Arthritis, Rheumatoid
Conditions
Keywords
Arthritis, Rheumatoid, Antirheumatic Agents, Clinical Trial
Brief summary
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.
Interventions
DRUGCP-690,550
Film coated tablet, 5 mg PO BID, 1 year
DRUGPlacebo
Film coated tablet, 1 tablet PO BID, 3-6 months
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
* The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria. * The patient has active disease as defined by both \>=4 tender or painful joints on motion and \>= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL. * Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity. * Patient must remain on at least one background traditional disease modifying antirheumatic drug. * No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Exclusion criteria
* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L. * History of any other rheumatic autoimmune disease other than Sjogren's syndrome. * No malignancy or history of malignancy. * History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 | Month 6 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour\[mm/hour\]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline, Month 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | Month 6 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2, Month 1, 2, 3, 4.5, 6 | ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 9, 12 | ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2, Month 1, 2, 3, 4.5, 6 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 9, 12 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2, Month 1, 2, 3, 4.5, 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9, 12 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12 | Month 12 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) | Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12 | DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP \[mg/L\] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 \[CRP\] \<=3.2 implied low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 implied moderate to high disease activity and DAS28 \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Baseline, Month 3, 6, 12 | DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline, Week 2, Month 1, 2, 3, 4.5, 6 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 9, Month 12 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty. |
| Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline, Week 2, Month 1, 2, 3, 4.5, 6 | Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9, 12 | Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline, Week 2, Month 1, 2, 3, 4.5, 6 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9, 12 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. |
| Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline, Week 2, Month 1, 2, 3, 4.5, 6 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 9, 12 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9, 12 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. |
| Medical Outcome Study (MOS) Sleep Scale at Month 12 | Month 12 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12 | Month 12 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline, Month 1, 3, 6 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 | Month 12 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12 | Month 12 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]). |
| Work Limitations Questionnaire (WLQ) Score at Month 12 | Month 12 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]). |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Month 12 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Month 12 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Days as Assessed Using RA-HCRU at Month 12 | Month 12 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline, Month 3, 6 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | Month 12 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Month 12 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2, Month 1, 2, 3, 4.5, 6 | ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 9, 12 | ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 2 weeks | Patient global assessment of arthritis: participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly. |
| Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 2 weeks | Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. |
Countries
Australia, Chile, China, Colombia, Croatia, Denmark, Finland, Germany, Greece, Malaysia, Mexico, Poland, Russia, Slovakia, Spain, Sweden, Thailand, United Kingdom, United States, Venezuela
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 12. | 315 |
| CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 12. | 318 |
| Placebo Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12. | 79 |
| Placebo Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12. | 80 |
| Total | 792 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 20 | 29 | 2 | 3 |
| Overall Study | Death | 0 | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 16 | 12 | 3 | 3 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 | 0 |
| Overall Study | Other | 9 | 16 | 1 | 6 |
| Overall Study | Randomized but not treated | 3 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 5 | 0 | 1 |
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 | 52.7 Years STANDARD_DEVIATION 11.7 | 51.9 Years STANDARD_DEVIATION 11.8 | 50.8 Years STANDARD_DEVIATION 11.2 | 53.3 Years STANDARD_DEVIATION 10.8 | 52.3 Years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 264 Participants | 258 Participants | 63 Participants | 60 Participants | 645 Participants |
| Sex: Female, Male Male | 51 Participants | 60 Participants | 16 Participants | 20 Participants | 147 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 | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 95 / 315 | 89 / 318 | 51 / 159 | 69 / 315 | 73 / 318 | 12 / 81 | 16 / 38 | 18 / 40 | 32 / 315 | 47 / 318 | 15 / 79 | 17 / 80 |
| serious Total, serious adverse events | 9 / 315 | 8 / 318 | 6 / 159 | 5 / 315 | 7 / 318 | 0 / 81 | 0 / 38 | 0 / 40 | 7 / 315 | 9 / 318 | 2 / 79 | 0 / 80 |
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;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Baseline, Month 3
Population: FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Here 'n' is number of participants evaluable at specific time points for each arm group, respectively.
| Arm | 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 (n= 311, 315, 157) | 1.44 units on a scale | Standard Deviation 0.69 |
| CP-690,550 5 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n= 292, 292, 147) | -0.45 units on a scale | Standard Deviation 0.53 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n= 311, 315, 157) | 1.43 units on a scale | Standard Deviation 0.68 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n= 292, 292, 147) | -0.54 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n= 311, 315, 157) | 1.35 units on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n= 292, 292, 147) | -0.16 units on a scale | Standard Deviation 0.54 |
Comparison: Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.p-value: <0.000195% CI: [-0.44, -0.26]Mixed Models Analysis
Comparison: LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatments, visits and treatment-by-visit interaction as fixed effects and participants as a random effect.p-value: <0.000195% CI: [-0.35, -0.16]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 (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time frame: Month 6
Population: Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 52.73 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 58.25 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 31.21 percentage of participants |
Comparison: Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.p-value: <0.000195% CI: [17.94, 36.13]Normal approximation
Comparison: Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: <0.000195% CI: [12.39, 30.65]Normal Approximation
Primary
Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour\[mm/hour\]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time frame: Month 6
Population: FAS population included all randomized participants who received at least 1 dose of study medication. N (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 | 9.13 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 | 13.33 percentage of participants |
| Placebo | Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6 | 2.70 percentage of participants |
Comparison: Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: <0.000195% CI: [5.8, 15.45]Normal Approximation
Comparison: Normal approximation to the binomial distribution was used to test the superiority of each dose of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.003895% CI: [2.07, 10.77]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 population included participants who received at least 1 dose of study medication. Here, 'n' is signifying those participants who were evaluable for the measure at given time points for each group respectively.
| Arm | 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 1:physical functioning(n=303,302,154) | 36.17 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 | Baseline:role physical(n=312,315,158) | 33.73 units on a scale | Standard Deviation 9.74 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:social functioning(n=312,315,158) | 36.22 units on a scale | Standard Deviation 11.15 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:bodily pain(n=312,315,158) | 33.38 units on a scale | Standard Deviation 7.25 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental health(n=312,315,158) | 39.94 units on a scale | Standard Deviation 12.52 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role emotional(n=312,315,158) | 35.51 units on a scale | Standard Deviation 13.65 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:vitality(n=312,315,158) | 40.84 units on a scale | Standard Deviation 10.29 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:general health(n=312,315,158) | 33.95 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 | Baseline:mental component(n=312,315,158) | 40.86 units on a scale | Standard Deviation 12.59 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical component(n=312,315,158) | 32.44 units on a scale | Standard Deviation 7.82 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical functioning(n=312,315,158) | 32.53 units on a scale | Standard Deviation 9.58 |
| 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=303,301,154) | 38.20 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 1:social functioning(n=303,302,154) | 40.25 units on a scale | Standard Deviation 10.99 |
| 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=303,302,154) | 39.02 units on a scale | Standard Deviation 7.86 |
| 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=303,302,153) | 43.40 units on a scale | Standard Deviation 11.43 |
| 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=303,301,154) | 38.36 units on a scale | Standard Deviation 12.79 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:vitality(n=303,302,153) | 45.87 units on a scale | Standard Deviation 10.17 |
| 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=303,302,154) | 37.86 units on a scale | Standard Deviation 9.45 |
| 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=303,301,153) | 44.04 units on a scale | Standard Deviation 11.64 |
| 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=303,301,153) | 37.12 units on a scale | Standard Deviation 8.31 |
| 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=294,291,147) | 37.15 units on a scale | Standard Deviation 10.47 |
| 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=294,292,147) | 39.25 units on a scale | Standard Deviation 9.91 |
| 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=294,292,147) | 41.51 units on a scale | Standard Deviation 10.46 |
| 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=294,292,147) | 40.22 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 3:mental health(n=294,292,147) | 44.69 units on a scale | Standard Deviation 10.45 |
| 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=293,291,146) | 38.36 units on a scale | Standard Deviation 11.98 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:vitality(n=294,292,147) | 47.05 units on a scale | Standard Deviation 9.71 |
| 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=294,291,147) | 38.98 units on a scale | Standard Deviation 9.69 |
| 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=293,290,146) | 44.96 units on a scale | Standard Deviation 10.75 |
| 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=293,290,146) | 38.26 units on a scale | Standard Deviation 8.46 |
| 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=279,280,68) | 38.55 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:role physical(n=279,279,68) | 39.86 units on a scale | Standard Deviation 9.82 |
| 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=279,280,68) | 41.97 units on a scale | Standard Deviation 10.22 |
| 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=279,280,68) | 41.01 units on a scale | Standard Deviation 8.17 |
| 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=279,280,68) | 44.43 units on a scale | Standard Deviation 10.26 |
| 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=279,279,68) | 39.37 units on a scale | Standard Deviation 12.11 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:vitality(n=279,280,68) | 47.02 units on a scale | Standard Deviation 9.82 |
| 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=279,280,68) | 40.03 units on a scale | Standard Deviation 9.51 |
| 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=279,279,68) | 44.73 units on a scale | Standard Deviation 10.59 |
| 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=279,279,68) | 39.49 units on a scale | Standard Deviation 8.64 |
| 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=303,302,154) | 40.70 units on a scale | Standard Deviation 7.69 |
| 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=279,279,68) | 41.02 units on a scale | Standard Deviation 9.41 |
| 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=303,302,153) | 44.70 units on a scale | Standard Deviation 10 |
| 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=303,301,154) | 39.27 units on a scale | Standard Deviation 11.91 |
| 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=279,280,68) | 39.71 units on a scale | Standard Deviation 9.17 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:vitality(n=303,302,153) | 46.71 units on a scale | Standard Deviation 8.76 |
| 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=279,280,68) | 43.36 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:general health(n=303,302,154) | 38.81 units on a scale | Standard Deviation 8.65 |
| 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=303,301,153) | 45.32 units on a scale | Standard Deviation 10.13 |
| 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=303,301,153) | 37.94 units on a scale | Standard Deviation 7.96 |
| 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=279,280,68) | 42.12 units on a scale | Standard Deviation 8.45 |
| 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=294,291,147) | 38.29 units on a scale | Standard Deviation 10.6 |
| 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=294,292,147) | 40.57 units on a scale | Standard Deviation 9.69 |
| 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=279,279,68) | 40.24 units on a scale | Standard Deviation 8.43 |
| 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=294,292,147) | 42.44 units on a scale | Standard Deviation 9.92 |
| 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=279,280,68) | 45.01 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 3:bodily pain(n=294,292,147) | 41.82 units on a scale | Standard Deviation 8.7 |
| 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=294,292,147) | 45.15 units on a scale | Standard Deviation 10.28 |
| 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=279,279,68) | 45.63 units on a scale | Standard Deviation 10.29 |
| 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=293,291,146) | 39.81 units on a scale | Standard Deviation 12.04 |
| 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=279,279,68) | 40.49 units on a scale | Standard Deviation 11.79 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:vitality(n=294,292,147) | 47.22 units on a scale | Standard Deviation 9.05 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical functioning(n=312,315,158) | 31.74 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 | Baseline:role physical(n=312,315,158) | 33.15 units on a scale | Standard Deviation 9.43 |
| 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=294,291,147) | 39.45 units on a scale | Standard Deviation 9.19 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:social functioning(n=312,315,158) | 37.04 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 | Baseline:bodily pain(n=312,315,158) | 33.94 units on a scale | Standard Deviation 7.28 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental health(n=312,315,158) | 41.05 units on a scale | Standard Deviation 10.54 |
| 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=293,290,146) | 45.35 units on a scale | Standard Deviation 10.26 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role emotional(n=312,315,158) | 34.91 units on a scale | Standard Deviation 13 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:vitality(n=312,315,158) | 40.87 units on a scale | Standard Deviation 8.89 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:vitality(n=279,280,68) | 47.80 units on a scale | Standard Deviation 9.55 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:general health(n=312,315,158) | 34.27 units on a scale | Standard Deviation 8.58 |
| 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=293,290,146) | 39.53 units on a scale | Standard Deviation 8.58 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental component(n=312,315,158) | 41.56 units on a scale | Standard Deviation 11.14 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical component(n=312,315,158) | 32.02 units on a scale | Standard Deviation 7.46 |
| 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=303,302,154) | 36.71 units on a scale | Standard Deviation 10.08 |
| 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=279,280,68) | 39.42 units on a scale | Standard Deviation 10.38 |
| 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=303,301,154) | 39.00 units on a scale | Standard Deviation 9.6 |
| 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=303,302,154) | 41.96 units on a scale | Standard Deviation 9.73 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:vitality(n=294,292,147) | 43.84 units on a scale | Standard Deviation 9.68 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:bodily pain(n=303,302,154) | 36.87 units on a scale | Standard Deviation 7.14 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical functioning(n=303,302,154) | 33.95 units on a scale | Standard Deviation 9.72 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical functioning(n=312,315,158) | 32.76 units on a scale | Standard Deviation 9.59 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental health(n=303,302,153) | 42.79 units on a scale | Standard Deviation 11.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role physical(n=279,279,68) | 40.27 units on a scale | Standard Deviation 8.86 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:role emotional(n=279,279,68) | 39.81 units on a scale | Standard Deviation 12.38 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role emotional(n=303,301,154) | 38.18 units on a scale | Standard Deviation 12.97 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:general health(n=312,315,158) | 34.65 units on a scale | Standard Deviation 8.32 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role physical(n=312,315,158) | 33.91 units on a scale | Standard Deviation 9.57 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:vitality(n=303,302,153) | 43.74 units on a scale | Standard Deviation 9 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical component(n=279,279,68) | 39.24 units on a scale | Standard Deviation 7.19 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:social functioning(n=303,302,154) | 39.29 units on a scale | Standard Deviation 9.92 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:general health(n=303,302,154) | 36.39 units on a scale | Standard Deviation 8.35 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:social functioning(n=279,280,68) | 43.67 units on a scale | Standard Deviation 9.96 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:social functioning(n=312,315,158) | 36.87 units on a scale | Standard Deviation 11.63 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:mental component(n=303,301,153) | 43.80 units on a scale | Standard Deviation 11.22 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:general health(n=279,280,68) | 38.10 units on a scale | Standard Deviation 9.05 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:general health(n=294,291,147) | 35.56 units on a scale | Standard Deviation 9.37 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:physical component(n=303,301,153) | 34.86 units on a scale | Standard Deviation 7.48 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental component(n=312,315,158) | 41.67 units on a scale | Standard Deviation 11.57 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:bodily pain(n=312,315,158) | 34.22 units on a scale | Standard Deviation 7.47 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical functioning(n=294,291,147) | 34.35 units on a scale | Standard Deviation 10.42 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:bodily pain(n=279,280,68) | 41.91 units on a scale | Standard Deviation 7.74 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental component(n=279,279,68) | 45.13 units on a scale | Standard Deviation 11.02 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:role physical(n=294,292,147) | 36.50 units on a scale | Standard Deviation 9.76 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:physical component(n=293,290,146) | 34.90 units on a scale | Standard Deviation 8.37 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:mental health(n=312,315,158) | 41.50 units on a scale | Standard Deviation 11.38 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:social functioning(n=294,292,147) | 38.62 units on a scale | Standard Deviation 11.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1:role physical(n=303,301,154) | 37.15 units on a scale | Standard Deviation 9.41 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:physical component(n=312,315,158) | 32.74 units on a scale | Standard Deviation 7.6 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:bodily pain(n=294,292,147) | 37.50 units on a scale | Standard Deviation 8.26 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:mental health(n=279,280,68) | 44.12 units on a scale | Standard Deviation 10.13 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:role emotional(n=312,315,158) | 35.36 units on a scale | Standard Deviation 12.97 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental health(n=294,292,147) | 42.68 units on a scale | Standard Deviation 10.88 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3:mental component(n=293,290,146) | 43.10 units on a scale | Standard Deviation 11.12 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:vitality(n=279,280,68) | 46.67 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 3:role emotional(n=293,291,146) | 37.42 units on a scale | Standard Deviation 13.23 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:vitality(n=312,315,158) | 41.33 units on a scale | Standard Deviation 9.37 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6:physical functioning(n=279,280,68) | 38.18 units on a scale | Standard Deviation 9.63 |
Secondary
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for the measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role emotional(n=258, 250,70,67) | 40.02 units on a scale | Standard Deviation 12.1 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role physical(n=258, 250,70,67) | 40.51 units on a scale | Standard Deviation 9.99 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:bodily pain(n=267,264,72,70) | 41.83 units on a scale | Standard Deviation 8.89 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental health(n=258, 250,70,67) | 44.86 units on a scale | Standard Deviation 10.63 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:social functioning(n=258, 250,70,67) | 42.69 units on a scale | Standard Deviation 10.14 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical functioning(n=267,263,72,70) | 39.40 units on a scale | Standard Deviation 10.6 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:bodily pain(n=258, 250,70,67) | 41.95 units on a scale | Standard Deviation 8.77 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role physical(n=267,263,72,70) | 40.21 units on a scale | Standard Deviation 9.99 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental component(n=258, 250,70,67) | 45.39 units on a scale | Standard Deviation 10.69 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental health(n=267,264,72,70) | 45.49 units on a scale | Standard Deviation 10.69 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role emotional(n=267,264,72,70) | 40.55 units on a scale | Standard Deviation 11.54 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:general health(n=258, 250,70,67) | 39.63 units on a scale | Standard Deviation 9.64 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:vitality(n=267,264,72,70) | 48.39 units on a scale | Standard Deviation 9.53 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical component(n=258, 250,70,67) | 39.94 units on a scale | Standard Deviation 8.83 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:general health(n=266,264,72,70) | 39.77 units on a scale | Standard Deviation 9.63 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:social functioning(n=267,264,72,70) | 42.43 units on a scale | Standard Deviation 9.97 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:vitality(n=258, 250,70,67) | 48.08 units on a scale | Standard Deviation 9.83 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental component(n=266,262,72,70) | 45.97 units on a scale | Standard Deviation 10.45 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical component(n=266,262,72,70) | 39.79 units on a scale | Standard Deviation 8.6 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical functioning(n=258, 250,70,67) | 39.07 units on a scale | Standard Deviation 11.18 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role emotional(n=258, 250,70,67) | 41.37 units on a scale | Standard Deviation 11.79 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical functioning(n=258, 250,70,67) | 40.38 units on a scale | Standard Deviation 10.24 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental component(n=258, 250,70,67) | 45.92 units on a scale | Standard Deviation 10.65 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental health(n=258, 250,70,67) | 45.52 units on a scale | Standard Deviation 10.27 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role emotional(n=267,264,72,70) | 42.16 units on a scale | Standard Deviation 11.43 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role physical(n=258, 250,70,67) | 42.11 units on a scale | Standard Deviation 9.31 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical functioning(n=267,263,72,70) | 40.67 units on a scale | Standard Deviation 10.12 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical component(n=258, 250,70,67) | 41.13 units on a scale | Standard Deviation 8.13 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical component(n=266,262,72,70) | 41.15 units on a scale | Standard Deviation 8.15 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:social functioning(n=258, 250,70,67) | 43.63 units on a scale | Standard Deviation 9.71 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:vitality(n=267,264,72,70) | 48.70 units on a scale | Standard Deviation 9.41 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:bodily pain(n=258, 250,70,67) | 43.28 units on a scale | Standard Deviation 8.7 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental component(n=266,262,72,70) | 46.61 units on a scale | Standard Deviation 10.74 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:bodily pain(n=267,264,72,70) | 43.37 units on a scale | Standard Deviation 8.45 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:vitality(n=258, 250,70,67) | 48.12 units on a scale | Standard Deviation 9.22 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:social functioning(n=267,264,72,70) | 43.67 units on a scale | Standard Deviation 9.6 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:general health(n=266,264,72,70) | 40.57 units on a scale | Standard Deviation 9.29 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental health(n=267,264,72,70) | 46.03 units on a scale | Standard Deviation 10.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role physical(n=267,263,72,70) | 42.03 units on a scale | Standard Deviation 9.05 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:general health(n=258, 250,70,67) | 39.88 units on a scale | Standard Deviation 8.88 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:social functioning(n=258, 250,70,67) | 44.27 units on a scale | Standard Deviation 9.72 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical functioning(n=267,263,72,70) | 38.86 units on a scale | Standard Deviation 10.47 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role physical(n=267,263,72,70) | 41.44 units on a scale | Standard Deviation 9.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:social functioning(n=267,264,72,70) | 43.26 units on a scale | Standard Deviation 11.23 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:bodily pain(n=267,264,72,70) | 42.31 units on a scale | Standard Deviation 8.42 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental health(n=267,264,72,70) | 46.12 units on a scale | Standard Deviation 10.49 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role emotional(n=267,264,72,70) | 40.75 units on a scale | Standard Deviation 12.67 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:vitality(n=267,264,72,70) | 48.38 units on a scale | Standard Deviation 8.71 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:general health(n=266,264,72,70) | 40.38 units on a scale | Standard Deviation 9.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental component(n=266,262,72,70) | 46.42 units on a scale | Standard Deviation 11.01 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical component(n=266,262,72,70) | 40.07 units on a scale | Standard Deviation 7.97 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical functioning(n=258, 250,70,67) | 38.61 units on a scale | Standard Deviation 11.38 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role physical(n=258, 250,70,67) | 42.51 units on a scale | Standard Deviation 9.72 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:bodily pain(n=258, 250,70,67) | 42.59 units on a scale | Standard Deviation 9.07 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental health(n=258, 250,70,67) | 46.10 units on a scale | Standard Deviation 10.81 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role emotional(n=258, 250,70,67) | 42.92 units on a scale | Standard Deviation 11.8 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:vitality(n=258, 250,70,67) | 49.77 units on a scale | Standard Deviation 9.52 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:general health(n=258, 250,70,67) | 40.86 units on a scale | Standard Deviation 9.34 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental component(n=258, 250,70,67) | 47.84 units on a scale | Standard Deviation 11.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical component(n=258, 250,70,67) | 40.16 units on a scale | Standard Deviation 9.14 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical component(n=266,262,72,70) | 42.05 units on a scale | Standard Deviation 6.93 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental component(n=266,262,72,70) | 45.22 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 and 12 | Month 12:mental component(n=258, 250,70,67) | 46.33 units on a scale | Standard Deviation 11.21 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role emotional(n=258, 250,70,67) | 42.40 units on a scale | Standard Deviation 11.92 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:general health(n=266,264,72,70) | 40.08 units on a scale | Standard Deviation 9.5 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:vitality(n=267,264,72,70) | 47.29 units on a scale | Standard Deviation 10.43 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role physical(n=267,263,72,70) | 42.99 units on a scale | Standard Deviation 9.18 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:vitality(n=258, 250,70,67) | 47.75 units on a scale | Standard Deviation 10.45 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:role emotional(n=267,264,72,70) | 41.02 units on a scale | Standard Deviation 11.46 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:mental health(n=267,264,72,70) | 45.11 units on a scale | Standard Deviation 10.51 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:physical functioning(n=267,263,72,70) | 40.83 units on a scale | Standard Deviation 9.76 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:general health(n=258, 250,70,67) | 39.43 units on a scale | Standard Deviation 10.35 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:bodily pain(n=267,264,72,70) | 44.03 units on a scale | Standard Deviation 8.26 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:social functioning(n=258, 250,70,67) | 44.36 units on a scale | Standard Deviation 10.3 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9:social functioning(n=267,264,72,70) | 44.11 units on a scale | Standard Deviation 10.32 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:bodily pain(n=258, 250,70,67) | 45.49 units on a scale | Standard Deviation 8.11 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:role physical(n=258, 250,70,67) | 43.16 units on a scale | Standard Deviation 9.51 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical functioning(n=258, 250,70,67) | 39.85 units on a scale | Standard Deviation 10.97 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:physical component(n=258, 250,70,67) | 41.62 units on a scale | Standard Deviation 8.16 |
| Placebo Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:mental health(n=258, 250,70,67) | 45.65 units on a scale | Standard Deviation 11.29 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=309, 304, 156) | 4.41 units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=293, 291, 147) | 3.62 units on a scale | Standard Deviation 1.22 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=294, 300, 148) | 3.70 units on a scale | Standard Deviation 1.2 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=312, 315, 158) | 5.21 units on a scale | Standard Deviation 0.92 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=279,278,68) | 3.39 units on a scale | Standard Deviation 1.21 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=281,286,71) | 3.46 units on a scale | Standard Deviation 1.27 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=304, 300, 151) | 4.08 units on a scale | Standard Deviation 1.13 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=294, 300, 148) | 3.49 units on a scale | Standard Deviation 1.15 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=312, 315, 158) | 5.26 units on a scale | Standard Deviation 0.96 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=309, 304, 156) | 4.18 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, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=304, 300, 151) | 3.83 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, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=293, 291, 147) | 3.44 units on a scale | Standard Deviation 1.15 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=281,286,71) | 3.15 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, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=279,278,68) | 3.09 units on a scale | Standard Deviation 1.13 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=293, 291, 147) | 4.51 units on a scale | Standard Deviation 1.15 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=309, 304, 156) | 4.92 units on a scale | Standard Deviation 1.01 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=279,278,68) | 3.60 units on a scale | Standard Deviation 1.12 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=281,286,71) | 3.92 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, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=294, 300, 148) | 4.59 units on a scale | Standard Deviation 1.16 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=304, 300, 151) | 4.68 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, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=312, 315, 158) | 5.22 units on a scale | Standard Deviation 0.92 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | 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 and 12 | Month 9 | 3.21 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 Month 9 and 12 | Month 12 | 3.08 units on a scale | Standard Deviation 1.19 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 12 | 2.81 units on a scale | Standard Deviation 1.04 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9 | 2.88 units on a scale | Standard Deviation 1.05 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9 | 3.22 units on a scale | Standard Deviation 1.05 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 12 | 3.03 units on a scale | Standard Deviation 1.15 |
| 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 and 12 | Month 9 | 2.83 units on a scale | Standard Deviation 0.93 |
| 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 and 12 | Month 12 | 2.99 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, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
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 3, 6, 12
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 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 3, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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 3 and 6 | Month 3 (n=206,263,140) | 4.41 units on a scale | Standard Deviation 1.39 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Baseline (n=309,313,158) | 6.29 units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Month 6 (n=241,248,62) | 4.14 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 3 and 6 | Month 3 (n=206,263,140) | 4.20 units on a scale | Standard Deviation 1.3 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Baseline (n=309,313,158) | 6.36 units on a scale | Standard Deviation 1.01 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Month 6 (n=241,248,62) | 3.84 units on a scale | Standard Deviation 1.26 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Baseline (n=309,313,158) | 6.30 units on a scale | Standard Deviation 0.92 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Month 6 (n=241,248,62) | 4.34 units on a scale | Standard Deviation 1.19 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6 | Month 3 (n=206,263,140) | 5.32 units on a scale | Standard Deviation 1.26 |
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | 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 12 | 3.82 units on a scale | Standard Deviation 1.3 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12 | 3.50 units on a scale | Standard Deviation 1.11 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12 | 3.76 units on a scale | Standard Deviation 1.31 |
| 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 12 | 3.62 units on a scale | Standard Deviation 1.19 |
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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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 3 (n=294,291,147) | 0.63 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline (n=311,314,158) | 0.46 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 6 (n=277,280,68) | 0.66 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 | Month 3 (n=294,291,147) | 0.68 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline (n=311,314,158) | 0.48 units on a scale | Standard Deviation 0.29 |
| 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=277,280,68) | 0.70 units on a scale | Standard Deviation 0.21 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Baseline (n=311,314,158) | 0.51 units on a scale | Standard Deviation 0.27 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 6 (n=277,280,68) | 0.65 units on a scale | Standard Deviation 0.2 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 | Month 3 (n=294,291,147) | 0.56 units on a scale | Standard Deviation 0.28 |
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12 | 0.68 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 Month 12 | 0.70 units on a scale | Standard Deviation 0.21 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12 | 0.66 units on a scale | Standard Deviation 0.24 |
| Placebo Then CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12 | 0.69 units on a scale | Standard Deviation 0.23 |
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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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=312,314,158) | 29.01 units on a scale | Standard Deviation 11.01 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 1 (n=301,302,153) | 33.16 units on a scale | Standard Deviation 10.75 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 3 (n=294,292,147) | 34.38 units on a scale | Standard Deviation 10.07 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 6 (n=277,280,68) | 35.14 units on a scale | Standard Deviation 9.91 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 6 (n=277,280,68) | 35.01 units on a scale | Standard Deviation 9.45 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline (n=312,314,158) | 28.65 units on a scale | Standard Deviation 9.49 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 3 (n=294,292,147) | 34.99 units on a scale | Standard Deviation 9.2 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 1 (n=301,302,153) | 33.94 units on a scale | Standard Deviation 8.91 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 6 (n=277,280,68) | 35.24 units on a scale | Standard Deviation 9.3 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 1 (n=301,302,153) | 31.78 units on a scale | Standard Deviation 9.58 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Month 3 (n=294,292,147) | 31.41 units on a scale | Standard Deviation 9.95 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 | Baseline (n=312,314,158) | 29.72 units on a scale | Standard Deviation 8.97 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 | 35.02 units on a scale | Standard Deviation 9.83 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 | 36.34 units on a scale | Standard Deviation 9.15 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 | 36.93 units on a scale | Standard Deviation 9.19 |
| Placebo Then CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12 | 36.07 units on a scale | Standard Deviation 9.64 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n = 310, 305, 156) | 1.24 units on a scale | Standard Deviation 0.69 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n = 293, 292, 148) | 0.98 units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n = 299, 300, 150) | 1.03 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n = 311, 315, 157) | 1.44 units on a scale | Standard Deviation 0.69 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n = 278, 279, 68) | 0.91 units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n = 282, 289, 71) | 0.97 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n = 304, 303, 154) | 1.12 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n = 299, 300, 150) | 0.93 units on a scale | Standard Deviation 0.66 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n = 311, 315, 157) | 1.43 units on a scale | Standard Deviation 0.68 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n = 310, 305, 156) | 1.14 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n = 304, 303, 154) | 1.01 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n = 293, 292, 148) | 0.88 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n = 282, 289, 71) | 0.84 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n = 278, 279, 68) | 0.81 units on a scale | Standard Deviation 0.65 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n = 293, 292, 148) | 1.16 units on a scale | Standard Deviation 0.67 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n = 310, 305, 156) | 1.28 units on a scale | Standard Deviation 0.66 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n = 278, 279, 68) | 0.93 units on a scale | Standard Deviation 0.61 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n = 282, 289, 71) | 0.95 units on a scale | Standard Deviation 0.62 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n = 299, 300, 150) | 1.20 units on a scale | Standard Deviation 0.63 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n = 304, 303, 154) | 1.20 units on a scale | Standard Deviation 0.67 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n = 311, 315, 157) | 1.35 units on a scale | Standard Deviation 0.66 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
Time frame: Month 9, Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 | 0.89 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 | 0.86 units on a scale | Standard Deviation 0.68 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 | 0.73 units on a scale | Standard Deviation 0.64 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 | 0.71 units on a scale | Standard Deviation 0.64 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 | 0.85 units on a scale | Standard Deviation 0.65 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 | 0.81 units on a scale | Standard Deviation 0.68 |
| Placebo Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 | 0.70 units on a scale | Standard Deviation 0.64 |
| Placebo Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 | 0.73 units on a scale | Standard Deviation 0.69 |
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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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 1:overall sleep problem(n=301,301,154) | 36.51 units on a scale | Standard Deviation 19.94 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep problem summary(n=312,314,158) | 39.51 units on a scale | Standard Deviation 21.22 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:somnolence(n=312,314,158) | 34.38 units on a scale | Standard Deviation 21.95 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:snoring(n=310,314,157) | 32.26 units on a scale | Standard Deviation 30.31 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:quantity(n=312,313,158) | 6.88 units on a scale | Standard Deviation 2.13 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep disturbance(n=312,313,158) | 44.39 units on a scale | Standard Deviation 26.68 |
| 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=312,314,158) | 18.91 units on a scale | Standard Deviation 24.38 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:adequacy(n=312,314,158) | 47.56 units on a scale | Standard Deviation 28.78 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:overall sleep problem(n=312,313,158) | 41.05 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 1:sleep problem summary(n=301,301,154) | 35.87 units on a scale | Standard Deviation 20.5 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:somnolence(n=301,302,154) | 31.58 units on a scale | Standard Deviation 21.01 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:snoring(n=300,302,153) | 29.87 units on a scale | Standard Deviation 29.33 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:quantity(n=301,301,154) | 6.90 units on a scale | Standard Deviation 1.54 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep disturbance(n=301,302,154) | 38.43 units on a scale | Standard Deviation 26.01 |
| 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=301,301,154) | 18.34 units on a scale | Standard Deviation 23.41 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:adequacy(n=301,302,154) | 52.92 units on a scale | Standard Deviation 27.91 |
| 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=292,292,146) | 35.10 units on a scale | Standard Deviation 18.58 |
| 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=292,292,146) | 34.41 units on a scale | Standard Deviation 19.04 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:somnolence(n=292,292,146) | 30.07 units on a scale | Standard Deviation 19.89 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:snoring(n=290,292,144) | 31.31 units on a scale | Standard Deviation 29.56 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:quantity(n=293,292,147) | 6.87 units on a scale | Standard Deviation 1.54 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep disturbance(n=292,292,146) | 36.67 units on a scale | Standard Deviation 23.98 |
| 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=292,292,146) | 19.38 units on a scale | Standard Deviation 24.67 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:adequacy(n=292,292,146) | 54.66 units on a scale | Standard Deviation 27.42 |
| 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=277,280,68) | 33.92 units on a scale | Standard Deviation 19.36 |
| 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=277,280,68) | 33.26 units on a scale | Standard Deviation 19.87 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:somnolence(n=277,280,68) | 31.12 units on a scale | Standard Deviation 20.03 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:snoring(n=271,280,68) | 31.14 units on a scale | Standard Deviation 28.98 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:quantity(n=278,279,68) | 6.86 units on a scale | Standard Deviation 1.52 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep disturbance(n=277,280,68) | 34.48 units on a scale | Standard Deviation 24.11 |
| 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=277,280,68) | 17.62 units on a scale | Standard Deviation 19.89 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:adequacy(n=277,280,68) | 54.40 units on a scale | Standard Deviation 28.34 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep disturbance(n=292,292,146) | 33.69 units on a scale | Standard Deviation 23.01 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:overall sleep problem(n=312,313,158) | 40.89 units on a scale | Standard Deviation 18.47 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep disturbance(n=301,302,154) | 34.64 units on a scale | Standard Deviation 24.2 |
| 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=292,292,146) | 34.06 units on a scale | Standard Deviation 17.33 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep problem summary(n=312,314,158) | 40.08 units on a scale | Standard Deviation 19.02 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:quantity(n=301,301,154) | 7.02 units on a scale | Standard Deviation 1.55 |
| 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=277,280,68) | 17.57 units on a scale | Standard Deviation 20.87 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:somnolence(n=312,314,158) | 36.09 units on a scale | Standard Deviation 21.59 |
| 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=292,292,146) | 33.80 units on a scale | Standard Deviation 17.65 |
| 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=292,292,146) | 17.26 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 | Baseline:snoring(n=310,314,157) | 31.27 units on a scale | Standard Deviation 31.27 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:adequacy(n=277,280,68) | 51.64 units on a scale | Standard Deviation 26.36 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:snoring(n=271,280,68) | 32.07 units on a scale | Standard Deviation 29.21 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:quantity(n=312,313,158) | 6.72 units on a scale | Standard Deviation 1.55 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:somnolence(n=292,292,146) | 28.90 units on a scale | Standard Deviation 18.75 |
| 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=301,301,154) | 17.21 units on a scale | Standard Deviation 21.91 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep disturbance(n=312,313,158) | 41.58 units on a scale | Standard Deviation 24.61 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:snoring(n=300,302,153) | 28.74 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 3:adequacy(n=292,292,146) | 51.58 units on a scale | Standard Deviation 26.71 |
| 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=312,314,158) | 19.81 units on a scale | Standard Deviation 24.38 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:snoring(n=290,292,144) | 31.78 units on a scale | Standard Deviation 30.23 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:somnolence(n=277,280,68) | 29.81 units on a scale | Standard Deviation 18.23 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:adequacy(n=312,314,158) | 44.97 units on a scale | Standard Deviation 26.89 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:adequacy(n=301,302,154) | 51.52 units on a scale | Standard Deviation 26.23 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep disturbance(n=277,280,68) | 31.33 units on a scale | Standard Deviation 21.96 |
| 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=301,301,154) | 34.77 units on a scale | Standard Deviation 17.79 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:quantity(n=293,292,147) | 6.96 units on a scale | Standard Deviation 1.46 |
| 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=277,280,68) | 33.11 units on a scale | Standard Deviation 16.94 |
| 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=301,301,154) | 34.45 units on a scale | Standard Deviation 17.94 |
| 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=277,280,68) | 33.30 units on a scale | Standard Deviation 17.17 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:quantity(n=278,279,68) | 6.94 units on a scale | Standard Deviation 1.42 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:somnolence(n=301,302,154) | 30.49 units on a scale | Standard Deviation 20.05 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:adequacy(n=312,314,158) | 46.84 units on a scale | Standard Deviation 25.69 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep disturbance(n=277,280,68) | 34.78 units on a scale | Standard Deviation 24.36 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:snoring(n=300,302,153) | 32.03 units on a scale | Standard Deviation 29.68 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:quantity(n=301,301,154) | 6.81 units on a scale | Standard Deviation 1.54 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:sleep problem summary(n=277,280,68) | 34.85 units on a scale | Standard Deviation 18.81 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep disturbance(n=301,302,154) | 37.42 units on a scale | Standard Deviation 24.86 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:awaken short of breath(n=301,301,154) | 14.94 units on a scale | Standard Deviation 20.01 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:adequacy(n=301,302,154) | 49.16 units on a scale | Standard Deviation 23.51 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:somnolence(n=277,280,68) | 30.29 units on a scale | Standard Deviation 19.19 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:overall sleep problem(n=292,292,146) | 38.66 units on a scale | Standard Deviation 17.32 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep problem summary(n=292,292,146) | 37.97 units on a scale | Standard Deviation 17.21 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:somnolence(n=292,292,146) | 35.43 units on a scale | Standard Deviation 20.29 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:snoring(n=271,280,68) | 31.47 units on a scale | Standard Deviation 29.79 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:snoring(n=290,292,144) | 31.81 units on a scale | Standard Deviation 29.77 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:awaken short of breath(n=277,280,68) | 17.06 units on a scale | Standard Deviation 24.98 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:quantity(n=293,292,147) | 6.76 units on a scale | Standard Deviation 1.55 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:overall sleep problem(n=312,313,158) | 39.75 units on a scale | Standard Deviation 18.25 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:sleep disturbance(n=292,292,146) | 37.77 units on a scale | Standard Deviation 24.18 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep problem summary(n=312,314,158) | 37.87 units on a scale | Standard Deviation 18.37 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:quantity(n=278,279,68) | 6.82 units on a scale | Standard Deviation 1.41 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:somnolence(n=312,314,158) | 34.94 units on a scale | Standard Deviation 17.94 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:snoring(n=310,314,157) | 33.76 units on a scale | Standard Deviation 32.09 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:awaken short of breath(n=292,292,146) | 18.08 units on a scale | Standard Deviation 21.57 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:quantity(n=312,313,158) | 6.82 units on a scale | Standard Deviation 1.51 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:adequacy(n=277,280,68) | 50.29 units on a scale | Standard Deviation 26.76 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:sleep disturbance(n=312,313,158) | 41.20 units on a scale | Standard Deviation 25.42 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline:awaken short of breath(n=312,314,158) | 17.34 units on a scale | Standard Deviation 21.78 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3:adequacy(n=292,292,146) | 45.82 units on a scale | Standard Deviation 25.54 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:somnolence(n=301,302,154) | 33.33 units on a scale | Standard Deviation 19.02 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:overall sleep problem(n=301,301,154) | 37.09 units on a scale | Standard Deviation 18.02 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1:sleep problem summary(n=301,301,154) | 35.95 units on a scale | Standard Deviation 18.32 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6:overall sleep problem(n=277,280,68) | 34.87 units on a scale | Standard Deviation 18.29 |
Secondary
Medical Outcome Study (MOS) Sleep Scale at Month 12
Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Awaken short of breath | 19.77 units on a scale | Standard Deviation 24.38 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Adequacy | 54.38 units on a scale | Standard Deviation 26.14 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Somnolence | 29.30 units on a scale | Standard Deviation 19.09 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Snoring | 30.32 units on a scale | Standard Deviation 28.59 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Quantity | 6.94 units on a scale | Standard Deviation 1.51 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Overall sleep problem | 34.17 units on a scale | Standard Deviation 18.71 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep disturbance | 34.78 units on a scale | Standard Deviation 24.31 |
| CP-690,550 5 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep problem summary | 33.71 units on a scale | Standard Deviation 19.11 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep disturbance | 31.75 units on a scale | Standard Deviation 21.95 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Awaken short of breath | 17.19 units on a scale | Standard Deviation 21.25 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Snoring | 32.37 units on a scale | Standard Deviation 29.7 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep problem summary | 32.58 units on a scale | Standard Deviation 17.42 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Quantity | 7.04 units on a scale | Standard Deviation 1.3 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Adequacy | 53.29 units on a scale | Standard Deviation 25.26 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Somnolence | 27.93 units on a scale | Standard Deviation 17.7 |
| CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Overall sleep problem | 32.24 units on a scale | Standard Deviation 17.13 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep problem summary | 30.95 units on a scale | Standard Deviation 17.09 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Quantity | 6.83 units on a scale | Standard Deviation 1.36 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Somnolence | 30.86 units on a scale | Standard Deviation 21.18 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Overall sleep problem | 31.74 units on a scale | Standard Deviation 17.41 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Snoring | 31.43 units on a scale | Standard Deviation 31.13 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep disturbance | 29.41 units on a scale | Standard Deviation 24.04 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Awaken short of breath | 17.71 units on a scale | Standard Deviation 19.42 |
| Placebo | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Adequacy | 55.00 units on a scale | Standard Deviation 25.01 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Adequacy | 55.76 units on a scale | Standard Deviation 26.37 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Overall sleep problem | 33.58 units on a scale | Standard Deviation 17.44 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep problem summary | 32.53 units on a scale | Standard Deviation 17.89 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Somnolence | 28.48 units on a scale | Standard Deviation 15.45 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Quantity | 6.95 units on a scale | Standard Deviation 1.42 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Sleep disturbance | 35.63 units on a scale | Standard Deviation 22.81 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Awaken short of breath | 14.85 units on a scale | Standard Deviation 17.3 |
| Placebo Then CP-690,550 10 mg | Medical Outcome Study (MOS) Sleep Scale at Month 12 | Snoring | 31.38 units on a scale | Standard Deviation 27.58 |
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 3, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.
| Arm | 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:Hospital length of stay(n=4,4,4) | 7.00 days | Standard Deviation 4.24 |
| 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=1,2,1) | 28.00 days | — |
| 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=8,7,2) | 9.63 days | Standard Deviation 7.76 |
| 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=1,2,0) | 10.00 days | — |
| 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=110,106,59) | 5.02 days | Standard Deviation 1.05 |
| 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=97,92,60) | 34.23 days | Standard Deviation 34.27 |
| 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=24,28,28) | 104.96 days | Standard Deviation 87.4 |
| 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=16,23,8) | 12.69 days | Standard Deviation 6.05 |
| 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=30,19,10) | 26.87 days | Standard Deviation 34.1 |
| 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=25,28,28) | 1.68 days | Standard Deviation 0.95 |
| 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=7,8,2) | 35.43 days | Standard Deviation 27.85 |
| 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=75,62,38) | 31.25 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 3:Days of work per week(n=104,99,52) | 5.16 days | Standard Deviation 1.01 |
| 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=71,61,27) | 27.06 days | Standard Deviation 33.38 |
| 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=16,11,8) | 20.06 days | Standard Deviation 28.06 |
| 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=31,22,24) | 28.23 days | Standard Deviation 34.67 |
| 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=26,13,6) | 22.42 days | Standard Deviation 28.69 |
| 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=21,14,4) | 27.71 days | Standard Deviation 36.77 |
| 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) | 22.77 days | Standard Deviation 28.95 |
| 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=37,40,19) | 84.92 days | Standard Deviation 71.64 |
| 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=92,95,24) | 5.15 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:Paid work, bothered by RA(n=94,93,48) | 40.11 days | Standard Deviation 30.69 |
| 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=78,68,14) | 29.53 days | Standard Deviation 31.6 |
| 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=24,26,5) | 1.79 days | Standard Deviation 1.18 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=46,37,18) | 27.17 days | Standard Deviation 35.34 |
| 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=54,46,13) | 30.80 days | Standard Deviation 31.45 |
| 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=23,26,5) | 135.04 days | Standard Deviation 104.11 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=154,158,79) | 41.26 days | Standard Deviation 38.38 |
| 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=37,42,19) | 1.65 days | Standard Deviation 1.18 |
| 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=0,0,0) | 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=23,26,5) | 116.27 days | Standard Deviation 130.92 |
| 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=16,23,8) | 15.26 days | Standard Deviation 13.03 |
| 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=1,2,1) | 14.50 days | Standard Deviation 0.71 |
| 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=37,40,19) | 100.78 days | Standard Deviation 109.26 |
| 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=37,42,19) | 1.90 days | Standard Deviation 1.36 |
| 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=110,106,59) | 5.01 days | Standard Deviation 0.88 |
| 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=71,61,27) | 30.26 days | Standard Deviation 35.56 |
| 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) | 20.86 days | Standard Deviation 29.44 |
| 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=94,93,48) | 39.26 days | Standard Deviation 29.85 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=46,37,18) | 19.73 days | Standard Deviation 28.01 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=154,158,79) | 34.92 days | Standard Deviation 33.94 |
| 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=4,4,4) | 8.25 days | Standard Deviation 2.99 |
| 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=1,2,0) | 14.00 days | Standard Deviation 9.9 |
| 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=24,28,28) | 104.36 days | Standard Deviation 128.12 |
| 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=25,28,28) | 1.68 days | Standard Deviation 1.39 |
| 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=104,99,52) | 5.12 days | Standard Deviation 1.08 |
| 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=31,22,24) | 28.45 days | Standard Deviation 39.07 |
| 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=16,11,8) | 36.91 days | Standard Deviation 37.77 |
| 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=75,62,38) | 33.15 days | Standard Deviation 30.42 |
| 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=30,19,10) | 16.58 days | Standard Deviation 26.03 |
| 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=97,92,60) | 30.51 days | Standard Deviation 33.93 |
| 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=8,7,2) | 6.43 days | Standard Deviation 5.03 |
| 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=0,0,0) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related aids used(n=24,26,5) | 1.85 days | Standard Deviation 1.43 |
| 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=92,95,24) | 5.04 days | Standard Deviation 0.94 |
| 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=21,14,4) | 24.43 days | Standard Deviation 31 |
| 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=7,8,2) | 28.00 days | Standard Deviation 36.01 |
| 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=54,46,13) | 31.74 days | Standard Deviation 30.04 |
| 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=26,13,6) | 20.92 days | Standard Deviation 31.17 |
| 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=78,68,14) | 24.90 days | Standard Deviation 31.36 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Hospital length of stay(n=4,4,4) | 3.75 days | Standard Deviation 0.5 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days aids/devices used(n=37,40,19) | 65.37 days | Standard Deviation 74.55 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Hospital length of stay(n=8,7,2) | 13.50 days | Standard Deviation 0.71 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=154,158,79) | 37.81 days | Standard Deviation 35.78 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Hospital length of stay(n=16,23,8) | 14.50 days | Standard Deviation 15.97 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days in nursing home(n=0,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=46,37,18) | 37.28 days | Standard Deviation 38.31 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related aids used(n=37,42,19) | 1.42 days | Standard Deviation 0.84 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days aids/devices used(n=23,26,5) | 129.20 days | Standard Deviation 42.11 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Paid work, bothered by RA(n=94,93,48) | 43.15 days | Standard Deviation 32.11 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Paid work, bothered by RA(n=54,46,13) | 33.31 days | Standard Deviation 30.18 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related aids used(n=24,26,5) | 1.80 days | Standard Deviation 1.48 |
| 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) | 34.83 days | Standard Deviation 34.89 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days in nursing home(n=1,2,1) | 21.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of work per week(n=92,95,24) | 4.88 days | Standard Deviation 0.99 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days on sick leave due to RA(n=71,61,27) | 31.41 days | Standard Deviation 32.27 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=78,68,14) | 33.93 days | Standard Deviation 37.88 |
| 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=31,22,24) | 24.58 days | Standard Deviation 33.18 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of work per week(n=104,99,52) | 4.94 days | Standard Deviation 1 |
| 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=21,14,4) | 10.75 days | Standard Deviation 13.45 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days of part time work(n=16,11,8) | 36.13 days | Standard Deviation 31.16 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related aids used(n=25,28,28) | 1.79 days | Standard Deviation 1.69 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Days of work per week(n=110,106,59) | 4.86 days | Standard Deviation 1.02 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Paid work, bothered by RA(n=75,62,38) | 42.32 days | Standard Deviation 31.88 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days aids/devices used(n=24,28,28) | 120.75 days | Standard Deviation 152.78 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=26,13,6) | 43.50 days | Standard Deviation 41.56 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=30,19,10) | 21.40 days | Standard Deviation 26.42 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Days in nursing home(n=1,2,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6:Days of part time work(n=7,8,2) | 7.50 days | Standard Deviation 3.54 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=97,92,60) | 41.92 days | Standard Deviation 36.89 |
Secondary
Number of Days as Assessed Using RA-HCRU at Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay(n=8,8,1,2) | 8.88 days | Standard Deviation 6.73 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home(n=4,0,0,0) | 19.50 days | Standard Deviation 8.35 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days aids/devices used(n=19,15,4,5) | 111.79 days | Standard Deviation 84.57 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related aids used(n=21,16,4,5) | 1.19 days | Standard Deviation 1.21 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week(n=86,84,34,23) | 5.20 days | Standard Deviation 1.03 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave due to RA(n=15,12,1,4) | 36.40 days | Standard Deviation 42.27 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work(n=8,7,1,2) | 14.88 days | Standard Deviation 30.48 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA(n=49,53,18,14) | 39.08 days | Standard Deviation 35.44 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper(n=23,9,0,5) | 32.17 days | Standard Deviation 36.69 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family(n=63,48,14,12) | 26.67 days | Standard Deviation 32.49 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days aids/devices used(n=19,15,4,5) | 161.40 days | Standard Deviation 382.2 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper(n=23,9,0,5) | 17.22 days | Standard Deviation 28.01 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related aids used(n=21,16,4,5) | 2.50 days | Standard Deviation 4.76 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week(n=86,84,34,23) | 5.35 days | Standard Deviation 0.74 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave due to RA(n=15,12,1,4) | 13.58 days | Standard Deviation 25.37 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work(n=8,7,1,2) | 6.71 days | Standard Deviation 3.15 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family(n=63,48,14,12) | 24.98 days | Standard Deviation 29.88 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA(n=49,53,18,14) | 40.02 days | Standard Deviation 33.5 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay(n=8,8,1,2) | 12.38 days | Standard Deviation 11.98 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home(n=4,0,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA(n=49,53,18,14) | 40.39 days | Standard Deviation 34.19 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work(n=8,7,1,2) | 24.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family(n=63,48,14,12) | 26.43 days | Standard Deviation 32.22 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay(n=8,8,1,2) | 2.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related aids used(n=21,16,4,5) | 2.50 days | Standard Deviation 1.73 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave due to RA(n=15,12,1,4) | 20.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper(n=23,9,0,5) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home(n=4,0,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week(n=86,84,34,23) | 5.00 days | Standard Deviation 1.1 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days aids/devices used(n=19,15,4,5) | 225.00 days | Standard Deviation 155.88 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week(n=86,84,34,23) | 5.22 days | Standard Deviation 0.8 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA(n=49,53,18,14) | 47.57 days | Standard Deviation 39.16 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave due to RA(n=15,12,1,4) | 31.00 days | Standard Deviation 41.49 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family(n=63,48,14,12) | 26.00 days | Standard Deviation 31.05 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work(n=8,7,1,2) | 52.50 days | Standard Deviation 53.03 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home(n=4,0,0,0) | NA days | — |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days aids/devices used(n=19,15,4,5) | 62.00 days | Standard Deviation 75.38 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related aids used(n=21,16,4,5) | 1.80 days | Standard Deviation 1.3 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay(n=8,8,1,2) | 1.50 days | Standard Deviation 0.71 |
| Placebo Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper(n=23,9,0,5) | 6.60 days | Standard Deviation 3.29 |
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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.
| Arm | 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 3:Doctor visit(n=183,174,94) | 4.50 events | Standard Deviation 4.18 |
| 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 6:Non-medical practitioner visit(n=3,1,1) | 12.67 events | Standard Deviation 11.02 |
| 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=168,178,39) | 3.54 events | Standard Deviation 3.87 |
| 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=183,174,94) | 1.06 events | Standard Deviation 0.75 |
| 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=266,280,130) | 4.27 events | Standard Deviation 3.99 |
| 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=6,6,1) | 0.67 events | Standard Deviation 1.03 |
| 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 | Month 3:Hospital ER visit(n=11,7,6) | 1.36 events | Standard Deviation 0.92 |
| 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=16,23,9) | 0.94 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 | Month 3:Non-medical practitioner visit(n=6,6,1) | 4.00 events | Standard Deviation 2.28 |
| 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=12,7,6) | 0.17 events | Standard Deviation 0.39 |
| 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=19,18,8) | 1.26 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 3:RA related diagnostic test(n=26,27,15) | 0.23 events | Standard Deviation 0.65 |
| 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=4,4,4) | 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 6:RA related outpatient surgery(n=5,5,5) | 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:Non-study diagnostic test(n=24,26,15) | 1.63 events | Standard Deviation 1.21 |
| 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=4,4,4) | 0.25 events | Standard Deviation 0.5 |
| 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=8,6,9) | 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 3:RA related outpatient surgery(n=6,5,6) | 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=6,5,6) | 2.17 events | Standard Deviation 1.94 |
| 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=266,280,130) | 1.33 events | Standard Deviation 0.85 |
| 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=5,5,5) | 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 | Baseline:RA related outpatient surgery(n=8,5,9) | 0.88 events | Standard Deviation 0.64 |
| 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=25,20,10) | 0.28 events | Standard Deviation 0.54 |
| 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=8,7,2) | 0.38 events | Standard Deviation 0.74 |
| 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=45,39,22) | 1.64 events | Standard Deviation 1.03 |
| 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 ER visit(n=19,18,8) | 0.58 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:Hospitalization(n=8,5,2) | 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 | Baseline:RA related diagnostic test(n=45,40,22) | 0.80 events | Standard Deviation 0.87 |
| 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=3,1,1) | 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 | Month 6:RA related ER visit(n=13,6,2) | 0.08 events | Standard Deviation 0.28 |
| 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=13,6,3) | 8.08 events | Standard Deviation 7.9 |
| 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=23,20,9) | 2.04 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 Baseline, Month 3 and 6 | Month 6:Hospital ER visit(n=13,4,2) | 1.31 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 | Baseline:RA related non-medical visit(n=13,6,3) | 1.23 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 | Baseline:Hospitalization(n=16,23,9) | 1.50 events | Standard Deviation 2 |
| 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=168,177,39) | 0.91 events | Standard Deviation 0.65 |
| 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=5,5,5) | 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 | Baseline:Doctor visit(n=266,280,130) | 4.17 events | Standard Deviation 3.58 |
| 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 | Baseline:RA related doctor visit(n=266,280,130) | 1.32 events | Standard Deviation 0.71 |
| 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=19,18,8) | 1.28 events | Standard Deviation 0.67 |
| 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=19,18,8) | 0.50 events | Standard Deviation 0.51 |
| 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 | Baseline:Hospitalization(n=16,23,9) | 1.26 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 | Baseline:RA related hospitalization(n=16,23,9) | 1.09 events | Standard Deviation 0.9 |
| 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=8,6,9) | 1.17 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 Baseline, Month 3 and 6 | Baseline:RA related outpatient surgery(n=8,5,9) | 0.20 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 | Baseline:Non-study diagnostic test(n=45,39,22) | 2.13 events | Standard Deviation 2.34 |
| 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 diagnostic test(n=45,40,22) | 0.90 events | Standard Deviation 0.98 |
| 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=13,6,3) | 2.83 events | Standard Deviation 1.83 |
| 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=13,6,3) | 1.00 events | Standard Deviation 0.89 |
| 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=183,174,94) | 4.05 events | Standard Deviation 3.77 |
| 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=183,174,94) | 0.97 events | Standard Deviation 0.72 |
| 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=11,7,6) | 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 3:RA related ER visit(n=12,7,6) | 0.29 events | Standard Deviation 0.76 |
| 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:Hospitalization(n=4,4,4) | 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 3:RA related hospitalization(n=4,4,4) | 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 Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=6,5,6) | 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 3:RA related outpatient surgery(n=6,5,6) | 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-study diagnostic test(n=24,26,15) | 1.35 events | Standard Deviation 0.63 |
| 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=26,27,15) | 0.22 events | Standard Deviation 0.51 |
| 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:Non-medical practitioner visit(n=6,6,1) | 3.00 events | Standard Deviation 3.52 |
| 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 3:RA related non-medical visit(n=6,6,1) | 0.67 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=168,178,39) | 3.07 events | Standard Deviation 2.73 |
| 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=168,177,39) | 0.97 events | Standard Deviation 0.71 |
| 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=13,4,2) | 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 ER visit(n=13,6,2) | 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:Hospitalization(n=8,5,2) | 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 hospitalization(n=8,7,2) | 0.29 events | Standard Deviation 0.76 |
| 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 6:Outpatient surgery(n=5,5,5) | 1.40 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 6:Non-study diagnostic test(n=23,20,9) | 1.60 events | Standard Deviation 1.1 |
| 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=25,20,10) | 0.35 events | Standard Deviation 0.67 |
| 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=3,1,1) | 12.00 events | — |
| 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=3,1,1) | 4.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3:Doctor visit(n=183,174,94) | 4.66 events | Standard Deviation 4.94 |
| 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=3,1,1) | NA events | — |
| 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=168,178,39) | 3.08 events | Standard Deviation 3.96 |
| 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=13,6,3) | 1.33 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:Non-study diagnostic test(n=23,20,9) | 1.11 events | Standard Deviation 0.33 |
| 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=168,177,39) | 0.74 events | Standard Deviation 0.59 |
| 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=13,6,3) | 8.00 events | Standard Deviation 2 |
| 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=19,18,8) | 1.38 events | Standard Deviation 0.74 |
| 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=13,4,2) | 2.50 events | Standard Deviation 2.12 |
| 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=45,40,22) | 0.73 events | Standard Deviation 0.88 |
| 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=266,280,130) | 4.13 events | Standard Deviation 3.8 |
| 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=13,6,2) | 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 | Baseline:Non-study diagnostic test(n=45,39,22) | 1.64 events | Standard Deviation 0.95 |
| 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=25,20,10) | 0.20 events | Standard Deviation 0.42 |
| 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=8,5,2) | 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:RA related outpatient surgery(n=8,5,9) | 0.56 events | Standard Deviation 0.88 |
| 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=266,280,130) | 1.25 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 hospitalization(n=8,7,2) | 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=8,6,9) | 1.33 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 non-medical visit(n=3,1,1) | NA events | — |
| 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=6,5,6) | 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:RA related hospitalization(n=4,4,4) | 0.25 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:Outpatient surgery(n=5,5,5) | 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 3:RA related outpatient surgery(n=6,5,6) | 0.17 events | Standard Deviation 0.41 |
| 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=4,4,4) | 0.75 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 | Baseline:RA related hospitalization(n=16,23,9) | 0.78 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:Non-study diagnostic test(n=24,26,15) | 1.33 events | Standard Deviation 0.82 |
| 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=12,7,6) | 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 | Baseline:Hospitalization(n=16,23,9) | 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 3:RA related diagnostic test(n=26,27,15) | 0.47 events | Standard Deviation 0.52 |
| 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=11,7,6) | 1.17 events | Standard Deviation 0.41 |
| 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=5,5,5) | 0.20 events | Standard Deviation 0.45 |
| 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=6,6,1) | 40.00 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=183,174,94) | 1.03 events | Standard Deviation 0.71 |
| 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=19,18,8) | 0.88 events | Standard Deviation 0.83 |
| 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=6,6,1) | 4.00 events | — |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure for given parameters for each group respectively.
| Arm | 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 | RA related diagnostic test(n=32,25,6,11) | 0.34 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 Month 12 | RA related non-medical visit(n=2,3,3,0) | 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 Month 12 | RA related outpatient surgery(n=8,5,2,2) | 0.13 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 Month 12 | Doctor visit(n=136,139,42,34) | 3.17 events | Standard Deviation 3.59 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic test(n=30,25,6,9) | 1.67 events | Standard Deviation 0.88 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospital ER visit(n=13,12,6,5) | 1.15 events | Standard Deviation 0.38 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related ER visit(n=13,12,6,5) | 0.15 events | Standard Deviation 0.55 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related doctor visit (n=136,139,42,34) | 0.89 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 | Non-medical practitioner visit(n=2,2,3,0) | 3.00 events | Standard Deviation 1.41 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospitalization(n=7,8,1,2) | 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 | RA related hospitalization(n=8,8,1,2) | 0.50 events | Standard Deviation 0.93 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Outpatient surgery(n=4,5,2,2) | 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 Month 12 | RA related doctor visit (n=136,139,42,34) | 0.74 events | Standard Deviation 0.64 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Outpatient surgery(n=4,5,2,2) | 1.60 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 Month 12 | RA related ER visit(n=13,12,6,5) | 0.33 events | Standard Deviation 0.65 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic test(n=30,25,6,9) | 1.68 events | Standard Deviation 1.44 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related diagnostic test(n=32,25,6,11) | 0.12 events | Standard Deviation 0.33 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related outpatient surgery(n=8,5,2,2) | 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 Month 12 | Doctor visit(n=136,139,42,34) | 2.58 events | Standard Deviation 2.62 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization(n=8,8,1,2) | 0.63 events | Standard Deviation 0.92 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospitalization(n=7,8,1,2) | 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 | Hospital ER visit(n=13,12,6,5) | 1.17 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 | RA related non-medical visit(n=2,3,3,0) | 0.67 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 | Non-medical practitioner visit(n=2,2,3,0) | 6.00 events | Standard Deviation 2.83 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related outpatient surgery(n=8,5,2,2) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Doctor visit(n=136,139,42,34) | 3.19 events | Standard Deviation 4.58 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related doctor visit (n=136,139,42,34) | 1.05 events | Standard Deviation 0.82 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospital ER visit(n=13,12,6,5) | 1.67 events | Standard Deviation 1.63 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related ER visit(n=13,12,6,5) | 0.33 events | Standard Deviation 0.82 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospitalization(n=7,8,1,2) | 1.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization(n=8,8,1,2) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Outpatient surgery(n=4,5,2,2) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic test(n=30,25,6,9) | 1.33 events | Standard Deviation 0.52 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related diagnostic test(n=32,25,6,11) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-medical practitioner visit(n=2,2,3,0) | 3.00 events | Standard Deviation 2.65 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related non-medical visit(n=2,3,3,0) | 0.67 events | Standard Deviation 0.58 |
| Placebo Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization(n=8,8,1,2) | 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 | Hospitalization(n=7,8,1,2) | 1.50 events | Standard Deviation 0.71 |
| Placebo Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Doctor visit(n=136,139,42,34) | 2.62 events | Standard Deviation 1.65 |
| Placebo Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related diagnostic test(n=32,25,6,11) | 0.09 events | Standard Deviation 0.3 |
| Placebo Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related ER visit(n=13,12,6,5) | 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 | Hospital ER visit(n=13,12,6,5) | 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 | RA related non-medical visit(n=2,3,3,0) | NA 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 | Non-medical practitioner visit(n=2,2,3,0) | NA 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 | RA related outpatient surgery(n=8,5,2,2) | 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 | Outpatient surgery(n=4,5,2,2) | 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 | RA related doctor visit (n=136,139,42,34) | 0.79 events | Standard Deviation 0.69 |
| Placebo Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic test(n=30,25,6,9) | 2.00 events | Standard Deviation 0.87 |
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 3, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.
| Arm | 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:Missed work due to RA(n=7,8,1) | 4.43 hours per day | Standard Deviation 1.62 |
| 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=2,4,2) | 1.50 hours per day | Standard Deviation 0.71 |
| 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=46,37,18) | 4.61 hours per day | Standard Deviation 3.96 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Work done(n=110,106,59) | 7.84 hours per day | Standard Deviation 2.85 |
| 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=2,4,2) | 0.00 hours per day | Standard Deviation 0 |
| 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=154,159,79) | 4.27 hours per day | Standard Deviation 4.81 |
| 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=25,13,6) | 4.64 hours per day | Standard Deviation 3.01 |
| 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=104,98,53) | 8.99 hours per day | Standard Deviation 7.48 |
| 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=92,95,24) | 8.12 hours per day | Standard Deviation 1.89 |
| 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=3,4,2) | 4.67 hours per day | Standard Deviation 6.35 |
| 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=16,11,8) | 3.94 hours per day | Standard Deviation 1.88 |
| 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=2,2,0) | 1.00 hours per day | Standard Deviation 1.41 |
| 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=30,29,12) | 4.30 hours per day | Standard Deviation 4.18 |
| 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=30,19,10) | 4.17 hours per day | Standard Deviation 2.68 |
| 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=77,66,14) | 3.73 hours per day | Standard Deviation 3.58 |
| 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=2,2,0) | 17.00 hours per day | Standard Deviation 9.9 |
| 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=98,89,59) | 3.32 hours per day | Standard Deviation 3.3 |
| 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=3,4,2) | 0.67 hours per day | Standard Deviation 0.58 |
| 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=98,89,59) | 2.98 hours per day | Standard Deviation 3.35 |
| 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=2,2,0) | 2.00 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 | Month 6:RA related home HC services(n=2,2,0) | 2.00 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:Chores by housekeeper(n=46,37,18) | 4.62 hours per day | Standard Deviation 2.78 |
| 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=92,95,24) | 7.53 hours per day | Standard Deviation 1.72 |
| 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=3,4,2) | 1.00 hours per day | Standard Deviation 0.82 |
| 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=7,8,1) | 3.38 hours per day | Standard Deviation 1.69 |
| 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=25,13,6) | 5.69 hours per day | Standard Deviation 6.45 |
| 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=154,159,79) | 3.86 hours per day | Standard Deviation 7.09 |
| 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=77,66,14) | 2.91 hours per day | Standard Deviation 3.3 |
| 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=3,4,2) | 2.75 hours per day | Standard Deviation 2.36 |
| 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=2,4,2) | 3.25 hours per day | Standard Deviation 2.06 |
| 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=2,4,2) | 0.25 hours per day | Standard Deviation 2.5 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Work done(n=110,106,59) | 7.45 hours per day | Standard Deviation 2.27 |
| 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=104,98,53) | 7.64 hours per day | Standard Deviation 2.2 |
| 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=16,11,8) | 4.18 hours per day | Standard Deviation 2.14 |
| 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=30,19,10) | 3.74 hours per day | Standard Deviation 3.74 |
| 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=30,29,12) | 6.24 hours per day | Standard Deviation 16.81 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by housekeeper(n=30,19,10) | 3.30 hours per day | Standard Deviation 2 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Home healthcare services (n=3,4,2) | 1.50 hours per day | Standard Deviation 0.71 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:RA related home HC services(n=3,4,2) | 0.50 hours per day | Standard Deviation 0.71 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Work done(n=110,106,59) | 7.24 hours per day | Standard Deviation 1.89 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Missed work due to RA(n=30,29,12) | 7.33 hours per day | Standard Deviation 8.07 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=46,37,18) | 5.17 hours per day | Standard Deviation 5.15 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline:Chores by family(n=154,159,79) | 4.30 hours per day | Standard Deviation 5.59 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=2,4,2) | 1.50 hours per day | Standard Deviation 0.71 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:RA related home HC services(n=2,4,2) | 1.00 hours per day | Standard Deviation 1.41 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Work done(n=104,98,53) | 8.06 hours per day | Standard Deviation 4.94 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Missed work due to RA(n=16,11,8) | 3.88 hours per day | Standard Deviation 1.13 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Chores by family(n=77,66,14) | 4.36 hours per day | Standard Deviation 2.68 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3:Chores by family(n=98,89,59) | 4.97 hours per day | Standard Deviation 5.77 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=2,2,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:RA related home HC services(n=2,2,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Work done(n=92,95,24) | 8.50 hours per day | Standard Deviation 5.34 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6:Missed work due to RA(n=7,8,1) | 2.00 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=25,13,6) | 5.17 hours per day | Standard Deviation 3.13 |
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for given parameters for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home healthcare services(n=1,1,1,0) | 1.00 hours per day | — |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related healthcare services(n=1,1,1,0) | 0.00 hours per day | — |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done(n=85,85,34,24) | 8.60 hours per day | Standard Deviation 4 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA(n=8,7,1,2) | 5.00 hours per day | Standard Deviation 6.21 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper(n=22,9,0,5) | 4.86 hours per day | Standard Deviation 2.71 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family(n=62,47,14,12) | 3.24 hours per day | Standard Deviation 3.26 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family(n=62,47,14,12) | 2.70 hours per day | Standard Deviation 2.22 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA(n=8,7,1,2) | 3.29 hours per day | Standard Deviation 1.8 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home healthcare services(n=1,1,1,0) | 2.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done(n=85,85,34,24) | 7.67 hours per day | Standard Deviation 1.77 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related healthcare services(n=1,1,1,0) | 2.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper(n=22,9,0,5) | 3.89 hours per day | Standard Deviation 1.96 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related healthcare services(n=1,1,1,0) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done(n=85,85,34,24) | 8.79 hours per day | Standard Deviation 5.85 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA(n=8,7,1,2) | 0.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family(n=62,47,14,12) | 2.50 hours per day | Standard Deviation 1.4 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper(n=22,9,0,5) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home healthcare services(n=1,1,1,0) | 1.00 hours per day | — |
| Placebo Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper(n=22,9,0,5) | 4.40 hours per day | Standard Deviation 2.3 |
| Placebo Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family(n=62,47,14,12) | 5.92 hours per day | Standard Deviation 8.08 |
| Placebo Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related healthcare services(n=1,1,1,0) | NA hours per day | — |
| Placebo Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA(n=8,7,1,2) | 4.00 hours per day | Standard Deviation 1.41 |
| Placebo Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home healthcare services(n=1,1,1,0) | NA hours per day | — |
| Placebo Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done(n=85,85,34,24) | 7.38 hours per day | Standard Deviation 1.86 |
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 population included participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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=312,315,158) | 139 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=305,303,155) | 155 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=294,292,147) | 139 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=278,280,145) | 142 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=278,280,145) | 143 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=312,315,158) | 139 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=294,292,147) | 152 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=305,303,155) | 145 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=278,280,145) | 66 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=305,303,155) | 72 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=294,292,147) | 65 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=312,315,158) | 70 participants |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | 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 | 134 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12 | 144 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12 | 37 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 | 36 participants |
Secondary
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n = 310, 306, 156) | 46.81 mm | Standard Deviation 22.82 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n = 294, 292, 148) | 34.92 mm | Standard Deviation 23.03 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n = 299, 301, 150) | 36.40 mm | Standard Deviation 22.63 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n = 311, 315, 158) | 57.08 mm | Standard Deviation 23.82 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n = 279, 280, 68) | 31.07 mm | Standard Deviation 21.84 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n = 284, 289, 71) | 34.43 mm | Standard Deviation 22.68 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n = 304, 303, 154) | 40.17 mm | Standard Deviation 23.2 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n = 299, 301, 150) | 32.84 mm | Standard Deviation 21.71 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n = 311, 315, 158) | 58.58 mm | Standard Deviation 22.19 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n = 310, 306, 156) | 41.85 mm | Standard Deviation 22.49 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n = 304, 303, 154) | 37.08 mm | Standard Deviation 22.14 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n = 294, 292, 148) | 32.96 mm | Standard Deviation 23.1 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n = 284, 289, 71) | 32.62 mm | Standard Deviation 21.74 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n = 279, 280, 68) | 29.94 mm | Standard Deviation 21.53 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n = 294, 292, 148) | 46.59 mm | Standard Deviation 27.14 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n = 310, 306, 156) | 51.01 mm | Standard Deviation 24.45 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n = 279, 280, 68) | 34.19 mm | Standard Deviation 21.69 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n = 284, 289, 71) | 40.23 mm | Standard Deviation 24.44 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n = 299, 301, 150) | 47.30 mm | Standard Deviation 24.29 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n = 304, 303, 154) | 45.69 mm | Standard Deviation 25 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n = 311, 315, 158) | 57.11 mm | Standard Deviation 22.84 |
Secondary
Patient Assessment of Arthritis Pain at Month 9 and 12
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 | 30.78 mm | Standard Deviation 22.28 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 | 30.18 mm | Standard Deviation 23.11 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 | 25.43 mm | Standard Deviation 20.57 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 | 27.13 mm | Standard Deviation 20.77 |
| Placebo | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 | 29.50 mm | Standard Deviation 21.34 |
| Placebo | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 | 28.20 mm | Standard Deviation 22.46 |
| Placebo Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 | 25.26 mm | Standard Deviation 21.96 |
| Placebo Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 | 25.39 mm | Standard Deviation 22.71 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=310,306,156) | 46.59 mm | Standard Deviation 22.52 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=294,292,148) | 36.27 mm | Standard Deviation 22.64 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=299,301,150) | 37.18 mm | Standard Deviation 22.52 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=311,315,158) | 59.03 mm | Standard Deviation 22.89 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=279,280,68) | 33.75 mm | Standard Deviation 23.01 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=284,289,71) | 35.92 mm | Standard Deviation 22.69 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=303,303,154) | 40.50 mm | Standard Deviation 23.29 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=299,301,150) | 33.80 mm | Standard Deviation 22.21 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=311,315,158) | 60.22 mm | Standard Deviation 22.53 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=310,306,156) | 42.99 mm | Standard Deviation 22.16 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=303,303,154) | 36.53 mm | Standard Deviation 21.42 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=294,292,148) | 33.43 mm | Standard Deviation 22.55 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=284,289,71) | 34.05 mm | Standard Deviation 22.09 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=279,280,68) | 31.31 mm | Standard Deviation 21.55 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=294,292,148) | 47.09 mm | Standard Deviation 26.13 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=310,306,156) | 51.27 mm | Standard Deviation 23.97 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=279,280,68) | 35.47 mm | Standard Deviation 20.28 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=284,289,71) | 41.03 mm | Standard Deviation 23.75 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=299,301,150) | 50.42 mm | Standard Deviation 23.56 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=303,303,154) | 46.25 mm | Standard Deviation 24.22 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=311,315,158) | 57.92 mm | Standard Deviation 23.33 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 | 32.06 mm | Standard Deviation 22.49 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 | 30.64 mm | Standard Deviation 22.03 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 | 27.94 mm | Standard Deviation 20.39 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 | 28.01 mm | Standard Deviation 20.81 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 | 28.97 mm | Standard Deviation 20.07 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 | 28.71 mm | Standard Deviation 23.05 |
| Placebo Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 | 28.56 mm | Standard Deviation 22.74 |
| Placebo Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 | 28.20 mm | Standard Deviation 24.29 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 9, 12
Population: FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 9 | 50.48 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 12 | 51.45 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 12 | 56.63 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 9 | 62.14 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 9 | 37.97 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 12 | 31.65 percentage of participants |
| Placebo Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 9 | 34.62 percentage of participants |
| Placebo Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12 | Month 12 | 34.62 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 27.33 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 38.59 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 54.02 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 56.27 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 50.80 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 52.73 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 58.25 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 32.25 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 64.72 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 57.93 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 48.54 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 64.40 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 22.93 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 26.11 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 31.21 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 27.39 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 10.90 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 25.48 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 9 | 31.51 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 12 | 33.44 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 12 | 42.72 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 9 | 43.04 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 9 | 25.32 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 12 | 24.05 percentage of participants |
| Placebo Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 9 | 26.92 percentage of participants |
| Placebo Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12 | Month 12 | 25.64 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population. N (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 5.79 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 11.58 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 23.15 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 27.33 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 27.97 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 33.76 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 36.57 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 8.14 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 33.98 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 33.33 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 18.12 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 29.77 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 1.27 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 4.46 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 12.74 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 9.55 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 1.28 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 8.28 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal, advancement to active treatment before Month 6 were imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 9 | 14.15 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 12 | 19.29 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 12 | 25.57 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 9 | 25.24 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 9 | 10.13 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 12 | 13.92 percentage of participants |
| Placebo Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 9 | 11.54 percentage of participants |
| Placebo Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12 | Month 12 | 20.51 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population. 'N' (number of participants analyzed)=participants who were evaluable for this measure. Missing values due to withdrawal from study or advancement to active treatment, before Month 6 was imputed using NRI method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 0.32 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 3.54 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 9.00 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 8.36 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 11.90 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 13.18 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 16.18 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 2.28 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 14.24 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 18.12 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 7.12 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 10.36 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 | 1.27 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 | 3.18 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 | 1.91 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 | 3.18 percentage of participants |
Secondary
Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Month 9, 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 9 | 24.36 mm | Standard Deviation 17.67 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 12 | 21.52 mm | Standard Deviation 17.14 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 12 | 18.12 mm | Standard Deviation 14.5 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 9 | 20.09 mm | Standard Deviation 14.23 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 9 | 22.70 mm | Standard Deviation 15.42 |
| Placebo | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 12 | 19.01 mm | Standard Deviation 15.01 |
| Placebo Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 9 | 20.63 mm | Standard Deviation 17.35 |
| Placebo Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis at Month 9 and 12 | Month 12 | 17.59 mm | Standard Deviation 15.21 |
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=302,303,154) | 38.35 mm | Standard Deviation 19.92 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=278,280,68) | 25.83 mm | Standard Deviation 17.29 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=293,292,148) | 31.97 mm | Standard Deviation 20.25 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=299,299,150) | 32.54 mm | Standard Deviation 19.36 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=308,304,155) | 46.41 mm | Standard Deviation 20.14 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=310,313,158) | 60.48 mm | Standard Deviation 17.83 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=283,288,71) | 29.45 mm | Standard Deviation 19.84 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=293,292,148) | 29.21 mm | Standard Deviation 19.31 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=310,313,158) | 59.66 mm | Standard Deviation 17.03 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=308,304,155) | 43.79 mm | Standard Deviation 18.17 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=302,303,154) | 34.31 mm | Standard Deviation 18.7 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=299,299,150) | 29.40 mm | Standard Deviation 17.36 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=283,288,71) | 26.11 mm | Standard Deviation 17.54 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=278,280,68) | 23.69 mm | Standard Deviation 16.62 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 3 (n=293,292,148) | 39.54 mm | Standard Deviation 21.09 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Week 2 (n=308,304,155) | 49.08 mm | Standard Deviation 18.9 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 6 (n=278,280,68) | 27.88 mm | Standard Deviation 19.1 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 4.5 (n=283,288,71) | 33.04 mm | Standard Deviation 21.06 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Baseline (n=310,313,158) | 58.87 mm | Standard Deviation 16.52 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 2 (n=299,299,150) | 41.25 mm | Standard Deviation 20.42 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6 | Month 1 (n=302,303,154) | 42.86 mm | Standard Deviation 20.13 |
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 population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:time management(n=139,131,69) | 38.56 units on a scale | Standard Deviation 30.11 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:mental demands(n=158,154,83) | 36.58 units on a scale | Standard Deviation 26.35 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:time management(n=112,108,27) | 34.43 units on a scale | Standard Deviation 28.4 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:physical demands(n=135, 32,66) | 43.14 units on a scale | Standard Deviation 26.03 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:physical demands(n=154,154,86) | 48.08 units on a scale | Standard Deviation 25.92 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:work loss index(n=145,138,73) | 9.29 units on a scale | Standard Deviation 6.32 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:mental demands(n=142,136,72) | 30.43 units on a scale | Standard Deviation 27.99 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:mental demands(n=115,112,27) | 25.94 units on a scale | Standard Deviation 26.35 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:output demands(n=136,132,68) | 32.23 units on a scale | Standard Deviation 27.77 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:output demands(n=153,149,79) | 41.93 units on a scale | Standard Deviation 27.66 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:work loss index(n=116,114,28) | 8.73 units on a scale | Standard Deviation 6.26 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:time management(n=152,149,80) | 47.13 units on a scale | Standard Deviation 27.4 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:work loss index(n=164,163,90) | 11.25 units on a scale | Standard Deviation 6.04 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:output demands(n=111,111,26) | 28.92 units on a scale | Standard Deviation 26.55 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:physical demands(n=114,110,24) | 48.72 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:physical demands(n=114,110,24) | 41.75 units on a scale | Standard Deviation 30.91 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:time management(n=152,149,80) | 46.05 units on a scale | Standard Deviation 27.83 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:physical demands(n=154,154,86) | 50.83 units on a scale | Standard Deviation 25.34 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:mental demands(n=158,154,83) | 35.86 units on a scale | Standard Deviation 25.72 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:output demands(n=153,149,79) | 38.76 units on a scale | Standard Deviation 28.34 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:work loss index(n=164,163,90) | 10.76 units on a scale | Standard Deviation 6.16 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:time management(n=139,131,69) | 37.39 units on a scale | Standard Deviation 30.53 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:physical demands(n=135, 32,66) | 45.07 units on a scale | Standard Deviation 30.63 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:mental demands(n=142,136,72) | 31.60 units on a scale | Standard Deviation 29.49 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:output demands(n=136,132,68) | 33.43 units on a scale | Standard Deviation 30.58 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:work loss index(n=145,138,73) | 9.64 units on a scale | Standard Deviation 7.1 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:time management(n=112,108,27) | 35.73 units on a scale | Standard Deviation 31.85 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:mental demands(n=115,112,27) | 27.98 units on a scale | Standard Deviation 28.18 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:output demands(n=111,111,26) | 28.98 units on a scale | Standard Deviation 28.12 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:work loss index(n=116,114,28) | 8.71 units on a scale | Standard Deviation 6.64 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:time management(n=139,131,69) | 36.99 units on a scale | Standard Deviation 28.24 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:output demands(n=111,111,26) | 29.52 units on a scale | Standard Deviation 29.09 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:time management(n=112,108,27) | 33.77 units on a scale | Standard Deviation 31.88 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:work loss index(n=164,163,90) | 9.22 units on a scale | Standard Deviation 5.28 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:output demands(n=153,149,79) | 32.72 units on a scale | Standard Deviation 25.35 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:physical demands(n=114,110,24) | 48.13 units on a scale | Standard Deviation 32.45 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:mental demands(n=158,154,83) | 30.31 units on a scale | Standard Deviation 24.19 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:time management(n=152,149,80) | 39.98 units on a scale | Standard Deviation 24.44 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:mental demands(n=115,112,27) | 22.34 units on a scale | Standard Deviation 26.57 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:mental demands(n=142,136,72) | 28.15 units on a scale | Standard Deviation 23.69 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Baseline:physical demands(n=154,154,86) | 51.88 units on a scale | Standard Deviation 24.98 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:output demands(n=136,132,68) | 27.33 units on a scale | Standard Deviation 24.32 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:physical demands(n=135, 32,66) | 52.78 units on a scale | Standard Deviation 24.73 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 6:work loss index(n=116,114,28) | 8.03 units on a scale | Standard Deviation 6.64 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 | Month 3:work loss index(n=145,138,73) | 8.77 units on a scale | Standard Deviation 5.47 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Month 12
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]).
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Output demands(n=105,95,35,29) | 26.75 units on a scale | Standard Deviation 25.54 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Physical demands(n=105,97,36,28) | 44.15 units on a scale | Standard Deviation 27.91 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Work loss index(n=108,101,38,32) | 8.65 units on a scale | Standard Deviation 6.12 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Mental demands(n=108,100,36,32) | 27.27 units on a scale | Standard Deviation 26.33 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Time management(n=105,98,35,31) | 37.01 units on a scale | Standard Deviation 30.03 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Mental demands(n=108,100,36,32) | 27.42 units on a scale | Standard Deviation 27.56 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Output demands(n=105,95,35,29) | 25.67 units on a scale | Standard Deviation 27.25 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Work loss index(n=108,101,38,32) | 8.28 units on a scale | Standard Deviation 6.59 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Physical demands(n=105,97,36,28) | 42.41 units on a scale | Standard Deviation 31.59 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Time management(n=105,98,35,31) | 35.29 units on a scale | Standard Deviation 31.8 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12 | Mental demands(n=108,100,36,32) | 20.70 units on a scale | Standard Deviation 26.37 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12 | Time management(n=105,98,35,31) | 30.82 units on a scale | Standard Deviation 29.59 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12 | Physical demands(n=105,97,36,28) | 47.15 units on a scale | Standard Deviation 30.4 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12 | Output demands(n=105,95,35,29) | 22.54 units on a scale | Standard Deviation 25.05 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 12 | Work loss index(n=108,101,38,32) | 7.06 units on a scale | Standard Deviation 5.81 |
| Placebo Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Output demands(n=105,95,35,29) | 28.43 units on a scale | Standard Deviation 27.66 |
| Placebo Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Physical demands(n=105,97,36,28) | 40.82 units on a scale | Standard Deviation 30.86 |
| Placebo Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Time management(n=105,98,35,31) | 36.57 units on a scale | Standard Deviation 30.8 |
| Placebo Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Mental demands(n=108,100,36,32) | 33.05 units on a scale | Standard Deviation 29.78 |
| Placebo Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 12 | Work loss index(n=108,101,38,32) | 8.89 units on a scale | Standard Deviation 6.29 |
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 3, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.
| Arm | 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= 223, 229, 124) | 3.74 units on a scale | Standard Deviation 3.04 |
| 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=239, 238, 119) | 5.03 units on a scale | Standard Deviation 5.89 |
| 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= 210, 224, 46) | 3.40 units on a scale | Standard Deviation 3.06 |
| 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= 223, 229, 124) | 3.18 units on a scale | Standard Deviation 3.21 |
| 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=239, 238, 119) | 4.72 units on a scale | Standard Deviation 3.22 |
| 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= 210, 224, 46) | 2.66 units on a scale | Standard Deviation 2.83 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline (n=239, 238, 119) | 4.55 units on a scale | Standard Deviation 3.14 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6 (n= 210, 224, 46) | 3.24 units on a scale | Standard Deviation 2.86 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3 (n= 223, 229, 124) | 3.97 units on a scale | Standard Deviation 3.15 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | 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 | 2.79 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 Month 12 | 2.52 units on a scale | Standard Deviation 2.74 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | 2.84 units on a scale | Standard Deviation 2.13 |
| Placebo Then CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | 3.08 units on a scale | Standard Deviation 2.6 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time frame: Baseline, Month 3, 6
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.'n' signifies those participants who were evaluable for each parameter at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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=286,278,145) | 1.75 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 | Baseline:Treated in emergency room(n=307,313,154) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Admitted for overnight stay(n=19,18,8) | 0.16 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 | Baseline:Hospitalization(n=307,313,154) | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=307,312,154) | 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-study diagnostic test(n=307,312,154) | 1.85 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:In nursing home(n=307,312,154) | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=307,312,154) | 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 | Baseline:Required aids/devices(n=307,311,154) | 1.88 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:Non-medical practitioner(n=307,312,154) | 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 | Baseline:Currently employed(n=307,312,154) | 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 | Baseline:Feel well enough to work(n=121,122,57) | 1.88 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:Unable to work due to RA(n=122,129,55) | 1.34 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=121,116,54) | 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 | Baseline:Work disabled due to RA(n=126,120,53) | 1.50 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:Retired(n=132,133,59) | 1.50 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=307,312,153) | 1.13 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:Performed part time work(n=285,278,143) | 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=287,277,144) | 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 | Baseline:Unable to do chores(n=305,307,153) | 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 | Baseline:Chores by housekeeper(n=306,312,154) | 1.85 units on a scale | Standard Deviation 0.36 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by family/friends(n=306,312,154) | 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 3:Seen any doctor(n=290,291,146) | 1.38 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 3:Treated in emergency room(n=290,291,146) | 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:Admitted for overnight stay(n=12,7,6) | 0.25 units on a scale | Standard Deviation 0.62 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=288,291,146) | 1.99 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=290,291,146) | 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=288,291,146) | 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:In nursing home(n=290,291,146) | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Home healthcare services(n=289,291,146) | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Required aids/devices(n=288,291,146) | 1.91 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner(n=290,291,146) | 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:Currently employed(n=289,291,146) | 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:Feel well enough to work(n=107,130,47) | 1.81 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:Unable to work due to RA(n=108,124,50) | 1.43 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:Lost job/retired early(n=109,125,49) | 1.58 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:Work disabled due to RA(n=108,123,47) | 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 3:Retired(n=132,129,57) | 1.45 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:Sick leave due to RA(n=265,266,139) | 1.88 units on a scale | Standard Deviation 0.32 |
| 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=264,265,139) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Performed paid work(n=265,266,139) | 1.72 units on a scale | Standard Deviation 0.45 |
| 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=284,286,147) | 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 3:Chores by housekeeper(n=289,290,146) | 1.90 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 3:Chores by family/friends(n=288,290,146) | 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:Seen any doctor(n=275,279,68) | 1.40 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=275,279,68) | 1.95 units on a scale | Standard Deviation 0.21 |
| 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=13,5,2) | 0.62 units on a scale | Standard Deviation 0.87 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Hospitalization(n=274,279,68) | 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:Outpatient surgery(n=275,279,68) | 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 6:Non-study diagnostic test(n=274,279,68) | 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 6:In nursing home(n=275,279,68) | 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 | Month 6:Home healthcare services(n=273,278,68) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Required aids/devices(n=274,278,68) | 1.91 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner(n=275,279,68) | 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:Currently employed(n=274,279,68) | 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:Feel well enough to work(n=117,129,25) | 1.80 units on a scale | Standard Deviation 0.4 |
| 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=121,126,23) | 1.45 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:Lost job/retired early(n=118,125,23) | 1.63 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:Work disabled due to RA(n=117,125,23) | 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:Retired(n=129,136,30) | 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 6:Sick leave due to RA(n=250,255,59) | 1.92 units on a scale | Standard Deviation 0.28 |
| 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=250,255,59) | 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:Performed paid work(n=249,255,59) | 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 6:Unable to do chores(n=269,276,67) | 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 6:Chores by housekeeper(n=275,277,68) | 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 | Month 6:Chores by family/friends(n=274,277,68) | 1.71 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:Feel well enough to work(n=107,130,47) | 1.75 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 | Baseline:Seen any doctor(n=307,312,153) | 1.11 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-medical practitioner(n=275,279,68) | 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 6:Seen any doctor(n=275,279,68) | 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:Treated in emergency room(n=307,313,154) | 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:Feel well enough to work(n=117,129,25) | 1.71 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:Unable to work due to RA(n=108,124,50) | 1.49 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:Admitted for overnight stay(n=19,18,8) | 0.22 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:In nursing home(n=290,291,146) | 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 3:Hospitalization(n=288,291,146) | 1.99 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 | Baseline:Hospitalization(n=307,313,154) | 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:Lost job/retired early(n=109,125,49) | 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 6:Treated in emergency room(n=275,279,68) | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=307,312,154) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Seen any doctor(n=290,291,146) | 1.41 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:Home healthcare services(n=289,291,146) | 1.99 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 | Baseline:Non-study diagnostic test(n=307,312,154) | 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 | Month 3:Work disabled due to RA(n=108,123,47) | 1.54 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:Retired(n=129,136,30) | 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 | Baseline:In nursing home(n=307,312,154) | 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:Performed part time work(n=250,255,59) | 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:Admitted for overnight stay (n=13,5,2) | 0.40 units on a scale | Standard Deviation 0.89 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=307,312,154) | 1.99 units on a scale | Standard Deviation 0.11 |
| 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=121,126,23) | 1.49 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:Retired(n=132,129,57) | 1.44 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:Required aids/devices(n=307,311,154) | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=290,291,146) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Required aids/devices(n=288,291,146) | 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=307,312,154) | 1.98 units on a scale | Standard Deviation 0.14 |
| 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=265,266,139) | 1.91 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:Hospitalization(n=274,279,68) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Currently employed(n=307,312,154) | 1.66 units on a scale | Standard Deviation 0.47 |
| 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=12,7,6) | 0.14 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Currently employed(n=274,279,68) | 1.66 units on a scale | Standard Deviation 0.47 |
| 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=121,122,57) | 1.89 units on a scale | Standard Deviation 0.32 |
| 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=264,265,139) | 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:Chores by family/friends(n=274,277,68) | 1.75 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 | Baseline:Unable to work due to RA(n=122,129,55) | 1.25 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:Non-medical practitioner(n=290,291,146) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=275,279,68) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Lost job/retired early(n=121,116,54) | 1.47 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:Lost job/retired early(n=118,125,23) | 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:Performed paid work(n=265,266,139) | 1.77 units on a scale | Standard Deviation 0.42 |
| 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=126,120,53) | 1.34 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:Treated in emergency room(n=290,291,146) | 1.98 units on a scale | Standard Deviation 0.15 |
| 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=250,255,59) | 1.95 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:Retired(n=132,133,59) | 1.41 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:Non-study diagnostic test(n=288,291,146) | 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 6:Non-study diagnostic test(n=274,279,68) | 1.93 units on a scale | Standard Deviation 0.25 |
| 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=286,278,145) | 1.78 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 3:Unable to do chores(n=284,286,147) | 1.71 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:Currently employed(n=289,291,146) | 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 | Baseline:Performed part time work(n=285,278,143) | 1.89 units on a scale | Standard Deviation 0.31 |
| 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=269,276,67) | 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:Chores by housekeeper(n=289,290,146) | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed paid work(n=287,277,144) | 1.66 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Required aids/devices(n=274,278,68) | 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 6:In nursing home(n=275,279,68) | 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 | Baseline:Unable to do chores(n=305,307,153) | 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:Work disabled due to RA(n=117,125,23) | 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:Chores by family/friends(n=288,290,146) | 1.68 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=306,312,154) | 1.88 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed paid work(n=249,255,59) | 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 | Month 6:Chores by housekeeper(n=275,277,68) | 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 | Baseline:Chores by family/friends(n=306,312,154) | 1.49 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:Home healthcare services(n=273,278,68) | 1.99 units on a scale | Standard Deviation 0.08 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by family/friends(n=306,312,154) | 1.48 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Seen any doctor(n=290,291,146) | 1.36 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Home healthcare services(n=273,278,68) | 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:Treated in emergency room(n=290,291,146) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Admitted for overnight stay(n=12,7,6) | 0.33 units on a scale | Standard Deviation 0.82 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Hospitalization(n=288,291,146) | 1.97 units on a scale | Standard Deviation 0.16 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Required aids/devices(n=274,278,68) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Outpatient surgery(n=290,291,146) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed part time work(n=250,255,59) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-study diagnostic test(n=288,291,146) | 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:In nursing home(n=290,291,146) | 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:Non-medical practitioner(n=275,279,68) | 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:Home healthcare services(n=289,291,146) | 1.99 units on a scale | Standard Deviation 0.12 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by housekeeper(n=275,277,68) | 1.91 units on a scale | Standard Deviation 0.29 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Required aids/devices(n=288,291,146) | 1.81 units on a scale | Standard Deviation 0.4 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Non-medical practitioner(n=290,291,146) | 1.99 units on a scale | Standard Deviation 0.08 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Currently employed(n=274,279,68) | 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 3:Currently employed(n=289,291,146) | 1.63 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Feel well enough to work(n=107,130,47) | 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:Unable to work due to RA(n=108,124,50) | 1.46 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=117,129,25) | 1.72 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Lost job/retired early(n=109,125,49) | 1.55 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Performed paid work(n=249,255,59) | 1.76 units on a scale | Standard Deviation 0.43 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Work disabled due to RA(n=108,123,47) | 1.51 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Retired(n=132,129,57) | 1.39 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to work due to RA(n=121,126,23) | 1.43 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Sick leave due to RA(n=265,266,139) | 1.83 units on a scale | Standard Deviation 0.38 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Chores by family/friends(n=274,277,68) | 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:Performed part time work(n=264,265,139) | 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 paid work(n=265,266,139) | 1.72 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Lost job/retired early(n=118,125,23) | 1.52 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Unable to do chores(n=284,286,147) | 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 3:Chores by housekeeper(n=289,290,146) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3:Chores by family/friends(n=288,290,146) | 1.59 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Work disabled due to RA(n=117,125,23) | 1.65 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Seen any doctor(n=307,312,153) | 1.16 units on a scale | Standard Deviation 0.37 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Treated in emergency room(n=307,313,154) | 1.95 units on a scale | Standard Deviation 0.22 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Seen any doctor(n=275,279,68) | 1.43 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Admitted for overnight stay(n=19,18,8) | 0.50 units on a scale | Standard Deviation 0.93 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Unable to do chores(n=269,276,67) | 1.69 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Hospitalization(n=307,313,154) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Outpatient surgery(n=307,312,154) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Treated in emergency room(n=275,279,68) | 1.97 units on a scale | Standard Deviation 0.17 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic test(n=307,312,154) | 1.86 units on a scale | Standard Deviation 0.35 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:In nursing home(n=307,312,154) | 1.99 units on a scale | Standard Deviation 0.11 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Home healthcare services(n=307,312,154) | 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:Admitted for overnight stay (n=13,5,2) | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices(n=307,311,154) | 1.88 units on a scale | Standard Deviation 0.33 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Retired(n=129,136,30) | 1.47 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Non-medical practitioner(n=307,312,154) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Currently employed(n=307,312,154) | 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:Hospitalization(n=274,279,68) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Feel well enough to work(n=121,122,57) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to work due to RA(n=122,129,55) | 1.42 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=121,116,54) | 1.50 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Outpatient surgery(n=275,279,68) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Work disabled due to RA(n=126,120,53) | 1.47 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Retired(n=132,133,59) | 1.41 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Sick leave due to RA(n=286,278,145) | 1.81 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:Non-study diagnostic test(n=274,279,68) | 1.85 units on a scale | Standard Deviation 0.36 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed part time work(n=285,278,143) | 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 6:Sick leave due to RA(n=250,255,59) | 1.93 units on a scale | Standard Deviation 0.52 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Performed paid work(n=287,277,144) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Unable to do chores(n=305,307,153) | 1.44 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6:In nursing home(n=275,279,68) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Chores by housekeeper(n=306,312,154) | 1.88 units on a scale | Standard Deviation 0.32 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time frame: Month 12
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for given parameters for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA(n=100,107,19,19) | 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 | Feel well enough to work(n=102,107,18,19) | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home(n=254,245,70,67) | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work(n=224,222,64,57) | 1.78 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed(n=254,246,70,67) | 1.66 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Non-medical practitioner(n=254,246,70,67) | 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 | Home healthcare services(n=252,246,70,67) | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted for overnight stay (n=13,12,6,5) | 0.23 units on a scale | Standard Deviation 0.6 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices(n=254,246,70,67) | 1.92 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper(n=254,246,70,67) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed part time work(n=224,217,64,57) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor(n=254,243,70,66) | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization(n=254,246,70,67) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER(n=254,246,70,67) | 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 | Sick leave due to RA(n=223,215,65,59) | 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 | Had outpatient surgery(n=253,246,70,67) | 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 | Retired(n=114,117,22,22) | 1.42 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family/friends(n=253,246,70,66) | 1.75 units on a scale | Standard Deviation 0.43 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA(n=103,106,18,19) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early(n=99,103,18,19) | 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 | Diagnostic test(n=253,246,70,67) | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores(n=250,246,69,66) | 1.73 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA(n=223,215,65,59) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor(n=254,243,70,66) | 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 | Treated in ER(n=254,246,70,67) | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted for overnight stay (n=13,12,6,5) | 0.25 units on a scale | Standard Deviation 0.62 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization(n=254,246,70,67) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Had outpatient surgery(n=253,246,70,67) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic test(n=253,246,70,67) | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home(n=254,245,70,67) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home healthcare services(n=252,246,70,67) | 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 | Required aids/devices(n=254,246,70,67) | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Non-medical practitioner(n=254,246,70,67) | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed(n=254,246,70,67) | 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 | Feel well enough to work(n=102,107,18,19) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA(n=100,107,19,19) | 1.54 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early(n=99,103,18,19) | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA(n=103,106,18,19) | 1.56 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired(n=114,117,22,22) | 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 | Performed part time work(n=224,217,64,57) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work(n=224,222,64,57) | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores(n=250,246,69,66) | 1.77 units on a scale | Standard Deviation 0.42 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper(n=254,246,70,67) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family/friends(n=253,246,70,66) | 1.80 units on a scale | Standard Deviation 0.4 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA(n=223,215,65,59) | 1.98 units on a scale | Standard Deviation 0.12 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA(n=100,107,19,19) | 1.37 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted for overnight stay (n=13,12,6,5) | 0.33 units on a scale | Standard Deviation 0.82 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Had outpatient surgery(n=253,246,70,67) | 1.97 units on a scale | Standard Deviation 0.17 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed part time work(n=224,217,64,57) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family/friends(n=253,246,70,66) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA(n=103,106,18,19) | 1.39 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor(n=254,243,70,66) | 1.40 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work(n=224,222,64,57) | 1.72 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores(n=250,246,69,66) | 1.74 units on a scale | Standard Deviation 0.44 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home healthcare services(n=252,246,70,67) | 1.99 units on a scale | Standard Deviation 0.12 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic test(n=253,246,70,67) | 1.91 units on a scale | Standard Deviation 0.28 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices(n=254,246,70,67) | 1.94 units on a scale | Standard Deviation 0.23 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper(n=254,246,70,67) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired(n=114,117,22,22) | 1.36 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER(n=254,246,70,67) | 1.91 units on a scale | Standard Deviation 0.28 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Non-medical practitioner(n=254,246,70,67) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Feel well enough to work(n=102,107,18,19) | 1.72 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home(n=254,245,70,67) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization(n=254,246,70,67) | 1.99 units on a scale | Standard Deviation 0.16 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed(n=254,246,70,67) | 1.50 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early(n=99,103,18,19) | 1.56 units on a scale | Standard Deviation 0.51 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed(n=254,246,70,67) | 1.63 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 | Feel well enough to work(n=102,107,18,19) | 1.74 units on a scale | Standard Deviation 0.45 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores(n=250,246,69,66) | 1.89 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 | Unable to work due to RA(n=100,107,19,19) | 1.63 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 | Had outpatient surgery(n=253,246,70,67) | 1.97 units on a scale | Standard Deviation 0.17 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor(n=254,243,70,66) | 1.50 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 | Lost job/retired early(n=99,103,18,19) | 1.58 units on a scale | Standard Deviation 0.51 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA(n=103,106,18,19) | 1.58 units on a scale | Standard Deviation 0.51 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization(n=254,246,70,67) | 1.97 units on a scale | Standard Deviation 0.12 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired(n=114,117,22,22) | 1.32 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 | Admitted for overnight stay (n=13,12,6,5) | 0.00 units on a scale | Standard Deviation 0 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA(n=223,215,65,59) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper(n=254,246,70,67) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed part time work(n=224,217,64,57) | 1.96 units on a scale | Standard Deviation 0.19 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER(n=254,246,70,67) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home healthcare services(n=252,246,70,67) | 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 | Performed paid work(n=224,222,64,57) | 1.75 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 | Required aids/devices(n=254,246,70,67) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home(n=254,245,70,67) | 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 | Non-medical practitioner(n=254,246,70,67) | 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 | Chores by family/friends(n=253,246,70,66) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic test(n=253,246,70,67) | 1.84 units on a scale | Standard Deviation 0.37 |
Other Pre-specified
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time frame: 2 weeks
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 3 days |
| CP-690,550 10 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 3 days |
| Placebo | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 3 days |
Other Pre-specified
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Patient global assessment of arthritis: participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
Time frame: 2 weeks
Population: FAS population included participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 3 days |
| CP-690,550 10 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 3 days |
| Placebo | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 3 days |