1.8 mmHg | Standard Deviation 7.5 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:systolic BP(n=251,265,67,63) | 1.1 mmHg | Standard Deviation 10.91 |
| Placebo | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:systolic BP(n=316,309,79,77) | 124.37 mmHg | Standard Deviation 14.78 |
| Placebo, Then CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:systolic BP(n=251,265,67,63) | 1.3 mmHg | Standard Deviation 14.59 |
| Placebo, Then CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 12:diastolic BP(n=251,265,67,63) | 0.7 mmHg | Standard Deviation 9.32 |
| Placebo, Then CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:diastolic BP(n=316,309,79,77) | 76.51 mmHg | Standard Deviation 8.81 |
| Placebo, Then CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:diastolic BP(n=265,278,69,63) | 1.0 mmHg | Standard Deviation 6.66 |
| Placebo, Then CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Baseline:systolic BP(n=316,309,79,77) | 123.35 mmHg | Standard Deviation 13.9 |
| Placebo, Then CP-690,550 10 mg | Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 | Change at Month 9:systolic BP(n=265,278,69,63) | 0.3 mmHg | Standard Deviation 13.09 |
Other Pre-specified
Change From Baseline in Body Temperature at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24
Time frame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.
Other Pre-specified
Change From Baseline in Heart Rate at Month 1, 3, 6, 9, 12, 15, 18, 21 and 24
Time frame: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24
Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.
Other Pre-specified
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 3 | 20.39 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 1 | 11.33 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 6 | 22.98 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 3 | 26.95 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 1 | 9.09 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 6 | 36.36 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 1 | 1.97 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 6 | 5.19 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 | Month 3 | 5.19 percentage of participants |
Other Pre-specified
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 26.86 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 28.80 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 39.61 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 38.31 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 22.78 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 17.72 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 14.67 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 18.67 percentage of participants |
Other Pre-specified
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 3 | 35.28 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1 | 23.62 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 6 | 37.86 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 3 | 44.48 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1 | 31.49 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 6 | 50.97 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1 | 6.58 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 6 | 10.39 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 3 | 11.69 percentage of participants |
Other Pre-specified
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 38.51 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 40.13 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 51.95 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 52.27 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 25.32 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 24.05 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 24.00 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 24.00 percentage of participants |
Other Pre-specified
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 1, 3 and 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | 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 1, 3 and 6 | Month 3 | 5.28 percentage of participants |
| CP-690,550 5 mg | 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 1, 3 and 6 | Month 1 | 1.55 percentage of participants |
| CP-690,550 5 mg | 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 1, 3 and 6 | Month 6 | 7.17 percentage of participants |
| CP-690,550 10 mg | 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 1, 3 and 6 | Month 3 | 11.28 percentage of participants |
| CP-690,550 10 mg | 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 1, 3 and 6 | Month 1 | 2.80 percentage of participants |
| CP-690,550 10 mg | 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 1, 3 and 6 | Month 6 | 15.95 percentage of participants |
| Placebo | 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 1, 3 and 6 | Month 1 | 0.00 percentage of participants |
| Placebo | 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 1, 3 and 6 | Month 6 | 1.55 percentage of participants |
| Placebo | 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 1, 3 and 6 | Month 3 | 1.55 percentage of participants |
Other Pre-specified
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 9, 12, 15, 18, 21 and 24
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | 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 9, 12, 15, 18, 21 and 24 | Month 9 | 10.57 percentage of participants |
| CP-690,550 5 mg | 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 9, 12, 15, 18, 21 and 24 | Month 12 | 9.81 percentage of participants |
| CP-690,550 10 mg | 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 9, 12, 15, 18, 21 and 24 | Month 12 | 14.40 percentage of participants |
| CP-690,550 10 mg | 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 9, 12, 15, 18, 21 and 24 | Month 9 | 14.01 percentage of participants |
| Placebo | 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 9, 12, 15, 18, 21 and 24 | Month 9 | 4.62 percentage of participants |
| Placebo | 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 9, 12, 15, 18, 21 and 24 | Month 12 | 3.08 percentage of participants |
| Placebo, Then CP-690,550 10 mg | 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 9, 12, 15, 18, 21 and 24 | Month 9 | 3.13 percentage of participants |
| Placebo, Then CP-690,550 10 mg | 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 9, 12, 15, 18, 21 and 24 | Month 12 | 7.81 percentage of participants |
Other Pre-specified
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 1, 3, 6
Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 3 | 13.96 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1 | 6.98 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 6 | 14.34 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 3 | 25.29 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1 | 10.40 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 6 | 28.40 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 1 | 3.15 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 6 | 3.10 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 | Month 3 | 3.88 percentage of participants |
Other Pre-specified
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12, 15, 18, 21, 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 18.87 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 21.13 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 28.79 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 33.46 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 10.77 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 9.23 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 9 | 12.50 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 | Month 12 | 17.19 percentage of participants |
Other Pre-specified
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR20 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time frame: Baseline through Month 12, Month 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 2 consecutive visits | 16.8 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 3 consecutive visits | 13.0 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 4 consecutive visits | 16.5 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 5 consecutive visits | 18.7 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 3 consecutive visits | 14.2 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 4 consecutive visits | 16.2 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 5 consecutive visits | 33.7 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 2 consecutive visits | 13.9 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 4 consecutive visits | 11.4 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 3 consecutive visits | 27.8 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 5 consecutive visits | 7.6 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 2 consecutive visits | 21.5 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 5 consecutive visits | 3.9 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 3 consecutive visits | 28.6 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 2 consecutive visits | 16.9 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response | 4 consecutive visits | 10.4 percentage of participants |
Other Pre-specified
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time frame: Baseline through Month 12, Month 24
Population: FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 2 consecutive visits | 12.0 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 3 consecutive visits | 7.9 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 4 consecutive visits | 8.2 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 5 consecutive visits | 7.3 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 3 consecutive visits | 11.3 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 4 consecutive visits | 12.3 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 5 consecutive visits | 9.4 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 2 consecutive visits | 16.5 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 4 consecutive visits | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 3 consecutive visits | 13.9 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 5 consecutive visits | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 2 consecutive visits | 21.5 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 5 consecutive visits | 0.0 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 3 consecutive visits | 13.0 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 2 consecutive visits | 19.5 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response | 4 consecutive visits | 2.6 percentage of participants |
Other Pre-specified
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR70 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time frame: Baseline through Month 12, Month 24
Population: FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 2 consecutive visits | 6.6 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 3 consecutive visits | 4.1 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 4 consecutive visits | 2.8 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 5 consecutive visits | 1.3 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 3 consecutive visits | 6.8 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 4 consecutive visits | 7.1 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 5 consecutive visits | 2.3 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 2 consecutive visits | 10.4 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 4 consecutive visits | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 3 consecutive visits | 5.1 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 5 consecutive visits | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 2 consecutive visits | 8.9 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 5 consecutive visits | 0.0 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 3 consecutive visits | 2.6 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 2 consecutive visits | 18.2 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response | 4 consecutive visits | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time frame: Baseline through Month 12, Month 24
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 2 consecutive visits | 13.0 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 3 consecutive visits | 7.9 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 4 consecutive visits | 5.7 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 5 consecutive visits | 2.2 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 3 consecutive visits | 11.7 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 4 consecutive visits | 13.3 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 5 consecutive visits | 3.2 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 2 consecutive visits | 12.6 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 4 consecutive visits | 3.8 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 3 consecutive visits | 5.1 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 5 consecutive visits | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 2 consecutive visits | 19.0 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 5 consecutive visits | 0.0 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 3 consecutive visits | 7.8 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 2 consecutive visits | 18.2 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 | 4 consecutive visits | 0.0 percentage of participants |
Other Pre-specified
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.
Time frame: Baseline through Month 12, Month 24
Population: FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 2 consecutive visits | 4.4 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 3 consecutive visits | 1.0 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 4 consecutive visits | 1.9 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 5 consecutive visits | 0.0 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 3 consecutive visits | 3.6 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 4 consecutive visits | 3.2 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 5 consecutive visits | 1.0 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 2 consecutive visits | 5.5 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 4 consecutive visits | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 3 consecutive visits | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 5 consecutive visits | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 2 consecutive visits | 3.8 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 5 consecutive visits | 0.0 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 3 consecutive visits | 1.3 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 2 consecutive visits | 7.8 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 | 4 consecutive visits | 0.0 percentage of participants |