Rheumatoid Arthritis
Conditions
Keywords
oral DMARD, JAK inhibitor, clinical trial
Brief summary
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.
Interventions
DRUGCP 690,550
tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
DRUGCP-690,550
tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
OTHERPlacebo
placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
BIOLOGICALBiologic TNFi
placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 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 RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria. * The patient must have had an inadequate response to methotrexate and have active disease, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory. * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. * The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.
Exclusion criteria
* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3,000 cu.mm. Absolute neutrophil count \<1,200 cu.mm; 4. Platelet count \<100,000/L * History of any other autoimmune rheumatic disease other than Sjogren's syndrome * No malignancy or history of malignancy. * History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug * Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event. * Patients who have previously received adalimumab therapy for any reason. * Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label. * Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | Month 6 | ACR20 response: greater than or equal to (\>=) 20% improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis. |
| Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) 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 With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | Month 6 | DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and \< 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response 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 the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 1, 3, 6 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response 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 the HAQ); and CRP. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| 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 1, 3 and 6 | Baseline, Month 1, 3, 6 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 9, 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, Month 1, 3, 6, 9, 12 | DAS28-4 \[CRP\] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) | Baseline, Month 1, 3, 6, 9, 12 | DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 1, 3, 6 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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. |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 9, 12 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. |
| Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Assessment of Arthritis Pain at Month 9 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, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = 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 mm = very well and 100 mm = very poorly. |
| Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| Physician Global Assessment (PGA) of Arthritis Pain 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning. |
| 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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 | Month 12 | FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 3, 6 | Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Month 12 | Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. |
| 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. |
| 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. |
| Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Baseline, Month 1, 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-5 Dimension (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 Month 3 and 6 | 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: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]). |
| Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | Baseline, Month 12 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]). |
| 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: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Month 12 | RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost. |
| 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, hours affected per day and average number of hours missed work per day were reported. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 1, 3 | ACR20 response: \>=20% improvement in TJC; \>= 20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| 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 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 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, hours affected per day and average number of hours missed work per day were reported. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response 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 the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 1, 3, 6 | ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
Countries
Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Finland, Germany, Mexico, Philippines, Poland, Slovakia, South Korea, Spain, Thailand, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. | 204 |
| CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. | 201 |
| Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. | 56 |
| Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. | 52 |
| Adalimumab Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12. | 204 |
| Total | 717 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 24 | 24 | 2 | 5 | 22 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 6 | 7 | 3 | 3 | 6 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 | 0 |
| Overall Study | Other | 18 | 9 | 4 | 4 | 12 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 | 1 | 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 | Adalimumab | Total |
|---|---|---|---|---|---|---|
| Age Continuous | 53.0 years STANDARD_DEVIATION 11.9 | 52.9 years STANDARD_DEVIATION 11.8 | 55.5 years STANDARD_DEVIATION 13.7 | 51.9 years STANDARD_DEVIATION 13.7 | 52.5 years STANDARD_DEVIATION 11.7 | 52.9 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 174 Participants | 168 Participants | 43 Participants | 39 Participants | 162 Participants | 586 Participants |
| Sex: Female, Male Male | 30 Participants | 33 Participants | 13 Participants | 13 Participants | 42 Participants | 131 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 204 | 44 / 201 | 18 / 108 | 50 / 204 | 18 / 232 | 8 / 222 | 3 / 59 | 18 / 204 | 36 / 260 | 44 / 253 | 24 / 204 |
| serious Total, serious adverse events | 12 / 204 | 10 / 201 | 2 / 108 | 5 / 204 | 10 / 232 | 7 / 222 | 2 / 59 | 6 / 204 | 11 / 260 | 10 / 253 | 7 / 204 |
Outcome results
Primary
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Baseline, Month 3
Population: Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Baseline (n=201, 199, 106, 201) | 1.50 units on a scale | Standard Deviation 0.64 |
| CP-690,550 5 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Month 3 (n=188, 185, 98, 190) | -0.49 units on a scale | Standard Deviation 0.59 |
| CP-690,550 10 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Month 3 (n=188, 185, 98, 190) | -0.59 units on a scale | Standard Deviation 0.58 |
| CP-690,550 10 mg | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Baseline (n=201, 199, 106, 201) | 1.53 units on a scale | Standard Deviation 0.63 |
| Placebo | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Baseline (n=201, 199, 106, 201) | 1.42 units on a scale | Standard Deviation 0.68 |
| Placebo | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Month 3 (n=188, 185, 98, 190) | -0.17 units on a scale | Standard Deviation 0.56 |
| Adalimumab | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Baseline (n=201, 199, 106, 201) | 1.50 units on a scale | Standard Deviation 0.59 |
| Adalimumab | Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3 | Month 3 (n=188, 185, 98, 190) | -0.45 units on a scale | Standard Deviation 0.52 |
Comparison: Least squares (LS) mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.p-value: <0.000195% CI: [-0.5, -0.25]Mixed Models Analysis
Comparison: LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.p-value: <0.000195% CI: [-0.43, -0.19]Mixed Models Analysis
Comparison: LS mean difference and corresponding 95% CI was calculated using a mixed-effect repeated measure model with treatment, visit and treatment-by-visit interaction as fixed effect and participant as random effect.p-value: <0.000195% CI: [-0.37, -0.13]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% 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: all randomized participants who received \>=1 dose and had \>=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 51.53 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 52.55 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 28.30 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6 | 47.24 percentage of participants |
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.p-value: <0.000195% CI: [13.18, 35.31]Normal approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: <0.000195% CI: [12.16, 34.29]Normal approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.000795% CI: [7.9, 29.96]Normal approximation
Primary
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and \< 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Time frame: Month 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 6.21 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 12.50 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 1.09 percentage of participants |
| Adalimumab | Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6 | 6.74 percentage of participants |
Comparison: Normal approximation to the binomial distribution was used to test the superiority of CP-690,550 10 mg to placebo and two-sided 95% CI was evaluated for the difference in percentages.p-value: <0.000195% CI: [6.08, 16.73]Normal approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.015195% CI: [0.98, 9.26]Normal approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of adalimumab to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.009195% CI: [1.4, 9.9]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 was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| 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=194,196,106,198) | 35.29 units on a scale | Standard Deviation 9.94 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role physical (n=201,199,106,201) | 34.00 units on a scale | Standard Deviation 9.11 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Social functioning (n=201,199,106,201) | 36.15 units on a scale | Standard Deviation 10.76 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Bodily pain (n=201,199,106,201) | 33.42 units on a scale | Standard Deviation 7.51 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Mental health (n=201,199,106,201) | 39.04 units on a scale | Standard Deviation 11.42 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role emotional (n=201,199,106,201) | 34.15 units on a scale | Standard Deviation 12.49 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Vitality (n=201,199,106,201) | 40.62 units on a scale | Standard Deviation 9.23 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: General health (n=201,199,106,201) | 35.22 units on a scale | Standard Deviation 8.95 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:Mental component (n=201,199,106,201) | 39.82 units on a scale | Standard Deviation 11.68 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical component (n=201,199,106,201) | 33.10 units on a scale | Standard Deviation 7.69 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical functioning (n=201,199,106,201) | 32.02 units on a scale | Standard Deviation 9.48 |
| 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=194,196,106,198) | 38.19 units on a scale | Standard Deviation 9.34 |
| 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=194,196,106,198) | 40.77 units on a scale | Standard Deviation 10.53 |
| 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=194,196,106,198) | 40.14 units on a scale | Standard Deviation 8.54 |
| 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=194,196,106,198) | 42.31 units on a scale | Standard Deviation 10.3 |
| 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=194,196,106,198) | 38.29 units on a scale | Standard Deviation 12.54 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Vitality (n=194,196,106,198) | 45.24 units on a scale | Standard Deviation 9.33 |
| 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=194,196,106,198) | 38.53 units on a scale | Standard Deviation 9.24 |
| 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=194,196,106,198) | 43.56 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 1: Physical component (n=194,196,106,198) | 37.50 units on a scale | Standard Deviation 7.99 |
| 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=187,185,99,190) | 38.11 units on a scale | Standard Deviation 10.39 |
| 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=188,185,99,190) | 39.79 units on a scale | Standard Deviation 9.55 |
| 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=188,185,99,190) | 41.59 units on a scale | Standard Deviation 11.04 |
| 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=187,185,99,190) | 41.08 units on a scale | Standard Deviation 9.15 |
| 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=188,185,99,190) | 42.43 units on a scale | Standard Deviation 11.02 |
| 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=188,185,99,190) | 38.74 units on a scale | Standard Deviation 12.56 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Vitality (n=188,185,99,190) | 45.63 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: General health (n=188,185,99,189) | 39.15 units on a scale | Standard Deviation 9.52 |
| 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=187,185,99,189) | 43.31 units on a scale | Standard Deviation 11.47 |
| 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=187,185,99,189) | 39.57 units on a scale | Standard Deviation 8.76 |
| 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=173,181,46,179) | 39.31 units on a scale | Standard Deviation 10.92 |
| 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=173,181,46,179) | 40.42 units on a scale | Standard Deviation 10.03 |
| 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=173,181,46,180) | 43.85 units on a scale | Standard Deviation 11.17 |
| 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=173,181,46,180) | 42.79 units on a scale | Standard Deviation 9.41 |
| 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=173,181,46,180) | 44.31 units on a scale | Standard Deviation 11.29 |
| 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=173,181, 46,179) | 40.78 units on a scale | Standard Deviation 12.03 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Vitality (n=173,181,46,180) | 47.35 units on a scale | Standard Deviation 10.37 |
| 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=173,180,46,180) | 40.53 units on a scale | Standard Deviation 9.44 |
| 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=173,180,46,179) | 45.44 units on a scale | Standard Deviation 11.19 |
| 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=173,180,46,179) | 40.45 units on a scale | Standard Deviation 9.29 |
| 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=187,185,99,189) | 40.30 units on a scale | Standard Deviation 8.94 |
| 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=187,185,99,190) | 38.49 units on a scale | Standard Deviation 11.12 |
| 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=173,181,46,180) | 43.98 units on a scale | Standard Deviation 11.3 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: General health (n=173,180,46,180) | 41.95 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: Role emotional (n=173,181, 46,179) | 40.68 units on a scale | Standard Deviation 11.77 |
| 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=188,185,99,190) | 40.93 units on a scale | Standard Deviation 10.4 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Vitality (n=201,199,106,201) | 40.79 units on a scale | Standard Deviation 9.36 |
| 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=187,185,99,189) | 46.49 units on a scale | Standard Deviation 11.45 |
| 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=194,196,106,198) | 38.45 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 3: Social functioning (n=188,185,99,190) | 44.34 units on a scale | Standard Deviation 11 |
| 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=194,196,106,198) | 43.35 units on a scale | Standard Deviation 11.13 |
| 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=173,180,46,179) | 40.86 units on a scale | Standard Deviation 8.71 |
| 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=188,185,99,189) | 41.35 units on a scale | Standard Deviation 8.93 |
| 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=187,185,99,190) | 43.09 units on a scale | Standard Deviation 9.58 |
| 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=194,196,106,198) | 35.23 units on a scale | Standard Deviation 10.57 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Vitality (n=188,185,99,190) | 48.09 units on a scale | Standard Deviation 10.79 |
| 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=188,185,99,190) | 41.76 units on a scale | Standard Deviation 12.66 |
| 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=188,185,99,190) | 44.79 units on a scale | Standard Deviation 11.25 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role emotional (n=201,199,106,201) | 34.11 units on a scale | Standard Deviation 12.63 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Vitality (n=173,181,46,180) | 48.66 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: Role physical (n=173,181,46,179) | 41.29 units on a scale | Standard Deviation 9.73 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Role emotional (n=194,196,106,198) | 38.64 units on a scale | Standard Deviation 12.05 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:Mental component (n=201,199,106,201) | 40.21 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: Mental health (n=201,199,106,201) | 39.15 units on a scale | Standard Deviation 11.19 |
| 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=173,180,46,179) | 46.14 units on a scale | Standard Deviation 11.43 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Vitality (n=194,196,106,198) | 46.99 units on a scale | Standard Deviation 9.58 |
| 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=194,196,106,198) | 42.22 units on a scale | Standard Deviation 10.64 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Bodily pain (n=201,199,106,201) | 33.29 units on a scale | Standard Deviation 7.42 |
| 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=173,181,46,180) | 45.32 units on a scale | Standard Deviation 11.43 |
| 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=194,196,106,198) | 39.98 units on a scale | Standard Deviation 9.16 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical component (n=201,199,106,201) | 32.62 units on a scale | Standard Deviation 7.78 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Social functioning (n=201,199,106,201) | 36.27 units on a scale | Standard Deviation 11.59 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: General health (n=201,199,106,201) | 35.81 units on a scale | Standard Deviation 8.93 |
| 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=194,196,106,198) | 44.92 units on a scale | Standard Deviation 11.21 |
| 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=173,181,46,180) | 43.63 units on a scale | Standard Deviation 9.31 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role physical (n=201,199,106,201) | 33.54 units on a scale | Standard Deviation 9.12 |
| 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=173,181,46,179) | 38.56 units on a scale | Standard Deviation 11.35 |
| 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=194,196,106,198) | 37.86 units on a scale | Standard Deviation 8.11 |
| 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=194,196,106,198) | 40.73 units on a scale | Standard Deviation 8.46 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical functioning (n=201,199,106,201) | 31.06 units on a scale | Standard Deviation 9.52 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Role physical (n=173,181,46,179) | 38.62 units on a scale | Standard Deviation 7.95 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Physical functioning (n=194,196,106,198) | 34.00 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: Role physical (n=194,196,106,198) | 36.79 units on a scale | Standard Deviation 9.39 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Social functioning (n=194,196,106,198) | 41.74 units on a scale | Standard Deviation 10.72 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Bodily pain (n=194,196,106,198) | 36.18 units on a scale | Standard Deviation 7.52 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Bodily pain (n=173,181,46,180) | 39.79 units on a scale | Standard Deviation 8.05 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Mental health (n=194,196,106,198) | 41.79 units on a scale | Standard Deviation 10.91 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Role emotional (n=194,196,106,198) | 38.18 units on a scale | Standard Deviation 11.89 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Mental component (n=173,180,46,179) | 43.43 units on a scale | Standard Deviation 10.6 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Vitality (n=194,196,106,198) | 43.71 units on a scale | Standard Deviation 8.74 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: General health (n=194,196,106,198) | 37.41 units on a scale | Standard Deviation 8.61 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Mental health (n=173,181,46,180) | 41.21 units on a scale | Standard Deviation 11.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Mental component (n=194,196,106,198) | 44.03 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: Physical component (n=194,196,106,198) | 35.01 units on a scale | Standard Deviation 7.36 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Physical functioning (n=187,185,99,190) | 34.77 units on a scale | Standard Deviation 8.92 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Role physical (n=188,185,99,190) | 37.25 units on a scale | Standard Deviation 8.88 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Role emotional (n=173,181, 46,179) | 39.22 units on a scale | Standard Deviation 11.82 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Social functioning (n=188,185,99,190) | 41.41 units on a scale | Standard Deviation 10.08 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Bodily pain (n=187,185,99,190) | 37.05 units on a scale | Standard Deviation 7.91 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Mental health (n=188,185,99,190) | 42.44 units on a scale | Standard Deviation 10.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Role emotional (n=188,185,99,190) | 38.59 units on a scale | Standard Deviation 12.42 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Vitality (n=173,181,46,180) | 45.06 units on a scale | Standard Deviation 9.36 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Vitality (n=188,185,99,190) | 44.06 units on a scale | Standard Deviation 9.22 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: General health (n=188,185,99,189) | 37.51 units on a scale | Standard Deviation 8.08 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Mental component (n=187,185,99,189) | 44.20 units on a scale | Standard Deviation 10.65 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Physical component (n=187,185,99,189) | 35.59 units on a scale | Standard Deviation 7.33 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: General health (n=173,180,46,180) | 39.03 units on a scale | Standard Deviation 9.3 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical functioning (n=201,199,106,201) | 32.23 units on a scale | Standard Deviation 9.43 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role physical (n=201,199,106,201) | 34.70 units on a scale | Standard Deviation 8.01 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Physical functioning (n=173,181,46,179) | 37.00 units on a scale | Standard Deviation 8.99 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Social functioning (n=201,199,106,201) | 39.36 units on a scale | Standard Deviation 11.17 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Bodily pain (n=201,199,106,201) | 34.53 units on a scale | Standard Deviation 6.57 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Mental health (n=201,199,106,201) | 41.11 units on a scale | Standard Deviation 10.51 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role emotional (n=201,199,106,201) | 37.32 units on a scale | Standard Deviation 11.97 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Social functioning (n=173,181,46,180) | 42.49 units on a scale | Standard Deviation 9.92 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Vitality (n=201,199,106,201) | 42.67 units on a scale | Standard Deviation 8.85 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: General health (n=201,199,106,201) | 36.29 units on a scale | Standard Deviation 8.38 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Physical component (n=173,180,46,179) | 38.44 units on a scale | Standard Deviation 6.67 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:Mental component (n=201,199,106,201) | 43.29 units on a scale | Standard Deviation 10.58 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical component (n=201,199,106,201) | 33.02 units on a scale | Standard Deviation 6.23 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline:Mental component (n=201,199,106,201) | 40.58 units on a scale | Standard Deviation 11.64 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Physical component (n=194,196,106,198) | 37.08 units on a scale | Standard Deviation 7.88 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Vitality (n=201,199,106,201) | 39.95 units on a scale | Standard Deviation 9.54 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical functioning (n=201,199,106,201) | 31.74 units on a scale | Standard Deviation 8.95 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Mental health (n=173,181,46,180) | 43.13 units on a scale | Standard Deviation 11.35 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Mental component (n=194,196,106,198) | 44.05 units on a scale | Standard Deviation 10.79 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Role physical (n=173,181,46,179) | 39.99 units on a scale | Standard Deviation 9.14 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role physical (n=201,199,106,201) | 34.79 units on a scale | Standard Deviation 8.69 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Social functioning (n=194,196,106,198) | 40.98 units on a scale | Standard Deviation 10.41 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: General health (n=194,196,106,198) | 38.35 units on a scale | Standard Deviation 8.43 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Social functioning (n=173,181,46,180) | 42.36 units on a scale | Standard Deviation 10.43 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Social functioning (n=201,199,106,201) | 36.23 units on a scale | Standard Deviation 11.52 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Physical functioning (n=173,181,46,179) | 37.29 units on a scale | Standard Deviation 10.4 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Vitality (n=194,196,106,198) | 44.44 units on a scale | Standard Deviation 10 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: General health (n=201,199,106,201) | 35.18 units on a scale | Standard Deviation 7.96 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Bodily pain (n=201,199,106,201) | 33.14 units on a scale | Standard Deviation 7.33 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: General health (n=173,180,46,180) | 39.91 units on a scale | Standard Deviation 8.72 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Role emotional (n=194,196,106,198) | 39.10 units on a scale | Standard Deviation 11.55 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Physical functioning (n=194,196,106,198) | 35.38 units on a scale | Standard Deviation 9.79 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Mental health (n=201,199,106,201) | 39.64 units on a scale | Standard Deviation 11.19 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Mental health (n=188,185,99,190) | 43.05 units on a scale | Standard Deviation 10.45 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Physical component (n=173,180,46,179) | 39.36 units on a scale | Standard Deviation 8.39 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Bodily pain (n=173,181,46,180) | 41.59 units on a scale | Standard Deviation 8.95 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Role emotional (n=188,185,99,190) | 39.24 units on a scale | Standard Deviation 11.53 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Mental health (n=194,196,106,198) | 42.83 units on a scale | Standard Deviation 10.93 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Bodily pain (n=187,185,99,190) | 40.60 units on a scale | Standard Deviation 9.54 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Role physical (n=194,196,106,198) | 38.37 units on a scale | Standard Deviation 9.06 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Vitality (n=188,185,99,190) | 45.57 units on a scale | Standard Deviation 9.76 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Vitality (n=173,181,46,180) | 45.93 units on a scale | Standard Deviation 9.88 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Role emotional (n=173,181, 46,179) | 39.54 units on a scale | Standard Deviation 11.85 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Role emotional (n=201,199,106,201) | 35.54 units on a scale | Standard Deviation 12.05 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: General health (n=188,185,99,189) | 39.33 units on a scale | Standard Deviation 9.32 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Social functioning (n=188,185,99,190) | 40.84 units on a scale | Standard Deviation 10.92 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Role physical (n=188,185,99,190) | 39.51 units on a scale | Standard Deviation 8.89 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Baseline: Physical component (n=201,199,106,201) | 32.74 units on a scale | Standard Deviation 6.83 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Mental component (n=187,185,99,189) | 43.90 units on a scale | Standard Deviation 10.84 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Physical functioning (n=187,185,99,190) | 36.56 units on a scale | Standard Deviation 10.24 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 6: Mental component (n=173,180,46,179) | 44.24 units on a scale | Standard Deviation 11.69 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 1: Bodily pain (n=194,196,106,198) | 39.58 units on a scale | Standard Deviation 8.36 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 | Month 3: Physical component (n=187,185,99,189) | 38.58 units on a scale | Standard Deviation 8.36 |
Secondary
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month9:Mental component (n=158,165,49,41,171) | 44.79 units on a scale | Standard Deviation 10.76 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Mental component (n=149,149,49,38,158) | 45.02 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 12: Social functioning (n=150,150,49,38,160) | 43.14 units on a scale | Standard Deviation 10.46 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical component (n=158,165,49,41,171) | 41.55 units on a scale | Standard Deviation 8.57 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Social functioning (n=159,167,49,41,171) | 43.52 units on a scale | Standard Deviation 10.65 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Role physical (n=150,150,49,38,160) | 41.15 units on a scale | Standard Deviation 9.35 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Physical functioning(n=149,149,49,38,160) | 40.16 units on a scale | Standard Deviation 10.25 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical functioning(n=158,167,49,41,171) | 39.77 units on a scale | Standard Deviation 10.29 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Bodily pain (n=159,166,49,41,171) | 43.45 units on a scale | Standard Deviation 9.02 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Physical component(n=149,149,49,38,158) | 41.44 units on a scale | Standard Deviation 8.81 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:General health (n=150,150,49,38,160) | 41.07 units on a scale | Standard Deviation 9.85 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Mental health (n=159,166,49,41,171) | 44.47 units on a scale | Standard Deviation 10.27 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role physical (n=159,167,49,41,171) | 41.66 units on a scale | Standard Deviation 9.62 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Vitality (n=150,149,49,38,159) | 47.60 units on a scale | Standard Deviation 9.01 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role emotional (n=159,167,49,41,171) | 39.98 units on a scale | Standard Deviation 11.99 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Role emotional (n=150,150,49,38,159) | 40.18 units on a scale | Standard Deviation 11.46 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Vitality (n=159,166,49,41,171) | 47.76 units on a scale | Standard Deviation 9.51 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Mental health (n=150,149,49,38,159) | 44.83 units on a scale | Standard Deviation 10.02 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: General health (n=159,166,49,41,171) | 41.15 units on a scale | Standard Deviation 9.79 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Bodily pain (n=150,150,49,38,160) | 43.44 units on a scale | Standard Deviation 9.48 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Vitality (n=159,166,49,41,171) | 48.69 units on a scale | Standard Deviation 9.68 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month9:Mental component (n=158,165,49,41,171) | 46.55 units on a scale | Standard Deviation 10.52 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Mental health (n=159,166,49,41,171) | 45.42 units on a scale | Standard Deviation 10.44 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical functioning(n=158,167,49,41,171) | 38.74 units on a scale | Standard Deviation 11.31 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Role physical (n=150,150,49,38,160) | 42.34 units on a scale | Standard Deviation 10.32 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Mental component (n=149,149,49,38,158) | 46.29 units on a scale | Standard Deviation 10.56 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical component (n=158,165,49,41,171) | 40.32 units on a scale | Standard Deviation 9.44 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Role emotional (n=150,150,49,38,159) | 42.25 units on a scale | Standard Deviation 11.68 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Bodily pain (n=150,150,49,38,160) | 44.02 units on a scale | Standard Deviation 10.02 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Physical functioning(n=149,149,49,38,160) | 40.34 units on a scale | Standard Deviation 11.59 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role emotional (n=159,167,49,41,171) | 40.58 units on a scale | Standard Deviation 12.07 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Social functioning (n=159,167,49,41,171) | 44.42 units on a scale | Standard Deviation 9.96 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Physical component(n=149,149,49,38,158) | 41.96 units on a scale | Standard Deviation 9.4 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role physical (n=159,167,49,41,171) | 40.55 units on a scale | Standard Deviation 10.15 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:General health (n=150,150,49,38,160) | 42.33 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: Social functioning (n=150,150,49,38,160) | 44.07 units on a scale | Standard Deviation 10.44 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Bodily pain (n=159,166,49,41,171) | 42.75 units on a scale | Standard Deviation 9.5 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Mental health (n=150,149,49,38,159) | 45.06 units on a scale | Standard Deviation 10.49 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: General health (n=159,166,49,41,171) | 41.34 units on a scale | Standard Deviation 9.2 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Vitality (n=150,149,49,38,159) | 49.12 units on a scale | Standard Deviation 9.95 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:General health (n=150,150,49,38,160) | 40.47 units on a scale | Standard Deviation 9.44 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical functioning(n=158,167,49,41,171) | 38.94 units on a scale | Standard Deviation 9.81 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role physical (n=159,167,49,41,171) | 41.77 units on a scale | Standard Deviation 8.36 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Social functioning (n=159,167,49,41,171) | 44.55 units on a scale | Standard Deviation 9.82 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Bodily pain (n=159,166,49,41,171) | 44.68 units on a scale | Standard Deviation 8.86 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Mental health (n=159,166,49,41,171) | 44.83 units on a scale | Standard Deviation 10.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role emotional (n=159,167,49,41,171) | 39.84 units on a scale | Standard Deviation 11.4 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Vitality (n=159,166,49,41,171) | 47.80 units on a scale | Standard Deviation 8.94 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: General health (n=159,166,49,41,171) | 41.39 units on a scale | Standard Deviation 8.54 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month9:Mental component (n=158,165,49,41,171) | 45.31 units on a scale | Standard Deviation 9.75 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical component (n=158,165,49,41,171) | 41.65 units on a scale | Standard Deviation 8.2 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Physical functioning(n=149,149,49,38,160) | 39.24 units on a scale | Standard Deviation 10.07 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Role physical (n=150,150,49,38,160) | 40.16 units on a scale | Standard Deviation 8.73 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Social functioning (n=150,150,49,38,160) | 43.78 units on a scale | Standard Deviation 9.97 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Bodily pain (n=150,150,49,38,160) | 43.90 units on a scale | Standard Deviation 8.28 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Mental health (n=150,149,49,38,159) | 44.09 units on a scale | Standard Deviation 9.2 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Role emotional (n=150,150,49,38,159) | 40.23 units on a scale | Standard Deviation 10.79 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Vitality (n=150,149,49,38,159) | 47.31 units on a scale | Standard Deviation 9.13 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Mental component (n=149,149,49,38,158) | 45.02 units on a scale | Standard Deviation 9.29 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Physical component(n=149,149,49,38,158) | 40.82 units on a scale | Standard Deviation 8.01 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month9:Mental component (n=158,165,49,41,171) | 45.23 units on a scale | Standard Deviation 11.22 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Mental component (n=149,149,49,38,158) | 46.12 units on a scale | Standard Deviation 11.75 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Social functioning (n=150,150,49,38,160) | 44.94 units on a scale | Standard Deviation 9.78 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: General health (n=159,166,49,41,171) | 40.57 units on a scale | Standard Deviation 9.34 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Bodily pain (n=150,150,49,38,160) | 43.18 units on a scale | Standard Deviation 7.76 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Vitality (n=159,166,49,41,171) | 46.41 units on a scale | Standard Deviation 10.03 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Mental health (n=150,149,49,38,159) | 45.28 units on a scale | Standard Deviation 10.94 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role emotional (n=159,167,49,41,171) | 41.46 units on a scale | Standard Deviation 11.81 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical functioning(n=158,167,49,41,171) | 38.59 units on a scale | Standard Deviation 10.08 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Role emotional (n=150,150,49,38,159) | 41.03 units on a scale | Standard Deviation 12.67 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Mental health (n=159,166,49,41,171) | 43.70 units on a scale | Standard Deviation 10.16 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Vitality (n=150,149,49,38,159) | 48.17 units on a scale | Standard Deviation 9.36 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Bodily pain (n=159,166,49,41,171) | 42.26 units on a scale | Standard Deviation 7.77 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Social functioning (n=159,167,49,41,171) | 42.76 units on a scale | Standard Deviation 9.78 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:General health (n=150,150,49,38,160) | 40.77 units on a scale | Standard Deviation 8.31 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role physical (n=159,167,49,41,171) | 39.75 units on a scale | Standard Deviation 9.2 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Physical functioning(n=149,149,49,38,160) | 40.42 units on a scale | Standard Deviation 9.84 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical component (n=158,165,49,41,171) | 39.73 units on a scale | Standard Deviation 7.73 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Physical component(n=149,149,49,38,158) | 41.12 units on a scale | Standard Deviation 6.49 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Role physical (n=150,150,49,38,160) | 41.18 units on a scale | Standard Deviation 9.3 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role physical (n=159,167,49,41,171) | 41.12 units on a scale | Standard Deviation 9.44 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: General health (n=159,166,49,41,171) | 40.12 units on a scale | Standard Deviation 9.58 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Bodily pain (n=159,166,49,41,171) | 41.81 units on a scale | Standard Deviation 9.73 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Physical component(n=149,149,49,38,158) | 40.72 units on a scale | Standard Deviation 8.84 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Social functioning (n=150,150,49,38,160) | 42.96 units on a scale | Standard Deviation 10.92 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical component (n=158,165,49,41,171) | 40.35 units on a scale | Standard Deviation 8.31 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Vitality (n=159,166,49,41,171) | 46.11 units on a scale | Standard Deviation 10.28 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Mental component (n=149,149,49,38,158) | 44.42 units on a scale | Standard Deviation 10.7 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Vitality (n=150,149,49,38,159) | 46.27 units on a scale | Standard Deviation 9.65 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Bodily pain (n=150,150,49,38,160) | 42.73 units on a scale | Standard Deviation 9.77 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Role physical (n=150,150,49,38,160) | 41.07 units on a scale | Standard Deviation 9.29 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Role emotional (n=159,167,49,41,171) | 40.07 units on a scale | Standard Deviation 12.15 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Physical functioning(n=158,167,49,41,171) | 38.75 units on a scale | Standard Deviation 10.23 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Social functioning (n=159,167,49,41,171) | 42.03 units on a scale | Standard Deviation 11.55 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12: Mental health (n=150,149,49,38,159) | 44.23 units on a scale | Standard Deviation 10.93 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month9:Mental component (n=158,165,49,41,171) | 44.08 units on a scale | Standard Deviation 11.45 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 9: Mental health (n=159,166,49,41,171) | 43.44 units on a scale | Standard Deviation 12.04 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Physical functioning(n=149,149,49,38,160) | 39.21 units on a scale | Standard Deviation 10.63 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:General health (n=150,150,49,38,160) | 40.40 units on a scale | Standard Deviation 9.13 |
| Adalimumab | 36-Item Short-Form Health Survey (SF-36) at Month 9 and 12 | Month 12:Role emotional (n=150,150,49,38,159) | 39.89 units on a scale | Standard Deviation 11.63 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 5.43 units on a scale | Standard Deviation 0.89 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 196, 104, 197) | 4.26 units on a scale | Standard Deviation 1.09 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 190) | 3.78 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, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 181) | 3.51 units on a scale | Standard Deviation 1.27 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 196, 104, 197) | 4.21 units on a scale | Standard Deviation 1.05 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 190) | 3.77 units on a scale | Standard Deviation 1.21 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 181) | 3.29 units on a scale | Standard Deviation 1.22 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 5.43 units on a scale | Standard Deviation 0.83 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 190) | 4.83 units on a scale | Standard Deviation 1.25 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 196, 104, 197) | 5.09 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, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 181) | 3.85 units on a scale | Standard Deviation 1.14 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 5.44 units on a scale | Standard Deviation 0.88 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 181) | 3.63 units on a scale | Standard Deviation 1.19 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 196, 104, 197) | 4.27 units on a scale | Standard Deviation 1.06 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 5.33 units on a scale | Standard Deviation 0.92 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 190) | 3.88 units on a scale | Standard Deviation 1.15 |
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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 12 (n=149, 150, 48, 37, 160) | 3.05 units on a scale | Standard Deviation 1.13 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 171) | 3.13 units on a scale | Standard Deviation 1.11 |
| 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 (n=149, 150, 48, 37, 160) | 3.00 units on a scale | Standard Deviation 1.18 |
| 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 (n=160, 167, 49, 41, 171) | 3.20 units on a scale | Standard Deviation 1.2 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 12 (n=149, 150, 48, 37, 160) | 3.12 units on a scale | Standard Deviation 0.96 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 171) | 3.11 units on a scale | Standard Deviation 1.11 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 171) | 3.03 units on a scale | Standard Deviation 1.1 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 12 (n=149, 150, 48, 37, 160) | 3.02 units on a scale | Standard Deviation 1.28 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 12 (n=149, 150, 48, 37, 160) | 3.18 units on a scale | Standard Deviation 1.25 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 171) | 3.46 units on a scale | Standard Deviation 1.21 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
DAS28-4 \[CRP\] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6, 9, 12
Population: Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6, 9, 12
Population: Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=195, 194, 103, 194) | 6.56 units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=172, 175, 90, 176) | 5.23 units on a scale | Standard Deviation 1.19 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=170, 166, 87, 167) | 4.64 units on a scale | Standard Deviation 1.33 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=155, 162, 41, 158) | 4.40 units on a scale | Standard Deviation 1.38 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=172, 175, 90, 176) | 5.14 units on a scale | Standard Deviation 1.26 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=170, 166, 87, 167) | 4.66 units on a scale | Standard Deviation 1.39 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=155, 162, 41, 158) | 4.21 units on a scale | Standard Deviation 1.38 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=195, 194, 103, 194) | 6.48 units on a scale | Standard Deviation 0.89 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=170, 166, 87, 167) | 5.60 units on a scale | Standard Deviation 1.31 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=172, 175, 90, 176) | 5.93 units on a scale | Standard Deviation 1.22 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=155, 162, 41, 158) | 4.61 units on a scale | Standard Deviation 1.17 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=195, 194, 103, 194) | 6.45 units on a scale | Standard Deviation 0.9 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 6 (n=155, 162, 41, 158) | 4.37 units on a scale | Standard Deviation 1.3 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 1 (n=172, 175, 90, 176) | 5.13 units on a scale | Standard Deviation 1.21 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Baseline (n=195, 194, 103, 194) | 6.36 units on a scale | Standard Deviation 0.93 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 | Month 3 (n=170, 166, 87, 167) | 4.66 units on a scale | Standard Deviation 1.28 |
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 12 (n=134, 136, 44, 32, 139) | 3.85 units on a scale | Standard Deviation 1.22 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 9 (n=140, 151, 45, 35, 149) | 4.00 units on a scale | Standard Deviation 1.21 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 9 (n=140, 151, 45, 35, 149) | 4.08 units on a scale | Standard Deviation 1.33 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 12 (n=134, 136, 44, 32, 139) | 3.88 units on a scale | Standard Deviation 1.35 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 12 (n=134, 136, 44, 32, 139) | 4.00 units on a scale | Standard Deviation 0.95 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 9 (n=140, 151, 45, 35, 149) | 3.99 units on a scale | Standard Deviation 1.25 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 9 (n=140, 151, 45, 35, 149) | 3.93 units on a scale | Standard Deviation 1.17 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 12 (n=134, 136, 44, 32, 139) | 3.70 units on a scale | Standard Deviation 1.24 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 12 (n=134, 136, 44, 32, 139) | 3.95 units on a scale | Standard Deviation 1.48 |
| Adalimumab | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12 | Month 9 (n=140, 151, 45, 35, 149) | 4.20 units on a scale | Standard Deviation 1.39 |
Secondary
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 0.43 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 195, 106, 198) | 0.61 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 189) | 0.62 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 6 (n=172, 180, 46, 178) | 0.66 units on a scale | Standard Deviation 0.26 |
| CP-690,550 10 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 195, 106, 198) | 0.60 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 189) | 0.64 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 6 (n=172, 180, 46, 178) | 0.65 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 0.43 units on a scale | Standard Deviation 0.32 |
| Placebo | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 189) | 0.55 units on a scale | Standard Deviation 0.27 |
| Placebo | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 195, 106, 198) | 0.56 units on a scale | Standard Deviation 0.25 |
| Placebo | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 6 (n=172, 180, 46, 178) | 0.58 units on a scale | Standard Deviation 0.28 |
| Placebo | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 0.50 units on a scale | Standard Deviation 0.28 |
| Adalimumab | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 6 (n=172, 180, 46, 178) | 0.64 units on a scale | Standard Deviation 0.24 |
| Adalimumab | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 195, 106, 198) | 0.58 units on a scale | Standard Deviation 0.27 |
| Adalimumab | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Baseline (n=200, 199, 106, 201) | 0.45 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 184, 99, 189) | 0.61 units on a scale | Standard Deviation 0.26 |
Secondary
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 | 0.69 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 | 0.69 units on a scale | Standard Deviation 0.22 |
| Placebo | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 | 0.68 units on a scale | Standard Deviation 0.2 |
| Adalimumab | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 | 0.66 units on a scale | Standard Deviation 0.19 |
| Adalimumab | Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12 | 0.66 units on a scale | Standard Deviation 0.27 |
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 28.18 units on a scale | Standard Deviation 10.48 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 196, 106, 198) | 32.54 units on a scale | Standard Deviation 9.94 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 185, 99, 190) | 33.86 units on a scale | Standard Deviation 10.18 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 6 (n=173, 181, 46, 180) | 34.58 units on a scale | Standard Deviation 10.53 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 196, 106, 198) | 33.95 units on a scale | Standard Deviation 10.54 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 185, 99, 190) | 35.12 units on a scale | Standard Deviation 11.07 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 6 (n=173, 181, 46, 180) | 36.09 units on a scale | Standard Deviation 10.07 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 28.56 units on a scale | Standard Deviation 10.84 |
| Placebo | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 185, 99, 190) | 30.96 units on a scale | Standard Deviation 10.21 |
| Placebo | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 196, 106, 198) | 31.66 units on a scale | Standard Deviation 10.09 |
| Placebo | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 6 (n=173, 181, 46, 180) | 32.37 units on a scale | Standard Deviation 8.92 |
| Placebo | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 30.49 units on a scale | Standard Deviation 10.23 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 6 (n=173, 181, 46, 180) | 33.69 units on a scale | Standard Deviation 10.58 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 1 (n=192, 196, 106, 198) | 31.94 units on a scale | Standard Deviation 10.48 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 27.95 units on a scale | Standard Deviation 10.07 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6 | Month 3 (n=187, 185, 99, 190) | 32.72 units on a scale | Standard Deviation 10.27 |
Secondary
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 | 35.76 units on a scale | Standard Deviation 9.53 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 | 37.53 units on a scale | Standard Deviation 10.41 |
| Placebo | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 | 36.71 units on a scale | Standard Deviation 7.81 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 | 35.71 units on a scale | Standard Deviation 9.65 |
| Adalimumab | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12 | 34.30 units on a scale | Standard Deviation 9.83 |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 1.15 units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 0.92 units on a scale | Standard Deviation 0.72 |
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 1.00 units on a scale | Standard Deviation 0.72 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 1.11 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 0.89 units on a scale | Standard Deviation 0.69 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 0.94 units on a scale | Standard Deviation 0.75 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 1.25 units on a scale | Standard Deviation 0.67 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 1.32 units on a scale | Standard Deviation 0.69 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 1.15 units on a scale | Standard Deviation 0.71 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 1.12 units on a scale | Standard Deviation 0.64 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 0.98 units on a scale | Standard Deviation 0.65 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 1.05 units on a scale | Standard Deviation 0.64 |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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 (n=158, 167, 49, 41, 171) | 0.86 units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 (n=149, 149, 49, 38, 159) | 0.83 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 9 (n=158, 167, 49, 41, 171) | 0.85 units on a scale | Standard Deviation 0.66 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 (n=149, 149, 49, 38, 159) | 0.81 units on a scale | Standard Deviation 0.71 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 0.89 units on a scale | Standard Deviation 0.69 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 (n=149, 149, 49, 38, 159) | 0.88 units on a scale | Standard Deviation 0.71 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 (n=149, 149, 49, 38, 159) | 0.91 units on a scale | Standard Deviation 0.72 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 0.90 units on a scale | Standard Deviation 0.64 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 0.97 units on a scale | Standard Deviation 0.67 |
| Adalimumab | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12 | Month 12 (n=149, 149, 49, 38, 159) | 0.90 units on a scale | Standard Deviation 0.67 |
Secondary
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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: SPS (n=194, 195, 105, 198) | 36.25 units on a scale | Standard Deviation 19.19 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: OSP (n=199, 198, 105, 200) | 43.24 units on a scale | Standard Deviation 19.91 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Ade (n=200, 198, 105, 200) | 42.95 units on a scale | Standard Deviation 27.92 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: ASOB (n=200, 198, 105, 200) | 19.10 units on a scale | Standard Deviation 24.91 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SD (n=200, 198, 105, 200) | 45.46 units on a scale | Standard Deviation 26.3 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Qua (n=200, 198, 104, 199) | 6.46 units on a scale | Standard Deviation 1.36 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Sno (n=198, 197, 105, 199) | 36.06 units on a scale | Standard Deviation 31.78 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Som (n=199, 198, 105, 199) | 36.52 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: SPS (n=199, 198, 105, 200) | 42.13 units on a scale | Standard Deviation 20.58 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: OSP (n=194, 195, 105, 198) | 36.70 units on a scale | Standard Deviation 18.13 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Ade (n=194, 195, 105, 198) | 48.97 units on a scale | Standard Deviation 27.11 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: ASOB (n=194, 195, 105, 198) | 18.35 units on a scale | Standard Deviation 22.52 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SD (n=194, 195, 105, 198) | 36.52 units on a scale | Standard Deviation 23.48 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Qua (n=193, 195, 105, 197) | 6.70 units on a scale | Standard Deviation 1.38 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Sno (n=194, 193, 104, 196) | 36.08 units on a scale | Standard Deviation 32.53 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Som (n=194, 195, 105, 198) | 31.68 units on a scale | Standard Deviation 21.26 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SPS (n=186, 185, 99, 190) | 35.39 units on a scale | Standard Deviation 18.66 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: OSP (n=186, 185, 99, 190) | 35.74 units on a scale | Standard Deviation 18.3 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Ade (n=187, 185, 99, 190) | 50.59 units on a scale | Standard Deviation 27.67 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: ASOB (n=187, 185, 99, 190) | 18.18 units on a scale | Standard Deviation 22.12 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SD (n=186, 185, 99, 190) | 35.93 units on a scale | Standard Deviation 24.29 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Qua (n=188, 185, 99, 190) | 6.82 units on a scale | Standard Deviation 1.32 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Sno (n=186, 184, 99, 189) | 33.66 units on a scale | Standard Deviation 30.78 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Som (n=187, 185, 99, 190) | 29.41 units on a scale | Standard Deviation 19.66 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SPS (n=173, 181, 46, 179) | 32.66 units on a scale | Standard Deviation 18.6 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: OSP (n=173, 181, 46, 179) | 33.28 units on a scale | Standard Deviation 17.93 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Ade (n=173, 181, 46, 179) | 53.12 units on a scale | Standard Deviation 28.85 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: ASOB (n=173, 181, 46, 179) | 16.65 units on a scale | Standard Deviation 22 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SD (n=173, 181, 46, 179) | 32.95 units on a scale | Standard Deviation 23.76 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Qua (n=173, 181, 45, 178) | 6.86 units on a scale | Standard Deviation 1.18 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Sno (n=171, 180, 46, 179) | 31.46 units on a scale | Standard Deviation 31.43 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Som (n=173, 181, 46, 179) | 28.17 units on a scale | Standard Deviation 17.55 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Som (n=187, 185, 99, 190) | 30.74 units on a scale | Standard Deviation 22.65 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SPS (n=186, 185, 99, 190) | 32.86 units on a scale | Standard Deviation 20.91 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Qua (n=200, 198, 104, 199) | 6.61 units on a scale | Standard Deviation 1.7 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Sno (n=186, 184, 99, 189) | 34.35 units on a scale | Standard Deviation 30.06 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SD (n=173, 181, 46, 179) | 32.00 units on a scale | Standard Deviation 24.3 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: OSP (n=186, 185, 99, 190) | 33.44 units on a scale | Standard Deviation 20.23 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: OSP (n=173, 181, 46, 179) | 32.46 units on a scale | Standard Deviation 18.5 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Qua (n=188, 185, 99, 190) | 7.03 units on a scale | Standard Deviation 1.45 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: ASOB (n=194, 195, 105, 198) | 14.56 units on a scale | Standard Deviation 20.13 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Ade (n=187, 185, 99, 190) | 53.24 units on a scale | Standard Deviation 28.9 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: OSP (n=194, 195, 105, 198) | 34.81 units on a scale | Standard Deviation 18.64 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Qua (n=173, 181, 45, 178) | 7.10 units on a scale | Standard Deviation 1.6 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SD (n=186, 185, 99, 190) | 32.86 units on a scale | Standard Deviation 25.1 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: ASOB (n=187, 185, 99, 190) | 14.81 units on a scale | Standard Deviation 20.62 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SD (n=200, 198, 105, 200) | 44.67 units on a scale | Standard Deviation 25.96 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Som (n=173, 181, 46, 179) | 30.39 units on a scale | Standard Deviation 22.37 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Sno (n=171, 180, 46, 179) | 35.00 units on a scale | Standard Deviation 29.13 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SD (n=194, 195, 105, 198) | 35.46 units on a scale | Standard Deviation 24.25 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SPS (n=194, 195, 105, 198) | 34.03 units on a scale | Standard Deviation 18.74 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: ASOB (n=200, 198, 105, 200) | 15.96 units on a scale | Standard Deviation 21.7 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: ASOB (n=173, 181, 46, 179) | 13.48 units on a scale | Standard Deviation 20.21 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Qua (n=193, 195, 105, 197) | 6.97 units on a scale | Standard Deviation 1.49 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Sno (n=198, 197, 105, 199) | 34.62 units on a scale | Standard Deviation 31.71 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Ade (n=200, 198, 105, 200) | 44.04 units on a scale | Standard Deviation 28.21 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Som (n=199, 198, 105, 199) | 35.66 units on a scale | Standard Deviation 22.28 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Sno (n=194, 193, 104, 196) | 34.30 units on a scale | Standard Deviation 29.56 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Ade (n=194, 195, 105, 198) | 52.62 units on a scale | Standard Deviation 27.62 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: OSP (n=199, 198, 105, 200) | 42.27 units on a scale | Standard Deviation 19.32 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SPS (n=173, 181, 46, 179) | 31.79 units on a scale | Standard Deviation 18.64 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Som (n=194, 195, 105, 198) | 31.04 units on a scale | Standard Deviation 22.02 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Ade (n=173, 181, 46, 179) | 53.76 units on a scale | Standard Deviation 27.87 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SPS (n=199, 198, 105, 200) | 40.20 units on a scale | Standard Deviation 19.48 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Sno (n=171, 180, 46, 179) | 23.91 units on a scale | Standard Deviation 23.33 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SPS (n=194, 195, 105, 198) | 37.62 units on a scale | Standard Deviation 18.83 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: OSP (n=194, 195, 105, 198) | 38.77 units on a scale | Standard Deviation 18.45 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Ade (n=173, 181, 46, 179) | 50.00 units on a scale | Standard Deviation 26.83 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Ade (n=194, 195, 105, 198) | 49.81 units on a scale | Standard Deviation 25.87 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: ASOB (n=194, 195, 105, 198) | 19.81 units on a scale | Standard Deviation 23.78 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SD (n=194, 195, 105, 198) | 40.43 units on a scale | Standard Deviation 26.13 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Qua (n=193, 195, 105, 197) | 6.74 units on a scale | Standard Deviation 1.49 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: ASOB (n=173, 181, 46, 179) | 16.52 units on a scale | Standard Deviation 20.79 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Sno (n=194, 193, 104, 196) | 31.35 units on a scale | Standard Deviation 27.13 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Som (n=194, 195, 105, 198) | 33.90 units on a scale | Standard Deviation 21.8 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SPS (n=186, 185, 99, 190) | 37.54 units on a scale | Standard Deviation 19.18 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: OSP (n=186, 185, 99, 190) | 38.55 units on a scale | Standard Deviation 18.97 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SD (n=173, 181, 46, 179) | 37.31 units on a scale | Standard Deviation 24.73 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Ade (n=187, 185, 99, 190) | 48.99 units on a scale | Standard Deviation 28.16 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: ASOB (n=187, 185, 99, 190) | 18.59 units on a scale | Standard Deviation 20.85 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SD (n=186, 185, 99, 190) | 38.66 units on a scale | Standard Deviation 26.24 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Qua (n=188, 185, 99, 190) | 6.51 units on a scale | Standard Deviation 1.56 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Qua (n=173, 181, 45, 178) | 6.71 units on a scale | Standard Deviation 1.5 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Sno (n=186, 184, 99, 189) | 30.10 units on a scale | Standard Deviation 22.92 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Som (n=187, 185, 99, 190) | 36.50 units on a scale | Standard Deviation 20.1 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Som (n=173, 181, 46, 179) | 33.62 units on a scale | Standard Deviation 17.72 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SPS (n=199, 198, 105, 200) | 39.14 units on a scale | Standard Deviation 19.04 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: OSP (n=199, 198, 105, 200) | 41.27 units on a scale | Standard Deviation 19.47 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SPS (n=173, 181, 46, 179) | 36.52 units on a scale | Standard Deviation 19.89 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Ade (n=200, 198, 105, 200) | 47.43 units on a scale | Standard Deviation 26.06 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: ASOB (n=200, 198, 105, 200) | 18.67 units on a scale | Standard Deviation 24.54 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SD (n=200, 198, 105, 200) | 43.95 units on a scale | Standard Deviation 27.4 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Qua (n=200, 198, 104, 199) | 6.70 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: OSP (n=173, 181, 46, 179) | 36.87 units on a scale | Standard Deviation 18.51 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Sno (n=198, 197, 105, 199) | 30.10 units on a scale | Standard Deviation 28.16 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Som (n=199, 198, 105, 199) | 36.70 units on a scale | Standard Deviation 20.55 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Ade (n=194, 195, 105, 198) | 46.87 units on a scale | Standard Deviation 27.3 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Som (n=194, 195, 105, 198) | 33.91 units on a scale | Standard Deviation 19.6 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: OSP (n=173, 181, 46, 179) | 36.73 units on a scale | Standard Deviation 19.04 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SPS (n=199, 198, 105, 200) | 40.90 units on a scale | Standard Deviation 19.68 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: ASOB (n=173, 181, 46, 179) | 19.22 units on a scale | Standard Deviation 22.37 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Sno (n=194, 193, 104, 196) | 32.76 units on a scale | Standard Deviation 28.19 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Qua (n=200, 198, 104, 199) | 6.65 units on a scale | Standard Deviation 1.82 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: OSP (n=199, 198, 105, 200) | 43.12 units on a scale | Standard Deviation 19.5 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SPS (n=194, 195, 105, 198) | 38.16 units on a scale | Standard Deviation 20.3 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: Qua (n=193, 195, 105, 197) | 6.89 units on a scale | Standard Deviation 1.55 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: OSP (n=194, 195, 105, 198) | 39.18 units on a scale | Standard Deviation 19.67 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Ade (n=200, 198, 105, 200) | 44.25 units on a scale | Standard Deviation 27.83 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SPS (n=173, 181, 46, 179) | 36.31 units on a scale | Standard Deviation 19.25 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: SD (n=194, 195, 105, 198) | 39.41 units on a scale | Standard Deviation 25.42 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Som (n=199, 198, 105, 199) | 33.47 units on a scale | Standard Deviation 19.68 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: ASOB (n=200, 198, 105, 200) | 20.00 units on a scale | Standard Deviation 24.31 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: ASOB (n=187, 185, 99, 190) | 18.42 units on a scale | Standard Deviation 24.42 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: SD (n=173, 181, 46, 179) | 36.39 units on a scale | Standard Deviation 24.2 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Sno (n=171, 180, 46, 179) | 33.18 units on a scale | Standard Deviation 27.32 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SD (n=186, 185, 99, 190) | 39.95 units on a scale | Standard Deviation 25.83 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Ade (n=187, 185, 99, 190) | 49.21 units on a scale | Standard Deviation 28.65 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: OSP (n=186, 185, 99, 190) | 38.32 units on a scale | Standard Deviation 20.05 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 1: ASOB (n=194, 195, 105, 198) | 18.69 units on a scale | Standard Deviation 25.26 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Qua (n=188, 185, 99, 190) | 6.83 units on a scale | Standard Deviation 1.47 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: Sno (n=198, 197, 105, 199) | 34.77 units on a scale | Standard Deviation 30.5 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: SPS (n=186, 185, 99, 190) | 37.21 units on a scale | Standard Deviation 20.47 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline: SD (n=200, 198, 105, 200) | 46.55 units on a scale | Standard Deviation 26.31 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Sno (n=186, 184, 99, 189) | 34.60 units on a scale | Standard Deviation 27.8 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Qua (n=173, 181, 45, 178) | 6.81 units on a scale | Standard Deviation 1.36 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Som (n=173, 181, 46, 179) | 31.84 units on a scale | Standard Deviation 20.38 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 6: Ade (n=173, 181, 46, 179) | 50.22 units on a scale | Standard Deviation 27.33 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Month 3: Som (n=187, 185, 99, 190) | 31.05 units on a scale | Standard Deviation 20.26 |
Secondary
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time frame: Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | ASOB (n=149, 150, 49, 37, 159) | 16.78 units on a scale | Standard Deviation 19.74 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Ade (n=149, 150, 49, 37, 159) | 51.21 units on a scale | Standard Deviation 26.96 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SPS (n=148, 150, 49, 37, 159) | 34.62 units on a scale | Standard Deviation 18.58 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Som (n=148, 150, 49, 37, 158) | 29.41 units on a scale | Standard Deviation 18.95 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Sno (n=148, 150, 48, 37, 159) | 33.78 units on a scale | Standard Deviation 29.95 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Qua (n=148, 150, 49, 37, 158) | 6.78 units on a scale | Standard Deviation 1.19 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | OSP (n=148, 150, 49, 37, 158) | 34.86 units on a scale | Standard Deviation 17.87 |
| CP-690,550 5 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SD (n=149, 150, 49, 37, 159) | 34.82 units on a scale | Standard Deviation 23.95 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | OSP (n=148, 150, 49, 37, 158) | 31.49 units on a scale | Standard Deviation 17.9 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SPS (n=148, 150, 49, 37, 159) | 30.64 units on a scale | Standard Deviation 18.42 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Ade (n=149, 150, 49, 37, 159) | 57.20 units on a scale | Standard Deviation 28.48 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | ASOB (n=149, 150, 49, 37, 159) | 14.13 units on a scale | Standard Deviation 20.67 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SD (n=149, 150, 49, 37, 159) | 32.32 units on a scale | Standard Deviation 22.41 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Qua (n=148, 150, 49, 37, 158) | 7.03 units on a scale | Standard Deviation 1.47 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Sno (n=148, 150, 48, 37, 159) | 30.53 units on a scale | Standard Deviation 27.29 |
| CP-690,550 10 mg | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Som (n=148, 150, 49, 37, 158) | 27.07 units on a scale | Standard Deviation 19.36 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Sno (n=148, 150, 48, 37, 159) | 27.50 units on a scale | Standard Deviation 22.83 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Qua (n=148, 150, 49, 37, 158) | 6.86 units on a scale | Standard Deviation 1.34 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Som (n=148, 150, 49, 37, 158) | 32.38 units on a scale | Standard Deviation 17.53 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SPS (n=148, 150, 49, 37, 159) | 34.69 units on a scale | Standard Deviation 19.1 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | OSP (n=148, 150, 49, 37, 158) | 36.00 units on a scale | Standard Deviation 17.63 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Ade (n=149, 150, 49, 37, 159) | 54.29 units on a scale | Standard Deviation 27.84 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SD (n=149, 150, 49, 37, 159) | 37.12 units on a scale | Standard Deviation 23.55 |
| Placebo | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | ASOB (n=149, 150, 49, 37, 159) | 21.22 units on a scale | Standard Deviation 22.14 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | OSP (n=148, 150, 49, 37, 158) | 35.38 units on a scale | Standard Deviation 20.4 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | ASOB (n=149, 150, 49, 37, 159) | 18.38 units on a scale | Standard Deviation 18.49 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SD (n=149, 150, 49, 37, 159) | 34.86 units on a scale | Standard Deviation 23.94 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Qua (n=148, 150, 49, 37, 158) | 6.84 units on a scale | Standard Deviation 1.34 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SPS (n=148, 150, 49, 37, 159) | 34.68 units on a scale | Standard Deviation 21.32 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Som (n=148, 150, 49, 37, 158) | 29.37 units on a scale | Standard Deviation 22.25 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Sno (n=148, 150, 48, 37, 159) | 32.43 units on a scale | Standard Deviation 26.81 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Ade (n=149, 150, 49, 37, 159) | 50.00 units on a scale | Standard Deviation 30.18 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SD (n=149, 150, 49, 37, 159) | 37.36 units on a scale | Standard Deviation 25.19 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Ade (n=149, 150, 49, 37, 159) | 49.81 units on a scale | Standard Deviation 27.2 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | OSP (n=148, 150, 49, 37, 158) | 36.52 units on a scale | Standard Deviation 19.68 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | SPS (n=148, 150, 49, 37, 159) | 35.72 units on a scale | Standard Deviation 20.25 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Sno (n=148, 150, 48, 37, 159) | 34.47 units on a scale | Standard Deviation 30.01 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Qua (n=148, 150, 49, 37, 158) | 6.72 units on a scale | Standard Deviation 1.31 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | Som (n=148, 150, 49, 37, 158) | 30.00 units on a scale | Standard Deviation 21.21 |
| Adalimumab | Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | ASOB (n=149, 150, 49, 37, 159) | 17.48 units on a scale | Standard Deviation 21.79 |
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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: Days on sick leave (n=11,9,17,15) | 24.27 days | Standard Deviation 33.73 |
| 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=60,47,34,58) | 24.10 days | Standard Deviation 32.38 |
| 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=51,47,31,53) | 29.10 days | Standard Deviation 27.47 |
| 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=31,25,10,33) | 14.71 days | Standard Deviation 18.47 |
| 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=17,11,7,12) | 12.59 days | Standard Deviation 23.15 |
| 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=70,66,38,68) | 4.83 days | Standard Deviation 0.95 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related devices/aids (n=17,28,9,17) | 1.76 days | Standard Deviation 1.15 |
| 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=46,46,15,50) | 13.59 days | Standard Deviation 16.95 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days devices/aids used (n=11,17,6,15) | 117.91 days | Standard Deviation 112.91 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days in nursing home (n=0,0,0,2) | NA days | — |
| 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=4,6,1,3) | 6.25 days | Standard Deviation 4.03 |
| 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=11,10,3,7) | 7.73 days | Standard Deviation 8.25 |
| 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=71,69,38,70) | 4.94 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: Days in nursing home (n=3,0,0,4) | 19.33 days | Standard Deviation 17.56 |
| 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=65,61,17,66) | 4.94 days | Standard Deviation 0.85 |
| 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=11,6,7,11) | 13.64 days | Standard Deviation 12.91 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper (n=23,19,6,18) | 15.57 days | Standard Deviation 25.73 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related devices/aids (n=15,16,6,14) | 2.00 days | Standard Deviation 1.73 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days devices/aids used (n=14,16,5,14) | 102.29 days | Standard Deviation 115.01 |
| 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=2,0,0,0) | 27.00 days | Standard Deviation 18.38 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,97) | 24.06 days | Standard Deviation 29.27 |
| 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=7,6,1,7) | 7.57 days | Standard Deviation 6.8 |
| 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=9,5,2,1) | 10.00 days | Standard Deviation 8.2 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related devices/aids (n=12,17,8,16) | 1.75 days | Standard Deviation 1.22 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days on sick leave (n=24,24,15,29) | 19.58 days | Standard Deviation 27.78 |
| 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 (n=7,9,3,9) | 29.57 days | Standard Deviation 41.48 |
| 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=39,28,28,44) | 16.08 days | Standard Deviation 21.77 |
| 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=7,4,6,10) | 13.29 days | Standard Deviation 13.76 |
| 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=13,13,6,10) | 13.31 days | Standard Deviation 18.94 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days devices/aids used (n=17,28,8,16) | 133.88 days | Standard Deviation 111.17 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days devices/aids used (n=14,16,5,14) | 126.25 days | Standard Deviation 134.08 |
| 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=11,6,7,11) | 10.83 days | Standard Deviation 9.89 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days in nursing home (n=3,0,0,4) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days devices/aids used (n=17,28,8,16) | 67.32 days | Standard Deviation 61.88 |
| 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=71,69,38,70) | 4.80 days | Standard Deviation 1.05 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper (n=23,19,6,18) | 14.95 days | Standard Deviation 27.24 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,97) | 26.57 days | Standard Deviation 31.02 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days on sick leave (n=24,24,15,29) | 16.33 days | Standard Deviation 27.21 |
| 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=13,13,6,10) | 25.31 days | Standard Deviation 61.19 |
| 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=51,47,31,53) | 29.45 days | Standard Deviation 31.37 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related devices/aids (n=17,28,9,17) | 1.39 days | Standard Deviation 0.69 |
| 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=4,6,1,3) | 10.00 days | Standard Deviation 10.75 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days in nursing home (n=0,0,0,2) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days devices/aids used (n=11,17,6,15) | 60.41 days | Standard Deviation 88.79 |
| 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=70,66,38,68) | 4.68 days | Standard Deviation 1.18 |
| 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=17,11,7,12) | 6.00 days | Standard Deviation 8.63 |
| 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=60,47,34,58) | 18.32 days | Standard Deviation 24.03 |
| 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 (n=11,9,17,15) | 18.44 days | Standard Deviation 29.37 |
| 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=7,4,6,10) | 25.50 days | Standard Deviation 27.77 |
| 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=39,28,28,44) | 26.57 days | Standard Deviation 32.41 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related devices/aids (n=12,17,8,16) | 1.12 days | Standard Deviation 1.36 |
| 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=9,5,2,1) | 12.80 days | Standard Deviation 16.71 |
| 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=2,0,0,0) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days of work per week (n=65,61,17,66) | 4.70 days | Standard Deviation 1.09 |
| 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=11,10,3,7) | 15.80 days | Standard Deviation 22.73 |
| 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=46,46,15,50) | 29.09 days | Standard Deviation 35.16 |
| 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 (n=7,9,3,9) | 12.44 days | Standard Deviation 14.6 |
| 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=7,6,1,7) | 24.67 days | Standard Deviation 33.07 |
| 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=31,25,10,33) | 20.40 days | Standard Deviation 25.93 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related devices/aids (n=15,16,6,14) | 1.56 days | Standard Deviation 1.46 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days devices/aids used (n=14,16,5,14) | 80.20 days | Standard Deviation 73.45 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days of part time work (n=13,13,6,10) | 5.33 days | Standard Deviation 3.44 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days of work per week (n=71,69,38,70) | 4.95 days | Standard Deviation 0.98 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related devices/aids (n=15,16,6,14) | 2.17 days | Standard Deviation 1.83 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days of work per week (n=65,61,17,66) | 5.35 days | Standard Deviation 0.93 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days of part time work (n=7,6,1,7) | 4.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related devices/aids (n=12,17,8,16) | 2.38 days | Standard Deviation 1.6 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Paid work, bothered by RA (n=31,25,10,33) | 11.00 days | Standard Deviation 9.13 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=11,10,3,7) | 44.00 days | Standard Deviation 42.57 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days in nursing home (n=3,0,0,4) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days devices/aids used (n=17,28,8,16) | 172.75 days | Standard Deviation 94.28 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,97) | 26.95 days | Standard Deviation 32.87 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Hospital length of stay (n=4,6,1,3) | 2.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days of part time work (n=7,4,6,10) | 5.50 days | Standard Deviation 3.27 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Hospital length of stay (n=9,5,2,1) | 8.50 days | Standard Deviation 2.12 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by family (n=46,46,15,50) | 35.53 days | Standard Deviation 39.39 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days in nursing home (n=0,0,0,2) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by family (n=60,47,34,58) | 24.97 days | Standard Deviation 31.72 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related devices/aids (n=17,28,9,17) | 2.33 days | Standard Deviation 1.66 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days on sick leave (n=24,24,15,29) | 29.60 days | Standard Deviation 34.88 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days devices/aids used (n=11,17,6,15) | 163.83 days | Standard Deviation 153.63 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days on sick leave (n=11,9,17,15) | 27.12 days | Standard Deviation 31.42 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days in nursing home (n=2,0,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Paid work, bothered by RA (n=39,28,28,44) | 19.93 days | Standard Deviation 20.79 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days of work per week (n=70,66,38,68) | 4.95 days | Standard Deviation 0.8 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper (n=23,19,6,18) | 38.83 days | Standard Deviation 41.44 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Paid work, bothered by RA(n=51,47,31,53) | 28.74 days | Standard Deviation 28.76 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Hospital length of stay (n=11,6,7,11) | 13.43 days | Standard Deviation 9.78 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by housekeeper (n=17,11,7,12) | 8.00 days | Standard Deviation 12.54 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days on sick leave (n=7,9,3,9) | 3.00 days | Standard Deviation 2 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by housekeeper (n=17,11,7,12) | 10.50 days | Standard Deviation 16.08 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by family (n=60,47,34,58) | 25.41 days | Standard Deviation 30.46 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days on sick leave (n=7,9,3,9) | 8.67 days | Standard Deviation 13.13 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days on sick leave (n=11,9,17,15) | 5.13 days | Standard Deviation 4.6 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days on sick leave (n=24,24,15,29) | 16.31 days | Standard Deviation 26.05 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days of part time work (n=7,4,6,10) | 14.90 days | Standard Deviation 27.04 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related devices/aids (n=15,16,6,14) | 2.07 days | Standard Deviation 1.27 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Paid work, bothered by RA (n=39,28,28,44) | 33.61 days | Standard Deviation 30.31 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,97) | 29.80 days | Standard Deviation 32.91 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related devices/aids (n=12,17,8,16) | 1.81 days | Standard Deviation 0.98 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days of part time work (n=7,6,1,7) | 9.29 days | Standard Deviation 8.67 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Hospital length of stay (n=9,5,2,1) | 6.00 days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper (n=23,19,6,18) | 6.94 days | Standard Deviation 6.86 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Hospital length of stay (n=11,6,7,11) | 12.82 days | Standard Deviation 10.93 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days in nursing home (n=2,0,0,0) | NA days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days of work per week (n=71,69,38,70) | 5.01 days | Standard Deviation 1.04 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days devices/aids used (n=14,16,5,14) | 94.21 days | Standard Deviation 76.92 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Days of work per week (n=65,61,17,66) | 4.95 days | Standard Deviation 0.92 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days devices/aids used (n=17,28,8,16) | 66.13 days | Standard Deviation 65.33 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=11,10,3,7) | 7.29 days | Standard Deviation 3.82 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Paid work, bothered by RA (n=31,25,10,33) | 24.55 days | Standard Deviation 26.88 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Hospital length of stay (n=4,6,1,3) | 10.33 days | Standard Deviation 8.14 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related devices/aids (n=17,28,9,17) | 1.65 days | Standard Deviation 1.06 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days in nursing home (n=0,0,0,2) | 17.50 days | Standard Deviation 4.95 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by family (n=46,46,15,50) | 22.64 days | Standard Deviation 29.51 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days devices/aids used (n=11,17,6,15) | 91.80 days | Standard Deviation 95.18 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Paid work, bothered by RA(n=51,47,31,53) | 42.74 days | Standard Deviation 31.81 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days in nursing home (n=3,0,0,4) | 14.25 days | Standard Deviation 9.95 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Days of work per week (n=70,66,38,68) | 4.75 days | Standard Deviation 1.25 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Days of part time work (n=13,13,6,10) | 18.50 days | Standard Deviation 26.88 |
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: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days devices/aids used (n=11,12,3,2,15) | 144.55 days | Standard Deviation 258.85 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related devices/aids used (n=11,12,3,3,15) | 2.18 days | Standard Deviation 2.79 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week (n=60,49,19,15,58) | 4.83 days | Standard Deviation 1.04 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA (n=20,20,7,9,22) | 24.10 days | Standard Deviation 30.75 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work (n=6,1,0,0,1) | 11.33 days | Standard Deviation 12.55 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home (n=2,0,0,0,1) | 24.50 days | Standard Deviation 4.95 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay (n=3,5,1,1,3) | 8.00 days | Standard Deviation 6.93 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave (n=5,3,2,0,4) | 10.40 days | Standard Deviation 11.41 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family (n=35,30,8,10,45) | 22.06 days | Standard Deviation 27.84 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper (n=9,4,1,2,10) | 4.44 days | Standard Deviation 3.4 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home (n=2,0,0,0,1) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay (n=3,5,1,1,3) | 5.60 days | Standard Deviation 2.7 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days devices/aids used (n=11,12,3,2,15) | 51.75 days | Standard Deviation 41.51 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week (n=60,49,19,15,58) | 5.04 days | Standard Deviation 0.93 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper (n=9,4,1,2,10) | 7.75 days | Standard Deviation 5.06 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family (n=35,30,8,10,45) | 13.13 days | Standard Deviation 12.28 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave (n=5,3,2,0,4) | 36.00 days | Standard Deviation 45.97 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work (n=6,1,0,0,1) | 33.00 days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA (n=20,20,7,9,22) | 20.40 days | Standard Deviation 27.9 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related devices/aids used (n=11,12,3,3,15) | 0.75 days | Standard Deviation 0.62 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family (n=35,30,8,10,45) | 51.88 days | Standard Deviation 40.91 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA (n=20,20,7,9,22) | 11.43 days | Standard Deviation 8.6 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days devices/aids used (n=11,12,3,2,15) | 163.67 days | Standard Deviation 173.7 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week (n=60,49,19,15,58) | 5.16 days | Standard Deviation 0.9 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home (n=2,0,0,0,1) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper (n=9,4,1,2,10) | 90.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave (n=5,3,2,0,4) | 50.00 days | Standard Deviation 56.57 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay (n=3,5,1,1,3) | 15.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related devices/aids used (n=11,12,3,3,15) | 2.33 days | Standard Deviation 1.53 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work (n=6,1,0,0,1) | NA days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home (n=2,0,0,0,1) | NA days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related devices/aids used (n=11,12,3,3,15) | 3.00 days | Standard Deviation 2.65 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay (n=3,5,1,1,3) | 1.00 days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days devices/aids used (n=11,12,3,2,15) | 321.50 days | Standard Deviation 327.39 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family (n=35,30,8,10,45) | 28.40 days | Standard Deviation 33.88 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work (n=6,1,0,0,1) | NA days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA (n=20,20,7,9,22) | 12.33 days | Standard Deviation 12.32 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave (n=5,3,2,0,4) | NA days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week (n=60,49,19,15,58) | 4.93 days | Standard Deviation 0.7 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper (n=9,4,1,2,10) | 24.00 days | Standard Deviation 16.97 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of work per week (n=60,49,19,15,58) | 4.95 days | Standard Deviation 1.07 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Paid work, bothered by RA (n=20,20,7,9,22) | 22.86 days | Standard Deviation 24.2 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by housekeeper (n=9,4,1,2,10) | 4.90 days | Standard Deviation 3.78 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Chores by family (n=35,30,8,10,45) | 23.49 days | Standard Deviation 28.68 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | RA related devices/aids used (n=11,12,3,3,15) | 1.53 days | Standard Deviation 0.74 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days on sick leave (n=5,3,2,0,4) | 18.25 days | Standard Deviation 14.06 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Hospital length of stay (n=3,5,1,1,3) | 15.33 days | Standard Deviation 4.51 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days of part time work (n=6,1,0,0,1) | 30.00 days | — |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days devices/aids used (n=11,12,3,2,15) | 79.33 days | Standard Deviation 74 |
| Adalimumab | Number of Days as Assessed Using RA-HCRU at Month 12 | Days in nursing home (n=2,0,0,0,1) | 10.00 days | — |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Baseline, Month 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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: RA related doctor visit(n=136,138,78,136) | 0.91 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 | Month 3: RA related ER visit (n=8,8,4,9) | 0.25 events | Standard Deviation 0.46 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic tests(n=37,33,19,36) | 1.73 events | Standard Deviation 1.04 |
| 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 visits (n=12,6,4,4) | 1.08 events | Standard Deviation 0.29 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA-diagnostic tests (n=19,24,9,21) | 0.11 events | Standard Deviation 0.32 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related hospitalization (n=4,6,1,3) | 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 6: NM practitioners visits (n=1,3,0,1) | 1.00 events | — |
| 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=3,4,4,6) | 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 | Baseline: Doctor visits (n=168,174,90,172) | 4.26 events | Standard Deviation 3.51 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related NM visit (n=5,0,2,2) | 0.60 events | Standard Deviation 0.89 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related hospitalization (n=9,5,2,1) | 0.22 events | Standard Deviation 0.67 |
| 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 visits (n=132,131,33,128) | 3.30 events | Standard Deviation 4.17 |
| 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=169,175,91,172) | 1.33 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 6: RA related NM visit (n=1,3,0,1) | 0.00 events | — |
| 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=11,14,6,12) | 0.64 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 | Baseline: Hospital ER visits (n=12,14,7,12) | 1.08 events | Standard Deviation 0.51 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA-diagnostic tests (n=21,25,5,19) | 0.18 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: RA diagnostic tests (n=38,33,19,37) | 0.50 events | Standard Deviation 0.76 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related hospitalization (n=11,6,7,11) | 0.91 events | Standard Deviation 0.83 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related ER visit (n=12,6,4,3) | 0.25 events | Standard Deviation 0.62 |
| 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=7,6,3,7) | 0.43 events | Standard Deviation 0.79 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related NM visit (n=3,6,2,6) | 0.67 events | Standard Deviation 0.58 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Number visits hospitalized(n=11,5,7,11) | 2.82 events | Standard Deviation 5.71 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related doctor visit(n=132,131,33,129) | 0.81 events | Standard Deviation 0.63 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Doctor visits (n=136,138,78,136) | 3.62 events | Standard Deviation 4.25 |
| 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: NM practitioners visits (n=5,0,2,2) | 2.40 events | Standard Deviation 0.89 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: NM practitioners visits (n=3,6,2,6) | 1.33 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: Non-study diagnostic tests (n=21,25,5,19) | 2.33 events | Standard Deviation 3.89 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Hospital ER visits (n=8,8,4,10) | 1.38 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 | Month 6: RA related outpatient surgery (n=4,7,1,2) | 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: Number visits hospitalized (n=4,6,1,3) | 1.50 events | Standard Deviation 1 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Number of outpatient surgeries(n=8,6,2,7) | 1.13 events | Standard Deviation 0.35 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Number of outpatient surgeries(n=4,7,1,2) | 1.25 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 | Month 3: Number of outpatient surgeries(n=3,4,4,6) | 1.67 events | Standard Deviation 0.58 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Non-study diagnostic tests (n=18,23,9,20) | 1.72 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 Baseline, Month 3 and 6 | Month 6: Number visits hospitalized (n=9,5,2,1) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Number visits hospitalized (n=9,5,2,1) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related doctor visit(n=136,138,78,136) | 0.92 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: RA related hospitalization (n=9,5,2,1) | 0.40 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 6: Hospital ER visits (n=12,6,4,4) | 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 hospitalization (n=11,6,7,11) | 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 3: RA related ER visit (n=8,8,4,9) | 0.50 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: RA related NM visit (n=1,3,0,1) | 0.67 events | Standard Deviation 1.15 |
| 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: NM practitioners visits (n=3,6,2,6) | 3.00 events | Standard Deviation 1.79 |
| 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 tests (n=18,23,9,20) | 1.52 events | Standard Deviation 0.79 |
| 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-diagnostic tests (n=19,24,9,21) | 0.21 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:Non-study diagnostic tests(n=37,33,19,36) | 1.79 events | Standard Deviation 1.17 |
| 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: NM practitioners visits (n=1,3,0,1) | 2.67 events | Standard Deviation 2.89 |
| 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 | Baseline: RA related outpatient surgery(n=7,6,3,7) | 0.33 events | Standard Deviation 0.82 |
| 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=4,6,1,3) | 0.17 events | Standard Deviation 0.41 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Doctor visits (n=168,174,90,172) | 4.06 events | Standard Deviation 3.57 |
| 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=4,7,1,2) | 0.43 events | Standard Deviation 0.79 |
| 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=132,131,33,129) | 0.96 events | Standard Deviation 0.74 |
| 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=3,4,4,6) | 0.25 events | Standard Deviation 0.5 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Hospital ER visits (n=8,8,4,10) | 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: Doctor visits (n=132,131,33,128) | 2.86 events | Standard Deviation 4.23 |
| 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 NM visit (n=3,6,2,6) | 0.50 events | Standard Deviation 0.84 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related NM visit (n=5,0,2,2) | NA 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 3: Number of outpatient surgeries(n=3,4,4,6) | 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 6: Number of outpatient surgeries(n=4,7,1,2) | 1.14 events | Standard Deviation 0.38 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Number of outpatient surgeries(n=8,6,2,7) | 1.33 events | Standard Deviation 0.82 |
| 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=169,175,91,172) | 1.17 events | Standard Deviation 0.7 |
| 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 visits (n=136,138,78,136) | 2.86 events | Standard Deviation 2.99 |
| 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-diagnostic tests (n=21,25,5,19) | 0.16 events | Standard Deviation 0.37 |
| 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: Number visits hospitalized(n=11,5,7,11) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related ER visit (n=11,14,6,12) | 0.64 events | Standard Deviation 0.74 |
| 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 tests (n=21,25,5,19) | 1.96 events | Standard Deviation 1.31 |
| 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: Number visits hospitalized (n=4,6,1,3) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: NM practitioners visits (n=5,0,2,2) | NA 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 | Baseline: RA diagnostic tests (n=38,33,19,37) | 0.55 events | Standard Deviation 0.62 |
| 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 visits (n=12,14,7,12) | 1.93 events | Standard Deviation 1.59 |
| 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=12,6,4,3) | 0.67 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 outpatient surgery (n=3,4,4,6) | 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 | Baseline: Doctor visits (n=168,174,90,172) | 4.50 events | Standard Deviation 5.32 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: NM practitioners visits (n=3,6,2,6) | 4.50 events | Standard Deviation 4.95 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Hospital ER visits (n=12,14,7,12) | 1.57 events | Standard Deviation 0.79 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Number visits hospitalized(n=11,5,7,11) | 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:Number of outpatient surgeries(n=8,6,2,7) | 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:Non-study diagnostic tests(n=37,33,19,36) | 1.21 events | Standard Deviation 0.54 |
| 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=169,175,91,172) | 1.26 events | Standard Deviation 0.81 |
| 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=11,14,6,12) | 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 | Baseline: RA diagnostic tests (n=38,33,19,37) | 0.47 events | Standard Deviation 0.61 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related hospitalization (n=11,6,7,11) | 0.57 events | Standard Deviation 0.79 |
| 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=7,6,3,7) | 0.33 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 | Baseline: RA related NM visit (n=3,6,2,6) | 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: Doctor visits (n=136,138,78,136) | 3.27 events | Standard Deviation 3.93 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: NM practitioners visits (n=5,0,2,2) | 17.00 events | Standard Deviation 21.21 |
| 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 visits (n=8,8,4,10) | 1.75 events | Standard Deviation 1.5 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Number visits hospitalized (n=4,6,1,3) | 1.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Number of outpatient surgeries(n=3,4,4,6) | 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: Non-study diagnostic tests (n=18,23,9,20) | 1.56 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 | Month 3: RA related doctor visit(n=136,138,78,136) | 0.90 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 | Month 3: RA related ER visit (n=8,8,4,9) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA-diagnostic tests (n=19,24,9,21) | 0.11 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 3: RA related hospitalization (n=4,6,1,3) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related NM visit (n=5,0,2,2) | 1.50 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 | Month 6: Doctor visits (n=132,131,33,128) | 2.52 events | Standard Deviation 1.91 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: NM practitioners visits (n=1,3,0,1) | 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: Hospital ER visits (n=12,6,4,4) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Number visits hospitalized (n=9,5,2,1) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Number of outpatient surgeries(n=4,7,1,2) | 1.00 events | — |
| 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 tests (n=21,25,5,19) | 1.80 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 6: RA related doctor visit(n=132,131,33,129) | 0.88 events | Standard Deviation 0.86 |
| 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=12,6,4,3) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA-diagnostic tests (n=21,25,5,19) | 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 6: RA related hospitalization (n=9,5,2,1) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related outpatient surgery (n=4,7,1,2) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related NM visit (n=1,3,0,1) | NA events | — |
| Adalimumab | 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 tests (n=18,23,9,20) | 1.45 events | Standard Deviation 0.83 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Number of outpatient surgeries(n=3,4,4,6) | 1.33 events | Standard Deviation 0.52 |
| Adalimumab | 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=9,5,2,1) | 0.00 events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Number visits hospitalized (n=9,5,2,1) | 1.00 events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Number visits hospitalized (n=4,6,1,3) | 1.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Hospital ER visits (n=8,8,4,10) | 1.90 events | Standard Deviation 1.1 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Number visits hospitalized(n=11,5,7,11) | 1.27 events | Standard Deviation 0.9 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Number of outpatient surgeries(n=4,7,1,2) | 1.50 events | Standard Deviation 0.71 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: NM practitioners visits (n=5,0,2,2) | 7.50 events | Standard Deviation 9.19 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: Doctor visits (n=136,138,78,136) | 3.05 events | Standard Deviation 2.87 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Hospital ER visits (n=12,14,7,12) | 1.58 events | Standard Deviation 1.73 |
| Adalimumab | 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 tests (n=21,25,5,19) | 1.53 events | Standard Deviation 0.61 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related NM visit (n=3,6,2,6) | 1.00 events | Standard Deviation 0.63 |
| Adalimumab | 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=7,6,3,7) | 0.43 events | Standard Deviation 0.79 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related NM visit (n=1,3,0,1) | 0.00 events | — |
| Adalimumab | 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=132,131,33,129) | 1.00 events | Standard Deviation 0.56 |
| Adalimumab | 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=11,6,7,11) | 0.82 events | Standard Deviation 0.6 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA diagnostic tests (n=38,33,19,37) | 0.84 events | Standard Deviation 0.73 |
| Adalimumab | 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=4,7,1,2) | 1.00 events | Standard Deviation 1.41 |
| Adalimumab | 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=12,6,4,3) | 0.00 events | Standard Deviation 0 |
| Adalimumab | 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=11,14,6,12) | 0.25 events | Standard Deviation 0.45 |
| Adalimumab | 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=169,175,91,172) | 1.19 events | Standard Deviation 0.73 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: NM practitioners visits (n=3,6,2,6) | 10.00 events | Standard Deviation 10.51 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA-diagnostic tests (n=21,25,5,19) | 0.11 events | Standard Deviation 0.32 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related NM visit (n=5,0,2,2) | 0.50 events | Standard Deviation 0.71 |
| Adalimumab | 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=3,4,4,6) | 0.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Non-study diagnostic tests(n=37,33,19,36) | 1.64 events | Standard Deviation 1.1 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Doctor visits (n=132,131,33,128) | 2.73 events | Standard Deviation 2.96 |
| Adalimumab | 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=4,6,1,3) | 0.67 events | Standard Deviation 1.15 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA-diagnostic tests (n=19,24,9,21) | 0.24 events | Standard Deviation 0.44 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline:Number of outpatient surgeries(n=8,6,2,7) | 2.57 events | Standard Deviation 4.16 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: NM practitioners visits (n=1,3,0,1) | 14.00 events | — |
| Adalimumab | 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=8,8,4,9) | 0.00 events | Standard Deviation 0 |
| Adalimumab | 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=136,138,78,136) | 0.93 events | Standard Deviation 0.65 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline: Doctor visits (n=168,174,90,172) | 3.87 events | Standard Deviation 3.74 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6: Hospital ER visits (n=12,6,4,4) | 1.75 events | Standard Deviation 0.96 |
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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 | Doctor visit (n=102,111,37,30,125) | 2.73 events | Standard Deviation 2.78 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospital ER visits (n=3,5,0,1,6) | 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 | NM practitioners visits (n=3,4,1,2,0) | 10.67 events | Standard Deviation 11.72 |
| 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=104,111,37,30,125) | 0.82 events | Standard Deviation 0.59 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization (n=3,5,1,1,3) | 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 ER visits (n=3,5,0,1,6) | 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 Month 12 | Non-study diagnostic tests (n=8,19,6,6,22) | 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 Month 12 | RA related outpatient surgery (n=5,2,0,2,5) | 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 Month 12 | RA-diagnostic tests (n=9,19,6,6,22) | 0.11 events | Standard Deviation 0.33 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of outpatient surgeries (n=5,2,0,2,5) | 1.40 events | Standard Deviation 0.89 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related NM visits (n=3,4,1,2,0) | 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 | Number of visits hospitalized (n=3,5,1,1,3) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Doctor visit (n=102,111,37,30,125) | 2.80 events | Standard Deviation 2.46 |
| 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 visits (n=3,5,0,1,6) | 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 Month 12 | Hospital ER visits (n=3,5,0,1,6) | 2.40 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 NM visits (n=3,4,1,2,0) | 0.50 events | Standard Deviation 1 |
| 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=5,2,0,2,5) | 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 Month 12 | NM practitioners visits (n=3,4,1,2,0) | 9.75 events | Standard Deviation 10.97 |
| 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=104,111,37,30,125) | 0.93 events | Standard Deviation 0.57 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA-diagnostic tests (n=9,19,6,6,22) | 0.21 events | Standard Deviation 0.42 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of outpatient surgeries (n=5,2,0,2,5) | 1.50 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 Month 12 | RA related hospitalization (n=3,5,1,1,3) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of visits hospitalized (n=3,5,1,1,3) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic tests (n=8,19,6,6,22) | 1.95 events | Standard Deviation 1.31 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of outpatient surgeries (n=5,2,0,2,5) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA-diagnostic tests (n=9,19,6,6,22) | 0.17 events | Standard Deviation 0.41 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization (n=3,5,1,1,3) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related outpatient surgery (n=5,2,0,2,5) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related NM visits (n=3,4,1,2,0) | 0.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Doctor visit (n=102,111,37,30,125) | 3.92 events | Standard Deviation 5.97 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | NM practitioners visits (n=3,4,1,2,0) | 192.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospital ER visits (n=3,5,0,1,6) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of visits hospitalized (n=3,5,1,1,3) | 1.00 events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related ER visits (n=3,5,0,1,6) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic tests (n=8,19,6,6,22) | 3.17 events | Standard Deviation 2.64 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related doctor visit (n=104,111,37,30,125) | 0.89 events | Standard Deviation 0.52 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospital ER visits (n=3,5,0,1,6) | 3.00 events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related NM visits (n=3,4,1,2,0) | 0.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related doctor visit (n=104,111,37,30,125) | 0.87 events | Standard Deviation 0.68 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of visits hospitalized (n=3,5,1,1,3) | 1.00 events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related outpatient surgery (n=5,2,0,2,5) | 0.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of outpatient surgeries (n=5,2,0,2,5) | 1.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization (n=3,5,1,1,3) | 0.00 events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic tests (n=8,19,6,6,22) | 1.33 events | Standard Deviation 0.82 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA-diagnostic tests (n=9,19,6,6,22) | 0.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | NM practitioners visits (n=3,4,1,2,0) | 10.50 events | Standard Deviation 6.36 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Doctor visit (n=102,111,37,30,125) | 3.50 events | Standard Deviation 3.34 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related ER visits (n=3,5,0,1,6) | 0.00 events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related hospitalization (n=3,5,1,1,3) | 0.67 events | Standard Deviation 0.58 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Hospital ER visits (n=3,5,0,1,6) | 1.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related NM visits (n=3,4,1,2,0) | NA events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | NM practitioners visits (n=3,4,1,2,0) | NA events | — |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related ER visits (n=3,5,0,1,6) | 0.17 events | Standard Deviation 0.41 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Doctor visit (n=102,111,37,30,125) | 2.94 events | Standard Deviation 3.93 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of visits hospitalized (n=3,5,1,1,3) | 1.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related outpatient surgery (n=5,2,0,2,5) | 0.00 events | Standard Deviation 0 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Non-study diagnostic tests (n=8,19,6,6,22) | 1.64 events | Standard Deviation 0.9 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA related doctor visit (n=104,111,37,30,125) | 0.84 events | Standard Deviation 0.8 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | RA-diagnostic tests (n=9,19,6,6,22) | 0.05 events | Standard Deviation 0.21 |
| Adalimumab | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12 | Number of outpatient surgeries (n=5,2,0,2,5) | 2.20 events | Standard Deviation 2.17 |
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time frame: Baseline, Month 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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: Home HC services (n=2,2,0,0) | 2.50 hours per day | Standard Deviation 2.12 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Home HC services (n=2,2,1,2) | 3.00 hours per day | Standard Deviation 2.83 |
| 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=7,4,6,9) | 4.57 hours per day | Standard Deviation 5.03 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Work done (n=72,69,38,70) | 7.76 hours per day | Standard Deviation 2.4 |
| 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=22,19,7,18) | 5.23 hours per day | Standard Deviation 4.6 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,95) | 4.24 hours per day | Standard Deviation 4.75 |
| 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=13,13,6,10) | 6.38 hours per day | Standard Deviation 7.22 |
| 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=2,2,1,3) | 0.50 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 | Month 3: Home HC services (n=1,0,0,0) | 1.00 hours per day | — |
| 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=70,66,38,68) | 8.06 hours per day | Standard Deviation 3.59 |
| 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=17,11,7,12) | 4.00 hours per day | Standard Deviation 2.12 |
| 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=59,46,34,59) | 3.46 hours per day | Standard Deviation 3.67 |
| 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=1,0,0,0) | 1.00 hours per day | — |
| 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=65,61,17,66) | 8.35 hours per day | Standard Deviation 4.46 |
| 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=11,10,3,7) | 3.36 hours per day | Standard Deviation 2.58 |
| 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=47,45,13,51) | 3.30 hours per day | Standard Deviation 2.69 |
| 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=7,6,1,7) | 4.57 hours per day | Standard Deviation 5.19 |
| 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=2,2,0,0) | 1.00 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 3: Chores by housekeeper (n=17,11,7,12) | 5.73 hours per day | Standard Deviation 2.61 |
| 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=2,2,0,0) | 0.50 hours per day | Standard Deviation 0.71 |
| 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=65,61,17,66) | 7.72 hours per day | Standard Deviation 2.24 |
| 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=7,6,1,7) | 3.17 hours per day | Standard Deviation 2.32 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by family (n=59,46,34,59) | 3.28 hours per day | Standard Deviation 2.6 |
| 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=22,19,7,18) | 5.53 hours per day | Standard Deviation 5.36 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Home HC services (n=2,2,0,0) | 16.00 hours per day | Standard Deviation 5.66 |
| 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=7,4,6,9) | 20.75 hours per day | Standard Deviation 39.51 |
| 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=1,0,0,0) | NA hours per day | — |
| 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=13,13,6,10) | 5.00 hours per day | Standard Deviation 5.85 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Home HC services (n=1,0,0,0) | NA hours per day | — |
| 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=101,102,39,95) | 3.31 hours per day | Standard Deviation 2.76 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Work done (n=72,69,38,70) | 7.54 hours per day | Standard Deviation 2.25 |
| 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=11,10,3,7) | 5.40 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 | Month 3: Work done (n=70,66,38,68) | 7.53 hours per day | Standard Deviation 1.92 |
| 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=47,45,13,51) | 2.91 hours per day | Standard Deviation 2 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Home HC services (n=2,2,1,2) | 1.50 hours per day | Standard Deviation 0.71 |
| 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=2,2,1,3) | 1.00 hours per day | Standard Deviation 0 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related home HC services (n=2,2,1,3) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Missed work due to RA (n=13,13,6,10) | 4.00 hours per day | Standard Deviation 1.26 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by family (n=47,45,13,51) | 3.69 hours per day | Standard Deviation 2.32 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Home HC services (n=1,0,0,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Work done (n=70,66,38,68) | 8.53 hours per day | Standard Deviation 5.62 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related home HC services (n=2,2,0,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by housekeeper (n=17,11,7,12) | 5.00 hours per day | Standard Deviation 2 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by family (n=59,46,34,59) | 3.41 hours per day | Standard Deviation 2.72 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Missed work due to RA (n=7,4,6,9) | 5.50 hours per day | Standard Deviation 5.01 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Missed work due to RA (n=7,6,1,7) | 5.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related home HC services (n=1,0,0,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Home HC services (n=2,2,0,0) | 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=65,61,17,66) | 9.71 hours per day | Standard Deviation 7.59 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Home HC services (n=2,2,1,2) | 2.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Work done (n=72,69,38,70) | 7.79 hours per day | Standard Deviation 1.76 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=11,10,3,7) | 5.33 hours per day | Standard Deviation 1.53 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper (n=22,19,7,18) | 8.00 hours per day | Standard Deviation 7.55 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,95) | 4.21 hours per day | Standard Deviation 4.71 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by family (n=101,102,39,95) | 2.82 hours per day | Standard Deviation 1.79 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Work done (n=65,61,17,66) | 8.00 hours per day | Standard Deviation 4.27 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Work done (n=70,66,38,68) | 8.38 hours per day | Standard Deviation 4.89 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper (n=22,19,7,18) | 3.89 hours per day | Standard Deviation 2.37 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: RA related home HC services (n=2,2,0,0) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Home HC services (n=2,2,1,2) | 1.00 hours per day | Standard Deviation 0 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by family (n=47,45,13,51) | 3.33 hours per day | Standard Deviation 3.55 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Home HC services (n=1,0,0,0) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=11,10,3,7) | 6.29 hours per day | Standard Deviation 7.95 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Work done (n=72,69,38,70) | 8.16 hours per day | Standard Deviation 2.85 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Missed work due to RA (n=7,4,6,9) | 3.56 hours per day | Standard Deviation 1.59 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: Missed work due to RA (n=13,13,6,10) | 4.00 hours per day | Standard Deviation 4.11 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: RA related home HC services (n=1,0,0,0) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by family (n=59,46,34,59) | 3.68 hours per day | Standard Deviation 3.72 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Baseline: RA related home HC services (n=2,2,1,3) | 0.33 hours per day | Standard Deviation 0.58 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Home HC services (n=2,2,0,0) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 6: Missed work due to RA (n=7,6,1,7) | 3.29 hours per day | Standard Deviation 1.7 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 | Month 3: Chores by housekeeper (n=17,11,7,12) | 4.17 hours per day | Standard Deviation 1.99 |
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Month 12
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Time frame: Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home HC services (n=0,0,0,0,1) | NA hours per day | — |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done (n=60,49,19,15,58) | 7.52 hours per day | Standard Deviation 2.27 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper (n=8,4,1,2,10) | 4.63 hours per day | Standard Deviation 3.16 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family (n=34,30,8,10,44) | 2.65 hours per day | Standard Deviation 1.95 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA (n=6,1,0,0,1) | 2.00 hours per day | Standard Deviation 1.67 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related home HC services (n=0,0,0,0,1) | NA hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA (n=6,1,0,0,1) | 4.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related home HC services (n=0,0,0,0,1) | NA hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home HC services (n=0,0,0,0,1) | NA hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper (n=8,4,1,2,10) | 4.75 hours per day | Standard Deviation 0.96 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family (n=34,30,8,10,44) | 4.00 hours per day | Standard Deviation 4.11 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done (n=60,49,19,15,58) | 7.82 hours per day | Standard Deviation 1.6 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family (n=34,30,8,10,44) | 2.88 hours per day | Standard Deviation 2.17 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA (n=6,1,0,0,1) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home HC services (n=0,0,0,0,1) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper (n=8,4,1,2,10) | 3.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done (n=60,49,19,15,58) | 9.53 hours per day | Standard Deviation 7.65 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related home HC services (n=0,0,0,0,1) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family (n=34,30,8,10,44) | 2.70 hours per day | Standard Deviation 2.26 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done (n=60,49,19,15,58) | 7.73 hours per day | Standard Deviation 2.4 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper (n=8,4,1,2,10) | 6.00 hours per day | Standard Deviation 1.41 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related home HC services (n=0,0,0,0,1) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA (n=6,1,0,0,1) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home HC services (n=0,0,0,0,1) | NA hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Missed work due to RA (n=6,1,0,0,1) | 4.00 hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by housekeeper (n=8,4,1,2,10) | 4.10 hours per day | Standard Deviation 2.08 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Work done (n=60,49,19,15,58) | 7.93 hours per day | Standard Deviation 3.12 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | RA related home HC services (n=0,0,0,0,1) | 1.00 hours per day | — |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Chores by family (n=34,30,8,10,44) | 2.55 hours per day | Standard Deviation 1.81 |
| Adalimumab | Number of Hours Per Day as Assessed RA-HCRU at Month 12 | Home HC services (n=0,0,0,0,1) | 1.00 hours per day | — |
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| 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=201, 199, 106, 201) | 94 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=194, 196, 106, 198) | 93 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=188, 185, 99, 190) | 100 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=174, 181, 94, 182) | 100 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=194, 196, 106, 198) | 107 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=188, 185, 99, 190) | 110 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=174, 181, 94, 182) | 100 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=201, 199, 106, 201) | 94 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=188, 185, 99, 190) | 37 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=194, 196, 106, 198) | 55 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=174, 181, 94, 182) | 46 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=201, 199, 106, 201) | 49 participants |
| Adalimumab | 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=174, 181, 94, 182) | 93 participants |
| Adalimumab | 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=194, 196, 106, 198) | 95 participants |
| Adalimumab | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 88 participants |
| Adalimumab | 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=188, 185, 99, 190) | 93 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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
| 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 | 80 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | 84 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | 28 participants |
| Adalimumab | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | 19 participants |
| Adalimumab | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12 | 75 participants |
Secondary
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 59.29 mm | Standard Deviation 20.95 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 39.71 mm | Standard Deviation 22.6 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 32.98 mm | Standard Deviation 23.09 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 179) | 30.40 mm | Standard Deviation 23.26 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 36.77 mm | Standard Deviation 22.63 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 31.27 mm | Standard Deviation 22.39 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 179) | 28.36 mm | Standard Deviation 22.52 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 59.01 mm | Standard Deviation 22.18 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 48.53 mm | Standard Deviation 23.42 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 49.92 mm | Standard Deviation 23.94 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 179) | 35.04 mm | Standard Deviation 20.95 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 55.20 mm | Standard Deviation 21.27 |
| Adalimumab | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 179) | 32.78 mm | Standard Deviation 22.57 |
| Adalimumab | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 106, 198) | 39.27 mm | Standard Deviation 24.29 |
| Adalimumab | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 56.46 mm | Standard Deviation 21.92 |
| Adalimumab | Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 36.27 mm | Standard Deviation 25.67 |
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: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 27.04 mm | Standard Deviation 21.35 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 (n=150, 150, 49, 38, 160) | 26.99 mm | Standard Deviation 21.97 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 27.99 mm | Standard Deviation 22.97 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 (n=150, 150, 49, 38, 160) | 24.55 mm | Standard Deviation 20.68 |
| Placebo | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 31.31 mm | Standard Deviation 22.66 |
| Placebo | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 (n=150, 150, 49, 38, 160) | 28.23 mm | Standard Deviation 17.86 |
| Adalimumab | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 (n=150, 150, 49, 38, 160) | 29.37 mm | Standard Deviation 20.57 |
| Adalimumab | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 24.93 mm | Standard Deviation 19.38 |
| Adalimumab | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 32.70 mm | Standard Deviation 24.18 |
| Adalimumab | Patient Assessment of Arthritis Pain at Month 9 and 12 | Month 12 (n=150, 150, 49, 38, 160) | 27.94 mm | Standard Deviation 22.7 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 59.86 mm | Standard Deviation 21.38 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 105, 197) | 41.85 mm | Standard Deviation 23.02 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 35.56 mm | Standard Deviation 23.81 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 32.79 mm | Standard Deviation 25.56 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 105, 197) | 36.61 mm | Standard Deviation 23.51 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 31.25 mm | Standard Deviation 22.23 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 29.74 mm | Standard Deviation 22.41 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 56.55 mm | Standard Deviation 23.83 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 49.84 mm | Standard Deviation 22.45 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 105, 197) | 50.70 mm | Standard Deviation 24.24 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 37.76 mm | Standard Deviation 20.86 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 54.46 mm | Standard Deviation 21.27 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 181, 46, 180) | 33.50 mm | Standard Deviation 21.97 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=194, 196, 105, 197) | 39.32 mm | Standard Deviation 23.83 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=201, 199, 106, 201) | 57.22 mm | Standard Deviation 22.22 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=188, 185, 99, 190) | 36.97 mm | Standard Deviation 25.28 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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 (n=158, 167, 49, 41, 171) | 28.39 mm | Standard Deviation 22.31 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 49, 37, 160) | 26.86 mm | Standard Deviation 22.44 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 29.47 mm | Standard Deviation 21.99 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 49, 37, 160) | 27.70 mm | Standard Deviation 22.09 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 31.78 mm | Standard Deviation 20.75 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 49, 37, 160) | 30.78 mm | Standard Deviation 17.65 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 49, 37, 160) | 29.70 mm | Standard Deviation 20.69 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 30.00 mm | Standard Deviation 20.31 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=158, 167, 49, 41, 171) | 34.38 mm | Standard Deviation 24.93 |
| Adalimumab | Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 49, 37, 160) | 30.33 mm | Standard Deviation 24.46 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
ACR20 response: \>=20% improvement in TJC; \>= 20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 1, 3
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 1 | 41.24 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 3 | 60.71 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 3 | 58.67 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 1 | 45.92 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 1 | 16.04 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 3 | 26.42 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 1 | 37.88 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3 | Month 3 | 56.28 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 9 | 49.49 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 12 | 49.49 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 9 | 50.51 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 12 | 49.49 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 9 | 30.36 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 12 | 33.93 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 12 | 34.00 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 9 | 36.00 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 9 | 47.24 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12 | Month 12 | 49.25 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 1 | 14.95 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 6 | 36.73 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 3 | 34.18 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 1 | 16.33 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 6 | 34.69 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 3 | 27.55 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 3 | 6.60 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 1 | 4.72 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 6 | 12.26 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 1 | 12.12 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 6 | 27.64 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6 | Month 3 | 23.62 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 9 | 35.71 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 12 | 36.73 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 9 | 37.24 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 12 | 35.71 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 9 | 17.86 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 12 | 21.43 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 12 | 28.00 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 9 | 26.00 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 9 | 29.15 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12 | Month 12 | 33.67 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 1 | 2.58 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 6 | 19.90 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 3 | 12.24 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 1 | 4.08 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 6 | 21.94 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 3 | 14.80 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 3 | 1.89 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 1 | 0.94 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 6 | 1.89 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 1 | 3.03 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 6 | 9.05 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6 | Month 3 | 8.54 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 9 | 18.37 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 12 | 22.96 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 9 | 21.94 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 12 | 23.47 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 9 | 8.93 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 12 | 10.71 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 12 | 14.00 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 9 | 10.00 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 9 | 11.06 percentage of participants |
| Adalimumab | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12 | Month 12 | 16.58 percentage of participants |
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Baseline, Month 1, 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=199, 199, 106, 201) | 59.92 mm | Standard Deviation 16.77 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 195, 106, 197) | 38.90 mm | Standard Deviation 18.56 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 178) | 24.97 mm | Standard Deviation 19.26 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=186, 185, 99, 189) | 30.28 mm | Standard Deviation 20.71 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 195, 106, 197) | 36.16 mm | Standard Deviation 19.27 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 178) | 24.46 mm | Standard Deviation 19.78 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=186, 185, 99, 189) | 29.91 mm | Standard Deviation 21.04 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=199, 199, 106, 201) | 59.56 mm | Standard Deviation 16.7 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=199, 199, 106, 201) | 60.28 mm | Standard Deviation 16.55 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 178) | 29.76 mm | Standard Deviation 20.43 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=186, 185, 99, 189) | 45.12 mm | Standard Deviation 22.77 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 195, 106, 197) | 50.73 mm | Standard Deviation 22.08 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 6 (n=174, 180, 46, 178) | 27.77 mm | Standard Deviation 18.36 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Baseline (n=199, 199, 106, 201) | 58.64 mm | Standard Deviation 15.98 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 1 (n=193, 195, 106, 197) | 38.81 mm | Standard Deviation 20.08 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6 | Month 3 (n=186, 185, 99, 189) | 32.40 mm | Standard Deviation 21.08 |
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Month 9, 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 48, 38, 157) | 18.67 mm | Standard Deviation 16.18 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 170) | 19.93 mm | Standard Deviation 16.2 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 170) | 21.92 mm | Standard Deviation 17.87 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 48, 38, 157) | 18.87 mm | Standard Deviation 16.05 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 48, 38, 157) | 19.77 mm | Standard Deviation 13.88 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 170) | 25.82 mm | Standard Deviation 20.32 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 170) | 23.78 mm | Standard Deviation 15.54 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 48, 38, 157) | 20.68 mm | Standard Deviation 14.51 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 9 (n=160, 167, 49, 41, 170) | 25.45 mm | Standard Deviation 19.94 |
| Adalimumab | Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12 | Month 12 (n=149, 150, 48, 38, 157) | 20.44 mm | Standard Deviation 16.94 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Baseline, Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | PDS (n=55, 52, 18, 14, 58) | 54.35 units on a scale | Standard Deviation 32.96 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | MIDS (n=55, 51, 21, 14, 58) | 14.72 units on a scale | Standard Deviation 19.96 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | WLI (n=57, 55, 21, 14, 60) | 6.61 units on a scale | Standard Deviation 5.07 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | ODS (n=57, 50, 19, 14, 58) | 20.51 units on a scale | Standard Deviation 23.13 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | TMS (n=55, 53, 20, 14, 57) | 25.59 units on a scale | Standard Deviation 25.1 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | MIDS (n=55, 51, 21, 14, 58) | 13.96 units on a scale | Standard Deviation 23.76 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | TMS (n=55, 53, 20, 14, 57) | 20.77 units on a scale | Standard Deviation 28.68 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | PDS (n=55, 52, 18, 14, 58) | 55.69 units on a scale | Standard Deviation 38.22 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | ODS (n=57, 50, 19, 14, 58) | 17.35 units on a scale | Standard Deviation 27.77 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | WLI (n=57, 55, 21, 14, 60) | 5.78 units on a scale | Standard Deviation 5.59 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | WLI (n=57, 55, 21, 14, 60) | 7.75 units on a scale | Standard Deviation 6.53 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | PDS (n=55, 52, 18, 14, 58) | 51.81 units on a scale | Standard Deviation 32.57 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | MIDS (n=55, 51, 21, 14, 58) | 21.46 units on a scale | Standard Deviation 27.11 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | ODS (n=57, 50, 19, 14, 58) | 27.11 units on a scale | Standard Deviation 27.29 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | TMS (n=55, 53, 20, 14, 57) | 32.69 units on a scale | Standard Deviation 29.07 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | PDS (n=55, 52, 18, 14, 58) | 59.02 units on a scale | Standard Deviation 36.59 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | MIDS (n=55, 51, 21, 14, 58) | 19.44 units on a scale | Standard Deviation 24.29 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | TMS (n=55, 53, 20, 14, 57) | 28.75 units on a scale | Standard Deviation 28.26 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | WLI (n=57, 55, 21, 14, 60) | 8.06 units on a scale | Standard Deviation 6.01 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | ODS (n=57, 50, 19, 14, 58) | 25.36 units on a scale | Standard Deviation 29.64 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | ODS (n=57, 50, 19, 14, 58) | 21.55 units on a scale | Standard Deviation 22.63 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | WLI (n=57, 55, 21, 14, 60) | 6.85 units on a scale | Standard Deviation 5.21 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | MIDS (n=55, 51, 21, 14, 58) | 17.99 units on a scale | Standard Deviation 20.1 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | TMS (n=55, 53, 20, 14, 57) | 26.57 units on a scale | Standard Deviation 26.68 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12 | PDS (n=55, 52, 18, 14, 58) | 50.41 units on a scale | Standard Deviation 33.98 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Month 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: TMS (n=79, 77, 40, 76) | 41.46 units on a scale | Standard Deviation 23.42 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: TMS (n=68, 65, 16, 67) | 29.87 units on a scale | Standard Deviation 26.81 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: ODS (n=75, 70, 39, 76) | 26.64 units on a scale | Standard Deviation 23.61 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: MIDS (n=82, 79, 41, 77) | 26.80 units on a scale | Standard Deviation 22.8 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: WLI (n=80, 74, 41, 78) | 7.89 units on a scale | Standard Deviation 5.12 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: PDS (n=66, 65, 15, 71) | 55.62 units on a scale | Standard Deviation 30.05 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: ODS (n=80, 74, 40, 77) | 36.34 units on a scale | Standard Deviation 26.55 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: PDS (n=85, 76, 40, 77) | 49.99 units on a scale | Standard Deviation 23.16 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: ODS (n=67, 67, 16, 69) | 23.18 units on a scale | Standard Deviation 25.53 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: WLI (n=85, 81, 42, 81) | 9.76 units on a scale | Standard Deviation 5.34 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: TMS (n=74, 68, 40, 70) | 31.31 units on a scale | Standard Deviation 25.5 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: MIDS (n=70, 68, 16, 71) | 17.50 units on a scale | Standard Deviation 21.18 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: PDS (n=77, 72, 39, 76) | 53.03 units on a scale | Standard Deviation 26.21 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: WLI (n= 70, 69, 16, 73) | 7.32 units on a scale | Standard Deviation 5.47 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: MIDS (n=78, 72, 41, 73) | 21.45 units on a scale | Standard Deviation 22.03 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: MIDS (n=78, 72, 41, 73) | 15.14 units on a scale | Standard Deviation 20.53 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: TMS (n=68, 65, 16, 67) | 21.30 units on a scale | Standard Deviation 27.67 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: WLI (n=85, 81, 42, 81) | 9.85 units on a scale | Standard Deviation 5.67 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: ODS (n=75, 70, 39, 76) | 19.31 units on a scale | Standard Deviation 23.89 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: PDS (n=85, 76, 40, 77) | 52.14 units on a scale | Standard Deviation 24.22 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: PDS (n=66, 65, 15, 71) | 53.57 units on a scale | Standard Deviation 36.13 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: MIDS (n=70, 68, 16, 71) | 12.87 units on a scale | Standard Deviation 22.77 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: WLI (n=80, 74, 41, 78) | 5.92 units on a scale | Standard Deviation 5.17 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: MIDS (n=82, 79, 41, 77) | 27.30 units on a scale | Standard Deviation 22.32 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: PDS (n=77, 72, 39, 76) | 47.04 units on a scale | Standard Deviation 33.97 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: WLI (n= 70, 69, 16, 73) | 5.69 units on a scale | Standard Deviation 5.54 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: ODS (n=67, 67, 16, 69) | 16.44 units on a scale | Standard Deviation 23.79 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: TMS (n=74, 68, 40, 70) | 21.97 units on a scale | Standard Deviation 25.52 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: ODS (n=80, 74, 40, 77) | 37.29 units on a scale | Standard Deviation 28.16 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: TMS (n=79, 77, 40, 76) | 42.09 units on a scale | Standard Deviation 28.98 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: MIDS (n=78, 72, 41, 73) | 23.20 units on a scale | Standard Deviation 26.04 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: TMS (n=79, 77, 40, 76) | 37.65 units on a scale | Standard Deviation 23.69 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: PDS (n=85, 76, 40, 77) | 53.24 units on a scale | Standard Deviation 23.62 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: MIDS (n=82, 79, 41, 77) | 24.85 units on a scale | Standard Deviation 28.33 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: ODS (n=80, 74, 40, 77) | 29.28 units on a scale | Standard Deviation 26.41 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: WLI (n=85, 81, 42, 81) | 8.83 units on a scale | Standard Deviation 5.9 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: TMS (n=74, 68, 40, 70) | 34.26 units on a scale | Standard Deviation 26.4 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: PDS (n=77, 72, 39, 76) | 55.57 units on a scale | Standard Deviation 27.38 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: ODS (n=75, 70, 39, 76) | 27.44 units on a scale | Standard Deviation 25.18 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: WLI (n=80, 74, 41, 78) | 8.39 units on a scale | Standard Deviation 5.73 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: PDS (n=66, 65, 15, 71) | 55.03 units on a scale | Standard Deviation 29.84 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: TMS (n=68, 65, 16, 67) | 24.53 units on a scale | Standard Deviation 24.19 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: MIDS (n=70, 68, 16, 71) | 18.26 units on a scale | Standard Deviation 23.15 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: ODS (n=67, 67, 16, 69) | 19.69 units on a scale | Standard Deviation 20.77 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: WLI (n= 70, 69, 16, 73) | 6.89 units on a scale | Standard Deviation 4.9 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: PDS (n=77, 72, 39, 76) | 54.38 units on a scale | Standard Deviation 28.15 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: PDS (n=85, 76, 40, 77) | 44.51 units on a scale | Standard Deviation 21.15 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: TMS (n=68, 65, 16, 67) | 29.70 units on a scale | Standard Deviation 25.24 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: TMS (n=74, 68, 40, 70) | 35.73 units on a scale | Standard Deviation 28.5 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: WLI (n=85, 81, 42, 81) | 9.92 units on a scale | Standard Deviation 5.01 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: TMS (n=79, 77, 40, 76) | 46.43 units on a scale | Standard Deviation 25.94 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: MIDS (n=70, 68, 16, 71) | 22.61 units on a scale | Standard Deviation 22.38 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: ODS (n=80, 74, 40, 77) | 36.82 units on a scale | Standard Deviation 22.71 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Baseline: MIDS (n=82, 79, 41, 77) | 28.45 units on a scale | Standard Deviation 23.77 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: WLI (n= 70, 69, 16, 73) | 7.84 units on a scale | Standard Deviation 5.04 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: WLI (n=80, 74, 41, 78) | 8.23 units on a scale | Standard Deviation 5.47 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: ODS (n=75, 70, 39, 76) | 26.57 units on a scale | Standard Deviation 22.5 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: ODS (n=67, 67, 16, 69) | 25.82 units on a scale | Standard Deviation 22.93 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 6: PDS (n=66, 65, 15, 71) | 52.17 units on a scale | Standard Deviation 28.69 |
| Adalimumab | Work Limitations Questionnaire (WLQ) Score at Month 3 and 6 | Month 3: MIDS (n=78, 72, 41, 73) | 22.64 units on a scale | Standard Deviation 21.97 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Month 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| 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 | Baseline (n=139,141,83,142) | 4.16 units on a scale | Standard Deviation 3.05 |
| 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=125,125,35,127) | 2.31 units on a scale | Standard Deviation 2.51 |
| 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=137,129,76,139) | 2.68 units on a scale | Standard Deviation 2.75 |
| 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=139,141,83,142) | 4.16 units on a scale | Standard Deviation 3.33 |
| 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=125,125,35,127) | 2.39 units on a scale | Standard Deviation 2.84 |
| 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=137,129,76,139) | 2.81 units on a scale | Standard Deviation 2.89 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3 (n=137,129,76,139) | 3.38 units on a scale | Standard Deviation 2.84 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline (n=139,141,83,142) | 4.08 units on a scale | Standard Deviation 3.32 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6 (n=125,125,35,127) | 2.17 units on a scale | Standard Deviation 2.64 |
| Adalimumab | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Baseline (n=139,141,83,142) | 4.19 units on a scale | Standard Deviation 3.09 |
| Adalimumab | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 6 (n=125,125,35,127) | 2.66 units on a scale | Standard Deviation 2.54 |
| Adalimumab | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 | Month 3 (n=137,129,76,139) | 3.09 units on a scale | Standard Deviation 2.81 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Time frame: Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
| 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 | 2.18 units on a scale | Standard Deviation 2.65 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | 1.92 units on a scale | Standard Deviation 2.5 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | 2.69 units on a scale | Standard Deviation 2.66 |
| Adalimumab | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | 2.23 units on a scale | Standard Deviation 3.02 |
| Adalimumab | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12 | 1.93 units on a scale | Standard Deviation 2.45 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time frame: Baseline, Month 3, 6
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Feel well enough to work (n=74,79,41,80) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Currently employed (n=185,185,99,190) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Part time work (n=169,166,92,167) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Chores by family (n=172,180,46,180) | 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: Seen NM practitioner (n=185,185,99,190) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Required aids/devices (n=185,185,99,190) | 1.94 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Performed paid work(n=169,166,91,167) | 1.69 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Lost job/retired early (n=70,82,22,72) | 1.57 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: Home HC services (n=184,185,99,190) | 1.99 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: In nursing home (n=185,185,99,190) | 1.99 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to do chores (n=201,199,105,198) | 1.41 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Retired (n=77,87,22,82) | 1.32 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Diagnostic tests (n=184,185,99,190) | 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 3: Outpatient surgeries (n=185,185,99,190) | 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 | Baseline: Chores by housekeeper(n=201,199,106,201) | 1.89 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 | Baseline: Diagnostic tests (n=200,199,106,200) | 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: Hospitalization (n=185,185,99,190) | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Admitted overnight stay (n=8,8,4,9) | 0.25 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Chores by family (n=200,199,106,201) | 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 | Month 6: Unable to do chores(n=171,178,45,175) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Treated in ER (n=186,185,99,190) | 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: Seen any doctor (n=186,185,99,190) | 1.27 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 6: Feel well enough to work (72,81,23,76) | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Currently employed (n=173,180,46,179) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: In nursing home (n=201, 199, 106, 201) | 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 6: Performed paid work (n=136,136,38,142) | 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 | Month 6: Seen NM practitioner (n=173,180,45,178) | 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: Required aids/devices (n=173,180,46,178) | 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 | Baseline: Home HC services (n=201, 198, 106, 201) | 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: Admitted overnight stay (n=11,14,6,12) | 0.45 units on a scale | Standard Deviation 0.82 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Home HC services (n=173,180,46,177) | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: In nursing home (n=173,180,46,178) | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices (n=201,199,106,201) | 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 | Baseline: Seen any doctor (n=201, 199, 106, 201) | 1.16 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 | Month 6: Diagnostic tests (n=173,180,46,178) | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Outpatient surgeries (n=173,180,46,178) | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen NM practitioner (n=201,199,106,201) | 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 6: Chores by housekeeper (n=172,180,45,180) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Hospitalization (n=172,180,46,179) | 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 | Month 6: Admitted overnight stay (n=12,6,4,3) | 0.58 units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Currently employed (n=201,199,106,201) | 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 6: Part time work (n=135,134,37,142) | 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 6: Treated in ER (n=173,180,46,179) | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Seen any doctor (n=173,180,45,179) | 1.25 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: Feel well enough to work (n=73,83,39,81) | 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: Sick leave due to RA (n=138,134,38,144) | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Chores by family (n=183,183,99,190) | 1.67 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Chores by housekeeper (n=184,183,99,190) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Retired (n=80,88,45,89) | 1.41 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: Hospitalization (n=201, 199, 106, 201) | 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: Unable to do chores(n=182,182,99,189) | 1.62 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: Performed paid work(n=153,145,85,157) | 1.73 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 | Baseline: Lost job/retired early(n=66,82,39,81) | 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: Treated in ER (n=201, 199, 106, 201) | 1.95 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Part time work (n=153,145,85,155) | 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 3: Sick leave due to RA (n=153,146,85,157) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to work due to RA (n=76,84,40,78) | 1.36 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: Work disabled due to RA (n=67,80,22,72) | 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: Work disabled due to RA (n=71,82,41,73) | 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 3: Unable to work due to RA (n=76,83,44,77) | 1.42 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: Work disabled due to RA (n=66,82,40,79) | 1.56 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: Unable to work due to RA (n=73,83,23,74) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Lost job/retired early(n=73,78,40,79) | 1.55 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=80,86,47,86) | 1.39 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Sick leave due to RA (n=167,166,92,167) | 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: Outpatient surgeries (n=200,199,106,201) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices (n=201,199,106,201) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen any doctor (n=201, 199, 106, 201) | 1.13 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 | Baseline: Treated in ER (n=201, 199, 106, 201) | 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 | Baseline: Admitted overnight stay (n=11,14,6,12) | 0.21 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: Hospitalization (n=201, 199, 106, 201) | 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 | Baseline: Outpatient surgeries (n=200,199,106,201) | 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 | Baseline: Diagnostic tests (n=200,199,106,200) | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: In nursing home (n=201, 199, 106, 201) | 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: Home HC services (n=201, 198, 106, 201) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen NM practitioner (n=201,199,106,201) | 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 | Baseline: Currently employed (n=201,199,106,201) | 1.65 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: Feel well enough to work (n=73,83,39,81) | 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 | Baseline: Retired (n=80,88,45,89) | 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 | Baseline: Lost job/retired early(n=66,82,39,81) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to work due to RA (n=76,84,40,78) | 1.37 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Work disabled due to RA (n=66,82,40,79) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Sick leave due to RA (n=167,166,92,167) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Part time work (n=169,166,92,167) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Performed paid work(n=169,166,91,167) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to do chores (n=201,199,105,198) | 1.46 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper(n=201,199,106,201) | 1.90 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: Chores by family (n=200,199,106,201) | 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 3: Seen any doctor (n=186,185,99,190) | 1.28 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: Treated in ER (n=186,185,99,190) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Admitted overnight stay (n=8,8,4,9) | 0.88 units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Hospitalization (n=185,185,99,190) | 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 | Month 3: Outpatient surgeries (n=185,185,99,190) | 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 3: Diagnostic tests (n=184,185,99,190) | 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: In nursing home (n=185,185,99,190) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Home HC services (n=184,185,99,190) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Required aids/devices (n=185,185,99,190) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Seen NM practitioner (n=185,185,99,190) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Currently employed (n=185,185,99,190) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Feel well enough to work (n=74,79,41,80) | 1.73 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Retired (n=80,86,47,86) | 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: Lost job/retired early(n=73,78,40,79) | 1.59 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Unable to work due to RA (n=76,83,44,77) | 1.46 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: Work disabled due to RA (n=71,82,41,73) | 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 | Month 3: Sick leave due to RA (n=153,146,85,157) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Part time work (n=153,145,85,155) | 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 | Month 3: Performed paid work(n=153,145,85,157) | 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 3: Unable to do chores(n=182,182,99,189) | 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: Chores by housekeeper (n=184,183,99,190) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Chores by family (n=183,183,99,190) | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Seen any doctor (n=173,180,45,179) | 1.28 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 6: Treated in ER (n=173,180,46,179) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Admitted overnight stay (n=12,6,4,3) | 0.17 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Hospitalization (n=172,180,46,179) | 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 | Month 6: Outpatient surgeries (n=173,180,46,178) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Diagnostic tests (n=173,180,46,178) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: In nursing home (n=173,180,46,178) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Home HC services (n=173,180,46,177) | 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: Required aids/devices (n=173,180,46,178) | 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: Seen NM practitioner (n=173,180,45,178) | 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 6: Currently employed (n=173,180,46,179) | 1.66 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Feel well enough to work (72,81,23,76) | 1.77 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Retired (n=77,87,22,82) | 1.30 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 6: Lost job/retired early (n=70,82,22,72) | 1.66 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Unable to work due to RA (n=73,83,23,74) | 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: Work disabled due to RA (n=67,80,22,72) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Sick leave due to RA (n=138,134,38,144) | 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 | Month 6: Part time work (n=135,134,37,142) | 1.96 units on a scale | Standard Deviation 0.21 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Performed paid work (n=136,136,38,142) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Unable to do chores(n=171,178,45,175) | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=172,180,45,180) | 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: Chores by family (n=172,180,46,180) | 1.74 units on a scale | Standard Deviation 0.44 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Retired (n=80,88,45,89) | 1.40 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Feel well enough to work (n=74,79,41,80) | 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: Retired (n=80,86,47,86) | 1.38 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Work disabled due to RA (n=66,82,40,79) | 1.70 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Lost job/retired early(n=73,78,40,79) | 1.75 units on a scale | Standard Deviation 0.44 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Unable to work due to RA (n=73,83,23,74) | 1.48 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 work due to RA (n=76,83,44,77) | 1.45 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to work due to RA (n=76,84,40,78) | 1.45 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Work disabled due to RA (n=71,82,41,73) | 1.61 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Hospitalization (n=201, 199, 106, 201) | 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: Sick leave due to RA (n=153,146,85,157) | 1.81 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Lost job/retired early(n=66,82,39,81) | 1.74 units on a scale | Standard Deviation 0.44 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Chores by family (n=172,180,46,180) | 1.67 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Part time work (n=153,145,85,155) | 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: Work disabled due to RA (n=67,80,22,72) | 1.73 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Performed paid work(n=153,145,85,157) | 1.68 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Sick leave due to RA (n=167,166,92,167) | 1.84 units on a scale | Standard Deviation 0.37 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Unable to do chores(n=182,182,99,189) | 1.59 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=184,183,99,190) | 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: Feel well enough to work (n=73,83,39,81) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=172,180,45,180) | 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 (n=183,183,99,190) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Sick leave due to RA (n=138,134,38,144) | 1.92 units on a scale | Standard Deviation 0.27 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Seen any doctor (n=173,180,45,179) | 1.27 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Currently employed (n=201,199,106,201) | 1.64 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Treated in ER (n=173,180,46,179) | 1.91 units on a scale | Standard Deviation 0.28 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Admitted overnight stay (n=11,14,6,12) | 0.17 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Admitted overnight stay (n=12,6,4,3) | 0.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen NM practitioner (n=201,199,106,201) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Hospitalization (n=172,180,46,179) | 1.96 units on a scale | Standard Deviation 0.21 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Part time work (n=135,134,37,142) | 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: Outpatient surgeries (n=173,180,46,178) | 1.98 units on a scale | Standard Deviation 0.15 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices (n=201,199,106,201) | 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: Diagnostic tests (n=173,180,46,178) | 1.89 units on a scale | Standard Deviation 0.31 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: In nursing home (n=173,180,46,178) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Home HC services (n=201, 198, 106, 201) | 1.99 units on a scale | Standard Deviation 0.1 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen any doctor (n=201, 199, 106, 201) | 1.15 units on a scale | Standard Deviation 0.36 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Home HC services (n=173,180,46,177) | 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: Performed paid work (n=136,136,38,142) | 1.74 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Required aids/devices (n=173,180,46,178) | 1.87 units on a scale | Standard Deviation 0.34 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: In nursing home (n=201, 199, 106, 201) | 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: Seen NM practitioner (n=173,180,45,178) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Treated in ER (n=201, 199, 106, 201) | 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 6: Currently employed (n=173,180,46,179) | 1.63 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Diagnostic tests (n=200,199,106,200) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Seen any doctor (n=186,185,99,190) | 1.22 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Chores by family (n=200,199,106,201) | 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 3: Treated in ER (n=186,185,99,190) | 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: Feel well enough to work (72,81,23,76) | 1.83 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Admitted overnight stay (n=8,8,4,9) | 0.00 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=201,199,106,201) | 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: Hospitalization (n=185,185,99,190) | 1.99 units on a scale | Standard Deviation 0.1 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Outpatient surgeries (n=185,185,99,190) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to do chores (n=201,199,105,198) | 1.53 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Unable to do chores(n=171,178,45,175) | 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 3: Diagnostic tests (n=184,185,99,190) | 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 6: Retired (n=77,87,22,82) | 1.32 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: In nursing home (n=185,185,99,190) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Performed paid work(n=169,166,91,167) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Home HC services (n=184,185,99,190) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Outpatient surgeries (n=200,199,106,201) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Required aids/devices (n=185,185,99,190) | 1.92 units on a scale | Standard Deviation 0.27 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Part time work (n=169,166,92,167) | 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: Seen NM practitioner (n=185,185,99,190) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Lost job/retired early (n=70,82,22,72) | 1.68 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=185,185,99,190) | 1.63 units on a scale | Standard Deviation 0.49 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Admitted overnight stay (n=8,8,4,9) | 0.22 units on a scale | Standard Deviation 0.44 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Lost job/retired early (n=70,82,22,72) | 1.67 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Diagnostic tests (n=173,180,46,178) | 1.89 units on a scale | Standard Deviation 0.31 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Feel well enough to work (n=74,79,41,80) | 1.74 units on a scale | Standard Deviation 0.44 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Work disabled due to RA (n=66,82,40,79) | 1.65 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Hospitalization (n=201, 199, 106, 201) | 1.95 units on a scale | Standard Deviation 0.23 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Home HC services (n=201, 198, 106, 201) | 1.99 units on a scale | Standard Deviation 0.12 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Retired (n=80,86,47,86) | 1.38 units on a scale | Standard Deviation 0.49 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Treated in ER (n=201, 199, 106, 201) | 1.94 units on a scale | Standard Deviation 0.25 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen any doctor (n=201, 199, 106, 201) | 1.15 units on a scale | Standard Deviation 0.36 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Sick leave due to RA (n=167,166,92,167) | 1.83 units on a scale | Standard Deviation 0.38 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Lost job/retired early(n=73,78,40,79) | 1.65 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to work due to RA (n=76,84,40,78) | 1.37 units on a scale | Standard Deviation 0.49 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: In nursing home (n=173,180,46,178) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Feel well enough to work (72,81,23,76) | 1.71 units on a scale | Standard Deviation 0.46 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Unable to work due to RA (n=76,83,44,77) | 1.58 units on a scale | Standard Deviation 0.5 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Retired (n=77,87,22,82) | 1.35 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Unable to work due to RA (n=73,83,23,74) | 1.57 units on a scale | Standard Deviation 0.5 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Hospitalization (n=185,185,99,190) | 1.98 units on a scale | Standard Deviation 0.12 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Work disabled due to RA (n=71,82,41,73) | 1.74 units on a scale | Standard Deviation 0.44 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Lost job/retired early(n=66,82,39,81) | 1.57 units on a scale | Standard Deviation 0.5 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Home HC services (n=173,180,46,177) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: In nursing home (n=201, 199, 106, 201) | 1.98 units on a scale | Standard Deviation 0.14 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Sick leave due to RA (n=153,146,85,157) | 1.90 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Unable to do chores (n=201,199,105,198) | 1.41 units on a scale | Standard Deviation 0.49 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Outpatient surgeries (n=200,199,106,201) | 1.97 units on a scale | Standard Deviation 0.18 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Required aids/devices (n=173,180,46,178) | 1.92 units on a scale | Standard Deviation 0.27 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Part time work (n=153,145,85,155) | 1.94 units on a scale | Standard Deviation 0.25 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Retired (n=80,88,45,89) | 1.39 units on a scale | Standard Deviation 0.49 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Unable to do chores(n=171,178,45,175) | 1.67 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Performed paid work (n=136,136,38,142) | 1.76 units on a scale | Standard Deviation 0.43 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Performed paid work(n=153,145,85,157) | 1.70 units on a scale | Standard Deviation 0.46 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Outpatient surgeries (n=185,185,99,190) | 1.97 units on a scale | Standard Deviation 0.18 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Work disabled due to RA (n=67,80,22,72) | 1.72 units on a scale | Standard Deviation 0.45 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Seen NM practitioner (n=173,180,45,178) | 1.99 units on a scale | Standard Deviation 0.07 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Unable to do chores(n=182,182,99,189) | 1.66 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Feel well enough to work (n=73,83,39,81) | 1.80 units on a scale | Standard Deviation 0.4 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Admitted overnight stay (n=11,14,6,12) | 0.08 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Diagnostic tests (n=200,199,106,200) | 1.82 units on a scale | Standard Deviation 0.39 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Chores by housekeeper (n=184,183,99,190) | 1.94 units on a scale | Standard Deviation 0.24 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Home HC services (n=184,185,99,190) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Part time work (n=169,166,92,167) | 1.94 units on a scale | Standard Deviation 0.24 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Currently employed (n=173,180,46,179) | 1.63 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Chores by family (n=183,183,99,190) | 1.68 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Currently employed (n=201,199,106,201) | 1.65 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Chores by family (n=200,199,106,201) | 1.51 units on a scale | Standard Deviation 0.5 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Currently employed (n=185,185,99,190) | 1.64 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Seen any doctor (n=173,180,45,179) | 1.31 units on a scale | Standard Deviation 0.46 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Diagnostic tests (n=184,185,99,190) | 1.89 units on a scale | Standard Deviation 0.31 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Sick leave due to RA (n=138,134,38,144) | 1.94 units on a scale | Standard Deviation 0.24 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Seen any doctor (n=186,185,99,190) | 1.29 units on a scale | Standard Deviation 0.45 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Treated in ER (n=173,180,46,179) | 1.98 units on a scale | Standard Deviation 0.15 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Seen NM practitioner (n=201,199,106,201) | 1.97 units on a scale | Standard Deviation 0.17 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Performed paid work(n=169,166,91,167) | 1.67 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Chores by family (n=172,180,46,180) | 1.71 units on a scale | Standard Deviation 0.45 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Admitted overnight stay (n=12,6,4,3) | 0.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Seen NM practitioner (n=185,185,99,190) | 1.98 units on a scale | Standard Deviation 0.12 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Chores by housekeeper (n=172,180,45,180) | 1.96 units on a scale | Standard Deviation 0.19 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Treated in ER (n=186,185,99,190) | 1.95 units on a scale | Standard Deviation 0.22 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Hospitalization (n=172,180,46,179) | 1.99 units on a scale | Standard Deviation 0.07 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline:Required aids/devices (n=201,199,106,201) | 1.91 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Baseline: Chores by housekeeper(n=201,199,106,201) | 1.91 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: Required aids/devices (n=185,185,99,190) | 1.92 units on a scale | Standard Deviation 0.28 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Outpatient surgeries (n=173,180,46,178) | 1.99 units on a scale | Standard Deviation 0.11 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 3: In nursing home (n=185,185,99,190) | 1.99 units on a scale | Standard Deviation 0.1 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 | Month 6: Part time work (n=135,134,37,142) | 1.95 units on a scale | Standard Deviation 0.22 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Time frame: Month 12
Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER (n=149,151,49,38,160) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Feel well enough to work (n=61,79,19,19,76) | 1.72 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Part time work (n=117,112,37,30,123) | 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 | Diagnostic tests (n=149,151,49,38,159) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed (n=148,151,49,38,160) | 1.59 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted overnight stay (n=3,5,0,1,6) | 0.33 units on a scale | Standard Deviation 0.58 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores (n=146,150,47,38,154) | 1.81 units on a scale | Standard Deviation 0.4 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA (n=118,112,37,30,124) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home (n=149,151,49,38,159) | 1.99 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization (n=148,151,49,38,160) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early (n=58,75,19,18,75) | 1.53 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 (n=145,151,49,38,160) | 1.76 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=58,76,19,18,75) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home HC services (n=148,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired (n=64,84,21,19,80) | 1.25 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work (n=118,114,37,31,123) | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Outpatient surgeries (n=148,151,49,38,160) | 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 | Unable to work due to RA (n=59,77,19,19,77) | 1.56 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices (n=148,151,49,38,160) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen NM practitioner(n=149,151,49,38,160) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper (n=148,151,49,38,160) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor (n=148,151,49,38,160) | 1.31 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA (n=59,77,19,19,77) | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen NM practitioner(n=149,151,49,38,160) | 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 | Retired (n=64,84,21,19,80) | 1.31 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed (n=148,151,49,38,160) | 1.68 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted overnight stay (n=3,5,0,1,6) | 0.20 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Feel well enough to work (n=61,79,19,19,76) | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family (n=145,151,49,38,160) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores (n=146,150,47,38,154) | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization (n=148,151,49,38,160) | 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=118,114,37,31,123) | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Outpatient surgeries (n=148,151,49,38,160) | 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 | Part time work (n=117,112,37,30,123) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic tests (n=149,151,49,38,159) | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER (n=149,151,49,38,160) | 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 | Sick leave due to RA (n=118,112,37,30,124) | 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 | In nursing home (n=149,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor (n=148,151,49,38,160) | 1.27 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA (n=58,76,19,18,75) | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home HC services (n=148,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper (n=148,151,49,38,160) | 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 | Lost job/retired early (n=58,75,19,18,75) | 1.72 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices (n=148,151,49,38,160) | 1.92 units on a scale | Standard Deviation 0.27 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA (n=118,112,37,30,124) | 1.95 units on a scale | Standard Deviation 0.23 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor (n=148,151,49,38,160) | 1.24 units on a scale | Standard Deviation 0.43 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER (n=149,151,49,38,160) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted overnight stay (n=3,5,0,1,6) | NA units on a scale | — |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization (n=148,151,49,38,160) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Outpatient surgeries (n=148,151,49,38,160) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic tests (n=149,151,49,38,159) | 1.88 units on a scale | Standard Deviation 0.33 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home (n=149,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home HC services (n=148,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices (n=148,151,49,38,160) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen NM practitioner(n=149,151,49,38,160) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed (n=148,151,49,38,160) | 1.61 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Feel well enough to work (n=61,79,19,19,76) | 1.84 units on a scale | Standard Deviation 0.37 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired (n=64,84,21,19,80) | 1.19 units on a scale | Standard Deviation 0.4 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early (n=58,75,19,18,75) | 1.68 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA (n=59,77,19,19,77) | 1.58 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA (n=58,76,19,18,75) | 1.79 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Part time work (n=117,112,37,30,123) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work (n=118,114,37,31,123) | 1.78 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores (n=146,150,47,38,154) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper (n=148,151,49,38,160) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family (n=145,151,49,38,160) | 1.84 units on a scale | Standard Deviation 0.37 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen NM practitioner(n=149,151,49,38,160) | 1.95 units on a scale | Standard Deviation 0.23 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family (n=145,151,49,38,160) | 1.71 units on a scale | Standard Deviation 0.46 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices (n=148,151,49,38,160) | 1.92 units on a scale | Standard Deviation 0.27 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early (n=58,75,19,18,75) | 1.78 units on a scale | Standard Deviation 0.43 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home HC services (n=148,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper (n=148,151,49,38,160) | 1.95 units on a scale | Standard Deviation 0.23 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA (n=59,77,19,19,77) | 1.58 units on a scale | Standard Deviation 0.51 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home (n=149,151,49,38,159) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA (n=58,76,19,18,75) | 1.67 units on a scale | Standard Deviation 0.49 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic tests (n=149,151,49,38,159) | 1.84 units on a scale | Standard Deviation 0.37 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA (n=118,112,37,30,124) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Outpatient surgeries (n=148,151,49,38,160) | 1.95 units on a scale | Standard Deviation 0.23 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Part time work (n=117,112,37,30,123) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization (n=148,151,49,38,160) | 1.97 units on a scale | Standard Deviation 0.16 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor (n=148,151,49,38,160) | 1.24 units on a scale | Standard Deviation 0.43 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work (n=118,114,37,31,123) | 1.71 units on a scale | Standard Deviation 0.46 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted overnight stay (n=3,5,0,1,6) | 0.00 units on a scale | — |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores (n=146,150,47,38,154) | 1.84 units on a scale | Standard Deviation 0.37 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Feel well enough to work (n=61,79,19,19,76) | 1.84 units on a scale | Standard Deviation 0.37 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed (n=148,151,49,38,160) | 1.61 units on a scale | Standard Deviation 0.5 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER (n=149,151,49,38,160) | 1.97 units on a scale | Standard Deviation 0.16 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired (n=64,84,21,19,80) | 1.53 units on a scale | Standard Deviation 0.51 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Currently employed (n=148,151,49,38,160) | 1.64 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Part time work (n=117,112,37,30,123) | 1.99 units on a scale | Standard Deviation 0.09 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Hospitalization (n=148,151,49,38,160) | 1.98 units on a scale | Standard Deviation 0.14 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Treated in ER (n=149,151,49,38,160) | 1.96 units on a scale | Standard Deviation 0.19 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Lost job/retired early (n=58,75,19,18,75) | 1.67 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Home HC services (n=148,151,49,38,159) | 1.99 units on a scale | Standard Deviation 0.08 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Retired (n=64,84,21,19,80) | 1.35 units on a scale | Standard Deviation 0.48 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Feel well enough to work (n=61,79,19,19,76) | 1.68 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Performed paid work (n=118,114,37,31,123) | 1.82 units on a scale | Standard Deviation 0.38 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to work due to RA (n=59,77,19,19,77) | 1.57 units on a scale | Standard Deviation 0.5 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | In nursing home (n=149,151,49,38,159) | 1.99 units on a scale | Standard Deviation 0.08 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Admitted overnight stay (n=3,5,0,1,6) | 0.17 units on a scale | Standard Deviation 0.41 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by housekeeper (n=148,151,49,38,160) | 1.93 units on a scale | Standard Deviation 0.25 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Required aids/devices (n=148,151,49,38,160) | 1.91 units on a scale | Standard Deviation 0.29 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Work disabled due to RA (n=58,76,19,18,75) | 1.67 units on a scale | Standard Deviation 0.47 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Diagnostic tests (n=149,151,49,38,159) | 1.86 units on a scale | Standard Deviation 0.35 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Chores by family (n=145,151,49,38,160) | 1.71 units on a scale | Standard Deviation 0.45 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen NM practitioner(n=149,151,49,38,160) | 2.00 units on a scale | Standard Deviation 0 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Sick leave due to RA (n=118,112,37,30,124) | 1.97 units on a scale | Standard Deviation 0.18 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Outpatient surgeries (n=148,151,49,38,160) | 1.97 units on a scale | Standard Deviation 0.17 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Unable to do chores (n=146,150,47,38,154) | 1.73 units on a scale | Standard Deviation 0.45 |
| Adalimumab | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12 | Seen any doctor (n=148,151,49,38,160) | 1.23 units on a scale | Standard Deviation 0.42 |