Arthritis, Rheumatoid
Conditions
Keywords
oral JAK inhibitor, MTX, DMARD, clinical trial, joint diseases, autoimmune diseases, anti-Inflammatory agents, rheumatic diseases
Brief summary
This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.
Interventions
DRUGCP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months
DRUGDisease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 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 99 Years
Healthy volunteers
No
Inclusion criteria
* Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate. * Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria. * Active disease as defined by both \>=6 tender or painful joints on motion and \>= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL
Exclusion criteria
* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L * History of any other rheumatic autoimmune disease other than Sjogren's syndrome * No malignancy or history of malignancy * History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug * No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Total Sharp Score (mTSS) at Month 6 | Month 6 | mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). |
| Change From Baseline at Month 6 in mTSS | Month 6 | mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement. |
| Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 | Month 6 | ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP). |
| Absolute Blood Pressure (BP) Values (mmHg) | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24 | BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart. |
| Change From Baseline in BP Values (mmHg) | Months 1, 2, 3, 6, 9, 12, 15, 18, and 24 | BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| JSN Scores | Baseline, Months 6, 12, and 24 | JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. |
| Change From Baseline in Erosion Scores | Months 6, 12, and 24 | Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in JSN Scores | Months 6, 12, and 24 | JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Percentage of Participants Achieving an ACR70 Response | Months 1, 2, 3, 9, 12, 15, 18, 21, and 24 | ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Percentage of Participants Achieving an ACR20 Response | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Percentage of Participants Achieving an ACR50 Response | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Tender Joints Count (TJC) | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V). |
| Change From Baseline in TJC | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V). |
| Swollen Joints Count (SJC) | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V). |
| Change From Baseline in SJC | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V). |
| Patient Assessment of Arthritis Pain | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | 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. |
| Change From Baseline in Patient Assessment of Arthritis Pain | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | 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. |
| Physician Global Assessment of Arthritis | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad. |
| Change From Baseline in Physician Global Assessment of Arthritis | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm=very good and 100 mm=very bad. |
| Patient Global Assessment of Arthritis | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. |
| Change From Baseline in Patient Global Assessment of Arthritis | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly. |
| C-Reactive Protein | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | CRP measured in milligrams per liter (mg/L) |
| Change From Baseline in CRP | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | Change from Baseline in CRP measured in mg/L. |
| Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) less than (\<)2.6 = remission. |
| Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour \[mm/hour\]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission. |
| Change From Baseline in DAS28-3(CRP) | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission. |
| Change From Baseline in DAS28-4(ESR) | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission. |
| Percentage of Participants With DAS28-3(CRP) ≤3.2 | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission. |
| Percentage of Participants With DAS28-4(ESR) ≤3.2 | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission. |
| Percentage of Participants With DAS28-3(CRP) <2.6 | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission. |
| Percentage of Participants With DAS28-4(ESR) <2.6 | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission. |
| Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL). |
| Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL). |
| Percentage of Participants With an ACR70 Response Sustained at Least 6 Months | Months 6, 9, 12, 15, 18, 21, and 24 | ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | Months 3, 6, 9, 12, 15, 18, 21, and 24 | ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | Months 3, 6, 9, 12, 15, 18, 21, and 24 | ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | Months 3, 6, 9, 12, 15, 18, 21, and 24 | ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP. |
| Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | Months 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission. |
| Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | Months 3, 6, 9, 12, 15, 18, 21, and 24 | DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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. |
| Change From Baseline in HAQ-DI Score | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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. |
| Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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. |
| Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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. |
| Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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. |
| Short Form 36 (SF-36) Mental Component Score | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| SF-36 Physical Component Score | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| Change From Baseline in SF-36 Mental Component Score | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| Change From Baseline in SF-36 Physical Component Score | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning. |
| SF-36 Domain Scores | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). |
| Change From Baseline in SF-36 Domain Scores | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). |
| Work Limitation Questionnaire (WLQ) Score | Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). |
| Change From Baseline in WLQ Scores | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). |
| WLQ Work Loss Index Score | Baseline and Months 3, 6, and 12 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]). |
| Change From Baseline in WLQ Work Loss Index Score | Months 3, 6, 12, 15, 18, 21, and 24 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]). |
| European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Baseline and Months 3, 6, 12, 18, and 24 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in EQ-5D Health State Profile Utility Score | Months 3, 6, 12, 18, and 24 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Baseline and Months 3 and 6 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Baseline and Months 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. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Baseline and Months 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. |
| Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Baseline and Months 3 and 6 | RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported. |
| Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Baseline, Months 3, 6, 12, 18, and 24 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Months 3 and 6 | RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost. |
| Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost. |
| Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Months 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. |
| Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed HC 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. |
| Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Months 3 and 6 | RA-HCRU assessed HC 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. |
| Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed HC 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. |
| Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Months 3 and 6 | RA-HCRU assessed HC 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 HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Months 12, 18, and 24 | RA-HCRU assessed HC 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 HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Months 3, 6, 12, 18, and 24 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Baseline and Months 1, 2, and 3 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute. |
| Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Months 1, 2, 3, 6, 12, 18, and 24 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported |
| mTSS Score at Baseline, Months 12 and 24 | Baseline, Months 12 and 24 | mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). |
| Change From Baseline in MOS-SS at Months 1, 2, and 3 | Months 1, 2, and 3 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute. |
| Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Months 6, 12, 18, and 24 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline and Months 1, 2, 3, 6, 12, 18, and 24 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status |
| Change From Baseline in FACIT-Fatigue Scale | Months 1, 2, 3, 6, 12, 18, and 24 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status |
| Change From Baseline in Heart Rate | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | — |
| Change From Baseline in Temperature | Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 | — |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Months 6, 12, 18, and 24 | Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute. |
| Change From Baseline in mTSS Score at Months 12 and 24 | Months 12 and 24 | mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement. |
| Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Months 6, 12, and 24 | mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS. |
| Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Months 6, 12, and 24 | Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score. |
| Erosion Scores | Baseline, Months 6, 12, and 24 | Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Czechia, Dominican Republic, Germany, Hungary, India, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg Twice Daily (BID) Participants received CP-690,550 5 mg tablets, orally, BID, matching placebo CP-690,550 tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months. | 373 |
| CP-690,550 10 mg BID Participants received CP-690,550 two 5 mg tablets, orally, BID, and matching placebo MTX capsules, orally, once per week, for up to 24 months. | 397 |
| MTX 10, 15, or 20 mg, Weekly Participants received MTX capsules at doses of 10 to 20 mg per week and matching placebo CP-690,550 tablets, orally, BID, for up to 24 months. MTX dose was titrated to a maximum of 20 mg/week as follows: 10 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 15 mg/once weekly for 4 weeks, if tolerated the dose was titrated to 20 mg/once weekly. One dose reduction was allowed for lack of tolerance. | 186 |
| Total | 956 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 38 | 39 | 24 |
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 20 | 11 | 26 |
| Overall Study | Lost to Follow-up | 11 | 9 | 5 |
| Overall Study | Other | 13 | 25 | 12 |
| Overall Study | Withdrawal by Subject | 23 | 27 | 13 |
Baseline characteristics
| Characteristic | CP-690,550 10 mg BID | MTX 10, 15, or 20 mg, Weekly | Total | CP-690,550 5 mg Twice Daily (BID) |
|---|---|---|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 12.8 | 48.8 years STANDARD_DEVIATION 13.3 | 49.6 years STANDARD_DEVIATION 12.7 | 50.3 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 327 Participants | 145 Participants | 758 Participants | 286 Participants |
| Sex: Female, Male Male | 70 Participants | 41 Participants | 198 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 252 / 373 | 279 / 397 | 122 / 186 |
| serious Total, serious adverse events | 40 / 373 | 43 / 397 | 22 / 186 |
Outcome results
Primary
Absolute Blood Pressure (BP) Values (mmHg)
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 21: diastolic BP | 77.28 mmHg | Standard Deviation 8.24 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 15: diastolic BP | 77.98 mmHg | Standard Deviation 8.77 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 6: systolic BP | 123.71 mmHg | Standard Deviation 14.56 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 1: diastolic BP | 77.79 mmHg | Standard Deviation 9.11 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 15: systolic BP | 124.63 mmHg | Standard Deviation 14.24 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 6: diastolic BP | 77.74 mmHg | Standard Deviation 8.7 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 24: diastolic BP | 78.25 mmHg | Standard Deviation 8.15 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 12: diastolic BP | 78.08 mmHg | Standard Deviation 9.14 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 9: systolic BP | 123.90 mmHg | Standard Deviation 13.98 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 21: systolic BP | 123.83 mmHg | Standard Deviation 13.53 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 12: systolic BP | 125.61 mmHg | Standard Deviation 15.05 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 9: diastolic BP | 78.01 mmHg | Standard Deviation 9.11 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 2: systolic BP | 123.65 mmHg | Standard Deviation 14.87 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 24: systolic BP | 124.48 mmHg | Standard Deviation 13.15 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 18: diastolic BP | 77.66 mmHg | Standard Deviation 8.9 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 2: diastolic BP | 77.77 mmHg | Standard Deviation 9.08 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 1: systolic BP | 123.76 mmHg | Standard Deviation 15.28 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Baseline: systolic BP | 123.37 mmHg | Standard Deviation 15.41 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 3: systolic BP | 124.08 mmHg | Standard Deviation 14.94 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Baseline: diastolic BP | 77.64 mmHg | Standard Deviation 8.97 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 18: systolic BP | 124.48 mmHg | Standard Deviation 13.65 |
| CP-690,550 5 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 3: diastolic BP | 77.80 mmHg | Standard Deviation 9.19 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 18: systolic BP | 124.39 mmHg | Standard Deviation 12.75 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Baseline: systolic BP | 124.30 mmHg | Standard Deviation 14.79 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Baseline: diastolic BP | 77.59 mmHg | Standard Deviation 8.9 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 1: systolic BP | 124.57 mmHg | Standard Deviation 14.17 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 1: diastolic BP | 78.30 mmHg | Standard Deviation 8.62 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 2: systolic BP | 124.28 mmHg | Standard Deviation 13.33 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 2: diastolic BP | 78.68 mmHg | Standard Deviation 8.81 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 3: systolic BP | 124.24 mmHg | Standard Deviation 14.4 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 3: diastolic BP | 78.33 mmHg | Standard Deviation 9.54 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 6: systolic BP | 125.02 mmHg | Standard Deviation 14.37 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 6: diastolic BP | 78.56 mmHg | Standard Deviation 8.69 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 9: systolic BP | 123.89 mmHg | Standard Deviation 13.71 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 9: diastolic BP | 77.70 mmHg | Standard Deviation 8.38 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 12: systolic BP | 124.34 mmHg | Standard Deviation 13.68 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 12: diastolic BP | 78.08 mmHg | Standard Deviation 8.16 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 15: systolic BP | 124.28 mmHg | Standard Deviation 13.48 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 15: diastolic BP | 78.04 mmHg | Standard Deviation 8.42 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 18: diastolic BP | 78.34 mmHg | Standard Deviation 8.02 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 21: systolic BP | 124.52 mmHg | Standard Deviation 12.91 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 21: diastolic BP | 78.44 mmHg | Standard Deviation 7.56 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 24: systolic BP | 124.34 mmHg | Standard Deviation 12.24 |
| CP-690,550 10 mg BID | Absolute Blood Pressure (BP) Values (mmHg) | Month 24: diastolic BP | 78.07 mmHg | Standard Deviation 7.73 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 15: systolic BP | 123.71 mmHg | Standard Deviation 13.46 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 3: diastolic BP | 76.52 mmHg | Standard Deviation 7.8 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Baseline: diastolic BP | 78.02 mmHg | Standard Deviation 8.89 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 15: diastolic BP | 76.46 mmHg | Standard Deviation 8.95 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 3: systolic BP | 122.61 mmHg | Standard Deviation 13.18 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 2: diastolic BP | 76.22 mmHg | Standard Deviation 9.82 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 18: systolic BP | 121.57 mmHg | Standard Deviation 13.08 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 2: systolic BP | 122.59 mmHg | Standard Deviation 13.89 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 24: diastolic BP | 76.57 mmHg | Standard Deviation 8.46 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 18: diastolic BP | 76.76 mmHg | Standard Deviation 8.89 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 1: diastolic BP | 76.09 mmHg | Standard Deviation 9 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 24: systolic BP | 122.47 mmHg | Standard Deviation 12.56 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 21: systolic BP | 123.29 mmHg | Standard Deviation 11.98 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 9: diastolic BP | 76.34 mmHg | Standard Deviation 8.53 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 9: systolic BP | 121.94 mmHg | Standard Deviation 13.01 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 1: systolic BP | 123.41 mmHg | Standard Deviation 14.59 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 12: systolic BP | 122.22 mmHg | Standard Deviation 12.7 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 6: diastolic BP | 76.50 mmHg | Standard Deviation 8.32 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Baseline: systolic BP | 123.47 mmHg | Standard Deviation 13.73 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 12: diastolic BP | 76.59 mmHg | Standard Deviation 8.12 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 6: systolic BP | 122.28 mmHg | Standard Deviation 12.81 |
| MTX 10, 15, or 20 mg, Weekly | Absolute Blood Pressure (BP) Values (mmHg) | Month 21: diastolic BP | 76.45 mmHg | Standard Deviation 8.34 |
Primary
Change From Baseline at Month 6 in mTSS
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time frame: Month 6
Population: FAS, imputation using LEP
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline at Month 6 in mTSS | 0.20 score on a scale | Standard Error 0.09 |
| CP-690,550 10 mg BID | Change From Baseline at Month 6 in mTSS | 0.15 score on a scale | Standard Error 0.08 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline at Month 6 in mTSS | 0.65 score on a scale | Standard Error 0.12 |
p-value: 0.001495% CI: [-0.73, -0.18]ANCOVA
p-value: 0.000495% CI: [-0.77, -0.23]ANCOVA
Primary
Change From Baseline in BP Values (mmHg)
BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 18: systolic BP | 1.09 mmHg | Standard Deviation 12.61 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 6: diastolic BP | -0.04 mmHg | Standard Deviation 8.29 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 1: systolic BP | 0.44 mmHg | Standard Deviation 11.7 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 15: diastolic BP | -0.11 mmHg | Standard Deviation 8.98 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 9: systolic BP | 0.35 mmHg | Standard Deviation 12.33 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 2: diastolic BP | 0.13 mmHg | Standard Deviation 8.56 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 15: systolic BP | 0.93 mmHg | Standard Deviation 12.9 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 9: diastolic BP | 0.14 mmHg | Standard Deviation 9.12 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 24: diastolic BP | 0.38 mmHg | Standard Deviation 8.94 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 12: diastolic BP | 0.29 mmHg | Standard Deviation 9 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 12: systolic BP | 2.32 mmHg | Standard Deviation 12.94 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 21: diastolic BP | -0.71 mmHg | Standard Deviation 8.94 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 3: systolic BP | 0.91 mmHg | Standard Deviation 13.84 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 24: systolic BP | 1.30 mmHg | Standard Deviation 12.73 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 21: systolic BP | 0.49 mmHg | Standard Deviation 13.08 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 3: diastolic BP | 0.16 mmHg | Standard Deviation 8.7 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 2: systolic BP | 0.41 mmHg | Standard Deviation 12.74 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 18: diastolic BP | -0.30 mmHg | Standard Deviation 8.42 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 6: systolic BP | 0.34 mmHg | Standard Deviation 12.6 |
| CP-690,550 5 mg BID | Change From Baseline in BP Values (mmHg) | Month 1: diastolic BP | 0.11 mmHg | Standard Deviation 7.35 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 21: diastolic BP | 0.65 mmHg | Standard Deviation 9.14 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 1: systolic BP | 0.32 mmHg | Standard Deviation 11.03 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 1: diastolic BP | 0.78 mmHg | Standard Deviation 7.88 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 2: systolic BP | 0.07 mmHg | Standard Deviation 12.84 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 2: diastolic BP | 1.18 mmHg | Standard Deviation 8.86 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 3: systolic BP | -0.25 mmHg | Standard Deviation 12.71 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 3: diastolic BP | 0.70 mmHg | Standard Deviation 8.37 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 6: systolic BP | 0.36 mmHg | Standard Deviation 12.15 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 6: diastolic BP | 0.87 mmHg | Standard Deviation 8.34 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 9: systolic BP | -0.43 mmHg | Standard Deviation 12.52 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 9: diastolic BP | 0.04 mmHg | Standard Deviation 8.47 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 12: systolic BP | -0.02 mmHg | Standard Deviation 13.17 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 12: diastolic BP | 0.37 mmHg | Standard Deviation 8.03 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 15: systolic BP | -0.00 mmHg | Standard Deviation 13.57 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 15: diastolic BP | 0.41 mmHg | Standard Deviation 8.38 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 18: systolic BP | 0.23 mmHg | Standard Deviation 12.45 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 18: diastolic BP | 0.59 mmHg | Standard Deviation 9.09 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 21: systolic BP | 0.31 mmHg | Standard Deviation 13.68 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 24: systolic BP | 0.06 mmHg | Standard Deviation 13.55 |
| CP-690,550 10 mg BID | Change From Baseline in BP Values (mmHg) | Month 24: diastolic BP | 0.28 mmHg | Standard Deviation 9.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 1: diastolic BP | -1.91 mmHg | Standard Deviation 7.96 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 15: diastolic BP | -1.63 mmHg | Standard Deviation 8.78 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 6: systolic BP | -0.97 mmHg | Standard Deviation 10.45 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 24: diastolic BP | -1.50 mmHg | Standard Deviation 7.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 18: systolic BP | -2.38 mmHg | Standard Deviation 13.23 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 3: diastolic BP | -1.31 mmHg | Standard Deviation 8.08 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 24: systolic BP | -1.11 mmHg | Standard Deviation 12.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 18: diastolic BP | -1.49 mmHg | Standard Deviation 8.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 3: systolic BP | -0.48 mmHg | Standard Deviation 11.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 1: systolic BP | -0.02 mmHg | Standard Deviation 11.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 21: systolic BP | -0.68 mmHg | Standard Deviation 11.18 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 2: diastolic BP | -1.63 mmHg | Standard Deviation 8.07 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 12: systolic BP | -1.36 mmHg | Standard Deviation 11.19 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 9: diastolic BP | -1.79 mmHg | Standard Deviation 8.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 2: systolic BP | -0.43 mmHg | Standard Deviation 10.93 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 12: diastolic BP | -1.41 mmHg | Standard Deviation 7.25 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 9: systolic BP | -1.69 mmHg | Standard Deviation 10.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 21: diastolic BP | -1.63 mmHg | Standard Deviation 8.06 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 15: systolic BP | -0.16 mmHg | Standard Deviation 12.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in BP Values (mmHg) | Month 6: diastolic BP | -1.41 mmHg | Standard Deviation 7.95 |
Primary
Modified Total Sharp Score (mTSS) at Month 6
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time frame: Month 6
Population: Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690,550) or MTX (in MTX-naive participants) with a baseline (BL) and at least 1 nonmissing on-study assessment. Missing values due to withdrawal were imputed using linear extrapolation (LEP) of BL/post-BL value before withdrawal.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg BID | Modified Total Sharp Score (mTSS) at Month 6 | 20.50 score on a scale | Standard Error 40.58 |
| CP-690,550 10 mg BID | Modified Total Sharp Score (mTSS) at Month 6 | 18.85 score on a scale | Standard Error 39.21 |
| MTX 10, 15, or 20 mg, Weekly | Modified Total Sharp Score (mTSS) at Month 6 | 17.54 score on a scale | Standard Error 29.96 |
Primary
Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP).
Time frame: Month 6
Population: FAS. Missing values due to participant withdrawal were imputed using nonresponder imputation (NRI) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 | 25.41 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 | 37.34 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6 | 12.09 percentage of participants |
p-value: <0.000195% CI: [6.81, 19.82]Normal approximation
p-value: <0.000195% CI: [18.51, 31.99]Normal approximation
Secondary
Change From Baseline in CRP
Change from Baseline in CRP measured in mg/L.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 15 | -16.10 mg/L | Standard Error 0.73 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 3 | -15.69 mg/L | Standard Error 0.69 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 18 | -17.06 mg/L | Standard Error 0.74 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 21 | -16.83 mg/L | Standard Error 0.75 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 1 | -15.64 mg/L | Standard Error 0.68 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 24 | -15.97 mg/L | Standard Error 0.75 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 6 | -16.98 mg/L | Standard Error 0.7 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 2 | -16.02 mg/L | Standard Error 0.69 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 9 | -16.03 mg/L | Standard Error 0.71 |
| CP-690,550 5 mg BID | Change From Baseline in CRP | Month 12 | -16.58 mg/L | Standard Error 0.72 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 15 | -18.80 mg/L | Standard Error 0.7 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 6 | -18.76 mg/L | Standard Error 0.67 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 12 | -19.16 mg/L | Standard Error 0.69 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 18 | -18.17 mg/L | Standard Error 0.72 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 3 | -19.01 mg/L | Standard Error 0.66 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 1 | -18.84 mg/L | Standard Error 0.66 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 21 | -17.67 mg/L | Standard Error 0.72 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 9 | -18.48 mg/L | Standard Error 0.68 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 2 | -18.59 mg/L | Standard Error 0.66 |
| CP-690,550 10 mg BID | Change From Baseline in CRP | Month 24 | -17.96 mg/L | Standard Error 0.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 24 | -10.31 mg/L | Standard Error 1.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 1 | -5.55 mg/L | Standard Error 0.95 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 2 | -6.83 mg/L | Standard Error 0.97 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 3 | -9.86 mg/L | Standard Error 0.97 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 6 | -9.68 mg/L | Standard Error 1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 9 | -12.75 mg/L | Standard Error 1.03 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 12 | -11.12 mg/L | Standard Error 1.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 15 | -12.35 mg/L | Standard Error 1.07 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 18 | -11.62 mg/L | Standard Error 1.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in CRP | Month 21 | -11.07 mg/L | Standard Error 1.11 |
Secondary
Change From Baseline in DAS28-3(CRP)
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 15 | -2.65 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 9 | -2.40 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 24 | -2.76 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 18 | -2.72 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 6 | -2.27 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 21 | -2.75 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 2 | -1.85 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 12 | -2.52 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 3 | -2.09 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-3(CRP) | Month 1 | -1.30 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 3 | -2.42 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 6 | -2.68 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 9 | -2.72 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 12 | -2.85 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 15 | -2.85 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 18 | -2.91 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 21 | -2.89 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 24 | -2.94 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 1 | -1.71 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-3(CRP) | Month 2 | -2.16 units on a scale | Standard Error 0.06 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 2 | -1.02 units on a scale | Standard Error 0.08 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 24 | -2.12 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 12 | -1.99 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 6 | -1.62 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 1 | -0.58 units on a scale | Standard Error 0.08 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 9 | -1.95 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 18 | -2.05 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 3 | -1.36 units on a scale | Standard Error 0.08 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 21 | -2.05 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-3(CRP) | Month 15 | -2.03 units on a scale | Standard Error 0.09 |
Secondary
Change From Baseline in DAS28-4(ESR)
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 1 | -1.40 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 2 | -2.03 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 3 | -2.34 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 6 | -2.47 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 9 | -2.64 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 12 | -2.78 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 15 | -2.87 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 18 | -2.92 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 21 | -2.96 units on a scale | Standard Error 0.08 |
| CP-690,550 5 mg BID | Change From Baseline in DAS28-4(ESR) | Month 24 | -2.99 units on a scale | Standard Error 0.08 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 21 | -3.10 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 1 | -1.83 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 12 | -3.05 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 9 | -2.93 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 2 | -2.36 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 24 | -3.16 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 18 | -3.09 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 3 | -2.59 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 15 | -3.08 units on a scale | Standard Error 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in DAS28-4(ESR) | Month 6 | -2.88 units on a scale | Standard Error 0.07 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 18 | -2.34 units on a scale | Standard Error 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 6 | -1.87 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 9 | -2.19 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 12 | -2.20 units on a scale | Standard Error 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 21 | -2.30 units on a scale | Standard Error 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 15 | -2.25 units on a scale | Standard Error 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 1 | -0.72 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 24 | -2.40 units on a scale | Standard Error 0.12 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 2 | -1.17 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in DAS28-4(ESR) | Month 3 | -1.53 units on a scale | Standard Error 0.1 |
Secondary
Change From Baseline in EQ-5D Health State Profile Utility Score
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: Months 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoints for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 18 | 0.31 units on a scale | Standard Error 0.01 |
| CP-690,550 5 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 12 | 0.28 units on a scale | Standard Error 0.01 |
| CP-690,550 5 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 3 | 0.26 units on a scale | Standard Error 0.01 |
| CP-690,550 5 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 6 | 0.27 units on a scale | Standard Error 0.01 |
| CP-690,550 5 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 24 | 0.30 units on a scale | Standard Error 0.01 |
| CP-690,550 10 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 12 | 0.31 units on a scale | Standard Error 0.01 |
| CP-690,550 10 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 3 | 0.28 units on a scale | Standard Error 0.01 |
| CP-690,550 10 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 6 | 0.30 units on a scale | Standard Error 0.01 |
| CP-690,550 10 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 18 | 0.33 units on a scale | Standard Error 0.01 |
| CP-690,550 10 mg BID | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 24 | 0.33 units on a scale | Standard Error 0.01 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 24 | 0.28 units on a scale | Standard Error 0.02 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 18 | 0.23 units on a scale | Standard Error 0.02 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 3 | 0.21 units on a scale | Standard Error 0.02 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 12 | 0.23 units on a scale | Standard Error 0.02 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in EQ-5D Health State Profile Utility Score | Month 6 | 0.20 units on a scale | Standard Error 0.02 |
Secondary
Change From Baseline in Erosion Scores
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Months 6, 12, and 24
Population: FAS, imputation using LEP
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Erosion Scores | Month 12 | 0.13 units on a scale | Standard Error 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in Erosion Scores | Month 6 | 0.14 units on a scale | Standard Error 0.04 |
| CP-690,550 5 mg BID | Change From Baseline in Erosion Scores | Month 24 | 0.16 units on a scale | Standard Error 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Erosion Scores | Month 12 | 0.12 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in Erosion Scores | Month 6 | 0.10 units on a scale | Standard Error 0.04 |
| CP-690,550 10 mg BID | Change From Baseline in Erosion Scores | Month 24 | 0.16 units on a scale | Standard Error 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Erosion Scores | Month 6 | 0.35 units on a scale | Standard Error 0.06 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Erosion Scores | Month 24 | 0.98 units on a scale | Standard Error 0.15 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Erosion Scores | Month 12 | 0.58 units on a scale | Standard Error 0.09 |
Secondary
Change From Baseline in FACIT-Fatigue Scale
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Time frame: Months 1, 2, 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 24 | 8.97 units on a scale | Standard Deviation 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 2 | 7.44 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 6 | 8.71 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 1 | 5.79 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 3 | 8.12 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 12 | 8.75 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 18 | 8.98 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 1 | 7.14 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 2 | 7.86 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 6 | 9.12 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 12 | 9.18 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 24 | 9.57 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 3 | 8.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in FACIT-Fatigue Scale | Month 18 | 9.41 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 3 | 5.25 units on a scale | Standard Deviation 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 24 | 6.24 units on a scale | Standard Deviation 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 6 | 6.33 units on a scale | Standard Deviation 0.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 12 | 6.89 units on a scale | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 2 | 4.22 units on a scale | Standard Deviation 0.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 1 | 3.15 units on a scale | Standard Deviation 0.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in FACIT-Fatigue Scale | Month 18 | 7.14 units on a scale | Standard Deviation 0.74 |
Secondary
Change From Baseline in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 24 | -0.90 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 2 | -0.65 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 21 | -0.90 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 12 | -0.87 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 3 | -0.75 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 9 | -0.85 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 6 | -0.83 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 18 | -0.90 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 15 | -0.90 units on a scale | Standard Error 0.03 |
| CP-690,550 5 mg BID | Change From Baseline in HAQ-DI Score | Month 1 | -0.48 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 3 | -0.85 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 9 | -0.95 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 12 | -0.98 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 18 | -1.01 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 24 | -1.01 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 1 | -0.62 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 2 | -0.77 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 6 | -0.94 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 15 | -0.98 units on a scale | Standard Error 0.03 |
| CP-690,550 10 mg BID | Change From Baseline in HAQ-DI Score | Month 21 | -1.00 units on a scale | Standard Error 0.03 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 1 | -0.23 units on a scale | Standard Error 0.04 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 2 | -0.35 units on a scale | Standard Error 0.4 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 24 | -0.70 units on a scale | Standard Error 0.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 21 | -0.72 units on a scale | Standard Error 0.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 15 | -0.65 units on a scale | Standard Error 0.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 12 | -0.68 units on a scale | Standard Error 0.04 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 18 | -0.74 units on a scale | Standard Error 0.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 3 | -0.47 units on a scale | Standard Error 0.04 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 9 | -0.65 units on a scale | Standard Error 0.04 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in HAQ-DI Score | Month 6 | -0.58 units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in Heart Rate
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: Heart rate was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline will be analyzed as part of the wider clinical program.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 1 | -1.64 beats per minute | Standard Deviation 8.15 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 2 | -1.37 beats per minute | Standard Deviation 8.48 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 3 | -1.91 beats per minute | Standard Deviation 9.27 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 6 | -1.62 beats per minute | Standard Deviation 8.64 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 9 | -1.31 beats per minute | Standard Deviation 9.07 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 12 | -2.36 beats per minute | Standard Deviation 9.69 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 15 | -1.60 beats per minute | Standard Deviation 9.22 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 18 | -2.45 beats per minute | Standard Deviation 9.38 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 21 | -1.77 beats per minute | Standard Deviation 9.97 |
| CP-690,550 5 mg BID | Change From Baseline in Heart Rate | Month 24 | -3.08 beats per minute | Standard Deviation 10.16 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 21 | -2.25 beats per minute | Standard Deviation 8.71 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 1 | -1.83 beats per minute | Standard Deviation 8.34 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 12 | -2.88 beats per minute | Standard Deviation 9.12 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 9 | -1.66 beats per minute | Standard Deviation 9.23 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 2 | -1.02 beats per minute | Standard Deviation 9.33 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 24 | -3.31 beats per minute | Standard Deviation 9.69 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 18 | -2.03 beats per minute | Standard Deviation 8.78 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 3 | -1.76 beats per minute | Standard Deviation 9.4 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 15 | -2.12 beats per minute | Standard Deviation 10.24 |
| CP-690,550 10 mg BID | Change From Baseline in Heart Rate | Month 6 | -1.70 beats per minute | Standard Deviation 9.13 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 18 | -2.23 beats per minute | Standard Deviation 8.47 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 6 | -2.24 beats per minute | Standard Deviation 8.65 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 9 | -3.50 beats per minute | Standard Deviation 9.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 12 | -4.08 beats per minute | Standard Deviation 10.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 21 | -3.34 beats per minute | Standard Deviation 9.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 15 | -3.78 beats per minute | Standard Deviation 9.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 1 | -0.73 beats per minute | Standard Deviation 7.96 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 24 | -4.26 beats per minute | Standard Deviation 10.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 2 | -2.19 beats per minute | Standard Deviation 7.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Heart Rate | Month 3 | -2.37 beats per minute | Standard Deviation 8.48 |
Secondary
Change From Baseline in JSN Scores
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Months 6, 12, and 24
Population: FAS, imputation using LEP
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in JSN Scores | Month 12 | 0.23 units on a scale | Standard Error 0.1 |
| CP-690,550 5 mg BID | Change From Baseline in JSN Scores | Month 6 | 0.06 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in JSN Scores | Month 24 | 0.39 units on a scale | Standard Error 0.18 |
| CP-690,550 10 mg BID | Change From Baseline in JSN Scores | Month 12 | 0.05 units on a scale | Standard Error 0.1 |
| CP-690,550 10 mg BID | Change From Baseline in JSN Scores | Month 6 | 0.05 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in JSN Scores | Month 24 | 0.12 units on a scale | Standard Error 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in JSN Scores | Month 6 | 0.29 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in JSN Scores | Month 24 | 1.10 units on a scale | Standard Error 0.25 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in JSN Scores | Month 12 | 0.60 units on a scale | Standard Error 0.14 |
Secondary
Change From Baseline in MOS-SS at Months 1, 2, and 3
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Months 1, 2, and 3
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: overall sleep problem | -12.46 units on a scale | Standard Error 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: overall sleep problem | -11.08 units on a scale | Standard Error 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: somnolence | -6.35 units on a scale | Standard Error 0.95 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: adequacy | 9.90 units on a scale | Standard Error 1.34 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: sleep problem summary | -9.81 units on a scale | Standard Error 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: adequacy | 8.56 units on a scale | Standard Error 1.33 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: awaken short of breath | -4.12 units on a scale | Standard Error 1.05 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: somnolence | -8.11 units on a scale | Standard Error 0.95 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: sleep disturbance | -14.27 units on a scale | Standard Error 1.08 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: snoring | -2.31 units on a scale | Standard Error 1.2 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: sleep disturbance | -15.67 units on a scale | Standard Error 1.08 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: quantity | 0.42 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: snoring | -3.12 units on a scale | Standard Error 1.19 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: adequacy | 13.46 units on a scale | Standard Error 1.35 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: quantity | 0.45 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: quantity | 0.41 units on a scale | Standard Error 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: sleep problem summary | -7.85 units on a scale | Standard Error 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: sleep disturbance | -11.28 units on a scale | Standard Error 1.07 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: snoring | -3.36 units on a scale | Standard Error 1.21 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: somnolence | -8.71 units on a scale | Standard Error 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: awaken short of breath | -2.81 units on a scale | Standard Error 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: overall sleep problem | -8.95 units on a scale | Standard Error 0.86 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: sleep problem summary | -10.98 units on a scale | Standard Error 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: awaken short of breath | -2.60 units on a scale | Standard Error 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: sleep disturbance | -11.06 units on a scale | Standard Error 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: somnolence | -7.56 units on a scale | Standard Error 0.91 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: overall sleep problem | -9.14 units on a scale | Standard Error 0.83 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: sleep problem summary | -8.12 units on a scale | Standard Error 0.86 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: somnolence | -7.31 units on a scale | Standard Error 0.91 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: snoring | -3.72 units on a scale | Standard Error 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: quantity | 0.38 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: awaken short of breath | -1.92 units on a scale | Standard Error 1 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: adequacy | 9.73 units on a scale | Standard Error 1.28 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: overall sleep problem | -10.15 units on a scale | Standard Error 0.83 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: sleep problem summary | -8.75 units on a scale | Standard Error 0.86 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: snoring | -3.16 units on a scale | Standard Error 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: quantity | 0.43 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: sleep disturbance | -12.53 units on a scale | Standard Error 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: awaken short of breath | -2.15 units on a scale | Standard Error 1 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: adequacy | 10.84 units on a scale | Standard Error 1.28 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: overall sleep problem | -11.16 units on a scale | Standard Error 0.83 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: sleep problem summary | -9.58 units on a scale | Standard Error 0.86 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: somnolence | -7.35 units on a scale | Standard Error 0.91 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: snoring | -4.25 units on a scale | Standard Error 1.15 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: quantity | 0.46 units on a scale | Standard Error 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: sleep disturbance | -14.67 units on a scale | Standard Error 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: awaken short of breath | -2.48 units on a scale | Standard Error 1.01 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: adequacy | 11.00 units on a scale | Standard Error 1.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: adequacy | 2.83 units on a scale | Standard Error 1.84 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: overall sleep problem | -4.72 units on a scale | Standard Error 1.19 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: overall sleep problem | -8.99 units on a scale | Standard Error 1.22 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: awaken short of breath | -2.00 units on a scale | Standard Error 1.44 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: sleep disturbance | -11.90 units on a scale | Standard Error 1.52 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: sleep problem summary | -7.65 units on a scale | Standard Error 1.26 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: sleep disturbance | -7.36 units on a scale | Standard Error 1.48 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: sleep problem summary | -3.98 units on a scale | Standard Error 1.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: somnolence | -6.39 units on a scale | Standard Error 1.34 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: quantity | 0.26 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: adequacy | 7.14 units on a scale | Standard Error 1.89 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: snoring | -3.36 units on a scale | Standard Error 1.69 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: snoring | -4.54 units on a scale | Standard Error 1.67 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: snoring | -1.66 units on a scale | Standard Error 1.65 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: quantity | 0.31 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: somnolence | -5.45 units on a scale | Standard Error 1.33 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: awaken short of breath | -2.67 units on a scale | Standard Error 1.48 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: sleep disturbance | -9.97 units on a scale | Standard Error 1.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: sleep problem summary | -6.54 units on a scale | Standard Error 1.25 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 3: quantity | 0.40 units on a scale | Standard Error 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: awaken short of breath | -3.32 units on a scale | Standard Error 1.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: overall sleep problem | -7.62 units on a scale | Standard Error 1.2 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 1: somnolence | -2.15 units on a scale | Standard Error 1.31 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 1, 2, and 3 | Month 2: adequacy | 6.24 units on a scale | Standard Error 1.87 |
Secondary
Change From Baseline in MOS-SS at Months 6, 12, 18, and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Months 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: snoring | -3.21 units on a scale | Standard Deviation 1.22 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: sleep disturbance | -14.89 units on a scale | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: snoring | -1.44 units on a scale | Standard Deviation 1.25 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: somnolence | -8.86 units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: quantity | 0.47 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: quantity | 0.49 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: snoring | -1.00 units on a scale | Standard Deviation 1.32 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18:snoring | -0.45 units on a scale | Standard Deviation 1.29 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: sleep disturbance | -15.94 units on a scale | Standard Deviation 1.12 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: quantity | 0.47 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: somnolence | -9.19 units on a scale | Standard Deviation 1.02 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: awaken short of breath | -3.65 units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: awaken short of breath | -3.77 units on a scale | Standard Deviation 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: sleep problem summary | -10.02 units on a scale | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: adequacy | 11.41 units on a scale | Standard Deviation 1.4 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: sleep disturbance | -15.44 units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: overall sleep problem | -11.55 units on a scale | Standard Deviation 0.92 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: sleep problem summary | -10.13 units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: somnolence | -9.29 units on a scale | Standard Deviation 1.04 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: awaken short of breath | -2.54 units on a scale | Standard Deviation 1.07 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: overall sleep problem | -11.62 units on a scale | Standard Deviation 0.88 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: sleep problem summary | -9.83 units on a scale | Standard Deviation 0.98 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: adequacy | 10.76 units on a scale | Standard Deviation 1.36 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: sleep disturbance | -14.67 units on a scale | Standard Deviation 1.18 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: overall sleep problem | -11.64 units on a scale | Standard Deviation 0.94 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: overall sleep problem | -12.21 units on a scale | Standard Deviation 0.9 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: adequacy | 11.02 units on a scale | Standard Deviation 1.47 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: adequacy | 10.91 units on a scale | Standard Deviation 1.44 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: sleep problem summary | -10.61 units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: quantity | 0.41 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: awaken short of breath | -3.69 units on a scale | Standard Deviation 1.14 |
| CP-690,550 5 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: somnolence | -8.85 units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: snoring | -1.11 units on a scale | Standard Deviation 1.17 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: adequacy | 11.87 units on a scale | Standard Deviation 1.43 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: overall sleep problem | -12.24 units on a scale | Standard Deviation 0.84 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: sleep problem summary | -11.12 units on a scale | Standard Deviation 0.87 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: somnolence | -8.83 units on a scale | Standard Deviation 0.93 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: quantity | 0.44 units on a scale | Standard Deviation 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: sleep disturbance | -15.60 units on a scale | Standard Deviation 1.05 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: awaken short of breath | -4.33 units on a scale | Standard Deviation 1.02 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: adequacy | 11.57 units on a scale | Standard Deviation 1.3 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: overall sleep problem | -11.94 units on a scale | Standard Deviation 0.86 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: sleep problem summary | -10.76 units on a scale | Standard Deviation 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: somnolence | -8.24 units on a scale | Standard Deviation 0.95 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: snoring | 0.20 units on a scale | Standard Deviation 1.2 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: quantity | 0.37 units on a scale | Standard Deviation 0.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: sleep disturbance | -15.24 units on a scale | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: awaken short of breath | -4.04 units on a scale | Standard Deviation 1.06 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: adequacy | 12.15 units on a scale | Standard Deviation 1.35 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: overall sleep problem | -12.82 units on a scale | Standard Deviation 0.89 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: sleep problem summary | -11.88 units on a scale | Standard Deviation 0.93 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: somnolence | -8.70 units on a scale | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18:snoring | -0.59 units on a scale | Standard Deviation 1.25 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: quantity | 0.38 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: sleep disturbance | -15.77 units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: awaken short of breath | -5.50 units on a scale | Standard Deviation 1.11 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: adequacy | 13.26 units on a scale | Standard Deviation 1.4 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: overall sleep problem | -11.93 units on a scale | Standard Deviation 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: sleep problem summary | -10.59 units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: somnolence | -8.63 units on a scale | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: snoring | -1.22 units on a scale | Standard Deviation 1.27 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: quantity | 0.31 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: sleep disturbance | -15.43 units on a scale | Standard Deviation 1.13 |
| CP-690,550 10 mg BID | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: awaken short of breath | -3.16 units on a scale | Standard Deviation 1.13 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: somnolence | -5.46 units on a scale | Standard Deviation 1.44 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: awaken short of breath | -1.69 units on a scale | Standard Deviation 1.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: sleep disturbance | -15.97 units on a scale | Standard Deviation 1.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: sleep problem summary | -7.41 units on a scale | Standard Deviation 1.35 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: quantity | 0.42 units on a scale | Standard Deviation 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: awaken short of breath | -1.55 units on a scale | Standard Deviation 1.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: overall sleep problem | -9.10 units on a scale | Standard Deviation 1.3 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: sleep problem summary | -8.64 units on a scale | Standard Deviation 1.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: adequacy | 9.71 units on a scale | Standard Deviation 2.15 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: adequacy | 8.41 units on a scale | Standard Deviation 1.94 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: quantity | 0.44 units on a scale | Standard Deviation 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: overall sleep problem | -10.84 units on a scale | Standard Deviation 1.39 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: awaken short of breath | -4.23 units on a scale | Standard Deviation 1.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: sleep disturbance | -14.20 units on a scale | Standard Deviation 1.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: sleep problem summary | -9.64 units on a scale | Standard Deviation 1.45 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: sleep disturbance | -12.69 units on a scale | Standard Deviation 1.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: overall sleep problem | -9.77 units on a scale | Standard Deviation 1.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: adequacy | 9.30 units on a scale | Standard Deviation 2.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: somnolence | -8.24 units on a scale | Standard Deviation 1.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: overall sleep problem | -11.27 units on a scale | Standard Deviation 1.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: awaken short of breath | -2.12 units on a scale | Standard Deviation 1.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: snoring | -4.00 units on a scale | Standard Deviation 1.74 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: sleep problem summary | -9.41 units on a scale | Standard Deviation 1.41 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: sleep disturbance | -12.00 units on a scale | Standard Deviation 1.63 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: adequacy | 11.35 units on a scale | Standard Deviation 2.22 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: somnolence | -7.88 units on a scale | Standard Deviation 1.51 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: quantity | 0.20 units on a scale | Standard Deviation 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 24: snoring | -3.49 units on a scale | Standard Deviation 1.97 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18:snoring | -3.61 units on a scale | Standard Deviation 1.92 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 12: snoring | -1.49 units on a scale | Standard Deviation 1.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 6: somnolence | -6.60 units on a scale | Standard Deviation 1.37 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in MOS-SS at Months 6, 12, 18, and 24 | Month 18: quantity | 0.44 units on a scale | Standard Deviation 0.1 |
Secondary
Change From Baseline in mTSS Score at Months 12 and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time frame: Months 12 and 24
Population: FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in mTSS Score at Months 12 and 24 | Month 12 | 0.37 score on a scale | Standard Error 0.14 |
| CP-690,550 5 mg BID | Change From Baseline in mTSS Score at Months 12 and 24 | Month 24 | 0.57 score on a scale | Standard Error 0.25 |
| CP-690,550 10 mg BID | Change From Baseline in mTSS Score at Months 12 and 24 | Month 12 | 0.17 score on a scale | Standard Error 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in mTSS Score at Months 12 and 24 | Month 24 | 0.28 score on a scale | Standard Error 0.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in mTSS Score at Months 12 and 24 | Month 12 | 1.20 score on a scale | Standard Error 0.2 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in mTSS Score at Months 12 and 24 | Month 24 | 2.11 score on a scale | Standard Error 0.35 |
Secondary
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC 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: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days aids/devices used | 79.90 days | Standard Deviation 127.89 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital length of stay | -2.00 days | Standard Deviation 2.83 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days aids/devices used | -27.07 days | Standard Deviation 159.25 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related aids used | -0.46 days | Standard Deviation 1.71 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of work per week | 0.11 days | Standard Deviation 0.86 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:days on sick leave due to RA | 5.25 days | Standard Deviation 28.21 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of part-time work | 2.20 days | Standard Deviation 6.83 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:paid work, bothered by RA | -18.49 days | Standard Deviation 28.09 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | -8.43 days | Standard Deviation 14.55 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | -13.11 days | Standard Deviation 34.25 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days aids/devices used | 65.09 days | Standard Deviation 81.85 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related aids used | 0.82 days | Standard Deviation 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of work per week | 0.13 days | Standard Deviation 0.85 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:days on sick leave due to RA | -4.80 days | Standard Deviation 13.18 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of part time work | -1.00 days | Standard Deviation 4.85 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:paid work, bothered by RA | -15.19 days | Standard Deviation 39.72 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | -24.50 days | Standard Deviation 32.54 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | -9.15 days | Standard Deviation 34.94 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related aids used | 1.10 days | Standard Deviation 1.2 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of work per week | 0.06 days | Standard Deviation 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:days on sick leave due to RA | -3.86 days | Standard Deviation 7.06 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of part time work | 1.67 days | Standard Deviation 6.03 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: paid work, bothered by RA | -12.54 days | Standard Deviation 37.97 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | -15.33 days | Standard Deviation 24.1 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | -7.30 days | Standard Deviation 31.83 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:days on sick leave due to RA | -6.78 days | Standard Deviation 8.94 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days aids/devices used | -5.00 days | Standard Deviation 81.85 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days aids/devices used | 96.00 days | Standard Deviation 53.39 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days aids/devices used | -38.50 days | Standard Deviation 50.79 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related aids used | 0.00 days | Standard Deviation 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:days on sick leave due to RA | -3.00 days | Standard Deviation 5.66 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of part time work | -35.00 days | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of work per week | -0.01 days | Standard Deviation 0.66 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of part time work | -45.00 days | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:paid work, bothered by RA | -20.12 days | Standard Deviation 33.9 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:days on sick leave due to RA | -2.80 days | Standard Deviation 16.41 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of work per week | -0.04 days | Standard Deviation 0.85 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related aids used | -0.50 days | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of part-time work | -15.00 days | Standard Deviation 17 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | -12.00 days | Standard Deviation 29.28 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:paid work, bothered by RA | -12.63 days | Standard Deviation 34.77 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | -19.22 days | Standard Deviation 28.8 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | -27.54 days | Standard Deviation 37.94 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | -1.92 days | Standard Deviation 6.19 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related aids used | 1.00 days | Standard Deviation 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of work per week | 0.05 days | Standard Deviation 0.78 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | -20.05 days | Standard Deviation 44.57 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: paid work, bothered by RA | -23.63 days | Standard Deviation 26.77 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | -14.17 days | Standard Deviation 35.55 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days in nursing home | 3.50 days | Standard Deviation 4.95 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:paid work, bothered by RA | -12.35 days | Standard Deviation 37.16 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital length of stay | 21.00 days | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of work per week | 0.05 days | Standard Deviation 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days aids/devices used | -77.33 days | Standard Deviation 289.83 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related aids used | 0.00 days | Standard Deviation 1.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of work per week | -0.06 days | Standard Deviation 0.6 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:days on sick leave due to RA | -5.00 days | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:days on sick leave due to RA | -31.67 days | Standard Deviation 47.93 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 0.00 days | Standard Deviation 5.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:paid work, bothered by RA | -15.07 days | Standard Deviation 43.23 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | -13.86 days | Standard Deviation 37.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | -5.50 days | Standard Deviation 7.78 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 3.36 days | Standard Deviation 30.47 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days aids/devices used | -75.00 days | Standard Deviation 63.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related aids used | 0.00 days | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days aids/devices used | -45.00 days | Standard Deviation 198.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of work per week | 0.04 days | Standard Deviation 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: paid work, bothered by RA | -22.47 days | Standard Deviation 25.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:days on sick leave due to RA | -2.20 days | Standard Deviation 2.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related aids used | -0.75 days | Standard Deviation 2.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | -15.24 days | Standard Deviation 29.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 4.67 days | Standard Deviation 5.03 |
Secondary
Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed HC 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: Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:days on sick leave due to RA | -18.27 days | Standard Deviation 17.19 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: paid work, bothered by RA | -15.31 days | Standard Deviation 39.58 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by housekeeper | -13.80 days | Standard Deviation 19.66 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days of work per week | 0.07 days | Standard Deviation 0.67 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -20.70 days | Standard Deviation 35.9 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days of work per week | 0.13 days | Standard Deviation 0.69 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related aids used | -0.64 days | Standard Deviation 1.5 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by family | -19.14 days | Standard Deviation 40.06 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by family | -14.94 days | Standard Deviation 39.94 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days aids/devices used | -46.93 days | Standard Deviation 127.42 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: paid work, bothered by RA | -15.90 days | Standard Deviation 36.8 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:days on sick leave due to RA | 0.40 days | Standard Deviation 32.44 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related aids used | -0.31 days | Standard Deviation 1.11 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days of part time work | 11.50 days | Standard Deviation 14.34 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days of part time work | 1.92 days | Standard Deviation 32.76 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days aids/devices used | -45.92 days | Standard Deviation 91 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:days on sick leave due to RA | 7.58 days | Standard Deviation 26.57 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days in nursing home | 0.00 days | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days aids/devices used | -12.36 days | Standard Deviation 173.11 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related aids used | -0.43 days | Standard Deviation 1.91 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days of work per week | 0.06 days | Standard Deviation 0.74 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: hospital length of stay | -10.00 days | Standard Deviation 7.07 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days of part time work | 15.14 days | Standard Deviation 34.6 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: paid work, bothered by RA | -15.16 days | Standard Deviation 34.88 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -11.61 days | Standard Deviation 31.25 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by family | -17.71 days | Standard Deviation 36.57 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: hospital length of stay | -22.00 days | Standard Deviation 2.83 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days in nursing home | 0.00 days | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days aids/devices used | 58.00 days | Standard Deviation 126.45 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related aids used | 0.13 days | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days of work per week | 0.03 days | Standard Deviation 0.73 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:days on sick leave due to RA | 13.56 days | Standard Deviation 27.92 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days of part time work | -2.60 days | Standard Deviation 18.57 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: paid work, bothered by RA | -16.43 days | Standard Deviation 30.15 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by housekeeper | -11.94 days | Standard Deviation 33.28 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by family | -20.54 days | Standard Deviation 37.4 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related aids used | -0.25 days | Standard Deviation 2.05 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days of work per week | 0.00 days | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days of part time work | -0.17 days | Standard Deviation 26.9 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by family | -20.94 days | Standard Deviation 40.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:days on sick leave due to RA | 13.82 days | Standard Deviation 46.97 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:days on sick leave due to RA | 10.94 days | Standard Deviation 33.96 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by housekeeper | -2.40 days | Standard Deviation 7.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days of part time work | 0.00 days | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: hospital length of stay | 8.00 days | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days of work per week | -0.01 days | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by family | -12.18 days | Standard Deviation 35.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: days aids/devices used | -65.50 days | Standard Deviation 200 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: days aids/devices used | -93.20 days | Standard Deviation 211.52 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -9.29 days | Standard Deviation 36.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: paid work, bothered by RA | -7.81 days | Standard Deviation 38.47 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related aids used | -1.60 days | Standard Deviation 2.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Days as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: paid work, bothered by RA | -9.30 days | Standard Deviation 31.97 |
Secondary
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC 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: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA related diagnostic test | -0.33 events | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related ER visit | 1.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospital ER visit | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related doctor visit | -0.71 events | Standard Deviation 1.37 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: doctor visit | -2.78 events | Standard Deviation 6 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | 0.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related outpatient surgery | 2.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic test | -1.55 events | Standard Deviation 2.73 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related hospitalization | -0.50 events | Standard Deviation 0.71 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related non-medical visit | 0.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related diagnostic test | -0.33 events | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | -0.09 events | Standard Deviation 2.88 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-medical practitioner visit | -10.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related doctor visit | -0.72 events | Standard Deviation 1.3 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic test | -1.50 events | Standard Deviation 4.2 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related diagnostic tests | -0.82 events | Standard Deviation 1.25 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: doctor visit | -2.57 events | Standard Deviation 5.87 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-relate outpatient surgery | -1.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-medical practitioner visit | -8.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-medical practitioner visit | -168.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:RA-related non-medical visit | -2.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital ER visit | -3.50 events | Standard Deviation 5.07 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: doctor visits | -2.58 events | Standard Deviation 4.37 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related non-medical visit | 0.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 4.00 events | — |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related doctor visit | -0.69 events | Standard Deviation 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related ER visit | -1.25 events | Standard Deviation 0.96 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related ER visit | -0.67 events | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital ER visit | 0.00 events | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital ER visit | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: doctor visit | -2.32 events | Standard Deviation 4.33 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related doctor visit | -0.68 events | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related ER visit | -1.00 events | Standard Deviation 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | -0.71 events | Standard Deviation 1.69 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related diagnostic tests | -0.88 events | Standard Deviation 1.69 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-medical practitioner visit | 8.00 events | Standard Deviation 11.31 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:RA-related non-medical visit | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: doctor visits | -1.98 events | Standard Deviation 3.67 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related doctor visit | -0.51 events | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital ER visit | -1.00 events | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related ER visit | -1.00 events | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic test | 0.00 events | Standard Deviation 2.24 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related diagnostic test | -0.64 events | Standard Deviation 0.67 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-medical practitioner visit | -15.67 events | Standard Deviation 28.01 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related non-medical visit | 0.33 events | Standard Deviation 1.53 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: doctor visit | -1.65 events | Standard Deviation 5.42 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related doctor visit | -0.63 events | Standard Deviation 1.15 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospital ER visit | -1.00 events | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related ER visit | -2.00 events | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic test | -0.18 events | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA related diagnostic test | -0.64 events | Standard Deviation 0.67 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-medical practitioner visit | -1.00 events | Standard Deviation 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related non-medical visit | -0.33 events | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related ER visit | -0.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: doctor visit | -3.17 events | Standard Deviation 5.86 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related doctor visit | -0.69 events | Standard Deviation 1.21 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA related diagnostic test | -0.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: doctor visits | -2.20 events | Standard Deviation 6.97 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related diagnostic tests | -0.60 events | Standard Deviation 0.89 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related diagnostic test | -0.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | -1.00 events | Standard Deviation 1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic test | -0.50 events | Standard Deviation 2.12 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related doctor visit | -0.72 events | Standard Deviation 1.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related hospitalization | -1.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic test | -0.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: doctor visit | -2.41 events | Standard Deviation 6.48 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospitalization | 0.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related ER visit | 0.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related doctor visit | -0.63 events | Standard Deviation 1.1 |
Secondary
Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 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: Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA related diagnostic test | -0.80 events | Standard Deviation 1.64 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related diagnostic test | -0.73 events | Standard Deviation 1.01 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: hospital ER visit | -4.33 events | Standard Deviation 5.86 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: non-study diagnostic test | -0.60 events | Standard Deviation 1.52 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:non-medical practitioner visit | -62.33 events | Standard Deviation 102.11 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:RA-related non-medical visit | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related doctor visit | -0.69 events | Standard Deviation 1.27 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:RA-related non-medical visit | -0.67 events | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related ER visit | -0.67 events | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: doctor visit | -2.44 events | Standard Deviation 4.87 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related doctor visit | -0.55 events | Standard Deviation 1.3 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: doctor visits | -1.83 events | Standard Deviation 5.24 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: non-study diagnostic test | -0.73 events | Standard Deviation 2.24 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:non-medical practitioner visit | -8.00 events | Standard Deviation 2.83 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related hospitalization | -0.50 events | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: doctor visits | -1.12 events | Standard Deviation 4.13 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related doctor visit | -0.50 events | Standard Deviation 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: hospital ER visit | 1.60 events | Standard Deviation 3.78 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related ER visit | -1.00 events | Standard Deviation 1.58 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: non-study diagnostic test | -0.61 events | Standard Deviation 1.5 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related diagnostic test | -0.67 events | Standard Deviation 1.2 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:non-medical practitioner visit | -2.33 events | Standard Deviation 2.52 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:RA-related non-medical visit | -0.33 events | Standard Deviation 0.58 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: doctor visit | -1.98 events | Standard Deviation 4.65 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related doctor visit | -0.66 events | Standard Deviation 1.23 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: hospital ER visit | 0.60 events | Standard Deviation 1.34 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related ER visit | -0.40 events | Standard Deviation 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related hospitalization | -1.50 events | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: non-study diagnostic test | -0.40 events | Standard Deviation 1.3 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA related diagnostic test | -0.88 events | Standard Deviation 1.09 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:non-medical practitioner visit | -5.00 events | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:RA-related non-medical visit | -1.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:RA-related non-medical visit | 1.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related hospitalization | 0.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related diagnostic test | -0.50 events | Standard Deviation 0.93 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6:non-medical practitioner visit | 1.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:RA-related non-medical visit | 0.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: non-study diagnostic test | -0.67 events | Standard Deviation 2.16 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: doctor visit | -2.72 events | Standard Deviation 5.43 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:non-medical practitioner visit | 0.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: non-study diagnostic test | 0.38 events | Standard Deviation 1.19 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA-related doctor visit | -0.77 events | Standard Deviation 1.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: doctor visits | -1.52 events | Standard Deviation 5.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: RA related diagnostic test | -0.67 events | Standard Deviation 0.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: RA-related doctor visit | -0.48 events | Standard Deviation 0.99 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: hospitalization | 0.00 events | — |
Secondary
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC 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 HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: work done | 0.34 hours per day | Standard Deviation 4.3 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: missed work due to RA | -1.60 hours per day | Standard Deviation 4.93 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 0.29 hours per day | Standard Deviation 2.63 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | -0.67 hours per day | Standard Deviation 4.67 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: work done | 0.17 hours per day | Standard Deviation 4.56 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: missed work due to RA | -5.80 hours per day | Standard Deviation 11.97 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | -2.00 hours per day | Standard Deviation 2.16 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 0.03 hours per day | Standard Deviation 3.43 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: work done | 0.42 hours per day | Standard Deviation 5.37 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: missed work due to RA | -5.33 hours per day | Standard Deviation 7.57 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 0.17 hours per day | Standard Deviation 3.06 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | -0.97 hours per day | Standard Deviation 3.4 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: work done | 0.16 hours per day | Standard Deviation 5.24 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | -1.00 hours per day | Standard Deviation 3 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | -8.78 hours per day | Standard Deviation 22.26 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 0.50 hours per day | Standard Deviation 1.51 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | -1.57 hours per day | Standard Deviation 5.25 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: work done | -0.21 hours per day | Standard Deviation 4.37 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: missed work due to RA | 0.00 hours per day | Standard Deviation 1 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: work done | -0.04 hours per day | Standard Deviation 2.51 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | -5.23 hours per day | Standard Deviation 18.66 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | -1.35 hours per day | Standard Deviation 6.69 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: missed work due to RA | 0.00 hours per day | — |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: missed work due to RA | 1.00 hours per day | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: work done | 0.04 hours per day | Standard Deviation 1.37 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | -0.50 hours per day | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: work done | 0.75 hours per day | Standard Deviation 4.43 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 1.00 hours per day | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: work done | 0.17 hours per day | Standard Deviation 1.32 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 0.00 hours per day | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | -0.47 hours per day | Standard Deviation 1.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | -0.24 hours per day | Standard Deviation 3.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | -0.17 hours per day | Standard Deviation 1.19 |
Secondary
Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6
RA-HCRU assessed HC 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 HC services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by housekeeper | -1.10 hours per day | Standard Deviation 2.38 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by family | -1.98 hours per day | Standard Deviation 4.92 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: work done | 0.23 hours per day | Standard Deviation 4.19 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -0.80 hours per day | Standard Deviation 1.62 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: work done | -0.34 hours per day | Standard Deviation 4.32 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by family | -0.68 hours per day | Standard Deviation 4.15 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: missed work due to RA | -1.00 hours per day | Standard Deviation 8.94 |
| CP-690,550 5 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: missed work due to RA | -1.67 hours per day | Standard Deviation 5.13 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3:RA-related home HC services | 0.00 hours per day | Standard Deviation 0 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: work done | 0.03 hours per day | Standard Deviation 4.79 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -0.61 hours per day | Standard Deviation 2.37 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: missed work due to RA | 1.29 hours per day | Standard Deviation 5.06 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by housekeeper | -0.25 hours per day | Standard Deviation 3.19 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by family | -0.51 hours per day | Standard Deviation 3.02 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: home healthcare services | -1.00 hours per day | Standard Deviation 1.41 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: missed work due to RA | -0.40 hours per day | Standard Deviation 1.14 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: work done | 0.34 hours per day | Standard Deviation 6.12 |
| CP-690,550 10 mg BID | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by family | -0.39 hours per day | Standard Deviation 3.9 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by family | -0.45 hours per day | Standard Deviation 6.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: work done | 0.80 hours per day | Standard Deviation 3.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: missed work due to RA | 3.00 hours per day | Standard Deviation 9.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -1.14 hours per day | Standard Deviation 1.86 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 3: chores by family | -1.63 hours per day | Standard Deviation 5.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: work done | 0.23 hours per day | Standard Deviation 1.48 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: missed work due to RA | -4.00 hours per day | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Number of Hours Per Day as Assessed Using RA-HCRU at Months 3 and 6 | Month 6: chores by housekeeper | -0.20 hours per day | Standard Deviation 1.3 |
Secondary
Change From Baseline in Patient Assessment of Arthritis Pain
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm=no pain and 100 mm=most severe pain.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 1 | -22.98 mm | Standard Error 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 12 | -32.31 mm | Standard Error 1.22 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 6 | -31.94 mm | Standard Error 1.19 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 24 | -34.78 mm | Standard Error 1.28 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 9 | -32.34 mm | Standard Error 1.21 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 18 | -34.26 mm | Standard Error 1.26 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 2 | -27.73 mm | Standard Error 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 21 | -34.57 mm | Standard Error 1.27 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 15 | -33.71 mm | Standard Error 1.25 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 3 | -29.97 mm | Standard Error 1.18 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 18 | -35.73 mm | Standard Error 1.22 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 1 | -27.26 mm | Standard Error 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 2 | -29.71 mm | Standard Error 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 3 | -32.90 mm | Standard Error 1.13 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 6 | -35.35 mm | Standard Error 1.15 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 9 | -35.26 mm | Standard Error 1.16 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 12 | -35.85 mm | Standard Error 1.18 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 15 | -34.54 mm | Standard Error 1.2 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 21 | -35.66 mm | Standard Error 1.23 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Assessment of Arthritis Pain | Month 24 | -37.57 mm | Standard Error 1.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 2 | -19.90 mm | Standard Error 1.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 18 | -29.42 mm | Standard Error 1.87 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 15 | -28.10 mm | Standard Error 1.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 1 | -13.43 mm | Standard Error 1.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 9 | -27.09 mm | Standard Error 1.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 6 | -27.71 mm | Standard Error 1.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 24 | -29.51 mm | Standard Error 1.93 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 3 | -22.22 mm | Standard Error 1.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 21 | -27.87 mm | Standard Error 1.9 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Assessment of Arthritis Pain | Month 12 | -27.76 mm | Standard Error 1.79 |
Secondary
Change From Baseline in Patient Global Assessment of Arthritis
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 1 | -22.22 mm | Standard Error 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 2 | -28.74 mm | Standard Error 1.17 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 3 | -30.03 mm | Standard Error 1.18 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 6 | -31.65 mm | Standard Error 1.19 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 9 | -32.70 mm | Standard Error 1.21 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 12 | -32.75 mm | Standard Error 1.22 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 15 | -33.82 mm | Standard Error 1.25 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 18 | -34.18 mm | Standard Error 1.26 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 21 | -34.18 mm | Standard Error 1.27 |
| CP-690,550 5 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 24 | -34.41 mm | Standard Error 1.29 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 21 | -35.26 mm | Standard Error 1.23 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 1 | -27.87 mm | Standard Error 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 12 | -34.62 mm | Standard Error 1.18 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 9 | -34.48 mm | Standard Error 1.16 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 2 | -31.54 mm | Standard Error 1.12 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 24 | -35.74 mm | Standard Error 1.24 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 18 | -34.65 mm | Standard Error 1.22 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 3 | -31.72 mm | Standard Error 1.13 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 15 | -34.94 mm | Standard Error 1.2 |
| CP-690,550 10 mg BID | Change From Baseline in Patient Global Assessment of Arthritis | Month 6 | -35.11 mm | Standard Error 1.15 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 18 | -28.64 mm | Standard Error 1.87 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 6 | -27.00 mm | Standard Error 1.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 9 | -26.15 mm | Standard Error 1.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 12 | -26.07 mm | Standard Error 1.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 21 | -27.56 mm | Standard Error 1.9 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 15 | -26.70 mm | Standard Error 1.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 1 | -14.12 mm | Standard Error 1.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 24 | -28.81 mm | Standard Error 1.93 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 2 | -18.86 mm | Standard Error 1.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Patient Global Assessment of Arthritis | Month 3 | -22.18 mm | Standard Error 1.66 |
Secondary
Change From Baseline in Physician Global Assessment of Arthritis
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: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 15 | -43.91 mm | Standard Error 0.92 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 3 | -36.41 mm | Standard Error 0.87 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 18 | -44.00 mm | Standard Error 0.93 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 21 | -44.76 mm | Standard Error 0.94 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 1 | -24.89 mm | Standard Error 0.86 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 24 | -45.07 mm | Standard Error 0.95 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 6 | -39.04 mm | Standard Error 0.88 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 2 | -33.92 mm | Standard Error 0.86 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 9 | -42.09 mm | Standard Error 0.89 |
| CP-690,550 5 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 12 | -43.07 mm | Standard Error 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 15 | -45.40 mm | Standard Error 0.88 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 6 | -42.49 mm | Standard Error 0.84 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 12 | -46.02 mm | Standard Error 0.87 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 18 | -46.50 mm | Standard Error 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 3 | -38.48 mm | Standard Error 0.83 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 1 | -28.32 mm | Standard Error 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 21 | -46.02 mm | Standard Error 0.9 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 9 | -43.94 mm | Standard Error 0.85 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 2 | -35.49 mm | Standard Error 0.82 |
| CP-690,550 10 mg BID | Change From Baseline in Physician Global Assessment of Arthritis | Month 24 | -46.30 mm | Standard Error 0.91 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 9 | -36.54 mm | Standard Error 1.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 1 | -15.79 mm | Standard Error 1.19 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 2 | -24.17 mm | Standard Error 1.2 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 3 | -28.62 mm | Standard Error 1.22 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 6 | -33.41 mm | Standard Error 1.25 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 24 | -38.93 mm | Standard Error 1.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 12 | -37.43 mm | Standard Error 1.32 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 15 | -36.17 mm | Standard Error 1.34 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 18 | -38.65 mm | Standard Error 1.38 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Physician Global Assessment of Arthritis | Month 21 | -38.92 mm | Standard Error 1.4 |
Secondary
Change From Baseline in SF-36 Domain Scores
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).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Vitality | 8.66 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Social Functioning | 4.69 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Social Functioning | 6.97 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Social Functioning | 8.06 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Bodily Pain | 10.90 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Bodily Pain | 12.35 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 General Health Perception | 6.14 units on a scale | Standard Error 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 General Health Perception | 6.08 units on a scale | Standard Error 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 General Health Perception | 6.08 units on a scale | Standard Error 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 General Health Perception | 6.39 units on a scale | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Vitality | 9.00 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Vitality | 8.65 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Vitality | 8.19 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Vitality | 6.04 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Vitality | 7.36 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Vitality | 8.13 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Vitality | 8.36 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Vitality | 8.32 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Vitality | 8.30 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Social Functioning | 8.35 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Social Functioning | 8.39 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Role Physical | 9.55 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Social Functioning | 8.46 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Social Functioning | 8.85 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Social Functioning | 8.99 units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Role Emotional | 6.39 units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Social Functioning | 8.76 units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Role Emotional | 7.20 units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Role Emotional | 7.49 units on a scale | Standard Error 0.57 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Role Emotional | 7.21 units on a scale | Standard Error 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Social Functioning | 9.05 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Role Emotional | 7.63 units on a scale | Standard Error 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Role Emotional | 8.21 units on a scale | Standard Error 0.59 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Role Emotional | 8.43 units on a scale | Standard Error 0.6 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Role Emotional | 7.48 units on a scale | Standard Error 0.6 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Role Emotional | 8.61 units on a scale | Standard Error 0.61 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Role Emotional | 5.06 units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Mental Health | 4.57 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Mental Health | 5.53 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Mental Health | 6.59 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Mental Health | 7.05 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Mental Health | 6.46 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Mental Health | 7.27 units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Mental Health | 7.01 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Mental Health | 7.21 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Mental Health | 6.78 units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Mental Health | 6.88 units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Physical Functioning | 5.74 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Physical Functioning | 7.59 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Physical Functioning | 9.18 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Role Physical | 8.88 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Role Physical | 9.79 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Role Physical | 10.27 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Role Physical | 10.10 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Physical Functioning | 9.70 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Physical Functioning | 9.98 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Physical Functioning | 10.68 units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Role Physical | 10.11 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Role Physical | 10.31 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Bodily Pain | 7.21 units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Bodily Pain | 9.45 units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Bodily Pain | 10.69 units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Physical Functioning | 11.18 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Physical Functioning | 11.50 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Physical Functioning | 11.33 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Physical Functioning | 11.66 units on a scale | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Role Physical | 5.52 units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Role Physical | 7.81 units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Role Physical | 8.77 units on a scale | Standard Error 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Bodily Pain | 10.66 units on a scale | Standard Error 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Bodily Pain | 11.64 units on a scale | Standard Error 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Bodily Pain | 12.09 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Bodily Pain | 11.75 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Bodily Pain | 12.16 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 General Health Perception | 3.94 units on a scale | Standard Error 0.41 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 General Health Perception | 5.37 units on a scale | Standard Error 0.41 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 General Health Perception | 6.04 units on a scale | Standard Error 0.41 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 General Health Perception | 6.41 units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 General Health Perception | 6.50 units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 General Health Perception | 6.62 units on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Role Emotional | 7.26 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Social Functioning | 9.87 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Role Emotional | 7.73 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Role Emotional | 9.17 units on a scale | Standard Error 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Physical Functioning | 12.29 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Role Emotional | 9.35 units on a scale | Standard Error 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Social Functioning | 10.43 units on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 General Health Perception | 7.37 units on a scale | Standard Error 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Role Emotional | 9.38 units on a scale | Standard Error 0.56 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Physical Functioning | 12.66 units on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Role Emotional | 9.61 units on a scale | Standard Error 0.57 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Role Emotional | 9.16 units on a scale | Standard Error 0.58 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 General Health Perception | 5.19 units on a scale | Standard Error 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Role Emotional | 9.70 units on a scale | Standard Error 0.58 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Physical Functioning | 12.71 units on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Role Emotional | 6.88 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Role Emotional | 10.51 units on a scale | Standard Error 0.59 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Mental Health | 6.37 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Physical Functioning | 13.04 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Mental Health | 6.05 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Mental Health | 6.35 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 General Health Perception | 6.95 units on a scale | Standard Error 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Mental Health | 6.81 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Mental Health | 7.39 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 General Health Perception | 5.97 units on a scale | Standard Error 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Mental Health | 7.31 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Role Physical | 9.05 units on a scale | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Mental Health | 6.73 units on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Mental Health | 7.74 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Mental Health | 7.75 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Mental Health | 8.05 units on a scale | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Bodily Pain | 12.74 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Physical Functioning | 7.41 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Physical Functioning | 9.19 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Physical Functioning | 10.16 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Bodily Pain | 13.32 units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Role Physical | 11.13 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Role Physical | 11.72 units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Role Physical | 11.64 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Bodily Pain | 13.10 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Vitality | 9.29 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Role Physical | 11.23 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Social Functioning | 7.46 units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Role Physical | 7.57 units on a scale | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Bodily Pain | 12.58 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Physical Functioning | 11.39 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 General Health Perception | 6.44 units on a scale | Standard Error 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 General Health Perception | 6.84 units on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 General Health Perception | 7.04 units on a scale | Standard Error 0.41 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 General Health Perception | 6.89 units on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Physical Functioning | 12.00 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 General Health Perception | 7.20 units on a scale | Standard Error 0.41 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 General Health Perception | 7.06 units on a scale | Standard Error 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Vitality | 9.31 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Bodily Pain | 13.43 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Vitality | 8.33 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Physical Functioning | 12.76 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Vitality | 9.09 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Vitality | 8.94 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Social Functioning | 7.15 units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Vitality | 7.27 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Role Physical | 11.78 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Vitality | 7.94 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Vitality | 8.79 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 21 Bodily Pain | 13.52 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Vitality | 8.58 units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Role Physical | 12.26 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Vitality | 9.06 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Social Functioning | 7.90 units on a scale | Standard Error 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Social Functioning | 9.23 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 1 Bodily Pain | 9.54 units on a scale | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 9 Social Functioning | 9.37 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Role Physical | 9.81 units on a scale | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 12 Social Functioning | 9.60 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 2 Bodily Pain | 10.88 units on a scale | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 6 Role Physical | 10.63 units on a scale | Standard Error 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 15 Social Functioning | 9.49 units on a scale | Standard Error 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 18 Social Functioning | 9.44 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 24 Bodily Pain | 13.80 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Domain Scores | Month 3 Bodily Pain | 11.49 units on a scale | Standard Error 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Social Functioning | 5.83 units on a scale | Standard Error 0.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Bodily Pain | 6.81 units on a scale | Standard Error 0.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Vitality | 6.73 units on a scale | Standard Error 0.78 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Bodily Pain | 9.11 units on a scale | Standard Error 0.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Role Emotional | 4.38 units on a scale | Standard Error 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Bodily Pain | 9.06 units on a scale | Standard Error 0.78 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Vitality | 6.47 units on a scale | Standard Error 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Role Emotional | 5.58 units on a scale | Standard Error 0.81 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Social Functioning | 7.37 units on a scale | Standard Error 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Social Functioning | 6.82 units on a scale | Standard Error 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Role Physical | 6.60 units on a scale | Standard Error 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Vitality | 3.03 units on a scale | Standard Error 0.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Role Emotional | 6.37 units on a scale | Standard Error 0.83 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Physical Functioning | 6.89 units on a scale | Standard Error 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Role Physical | 8.20 units on a scale | Standard Error 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Social Functioning | 4.18 units on a scale | Standard Error 0.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Physical Functioning | 4.30 units on a scale | Standard Error 0.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Role Emotional | 5.94 units on a scale | Standard Error 0.85 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Role Emotional | 6.32 units on a scale | Standard Error 0.9 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Bodily Pain | 5.40 units on a scale | Standard Error 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Role Emotional | 4.97 units on a scale | Standard Error 0.86 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Physical Functioning | 7.05 units on a scale | Standard Error 0.81 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Social Functioning | 6.85 units on a scale | Standard Error 0.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Bodily Pain | 8.72 units on a scale | Standard Error 0.74 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Role Emotional | 7.53 units on a scale | Standard Error 0.89 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Role Emotional | 3.62 units on a scale | Standard Error 0.78 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Bodily Pain | 8.32 units on a scale | Standard Error 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Vitality | 3.68 units on a scale | Standard Error 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Physical Functioning | 7.35 units on a scale | Standard Error 0.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Role Physical | 8.65 units on a scale | Standard Error 0.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Role Emotional | 2.58 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 General Health Perception | 3.86 units on a scale | Standard Error 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Role Emotional | 6.59 units on a scale | Standard Error 0.91 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 General Health Perception | 2.15 units on a scale | Standard Error 0.57 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Physical Functioning | 5.69 units on a scale | Standard Error 0.74 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Mental Health | 3.50 units on a scale | Standard Error 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Social Functioning | 7.78 units on a scale | Standard Error 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 General Health Perception | 4.87 units on a scale | Standard Error 0.59 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Mental Health | 3.94 units on a scale | Standard Error 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Physical Functioning | 7.93 units on a scale | Standard Error 0.83 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Vitality | 4.99 units on a scale | Standard Error 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Mental Health | 4.67 units on a scale | Standard Error 0.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Social Functioning | 7.33 units on a scale | Standard Error 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 General Health Perception | 4.71 units on a scale | Standard Error 0.6 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Mental Health | 4.65 units on a scale | Standard Error 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Role Physical | 2.75 units on a scale | Standard Error 0.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Role Physical | 5.24 units on a scale | Standard Error 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Mental Health | 6.10 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 6 Vitality | 5.89 units on a scale | Standard Error 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Bodily Pain | 4.10 units on a scale | Standard Error 0.66 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Mental Health | 5.38 units on a scale | Standard Error 0.78 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 General Health Perception | 4.96 units on a scale | Standard Error 0.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Physical Functioning | 6.32 units on a scale | Standard Error 0.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Mental Health | 5.02 units on a scale | Standard Error 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Role Physical | 4.57 units on a scale | Standard Error 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 General Health Perception | 4.57 units on a scale | Standard Error 0.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Mental Health | 5.41 units on a scale | Standard Error 0.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 General Health Perception | 3.27 units on a scale | Standard Error 0.57 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Vitality | 6.44 units on a scale | Standard Error 0.74 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Mental Health | 6.39 units on a scale | Standard Error 0.83 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 General Health Perception | 4.61 units on a scale | Standard Error 0.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Vitality | 6.33 units on a scale | Standard Error 0.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Mental Health | 6.40 units on a scale | Standard Error 0.84 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 Role Physical | 7.78 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Vitality | 5.79 units on a scale | Standard Error 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Physical Functioning | 1.34 units on a scale | Standard Error 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Bodily Pain | 8.77 units on a scale | Standard Error 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Social Functioning | 5.85 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 2 Physical Functioning | 3.66 units on a scale | Standard Error 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 General Health Perception | 5.33 units on a scale | Standard Error 0.61 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 3 Social Functioning | 5.18 units on a scale | Standard Error 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 18 Vitality | 6.46 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 21 Bodily Pain | 9.39 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 9 Role Physical | 6.57 units on a scale | Standard Error 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Bodily Pain | 8.43 units on a scale | Standard Error 0.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Physical Functioning | 7.41 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 12 Role Physical | 7.03 units on a scale | Standard Error 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 24 General Health Perception | 4.75 units on a scale | Standard Error 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 1 Social Functioning | 3.10 units on a scale | Standard Error 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Domain Scores | Month 15 Role Physical | 7.06 units on a scale | Standard Error 0.73 |
Secondary
Change From Baseline in SF-36 Mental Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 24 | 6.23 units on a scale | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 1 | 4.37 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 2 | 5.39 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 3 | 6.12 units on a scale | Standard Error 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 6 | 6.36 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 9 | 5.99 units on a scale | Standard Error 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 12 | 6.21 units on a scale | Standard Error 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 15 | 6.38 units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 18 | 6.51 units on a scale | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 21 | 5.80 units on a scale | Standard Error 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 9 | 6.83 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 21 | 6.94 units on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 24 | 7.49 units on a scale | Standard Error 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 3 | 5.89 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 6 | 6.53 units on a scale | Standard Error 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 1 | 6.14 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 18 | 6.70 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 15 | 6.30 units on a scale | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 2 | 5.51 units on a scale | Standard Error 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Mental Component Score | Month 12 | 6.62 units on a scale | Standard Error 0.51 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 2 | 3.41 units on a scale | Standard Error 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 3 | 4.33 units on a scale | Standard Error 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 21 | 5.58 units on a scale | Standard Error 0.81 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 6 | 4.84 units on a scale | Standard Error 0.73 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 9 | 6.04 units on a scale | Standard Error 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 18 | 5.78 units on a scale | Standard Error 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 12 | 4.72 units on a scale | Standard Error 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 24 | 5.54 units on a scale | Standard Error 0.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 1 | 3.25 units on a scale | Standard Error 0.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Mental Component Score | Month 15 | 4.09 units on a scale | Standard Error 0.78 |
Secondary
Change From Baseline in SF-36 Physical Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 1 | 5.83 units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 2 | 8.04 units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 3 | 9.23 units on a scale | Standard Error 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 6 | 9.66 units on a scale | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 9 | 9.63 units on a scale | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 12 | 10.30 units on a scale | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 15 | 10.87 units on a scale | Standard Error 0.45 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 18 | 10.76 units on a scale | Standard Error 0.45 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 21 | 11.19 units on a scale | Standard Error 0.46 |
| CP-690,550 5 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 24 | 11.03 units on a scale | Standard Error 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 21 | 12.19 units on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 1 | 7.54 units on a scale | Standard Error 0.41 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 12 | 12.35 units on a scale | Standard Error 0.43 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 9 | 11.53 units on a scale | Standard Error 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 2 | 9.45 units on a scale | Standard Error 0.41 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 24 | 12.46 units on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 18 | 12.04 units on a scale | Standard Error 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 3 | 10.32 units on a scale | Standard Error 0.41 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 15 | 12.06 units on a scale | Standard Error 0.43 |
| CP-690,550 10 mg BID | Change From Baseline in SF-36 Physical Component Score | Month 6 | 11.24 units on a scale | Standard Error 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 18 | 7.47 units on a scale | Standard Error 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 6 | 6.55 units on a scale | Standard Error 0.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 9 | 6.56 units on a scale | Standard Error 0.63 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 12 | 7.48 units on a scale | Standard Error 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 21 | 7.93 units on a scale | Standard Error 0.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 15 | 7.43 units on a scale | Standard Error 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 1 | 2.17 units on a scale | Standard Error 0.59 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 24 | 7.63 units on a scale | Standard Error 0.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 2 | 4.23 units on a scale | Standard Error 0.6 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SF-36 Physical Component Score | Month 3 | 4.98 units on a scale | Standard Error 0.6 |
Secondary
Change From Baseline in SJC
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 1 | -5.99 swollen joints | Standard Error 0.36 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 2 | -8.95 swollen joints | Standard Error 0.37 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 3 | -9.97 swollen joints | Standard Error 0.37 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 6 | -10.89 swollen joints | Standard Error 0.37 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 9 | -11.47 swollen joints | Standard Error 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 12 | -11.97 swollen joints | Standard Error 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 15 | -12.55 swollen joints | Standard Error 0.39 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 18 | -12.63 swollen joints | Standard Error 0.39 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 21 | -12.74 swollen joints | Standard Error 0.4 |
| CP-690,550 5 mg BID | Change From Baseline in SJC | Month 24 | -12.99 swollen joints | Standard Error 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 21 | -13.28 swollen joints | Standard Error 0.38 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 1 | -7.75 swollen joints | Standard Error 0.35 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 12 | -12.54 swollen joints | Standard Error 0.37 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 9 | -12.39 swollen joints | Standard Error 0.36 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 2 | -10.03 swollen joints | Standard Error 0.35 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 24 | -13.06 swollen joints | Standard Error 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 18 | -13.10 swollen joints | Standard Error 0.38 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 3 | -11.42 swollen joints | Standard Error 0.35 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 15 | -12.30 swollen joints | Standard Error 0.38 |
| CP-690,550 10 mg BID | Change From Baseline in SJC | Month 6 | -11.97 swollen joints | Standard Error 0.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 18 | -11.31 swollen joints | Standard Error 0.59 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 6 | -9.35 swollen joints | Standard Error 0.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 9 | -11.00 swollen joints | Standard Error 0.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 12 | -10.48 swollen joints | Standard Error 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 21 | -11.89 swollen joints | Standard Error 0.6 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 15 | -10.69 swollen joints | Standard Error 0.57 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 1 | -3.55 swollen joints | Standard Error 0.51 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 24 | -11.96 swollen joints | Standard Error 0.61 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 2 | -5.98 swollen joints | Standard Error 0.51 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in SJC | Month 3 | -7.97 swollen joints | Standard Error 0.52 |
Secondary
Change From Baseline in Temperature
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: Temperature was measured at every study visit to determine the overall health of the participants. Any abnormalities were recorded as adverse events. Change from baseline in temperature will be analyzed as part of the wider clinical program.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 1 | -0.07 degrees centigrade | Standard Deviation 0.3 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 2 | -0.07 degrees centigrade | Standard Deviation 0.32 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 3 | -0.08 degrees centigrade | Standard Deviation 0.34 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 6 | -0.07 degrees centigrade | Standard Deviation 0.35 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 9 | -0.07 degrees centigrade | Standard Deviation 0.37 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 12 | -0.10 degrees centigrade | Standard Deviation 0.34 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 15 | -0.08 degrees centigrade | Standard Deviation 0.35 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 18 | -0.07 degrees centigrade | Standard Deviation 0.41 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 21 | -0.09 degrees centigrade | Standard Deviation 0.36 |
| CP-690,550 5 mg BID | Change From Baseline in Temperature | Month 24 | -0.10 degrees centigrade | Standard Deviation 0.37 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 21 | -0.07 degrees centigrade | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 1 | -0.05 degrees centigrade | Standard Deviation 0.31 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 3 | -0.04 degrees centigrade | Standard Deviation 0.34 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 12 | -0.03 degrees centigrade | Standard Deviation 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 9 | -0.06 degrees centigrade | Standard Deviation 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 2 | -0.03 degrees centigrade | Standard Deviation 0.37 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 24 | -0.07 degrees centigrade | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 18 | -0.03 degrees centigrade | Standard Deviation 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 15 | -0.05 degrees centigrade | Standard Deviation 0.42 |
| CP-690,550 10 mg BID | Change From Baseline in Temperature | Month 6 | -0.04 degrees centigrade | Standard Deviation 0.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 18 | -0.11 degrees centigrade | Standard Deviation 0.38 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 6 | -0.09 degrees centigrade | Standard Deviation 0.38 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 9 | -0.08 degrees centigrade | Standard Deviation 0.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 12 | -0.12 degrees centigrade | Standard Deviation 0.37 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 21 | -0.13 degrees centigrade | Standard Deviation 0.4 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 15 | -0.10 degrees centigrade | Standard Deviation 0.35 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 1 | -0.05 degrees centigrade | Standard Deviation 0.32 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 24 | -0.12 degrees centigrade | Standard Deviation 0.37 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 2 | -0.04 degrees centigrade | Standard Deviation 0.35 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Temperature | Month 3 | -0.05 degrees centigrade | Standard Deviation 0.36 |
Secondary
Change From Baseline in TJC
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 1 | -9.43 tender joints | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 2 | -12.95 tender joints | Standard Error 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 3 | -14.95 tender joints | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 6 | -16.00 tender joints | Standard Error 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 9 | -17.16 tender joints | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 12 | -17.85 tender joints | Standard Error 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 15 | -18.86 tender joints | Standard Error 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 18 | -19.08 tender joints | Standard Error 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 21 | -19.54 tender joints | Standard Error 0.59 |
| CP-690,550 5 mg BID | Change From Baseline in TJC | Month 24 | -19.64 tender joints | Standard Error 0.59 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 21 | -19.70 tender joints | Standard Error 0.57 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 1 | -11.40 tender joints | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 12 | -18.44 tender joints | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 9 | -18.29 tender joints | Standard Error 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 2 | -14.33 tender joints | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 24 | -19.23 tender joints | Standard Error 0.57 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 18 | -19.41 tender joints | Standard Error 0.56 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 3 | -16.34 tender joints | Standard Error 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 15 | -18.57 tender joints | Standard Error 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in TJC | Month 6 | -18.09 tender joints | Standard Error 0.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 18 | -16.41 tender joints | Standard Error 0.86 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 6 | -12.38 tender joints | Standard Error 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 9 | -15.39 tender joints | Standard Error 0.81 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 12 | -14.74 tender joints | Standard Error 0.82 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 21 | -16.24 tender joints | Standard Error 0.87 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 15 | -15.70 tender joints | Standard Error 0.83 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 1 | -5.11 tender joints | Standard Error 0.75 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 24 | -17.01 tender joints | Standard Error 0.89 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 2 | -8.63 tender joints | Standard Error 0.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in TJC | Month 3 | -10.69 tender joints | Standard Error 0.77 |
Secondary
Change From Baseline in WLQ Scores
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 15 Mental/Interpersonal Demands | -17.52 units on a scale | Standard Error 17.41 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 15 Output Demand | -29.63 units on a scale | Standard Error 18.09 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 12 Physical Demand | -5.36 units on a scale | Standard Error 2.77 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 12 Time Management Scale | -16.22 units on a scale | Standard Error 2.23 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 12 Output Demand | -14.83 units on a scale | Standard Error 1.93 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 15 Physical Demand | -28.94 units on a scale | Standard Error 28.32 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 3 Time Management Scale | -14.28 units on a scale | Standard Error 2.11 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 6 Output Demand | -14.78 units on a scale | Standard Error 1.89 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 18 Physical Demand | -2.35 units on a scale | Standard Error 2.86 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 12 Mental/Interpersonal Demands | -9.35 units on a scale | Standard Error 1.77 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 15 Time Management Scale | -32.18 units on a scale | Standard Error 21.24 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 3 Output Demand | -12.69 units on a scale | Standard Error 1.84 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 21 Mental/Interpersonal Demands | -4.00 units on a scale | Standard Error 9.96 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 6 Mental/Interpersonal Demands | -10.03 units on a scale | Standard Error 1.72 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 24 Mental/Interpersonal Demands | -9.34 units on a scale | Standard Error 1.89 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 3 Mental/Interpersonal Demands | -6.81 units on a scale | Standard Error 1.68 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 18 Time Management Scale | -21.55 units on a scale | Standard Error 2.33 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 18 Mental/Interpersonal Demands | -11.09 units on a scale | Standard Error 1.83 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 24 Physical Demand | -2.71 units on a scale | Standard Error 3.02 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 21 Time Management Scale | 5.99 units on a scale | Standard Error 14.9 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 24 Output Demand | -13.60 units on a scale | Standard Error 2.05 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 21 Output Demand | 0.32 units on a scale | Standard Error 12.69 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 24 Time Management Scale | -15.44 units on a scale | Standard Error 2.37 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 6 Time Management Scale | -16.99 units on a scale | Standard Error 2.16 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 18 Output Demand | -14.17 units on a scale | Standard Error 1.98 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 3 Physical Demand | -6.44 units on a scale | Standard Error 2.62 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 21 Physical Demand | 3.65 units on a scale | Standard Error 16.22 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Scores | Month 6 Physical Demand | -1.25 units on a scale | Standard Error 2.68 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 21 Time Management Scale | -16.26 units on a scale | Standard Error 20.82 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 3 Output Demand | -13.43 units on a scale | Standard Error 1.82 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 3 Time Management Scale | -16.87 units on a scale | Standard Error 2.04 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 6 Time Management Scale | -20.12 units on a scale | Standard Error 2.1 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 12 Time Management Scale | -20.72 units on a scale | Standard Error 2.2 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 15 Time Management Scale | -14.92 units on a scale | Standard Error 15.04 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 18 Time Management Scale | -22.60 units on a scale | Standard Error 2.3 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 24 Time Management Scale | -22.25 units on a scale | Standard Error 2.35 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 3 Physical Demand | -8.36 units on a scale | Standard Error 2.55 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 6 Physical Demand | -9.48 units on a scale | Standard Error 2.64 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 12 Physical Demand | -6.66 units on a scale | Standard Error 2.76 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 15 Physical Demand | -12.26 units on a scale | Standard Error 16.51 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 18 Physical Demand | -11.77 units on a scale | Standard Error 2.95 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 18 Mental/Interpersonal Demands | -13.08 units on a scale | Standard Error 1.86 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 21 Mental/Interpersonal Demands | 23.24 units on a scale | Standard Error 17.09 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 24 Mental/Interpersonal Demands | -13.58 units on a scale | Standard Error 1.9 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 6 Output Demand | -19.16 units on a scale | Standard Error 1.89 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 12 Output Demand | -21.15 units on a scale | Standard Error 1.96 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 15 Output Demand | -18.43 units on a scale | Standard Error 10.61 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 18 Output Demand | -18.82 units on a scale | Standard Error 2.06 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 21 Output Demand | 16.85 units on a scale | Standard Error 17.72 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 24 Output Demand | -20.77 units on a scale | Standard Error 2.08 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 21 Physical Demand | -18.17 units on a scale | Standard Error 27.87 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 24 Physical Demand | -9.56 units on a scale | Standard Error 3.03 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 3 Mental/Interpersonal Demands | -8.56 units on a scale | Standard Error 1.64 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 6 Mental/Interpersonal Demands | -12.35 units on a scale | Standard Error 1.69 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 12 Mental/Interpersonal Demands | -15.21 units on a scale | Standard Error 11.76 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Scores | Month 15 Mental/Interpersonal Demands | -21.78 units on a scale | Standard Error 10.18 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 15 Output Demand | 17.17 units on a scale | Standard Error 13.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 24 Time Management Scale | -18.54 units on a scale | Standard Error 3.64 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 3 Time Management Scale | -10.46 units on a scale | Standard Error 2.98 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 18 Output Demand | -14.15 units on a scale | Standard Error 3.09 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 21 Time Management Scale | -7.27 units on a scale | Standard Error 20.89 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 6 Mental/Interpersonal Demands | -9.36 units on a scale | Standard Error 2.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 21 Output Demand | -20.75 units on a scale | Standard Error 17.79 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 3 Physical Demand | 0.13 units on a scale | Standard Error 3.74 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 12 Time Management Scale | -18.32 units on a scale | Standard Error 3.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 24 Output Demand | -16.40 units on a scale | Standard Error 3.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 18 Physical Demand | -7.77 units on a scale | Standard Error 4.38 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 15 Mental/Interpersonal Demands | 15.00 units on a scale | Standard Error 12.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 21 Physical Demand | 4.80 units on a scale | Standard Error 27.94 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 18 Time Management Scale | -18.68 units on a scale | Standard Error 3.47 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 12 Mental/Interpersonal Demands | -11.64 units on a scale | Standard Error 2.63 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 21 Mental/Interpersonal Demands | -29.23 units on a scale | Standard Error 17.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 24 Physical Demand | -8.03 units on a scale | Standard Error 4.62 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 24 Mental/Interpersonal Demands | -13.14 units on a scale | Standard Error 2.87 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 18 Mental/Interpersonal Demands | -11.33 units on a scale | Standard Error 2.76 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 3 Output Demand | -8.73 units on a scale | Standard Error 2.72 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 15 Physical Demand | -13.80 units on a scale | Standard Error 16.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 15 Time Management Scale | 29.59 units on a scale | Standard Error 21.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 6 Output Demand | -14.02 units on a scale | Standard Error 2.8 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 12 Physical Demand | -14.62 units on a scale | Standard Error 4.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 6 Time Management Scale | -15.78 units on a scale | Standard Error 3.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 12 Output Demand | -15.84 units on a scale | Standard Error 2.95 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 6 Physical Demand | -6.45 units on a scale | Standard Error 3.88 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Scores | Month 3 Mental/Interpersonal Demands | -5.99 units on a scale | Standard Error 2.39 |
Secondary
Change From Baseline in WLQ Work Loss Index Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Months 3, 6, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a specific timepoint for each treatment group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 3 | -2.82 units on a scale | Standard Error 0.41 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 12 | -3.35 units on a scale | Standard Error 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 18 | -3.61 units on a scale | Standard Error 0.45 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 6 | -3.24 units on a scale | Standard Error 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 24 | -3.18 units on a scale | Standard Error 0.46 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 21 | -1.14 units on a scale | Standard Error 2.33 |
| CP-690,550 5 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 15 | -7.10 units on a scale | Standard Error 4.07 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 15 | -4.99 units on a scale | Standard Error 2.39 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 6 | -4.23 units on a scale | Standard Error 0.41 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 12 | -4.99 units on a scale | Standard Error 0.43 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 3 | -3.21 units on a scale | Standard Error 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 18 | -4.90 units on a scale | Standard Error 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 21 | 2.24 units on a scale | Standard Error 3.99 |
| CP-690,550 10 mg BID | Change From Baseline in WLQ Work Loss Index Score | Month 24 | -4.96 units on a scale | Standard Error 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 18 | -3.48 units on a scale | Standard Error 0.68 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 12 | -3.84 units on a scale | Standard Error 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 24 | -4.11 units on a scale | Standard Error 0.7 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 21 | -4.92 units on a scale | Standard Error 4 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 15 | -0.19 units on a scale | Standard Error 2.43 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 3 | -2.03 units on a scale | Standard Error 0.59 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in WLQ Work Loss Index Score | Month 6 | -3.18 units on a scale | Standard Error 0.61 |
Secondary
Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Months 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 18 | -2.28 units on a scale | Standard Deviation 3.25 |
| CP-690,550 5 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 12 | -2.15 units on a scale | Standard Deviation 3.22 |
| CP-690,550 5 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 3 | -1.40 units on a scale | Standard Deviation 2.88 |
| CP-690,550 5 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 6 | -2.11 units on a scale | Standard Deviation 2.92 |
| CP-690,550 5 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 24 | -2.24 units on a scale | Standard Deviation 3.36 |
| CP-690,550 10 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 12 | -2.68 units on a scale | Standard Deviation 3.17 |
| CP-690,550 10 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 3 | -1.45 units on a scale | Standard Deviation 3.9 |
| CP-690,550 10 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 6 | -2.44 units on a scale | Standard Deviation 2.97 |
| CP-690,550 10 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 18 | -2.62 units on a scale | Standard Deviation 3.15 |
| CP-690,550 10 mg BID | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 24 | -2.38 units on a scale | Standard Deviation 3.11 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 24 | -1.88 units on a scale | Standard Deviation 3.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 18 | -2.22 units on a scale | Standard Deviation 3.33 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 3 | -0.81 units on a scale | Standard Deviation 2.94 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 12 | -1.51 units on a scale | Standard Deviation 2.93 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 6 | -1.22 units on a scale | Standard Deviation 3.39 |
Secondary
Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: feel well enough to work | -0.27 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: retired | -0.02 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: treated in ER | 0.01 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month24:admitted for overnight stay | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: Hospitalization | 0.09 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: sick leave due to RA | 0.21 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic test | 0.18 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: in nursing home | -0.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month12:admitted for overnight stay | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: home healthcare services | 0.02 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: performed part time work | 0.09 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: required aids/devices | 0.05 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: non-medical practitioner | 0.02 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: in a nursing home | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: currently employed | -0.04 units on a scale | Standard Deviation 0.37 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: performed paid work | 0.22 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: feel well enough to work | -0.26 units on a scale | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: unable to work due to RA | 0.30 units on a scale | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: lost job/retired early | 0.00 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: unable to do chores | 0.36 units on a scale | Standard Deviation 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: work disabled due to RA | 0.18 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: retired | -0.05 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: sick leave due to RA | 0.22 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 0.04 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: performed part-time work | 0.10 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: performed paid work | 0.24 units on a scale | Standard Deviation 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: home healthcare services | 0.01 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: unable to do chores | 0.41 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: chores by family/friends | 0.35 units on a scale | Standard Deviation 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 0.04 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: chores by family/friends | 0.40 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: seen any doctor | 0.34 units on a scale | Standard Deviation 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: seen any doctor | 0.32 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: treated in ER | 0.00 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: treated in ER | 0.01 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: used aids/devices | 0.04 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month18:admitted for overnight stay | 0.00 units on a scale | — |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18:hospitalization | 0.10 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: hospitalized | 0.08 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.21 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: non-medical practitioner | 0.03 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 0.16 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: in nursing home | -0.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: home healthcare services | 0.01 units on a scale | Standard Deviation 0.13 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: currently employed | -0.03 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: required aids/devices | 0.06 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: non-medical practitioner | 0.02 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: currently employed | -0.03 units on a scale | Standard Deviation 0.36 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: feel well enough to work | -0.17 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: seen any doctor | 0.34 units on a scale | Standard Deviation 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: unable to work due to RA | 0.28 units on a scale | Standard Deviation 0.57 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12:any outpatient surgery | -0.00 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: lost job/retired early | 0.05 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: unable to work due to RA | 0.18 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: work disabled due to RA | 0.21 units on a scale | Standard Deviation 0.56 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: retired | -0.04 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: sick leave due to RA | 0.20 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: Lost job/retired early | 0.02 units on a scale | Standard Deviation 0.43 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: performed part-time work | 0.09 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: performed paid work | 0.18 units on a scale | Standard Deviation 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: unable to do chores | 0.41 units on a scale | Standard Deviation 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: work disabled due to RA | 0.10 units on a scale | Standard Deviation 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 0.06 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: chores by family/friends | 0.37 units on a scale | Standard Deviation 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 0.15 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: unable to do chores | 0.47 units on a scale | Standard Deviation 0.56 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: seen any doctor | 0.36 units on a scale | Standard Deviation 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: seen any doctor | 0.36 units on a scale | Standard Deviation 0.55 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: feel well enough to work | -0.17 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: treated in ER | 0.03 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: retired | -0.07 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: feel well enough to work | -0.18 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month24:admitted for overnight stay | 0.00 units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: treated in ER | 0.04 units on a scale | Standard Deviation 0.31 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: Hospitalization | 0.06 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 0.13 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: work disabled due to RA | 0.13 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 0.02 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: unable to work due to RA | 0.21 units on a scale | Standard Deviation 0.58 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month18:admitted for overnight stay | 2.00 units on a scale | — |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic test | 0.16 units on a scale | Standard Deviation 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: sick leave due to RA | 0.27 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: used aids/devices | 0.06 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: in nursing home | 0.01 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: performed part-time work | 0.11 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18:hospitalization | 0.05 units on a scale | Standard Deviation 0.3 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: home healthcare services | 0.00 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: Lost job/retired early | -0.01 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: lost job/retired early | 0.03 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: required aids/devices | 0.04 units on a scale | Standard Deviation 0.3 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: performed part time work | 0.09 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: non-medical practitioner | 0.02 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: chores by family/friends | 0.41 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: performed paid work | 0.27 units on a scale | Standard Deviation 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: currently employed | 0.00 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 0.17 units on a scale | Standard Deviation 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: non-medical practitioner | 0.03 units on a scale | Standard Deviation 0.18 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: feel well enough to work | -0.19 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: performed paid work | 0.28 units on a scale | Standard Deviation 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: work disabled due to RA | 0.17 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: unable to work due to RA | 0.27 units on a scale | Standard Deviation 0.61 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: in a nursing home | 0.01 units on a scale | Standard Deviation 0.08 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: in nursing home | 0.01 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: lost job/retired early | 0.04 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: hospitalized | 0.06 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: unable to work due to RA | 0.23 units on a scale | Standard Deviation 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: work disabled due to RA | 0.19 units on a scale | Standard Deviation 0.57 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: unable to do chores | 0.44 units on a scale | Standard Deviation 0.56 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: home healthcare services | 0.01 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: retired | -0.05 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month12:admitted for overnight stay | 0.50 units on a scale | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: seen any doctor | 0.31 units on a scale | Standard Deviation 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: sick leave due to RA | 0.29 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: retired | -0.05 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: required aids/devices | 0.06 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: performed part-time work | 0.12 units on a scale | Standard Deviation 0.34 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 0.09 units on a scale | Standard Deviation 0.3 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: currently employed | -0.01 units on a scale | Standard Deviation 0.34 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: performed paid work | 0.28 units on a scale | Standard Deviation 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12:any outpatient surgery | 0.01 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: non-medical practitioner | 0.03 units on a scale | Standard Deviation 0.18 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: unable to do chores | 0.47 units on a scale | Standard Deviation 0.56 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: treated in ER | 0.05 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 0.10 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 0.08 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: chores by family/friends | 0.36 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: currently employed | -0.03 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: chores by family/friends | 0.40 units on a scale | Standard Deviation 0.53 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: sick leave due to RA | 0.26 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: home healthcare services | 0.01 units on a scale | Standard Deviation 0.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: chores by family/friends | 0.31 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: seen any doctor | 0.26 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: treated in ER | 0.04 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month12:admitted for overnight stay | 0.00 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: hospitalized | 0.09 units on a scale | Standard Deviation 0.33 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12:any outpatient surgery | -0.01 units on a scale | Standard Deviation 0.19 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 0.21 units on a scale | Standard Deviation 0.51 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: in a nursing home | 0.01 units on a scale | Standard Deviation 0.15 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: home healthcare services | 0.01 units on a scale | Standard Deviation 0.12 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: used aids/devices | 0.06 units on a scale | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: non-medical practitioner | 0.02 units on a scale | Standard Deviation 0.15 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: currently employed | -0.02 units on a scale | Standard Deviation 0.26 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: feel well enough to work | -0.19 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: unable to work due to RA | 0.18 units on a scale | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: Lost job/retired early | 0.02 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: work disabled due to RA | 0.11 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: retired | -0.03 units on a scale | Standard Deviation 0.43 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: sick leave due to RA | 0.20 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: performed part time work | 0.17 units on a scale | Standard Deviation 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: performed paid work | 0.18 units on a scale | Standard Deviation 0.52 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: unable to do chores | 0.30 units on a scale | Standard Deviation 0.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 0.01 units on a scale | Standard Deviation 0.21 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 12: chores by family/friends | 0.28 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: seen any doctor | 0.28 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: treated in ER | 0.03 units on a scale | Standard Deviation 0.28 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month18:admitted for overnight stay | 0.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18:hospitalization | 0.08 units on a scale | Standard Deviation 0.33 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | -0.01 units on a scale | Standard Deviation 0.21 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 0.19 units on a scale | Standard Deviation 0.57 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: in nursing home | 0.02 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: home healthcare services | 0.02 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: required aids/devices | 0.07 units on a scale | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: non-medical practitioner | 0.02 units on a scale | Standard Deviation 0.19 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: currently employed | 0.01 units on a scale | Standard Deviation 0.28 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: feel well enough to work | -0.08 units on a scale | Standard Deviation 0.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: unable to work due to RA | 0.15 units on a scale | Standard Deviation 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: lost job/retired early | 0.00 units on a scale | Standard Deviation 0.51 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: work disabled due to RA | 0.02 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: retired | 0.02 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: sick leave due to RA | 0.22 units on a scale | Standard Deviation 0.47 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: performed part-time work | 0.19 units on a scale | Standard Deviation 0.43 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: performed paid work | 0.27 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: unable to do chores | 0.29 units on a scale | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 0.00 units on a scale | Standard Deviation 0.26 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 18: chores by family/friends | 0.34 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: seen any doctor | 0.34 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: treated in ER | 0.03 units on a scale | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: Hospitalization | 0.07 units on a scale | Standard Deviation 0.32 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic test | 0.13 units on a scale | Standard Deviation 0.6 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: in nursing home | 0.00 units on a scale | Standard Deviation 0.2 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: home healthcare services | -0.01 units on a scale | Standard Deviation 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: required aids/devices | 0.08 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: non-medical practitioner | 0.03 units on a scale | Standard Deviation 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: currently employed | 0.01 units on a scale | Standard Deviation 0.32 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: feel well enough to work | -0.13 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: unable to work due to RA | 0.08 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: lost job/retired early | 0.04 units on a scale | Standard Deviation 0.41 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: work disabled due to RA | 0.13 units on a scale | Standard Deviation 0.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: retired | 0.08 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: sick leave due to RA | 0.16 units on a scale | Standard Deviation 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: performed part-time work | 0.15 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: performed paid work | 0.20 units on a scale | Standard Deviation 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: unable to do chores | 0.32 units on a scale | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 0.03 units on a scale | Standard Deviation 0.22 |
Secondary
Change From Baseline in Work Productivity and HCRU at Months 3 and 6
RA-HCRU assessed HC usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: non-medical practitioner | 0.01 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: retired | -0.01 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: performed part-time work | 0.09 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: required aids/devices | 0.04 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: sick leave due to RA | 0.14 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: in nursing home | -0.00 units on a scale | Standard Deviation 0.05 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: home healthcare services | 0.00 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: performed part-time work | 0.04 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: treated in ER | 0.01 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: in nursing home | -0.00 units on a scale | Standard Deviation 0.05 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: performed paid work | 0.09 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: seen any doctor | 0.24 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: non-study diagnostic test | 0.17 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: unable to do chores | 0.28 units on a scale | Standard Deviation 0.57 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: home healthcare services | 0.01 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.21 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: chores by housekeeper | 0.04 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3:hospitalization | 0.10 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: Hospitalization | 0.10 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: chores by family/friends | 0.21 units on a scale | Standard Deviation 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: sick leave due to RA | 0.21 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: treated in ER | 0.00 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: seen any doctor | 0.28 units on a scale | Standard Deviation 0.53 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: required aids/devices | 0.05 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: chores by family/friends | 0.30 units on a scale | Standard Deviation 0.52 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: retired | -0.01 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: non-medical practitioner | 0.01 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: unable to do chores | 0.37 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: work disabled due to RA | 0.14 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: currently employed | -0.03 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: lost job/retired early | 0.00 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: feel well enough to work | -0.16 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: chores by housekeeper | 0.04 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: unable to work due to RA | 0.18 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: unable to work due to RA | 0.12 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: performed paid work | 0.18 units on a scale | Standard Deviation 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: feel well enough to work | -0.24 units on a scale | Standard Deviation 0.55 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: lost job/retired early | -0.07 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: non-study diagnostic test | 0.16 units on a scale | Standard Deviation 0.51 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: currently employed | -0.04 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: work disabled due to RA | 0.10 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3:admitted for overnight stay | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: sick leave due to RA | 0.23 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: seen any doctor | 0.18 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: treated in ER | 0.04 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3:admitted for overnight stay | -0.60 units on a scale | Standard Deviation 0.89 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3:hospitalization | 0.07 units on a scale | Standard Deviation 0.26 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: outpatient surgery | 0.02 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: non-study diagnostic test | 0.17 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: in nursing home | 0.00 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: home healthcare services | 0.00 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: required aids/devices | 0.04 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: non-medical practitioner | 0.03 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: currently employed | -0.00 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: feel well enough to work | -0.17 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: unable to work due to RA | 0.13 units on a scale | Standard Deviation 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: lost job/retired early | -0.02 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: work disabled due to RA | 0.11 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: retired | -0.02 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: sick leave due to RA | 0.18 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: performed part-time work | 0.08 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: performed paid work | 0.16 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: unable to do chores | 0.32 units on a scale | Standard Deviation 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: chores by housekeeper | 0.05 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: chores by family/friends | 0.21 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: seen any doctor | 0.26 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: treated in ER | 0.03 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6:admitted for overnight stay | -0.20 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: Hospitalization | 0.06 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: outpatient surgery | 0.02 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: non-study diagnostic test | 0.15 units on a scale | Standard Deviation 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: in nursing home | 0.01 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: home healthcare services | 0.01 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: required aids/devices | 0.05 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: non-medical practitioner | 0.04 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: currently employed | -0.01 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: feel well enough to work | -0.19 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: unable to work due to RA | 0.15 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: lost job/retired early | 0.01 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: work disabled due to RA | 0.13 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: retired | -0.03 units on a scale | Standard Deviation 0.3 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: performed part-time work | 0.09 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: performed paid work | 0.26 units on a scale | Standard Deviation 0.52 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: unable to do chores | 0.41 units on a scale | Standard Deviation 0.54 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: chores by housekeeper | 0.08 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg BID | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: chores by family/friends | 0.34 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: retired | 0.01 units on a scale | Standard Deviation 0.33 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: performed part-time work | 0.12 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: required aids/devices | 0.04 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: work disabled due to RA | 0.06 units on a scale | Standard Deviation 0.43 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: outpatient surgery | 0.01 units on a scale | Standard Deviation 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: non-medical practitioner | 0.00 units on a scale | Standard Deviation 0.2 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: lost job/retired early | 0.05 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: chores by housekeeper | 0.01 units on a scale | Standard Deviation 0.24 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: currently employed | 0.00 units on a scale | Standard Deviation 0.28 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: unable to work due to RA | 0.05 units on a scale | Standard Deviation 0.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: performed paid work | 0.14 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: feel well enough to work | -0.10 units on a scale | Standard Deviation 0.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: feel well enough to work | -0.11 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3:hospitalization | 0.12 units on a scale | Standard Deviation 0.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: unable to work due to RA | 0.05 units on a scale | Standard Deviation 0.55 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: currently employed | 0.00 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: seen any doctor | 0.18 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: lost job/retired early | 0.04 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: non-medical practitioner | 0.03 units on a scale | Standard Deviation 0.2 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: unable to do chores | 0.24 units on a scale | Standard Deviation 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: work disabled due to RA | 0.07 units on a scale | Standard Deviation 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: required aids/devices | -0.01 units on a scale | Standard Deviation 0.25 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: seen any doctor | 0.22 units on a scale | Standard Deviation 0.47 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: chores by family/friends | 0.09 units on a scale | Standard Deviation 0.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: treated in ER | 0.06 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: treated in ER | 0.05 units on a scale | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: retired | 0.03 units on a scale | Standard Deviation 0.36 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: chores by housekeeper | -0.04 units on a scale | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: home healthcare services | 0.02 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: Hospitalization | 0.09 units on a scale | Standard Deviation 0.35 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: unable to do chores | 0.09 units on a scale | Standard Deviation 0.53 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: in nursing home | 0.02 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: outpatient surgery | -0.01 units on a scale | Standard Deviation 0.21 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: performed paid work | 0.12 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: sick leave due to RA | 0.17 units on a scale | Standard Deviation 0.44 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: non-study diagnostic test | 0.18 units on a scale | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: performed part-time work | 0.09 units on a scale | Standard Deviation 0.41 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: non-study diagnostic test | 0.23 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: in nursing home | 0.01 units on a scale | Standard Deviation 0.14 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 3: sick leave due to RA | 0.13 units on a scale | Standard Deviation 0.44 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: chores by family/friends | 0.22 units on a scale | Standard Deviation 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Change From Baseline in Work Productivity and HCRU at Months 3 and 6 | Month 6: home healthcare services | 0.01 units on a scale | Standard Deviation 0.11 |
Secondary
C-Reactive Protein
CRP measured in milligrams per liter (mg/L)
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | C-Reactive Protein | Baseline | 22.68 mg/L | Standard Deviation 27.09 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 15 | 5.57 mg/L | Standard Deviation 15.52 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 2 | 6.47 mg/L | Standard Deviation 15.24 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 18 | 4.57 mg/L | Standard Deviation 8.71 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 21 | 4.89 mg/L | Standard Deviation 7.58 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 24 | 5.57 mg/L | Standard Deviation 11.49 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 3 | 6.75 mg/L | Standard Deviation 12.81 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 6 | 5.22 mg/L | Standard Deviation 11.56 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 1 | 6.62 mg/L | Standard Deviation 9.68 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 9 | 6.01 mg/L | Standard Deviation 12.89 |
| CP-690,550 5 mg BID | C-Reactive Protein | Month 12 | 5.26 mg/L | Standard Deviation 9.93 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 12 | 2.72 mg/L | Standard Deviation 4.46 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 3 | 3.05 mg/L | Standard Deviation 5.6 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 15 | 2.96 mg/L | Standard Deviation 4.4 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 24 | 3.71 mg/L | Standard Deviation 7 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 9 | 3.39 mg/L | Standard Deviation 6.32 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 18 | 3.59 mg/L | Standard Deviation 11.42 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 2 | 3.48 mg/L | Standard Deviation 9.38 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 6 | 3.14 mg/L | Standard Deviation 5.51 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 21 | 4.07 mg/L | Standard Deviation 8.12 |
| CP-690,550 10 mg BID | C-Reactive Protein | Baseline | 20.25 mg/L | Standard Deviation 23.92 |
| CP-690,550 10 mg BID | C-Reactive Protein | Month 1 | 3.23 mg/L | Standard Deviation 5.35 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 6 | 12.21 mg/L | Standard Deviation 19.32 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Baseline | 25.92 mg/L | Standard Deviation 30.94 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 1 | 17.37 mg/L | Standard Deviation 24.26 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 2 | 16.12 mg/L | Standard Deviation 26.55 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 3 | 11.90 mg/L | Standard Deviation 17.11 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 24 | 10.07 mg/L | Standard Deviation 17.04 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 9 | 8.18 mg/L | Standard Deviation 12.36 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 12 | 9.64 mg/L | Standard Deviation 16.36 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 15 | 8.61 mg/L | Standard Deviation 13.02 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 18 | 8.98 mg/L | Standard Deviation 11.72 |
| MTX 10, 15, or 20 mg, Weekly | C-Reactive Protein | Month 21 | 9.54 mg/L | Standard Deviation 13.72 |
Secondary
Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) less than or equal to (≤)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) less than (\<)2.6 = remission.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 3 | 3.41 units on a scale | Standard Deviation 1.21 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 15 | 2.78 units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Baseline | 5.56 units on a scale | Standard Deviation 0.91 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 1 | 4.21 units on a scale | Standard Deviation 1.08 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 2 | 3.67 units on a scale | Standard Deviation 1.21 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 6 | 3.21 units on a scale | Standard Deviation 1.25 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 9 | 3.05 units on a scale | Standard Deviation 1.22 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 12 | 2.92 units on a scale | Standard Deviation 1.18 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 18 | 2.70 units on a scale | Standard Deviation 1.06 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 21 | 2.67 units on a scale | Standard Deviation 1.1 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 24 | 2.65 units on a scale | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 1 | 3.77 units on a scale | Standard Deviation 1.09 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 2 | 3.31 units on a scale | Standard Deviation 1.18 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 24 | 2.44 units on a scale | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 21 | 2.48 units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 12 | 2.52 units on a scale | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 15 | 2.50 units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 3 | 3.05 units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 6 | 2.76 units on a scale | Standard Deviation 1.08 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 9 | 2.69 units on a scale | Standard Deviation 1.15 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Baseline | 5.46 units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 18 | 2.47 units on a scale | Standard Deviation 0.98 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 15 | 3.38 units on a scale | Standard Deviation 1.27 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 18 | 3.32 units on a scale | Standard Deviation 1.17 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 24 | 3.22 units on a scale | Standard Deviation 1.15 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 2 | 4.50 units on a scale | Standard Deviation 1.19 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 3 | 4.14 units on a scale | Standard Deviation 1.27 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 1 | 4.96 units on a scale | Standard Deviation 1.17 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 6 | 3.85 units on a scale | Standard Deviation 1.34 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 9 | 3.49 units on a scale | Standard Deviation 1.2 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 21 | 3.33 units on a scale | Standard Deviation 1.27 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Baseline | 5.62 units on a scale | Standard Deviation 0.95 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3) CRP | Month 12 | 3.42 units on a scale | Standard Deviation 1.3 |
Secondary
Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter/hour \[mm/hour\]) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 24 | 3.43 units on a scale | Standard Deviation 1.25 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 3 | 4.21 units on a scale | Standard Deviation 1.45 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 1 | 5.18 units on a scale | Standard Deviation 1.28 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 12 | 3.69 units on a scale | Standard Deviation 1.33 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 2 | 4.54 units on a scale | Standard Deviation 1.45 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 9 | 3.84 units on a scale | Standard Deviation 1.37 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 21 | 3.49 units on a scale | Standard Deviation 1.26 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 15 | 3.59 units on a scale | Standard Deviation 1.23 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 18 | 3.51 units on a scale | Standard Deviation 1.22 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 6 | 4.05 units on a scale | Standard Deviation 1.44 |
| CP-690,550 5 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Baseline | 6.62 units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 24 | 3.29 units on a scale | Standard Deviation 1.29 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 9 | 3.53 units on a scale | Standard Deviation 1.36 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 12 | 3.37 units on a scale | Standard Deviation 1.29 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Baseline | 6.54 units on a scale | Standard Deviation 0.96 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 1 | 4.70 units on a scale | Standard Deviation 1.32 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 2 | 4.17 units on a scale | Standard Deviation 1.39 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 3 | 3.94 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 6 | 3.62 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 15 | 3.32 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 18 | 3.33 units on a scale | Standard Deviation 1.18 |
| CP-690,550 10 mg BID | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 21 | 3.33 units on a scale | Standard Deviation 1.29 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 24 | 3.99 units on a scale | Standard Deviation 1.33 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 6 | 4.61 units on a scale | Standard Deviation 1.48 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 21 | 4.09 units on a scale | Standard Deviation 1.39 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 15 | 4.17 units on a scale | Standard Deviation 1.46 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 18 | 4.05 units on a scale | Standard Deviation 1.37 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 1 | 5.84 units on a scale | Standard Deviation 1.24 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 9 | 4.27 units on a scale | Standard Deviation 1.36 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 2 | 5.35 units on a scale | Standard Deviation 1.24 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Baseline | 6.60 units on a scale | Standard Deviation 1.02 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 12 | 4.23 units on a scale | Standard Deviation 1.38 |
| MTX 10, 15, or 20 mg, Weekly | Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | Month 3 | 4.98 units on a scale | Standard Deviation 1.37 |
Secondary
Erosion Scores
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280.
Time frame: Baseline, Months 6, 12, and 24
Population: FAS, imputation using LEP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Erosion Scores | Baseline | 9.05 units on a scale | Standard Deviation 19 |
| CP-690,550 5 mg BID | Erosion Scores | Month 6 | 9.18 units on a scale | Standard Deviation 19.1 |
| CP-690,550 5 mg BID | Erosion Scores | Month 12 | 9.05 units on a scale | Standard Deviation 18.97 |
| CP-690,550 5 mg BID | Erosion Scores | Month 24 | 9.21 units on a scale | Standard Deviation 18.95 |
| CP-690,550 10 mg BID | Erosion Scores | Month 24 | 9.22 units on a scale | Standard Deviation 19.36 |
| CP-690,550 10 mg BID | Erosion Scores | Baseline | 9.06 units on a scale | Standard Deviation 19.5 |
| CP-690,550 10 mg BID | Erosion Scores | Month 12 | 9.18 units on a scale | Standard Deviation 19.42 |
| CP-690,550 10 mg BID | Erosion Scores | Month 6 | 9.15 units on a scale | Standard Deviation 19.5 |
| MTX 10, 15, or 20 mg, Weekly | Erosion Scores | Month 24 | 9.37 units on a scale | Standard Deviation 15.67 |
| MTX 10, 15, or 20 mg, Weekly | Erosion Scores | Month 6 | 8.78 units on a scale | Standard Deviation 15.54 |
| MTX 10, 15, or 20 mg, Weekly | Erosion Scores | Month 12 | 8.97 units on a scale | Standard Deviation 15.46 |
| MTX 10, 15, or 20 mg, Weekly | Erosion Scores | Baseline | 8.38 units on a scale | Standard Deviation 15.24 |
Secondary
European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score
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 and Months 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Baseline | 0.39 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 3 | 0.67 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 6 | 0.68 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 12 | 0.70 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 18 | 0.73 units on a scale | Standard Deviation 0.22 |
| CP-690,550 5 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 24 | 0.72 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 24 | 0.76 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Baseline | 0.42 units on a scale | Standard Deviation 0.31 |
| CP-690,550 10 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 12 | 0.74 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 18 | 0.75 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 3 | 0.69 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg BID | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 6 | 0.72 units on a scale | Standard Deviation 0.22 |
| MTX 10, 15, or 20 mg, Weekly | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 3 | 0.63 units on a scale | Standard Deviation 0.23 |
| MTX 10, 15, or 20 mg, Weekly | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 6 | 0.63 units on a scale | Standard Deviation 0.26 |
| MTX 10, 15, or 20 mg, Weekly | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 24 | 0.71 units on a scale | Standard Deviation 0.19 |
| MTX 10, 15, or 20 mg, Weekly | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 12 | 0.66 units on a scale | Standard Deviation 0.21 |
| MTX 10, 15, or 20 mg, Weekly | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Baseline | 0.46 units on a scale | Standard Deviation 0.3 |
| MTX 10, 15, or 20 mg, Weekly | European Quality of Life (EuroQol) Five Dimensions (EQ-5D) Health State Profile Utility Score | Month 18 | 0.66 units on a scale | Standard Deviation 0.24 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status
Time frame: Baseline and Months 1, 2, 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 28.47 units on a scale | Standard Deviation 10.9 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 1 | 34.39 units on a scale | Standard Deviation 10.06 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 2 | 36.08 units on a scale | Standard Deviation 10.16 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 3 | 36.93 units on a scale | Standard Deviation 10.09 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 6 | 37.55 units on a scale | Standard Deviation 9.96 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 12 | 37.85 units on a scale | Standard Deviation 10 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 18 | 38.45 units on a scale | Standard Deviation 9.2 |
| CP-690,550 5 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 24 | 38.52 units on a scale | Standard Deviation 9.37 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 2 | 36.76 units on a scale | Standard Deviation 10.2 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 18 | 39.22 units on a scale | Standard Deviation 9.39 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 3 | 37.63 units on a scale | Standard Deviation 10.3 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 6 | 38.38 units on a scale | Standard Deviation 9.93 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 12 | 38.95 units on a scale | Standard Deviation 9.73 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 29.06 units on a scale | Standard Deviation 10.72 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 1 | 36.03 units on a scale | Standard Deviation 10.25 |
| CP-690,550 10 mg BID | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 24 | 39.38 units on a scale | Standard Deviation 9.91 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 2 | 32.83 units on a scale | Standard Deviation 10.2 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 1 | 31.70 units on a scale | Standard Deviation 10.2 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Baseline | 28.55 units on a scale | Standard Deviation 10.54 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 3 | 34.09 units on a scale | Standard Deviation 9.56 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 18 | 35.97 units on a scale | Standard Deviation 10.12 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 12 | 35.99 units on a scale | Standard Deviation 9.4 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 6 | 35.38 units on a scale | Standard Deviation 10.15 |
| MTX 10, 15, or 20 mg, Weekly | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale | Month 24 | 35.16 units on a scale | Standard Deviation 10.65 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline | 1.54 units on a scale | Standard Deviation 0.65 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 1 | 1.05 units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 15 | 0.59 units on a scale | Standard Deviation 0.59 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 18 | 0.58 units on a scale | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 24 | 0.58 units on a scale | Standard Deviation 0.6 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 3 | 0.78 units on a scale | Standard Deviation 0.64 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 6 | 0.69 units on a scale | Standard Deviation 0.64 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 2 | 0.89 units on a scale | Standard Deviation 0.67 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 9 | 0.66 units on a scale | Standard Deviation 0.62 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 12 | 0.64 units on a scale | Standard Deviation 0.61 |
| CP-690,550 5 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 21 | 0.59 units on a scale | Standard Deviation 0.58 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 12 | 0.51 units on a scale | Standard Deviation 0.56 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 18 | 0.48 units on a scale | Standard Deviation 0.55 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 3 | 0.67 units on a scale | Standard Deviation 0.63 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 6 | 0.57 units on a scale | Standard Deviation 0.59 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 1 | 0.89 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 21 | 0.49 units on a scale | Standard Deviation 0.56 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 9 | 0.56 units on a scale | Standard Deviation 0.58 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline | 1.50 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 2 | 0.74 units on a scale | Standard Deviation 0.62 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 24 | 0.48 units on a scale | Standard Deviation 0.56 |
| CP-690,550 10 mg BID | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 15 | 0.51 units on a scale | Standard Deviation 0.56 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 6 | 0.92 units on a scale | Standard Deviation 0.62 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 15 | 0.83 units on a scale | Standard Deviation 0.64 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 12 | 0.79 units on a scale | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline | 1.52 units on a scale | Standard Deviation 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 3 | 1.03 units on a scale | Standard Deviation 0.63 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 18 | 0.74 units on a scale | Standard Deviation 0.6 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 9 | 0.83 units on a scale | Standard Deviation 0.57 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 21 | 0.76 units on a scale | Standard Deviation 0.64 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 1 | 1.30 units on a scale | Standard Deviation 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 24 | 0.77 units on a scale | Standard Deviation 0.64 |
| MTX 10, 15, or 20 mg, Weekly | Health Assessment Questionnaire Disability Index (HAQ-DI) | Month 2 | 1.17 units on a scale | Standard Deviation 0.66 |
Secondary
JSN Scores
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168.
Time frame: Baseline, Months 6, 12, and 24
Population: FAS, imputation using LEP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | JSN Scores | Baseline | 10.01 score on a scale | Standard Deviation 20.58 |
| CP-690,550 5 mg BID | JSN Scores | Month 6 | 10.09 score on a scale | Standard Deviation 20.62 |
| CP-690,550 5 mg BID | JSN Scores | Month 12 | 10.18 score on a scale | Standard Deviation 20.74 |
| CP-690,550 5 mg BID | JSN Scores | Month 24 | 10.50 score on a scale | Standard Deviation 21.12 |
| CP-690,550 10 mg BID | JSN Scores | Month 24 | 9.01 score on a scale | Standard Deviation 19.87 |
| CP-690,550 10 mg BID | JSN Scores | Baseline | 8.82 score on a scale | Standard Deviation 19.8 |
| CP-690,550 10 mg BID | JSN Scores | Month 12 | 8.90 score on a scale | Standard Deviation 19.77 |
| CP-690,550 10 mg BID | JSN Scores | Month 6 | 8.86 score on a scale | Standard Deviation 19.79 |
| MTX 10, 15, or 20 mg, Weekly | JSN Scores | Month 24 | 8.89 score on a scale | Standard Deviation 16.76 |
| MTX 10, 15, or 20 mg, Weekly | JSN Scores | Month 6 | 8.17 score on a scale | Standard Deviation 15.7 |
| MTX 10, 15, or 20 mg, Weekly | JSN Scores | Month 12 | 8.35 score on a scale | Standard Deviation 16.01 |
| MTX 10, 15, or 20 mg, Weekly | JSN Scores | Baseline | 7.72 score on a scale | Standard Deviation 15.28 |
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Baseline and Months 1, 2, and 3
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: adequacy | 58.55 units on a scale | Standard Deviation 27.53 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: awaken short of breath | 15.44 units on a scale | Standard Deviation 21.04 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: snoring | 30.30 units on a scale | Standard Deviation 29.3 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: overall sleep problem | 42.65 units on a scale | Standard Deviation 19.48 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: sleep disturbance | 30.93 units on a scale | Standard Deviation 23.06 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: sleep disturbance | 33.81 units on a scale | Standard Deviation 22.52 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: sleep disturbance | 45.61 units on a scale | Standard Deviation 25.91 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: snoring | 31.09 units on a scale | Standard Deviation 28.38 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: awaken short of breath | 16.66 units on a scale | Standard Deviation 22.84 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: awaken short of breath | 16.76 units on a scale | Standard Deviation 22.64 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: somnolence | 27.96 units on a scale | Standard Deviation 19.32 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: adequacy | 53.64 units on a scale | Standard Deviation 26.2 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: snoring | 30.06 units on a scale | Standard Deviation 30.12 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: sleep problem summary | 31.26 units on a scale | Standard Deviation 18.68 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: overall sleep problem | 31.73 units on a scale | Standard Deviation 18.37 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: awaken short of breath | 20.43 units on a scale | Standard Deviation 25.52 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: somnolence | 35.77 units on a scale | Standard Deviation 21.68 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: somnolence | 27.18 units on a scale | Standard Deviation 18.34 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: adequacy | 46.29 units on a scale | Standard Deviation 26.63 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: sleep problem summary | 40.66 units on a scale | Standard Deviation 19.84 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: sleep problem summary | 29.87 units on a scale | Standard Deviation 19.22 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: overall sleep problem | 33.74 units on a scale | Standard Deviation 18.23 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: sleep disturbance | 29.24 units on a scale | Standard Deviation 22.54 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: overall sleep problem | 30.07 units on a scale | Standard Deviation 18.59 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: sleep problem summary | 33.11 units on a scale | Standard Deviation 18.84 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: snoring | 34.30 units on a scale | Standard Deviation 32.9 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: adequacy | 54.83 units on a scale | Standard Deviation 26.71 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: somnolence | 29.75 units on a scale | Standard Deviation 19.71 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: snoring | 27.94 units on a scale | Standard Deviation 30.11 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: overall sleep problem | 42.82 units on a scale | Standard Deviation 20.51 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: sleep problem summary | 41.43 units on a scale | Standard Deviation 20.77 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: somnolence | 36.68 units on a scale | Standard Deviation 22.28 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: snoring | 31.99 units on a scale | Standard Deviation 32.37 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: sleep disturbance | 44.77 units on a scale | Standard Deviation 26.54 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: awaken short of breath | 19.35 units on a scale | Standard Deviation 24.42 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: adequacy | 44.41 units on a scale | Standard Deviation 26.95 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: overall sleep problem | 33.60 units on a scale | Standard Deviation 20.19 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: sleep problem summary | 33.21 units on a scale | Standard Deviation 20.83 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: somnolence | 29.15 units on a scale | Standard Deviation 19.65 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: snoring | 28.21 units on a scale | Standard Deviation 30.26 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: sleep disturbance | 33.58 units on a scale | Standard Deviation 24.94 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: awaken short of breath | 17.40 units on a scale | Standard Deviation 23.9 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: adequacy | 54.08 units on a scale | Standard Deviation 27.32 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: overall sleep problem | 32.76 units on a scale | Standard Deviation 20.25 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: sleep problem summary | 32.71 units on a scale | Standard Deviation 20.63 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: somnolence | 29.02 units on a scale | Standard Deviation 21.1 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: snoring | 28.92 units on a scale | Standard Deviation 30.4 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: sleep disturbance | 32.31 units on a scale | Standard Deviation 24.56 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: awaken short of breath | 17.16 units on a scale | Standard Deviation 22.07 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: adequacy | 55.08 units on a scale | Standard Deviation 27.81 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: overall sleep problem | 31.55 units on a scale | Standard Deviation 19.86 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: sleep problem summary | 31.76 units on a scale | Standard Deviation 20.55 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: somnolence | 29.16 units on a scale | Standard Deviation 20.99 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: sleep disturbance | 29.83 units on a scale | Standard Deviation 24.1 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: awaken short of breath | 16.87 units on a scale | Standard Deviation 22.25 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: adequacy | 55.27 units on a scale | Standard Deviation 27.6 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: sleep disturbance | 34.56 units on a scale | Standard Deviation 22.32 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: somnolence | 35.11 units on a scale | Standard Deviation 19.21 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: overall sleep problem | 42.84 units on a scale | Standard Deviation 18.07 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: awaken short of breath | 15.96 units on a scale | Standard Deviation 20.21 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: sleep problem summary | 37.28 units on a scale | Standard Deviation 18.17 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: sleep disturbance | 32.76 units on a scale | Standard Deviation 23.87 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: adequacy | 50.84 units on a scale | Standard Deviation 25.73 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: overall sleep problem | 38.15 units on a scale | Standard Deviation 17.57 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: sleep problem summary | 41.13 units on a scale | Standard Deviation 18.2 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: overall sleep problem | 33.93 units on a scale | Standard Deviation 18.86 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: adequacy | 44.65 units on a scale | Standard Deviation 26.22 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: adequacy | 51.74 units on a scale | Standard Deviation 26.72 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: sleep problem summary | 33.66 units on a scale | Standard Deviation 19.82 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: awaken short of breath | 18.71 units on a scale | Standard Deviation 23.4 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: awaken short of breath | 16.74 units on a scale | Standard Deviation 21.71 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: somnolence | 30.39 units on a scale | Standard Deviation 19.13 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: overall sleep problem | 35.25 units on a scale | Standard Deviation 17.24 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: adequacy | 47.23 units on a scale | Standard Deviation 24.62 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: sleep disturbance | 44.30 units on a scale | Standard Deviation 25.52 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: sleep problem summary | 34.66 units on a scale | Standard Deviation 17.19 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: awaken short of breath | 17.07 units on a scale | Standard Deviation 22.76 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: snoring | 32.58 units on a scale | Standard Deviation 32.13 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: somnolence | 31.65 units on a scale | Standard Deviation 19.75 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: sleep disturbance | 37.09 units on a scale | Standard Deviation 23.7 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 3: snoring | 28.60 units on a scale | Standard Deviation 28.46 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 2: snoring | 28.20 units on a scale | Standard Deviation 28.56 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | Month 1: snoring | 30.76 units on a scale | Standard Deviation 31.63 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Months 1, 2, and 3 | BL: somnolence | 38.21 units on a scale | Standard Deviation 21.19 |
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24
Participant-rated 12 item questionnaire to assess constructs of sleep over past week. 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes or no). 9-item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher cores=more impairment. Scores transformed (actual raw score \[RS\] minus lowest possible score divided by possible RS range\*100); total score range: 0-100, higher score=more intensity of attribute.
Time frame: Months 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: sleep disturbance | 29.04 units on a scale | Standard Deviation 21.28 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: somnolence | 26.62 units on a scale | Standard Deviation 18.29 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: snoring | 32.44 units on a scale | Standard Deviation 29.18 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18:snoring | 33.07 units on a scale | Standard Deviation 28.88 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: snoring | 32.13 units on a scale | Standard Deviation 28.8 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: snoring | 30.12 units on a scale | Standard Deviation 29.49 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: somnolence | 25.77 units on a scale | Standard Deviation 17.62 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: sleep disturbance | 28.73 units on a scale | Standard Deviation 20.85 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: awaken short of breath | 15.45 units on a scale | Standard Deviation 21.23 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: sleep problem summary | 29.94 units on a scale | Standard Deviation 17.82 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: awaken short of breath | 15.81 units on a scale | Standard Deviation 22.01 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: somnolence | 25.71 units on a scale | Standard Deviation 18.41 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: overall sleep problem | 29.99 units on a scale | Standard Deviation 17.44 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: adequacy | 56.98 units on a scale | Standard Deviation 27 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: sleep disturbance | 29.26 units on a scale | Standard Deviation 22.2 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: sleep problem summary | 30.59 units on a scale | Standard Deviation 19.02 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: sleep problem summary | 30.01 units on a scale | Standard Deviation 18.21 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: awaken short of breath | 17.00 units on a scale | Standard Deviation 22.24 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: overall sleep problem | 30.73 units on a scale | Standard Deviation 18.51 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: overall sleep problem | 29.78 units on a scale | Standard Deviation 17.64 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: adequacy | 56.09 units on a scale | Standard Deviation 26.92 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: sleep disturbance | 29.03 units on a scale | Standard Deviation 21 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: adequacy | 57.11 units on a scale | Standard Deviation 26.35 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: overall sleep problem | 30.01 units on a scale | Standard Deviation 17.75 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: somnolence | 26.82 units on a scale | Standard Deviation 18.62 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: awaken short of breath | 15.42 units on a scale | Standard Deviation 20.11 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: sleep problem summary | 29.89 units on a scale | Standard Deviation 18.87 |
| CP-690,550 5 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: adequacy | 57.46 units on a scale | Standard Deviation 28.15 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: adequacy | 59.01 units on a scale | Standard Deviation 27.11 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: overall sleep problem | 30.05 units on a scale | Standard Deviation 20.09 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: sleep problem summary | 29.81 units on a scale | Standard Deviation 20.75 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: somnolence | 27.34 units on a scale | Standard Deviation 20.69 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: snoring | 31.01 units on a scale | Standard Deviation 30.68 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: sleep disturbance | 28.61 units on a scale | Standard Deviation 24.64 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: awaken short of breath | 14.70 units on a scale | Standard Deviation 21.28 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: adequacy | 56.45 units on a scale | Standard Deviation 27.84 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: overall sleep problem | 29.30 units on a scale | Standard Deviation 18.5 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: sleep problem summary | 29.10 units on a scale | Standard Deviation 18.99 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: somnolence | 27.17 units on a scale | Standard Deviation 20.09 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: snoring | 31.76 units on a scale | Standard Deviation 31.54 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: sleep disturbance | 27.75 units on a scale | Standard Deviation 22.73 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: awaken short of breath | 14.73 units on a scale | Standard Deviation 21.89 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: adequacy | 58.18 units on a scale | Standard Deviation 27.13 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: overall sleep problem | 28.54 units on a scale | Standard Deviation 17.92 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: sleep problem summary | 28.15 units on a scale | Standard Deviation 18.38 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: somnolence | 26.73 units on a scale | Standard Deviation 18.78 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18:snoring | 31.13 units on a scale | Standard Deviation 29.89 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: sleep disturbance | 27.30 units on a scale | Standard Deviation 21.32 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: awaken short of breath | 13.38 units on a scale | Standard Deviation 19.82 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: overall sleep problem | 29.55 units on a scale | Standard Deviation 19.26 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: sleep problem summary | 29.57 units on a scale | Standard Deviation 19.8 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: somnolence | 26.98 units on a scale | Standard Deviation 20.53 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: snoring | 30.22 units on a scale | Standard Deviation 30.53 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: sleep disturbance | 27.74 units on a scale | Standard Deviation 23.4 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: awaken short of breath | 15.90 units on a scale | Standard Deviation 20.86 |
| CP-690,550 10 mg BID | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: adequacy | 57.52 units on a scale | Standard Deviation 27.7 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: sleep problem summary | 33.70 units on a scale | Standard Deviation 19.36 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: snoring | 30.00 units on a scale | Standard Deviation 28.32 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: sleep disturbance | 29.31 units on a scale | Standard Deviation 22.59 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: overall sleep problem | 33.49 units on a scale | Standard Deviation 18.56 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: sleep problem summary | 32.17 units on a scale | Standard Deviation 19.47 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: awaken short of breath | 16.55 units on a scale | Standard Deviation 21.47 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: adequacy | 53.61 units on a scale | Standard Deviation 26.74 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: awaken short of breath | 16.60 units on a scale | Standard Deviation 19.99 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: awaken short of breath | 14.68 units on a scale | Standard Deviation 20.98 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: adequacy | 53.62 units on a scale | Standard Deviation 29.5 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: overall sleep problem | 32.25 units on a scale | Standard Deviation 19.17 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: sleep disturbance | 31.76 units on a scale | Standard Deviation 25.72 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: sleep disturbance | 31.43 units on a scale | Standard Deviation 23.59 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: sleep problem summary | 31.79 units on a scale | Standard Deviation 19.69 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: snoring | 27.39 units on a scale | Standard Deviation 29.11 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: adequacy | 54.15 units on a scale | Standard Deviation 26.8 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: awaken short of breath | 16.59 units on a scale | Standard Deviation 21.1 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: overall sleep problem | 32.71 units on a scale | Standard Deviation 19.54 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: overall sleep problem | 31.93 units on a scale | Standard Deviation 19.62 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: sleep disturbance | 32.44 units on a scale | Standard Deviation 23.52 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: somnolence | 28.36 units on a scale | Standard Deviation 18.36 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: sleep problem summary | 32.24 units on a scale | Standard Deviation 20.72 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: snoring | 30.67 units on a scale | Standard Deviation 27.84 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 6: somnolence | 29.79 units on a scale | Standard Deviation 19.76 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18: somnolence | 28.68 units on a scale | Standard Deviation 19.9 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 12: somnolence | 31.11 units on a scale | Standard Deviation 18.47 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 24: adequacy | 56.42 units on a scale | Standard Deviation 26.66 |
| MTX 10, 15, or 20 mg, Weekly | Medical Outcomes Study Sleep Scale (MOS-SS) at Months 6, 12, 18, and 24 | Month 18:snoring | 29.74 units on a scale | Standard Deviation 29.9 |
Secondary
mTSS Score at Baseline, Months 12 and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).
Time frame: Baseline, Months 12 and 24
Population: FAS, imputation using LEP; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | mTSS Score at Baseline, Months 12 and 24 | Month 12 | 19.23 score on a scale | Standard Deviation 38.37 |
| CP-690,550 5 mg BID | mTSS Score at Baseline, Months 12 and 24 | Baseline | 19.05 score on a scale | Standard Deviation 38.27 |
| CP-690,550 5 mg BID | mTSS Score at Baseline, Months 12 and 24 | Month 24 | 19.70 score on a scale | Standard Deviation 38.69 |
| CP-690,550 10 mg BID | mTSS Score at Baseline, Months 12 and 24 | Month 12 | 18.08 score on a scale | Standard Deviation 38.41 |
| CP-690,550 10 mg BID | mTSS Score at Baseline, Months 12 and 24 | Baseline | 17.89 score on a scale | Standard Deviation 38.49 |
| CP-690,550 10 mg BID | mTSS Score at Baseline, Months 12 and 24 | Month 24 | 18.23 score on a scale | Standard Deviation 38.43 |
| MTX 10, 15, or 20 mg, Weekly | mTSS Score at Baseline, Months 12 and 24 | Baseline | 16.11 score on a scale | Standard Deviation 29.44 |
| MTX 10, 15, or 20 mg, Weekly | mTSS Score at Baseline, Months 12 and 24 | Month 24 | 18.26 score on a scale | Standard Deviation 30.99 |
| MTX 10, 15, or 20 mg, Weekly | mTSS Score at Baseline, Months 12 and 24 | Month 12 | 17.32 score on a scale | Standard Deviation 30.27 |
Secondary
Number of Days as Assessed Using RA-HCRU at Baseline and Months 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 and Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospital length of stay | 14.25 days | Standard Deviation 17.19 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days of work per week | 5.11 days | Standard Deviation 0.98 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospital length of stay | 9.33 days | Standard Deviation 5.03 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days in nursing home | 28.00 days | — |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days aids/devices used | 99.94 days | Standard Deviation 107.83 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days aids/devices used | 109.00 days | Standard Deviation 116.27 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:days on sick leave due to RA | 18.00 days | Standard Deviation 19.68 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by family | 23.13 days | Standard Deviation 29.61 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related aids used | 1.45 days | Standard Deviation 1.23 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days on sick leave due to RA | 23.52 days | Standard Deviation 25.55 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 22.53 days | Standard Deviation 30.49 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days of work per week | 5.16 days | Standard Deviation 1.06 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by family | 23.62 days | Standard Deviation 29.77 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: paid work, bothered by RA | 21.04 days | Standard Deviation 26.24 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:days on sick leave due to RA | 20.76 days | Standard Deviation 30.15 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days of work per week | 5.11 days | Standard Deviation 0.95 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days of part time work | 14.85 days | Standard Deviation 25.99 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days of part-time work | 11.94 days | Standard Deviation 20.56 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: paid work, bothered by RA | 26.23 days | Standard Deviation 30 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related aids used | 1.25 days | Standard Deviation 0.55 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: paid work, bothered by RA | 35.69 days | Standard Deviation 30.24 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related aids used | 1.61 days | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospital length of stay | 19.07 days | Standard Deviation 10.86 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by housekeeper | 19.56 days | Standard Deviation 27.62 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 21.57 days | Standard Deviation 29.1 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days aids/devices used | 74.15 days | Standard Deviation 65.25 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by family | 32.35 days | Standard Deviation 34.46 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days of part time work | 14.13 days | Standard Deviation 14.71 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days in nursing home | 14.00 days | — |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days aids/devices used | 159.08 days | Standard Deviation 138.46 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospital length of stay | 23.76 days | Standard Deviation 18.95 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days in nursing home | 30.60 days | Standard Deviation 33.62 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days aids/devices used | 93.06 days | Standard Deviation 130.53 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related aids used | 1.75 days | Standard Deviation 1.36 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days of work per week | 4.96 days | Standard Deviation 0.97 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days on sick leave due to RA | 16.59 days | Standard Deviation 22.38 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days of part-time work | 12.12 days | Standard Deviation 18.1 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: paid work, bothered by RA | 38.54 days | Standard Deviation 47.28 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by housekeeper | 25.46 days | Standard Deviation 33.29 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by family | 34.13 days | Standard Deviation 34.19 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospital length of stay | 7.00 days | Standard Deviation 7.21 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days in nursing home | 43.33 days | Standard Deviation 40.43 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days aids/devices used | 123.85 days | Standard Deviation 76.69 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related aids used | 1.75 days | Standard Deviation 0.55 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days of work per week | 4.99 days | Standard Deviation 1.02 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:days on sick leave due to RA | 26.97 days | Standard Deviation 34.53 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days of part time work | 29.67 days | Standard Deviation 38.1 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: paid work, bothered by RA | 19.48 days | Standard Deviation 25.23 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 21.43 days | Standard Deviation 28.45 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by family | 21.06 days | Standard Deviation 27.81 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospital length of stay | 9.00 days | Standard Deviation 13.62 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days in nursing home | 90.00 days | — |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related aids used | 2.00 days | Standard Deviation 1.36 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days of work per week | 4.93 days | Standard Deviation 1.05 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:days on sick leave due to RA | 21.94 days | Standard Deviation 33.32 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days of part time work | 7.11 days | Standard Deviation 5.49 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: paid work, bothered by RA | 16.41 days | Standard Deviation 23.15 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 20.57 days | Standard Deviation 28.22 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by family | 20.05 days | Standard Deviation 26.35 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days aids/devices used | 162.88 days | Standard Deviation 140.39 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospital length of stay | 10.75 days | Standard Deviation 9 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by family | 34.35 days | Standard Deviation 33.04 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospital length of stay | 15.45 days | Standard Deviation 11.61 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days in nursing home | 61.00 days | — |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by housekeeper | 21.25 days | Standard Deviation 32.37 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: paid work, bothered by RA | 31.68 days | Standard Deviation 30.31 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days aids/devices used | 190.25 days | Standard Deviation 93.12 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days of part-time work | 11.39 days | Standard Deviation 14.06 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: paid work, bothered by RA | 24.49 days | Standard Deviation 28.36 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related aids used | 2.38 days | Standard Deviation 0.74 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days on sick leave due to RA | 27.67 days | Standard Deviation 30.63 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days in nursing home | 41.67 days | Standard Deviation 42 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days of work per week | 5.10 days | Standard Deviation 0.99 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: days of work per week | 5.12 days | Standard Deviation 0.91 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by family | 22.09 days | Standard Deviation 28.5 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:days on sick leave due to RA | 36.61 days | Standard Deviation 37.92 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:days on sick leave due to RA | 40.07 days | Standard Deviation 41.32 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days of part time work | 16.17 days | Standard Deviation 25.29 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days of work per week | 5.08 days | Standard Deviation 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related aids used | 2.24 days | Standard Deviation 1.95 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: paid work, bothered by RA | 22.13 days | Standard Deviation 28.03 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related aids used | 1.71 days | Standard Deviation 0.91 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 13.80 days | Standard Deviation 27.2 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 17.33 days | Standard Deviation 28.24 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: days aids/devices used | 105.86 days | Standard Deviation 77.06 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: days of part time work | 11.71 days | Standard Deviation 21.31 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by family | 24.80 days | Standard Deviation 28.39 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospital length of stay | 20.00 days | Standard Deviation 1.41 |
Secondary
Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital length of stay | 6.67 days | Standard Deviation 3.06 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of work per week | 5.14 days | Standard Deviation 0.98 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospital length of stay | 5.33 days | Standard Deviation 5.77 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days in nursing home | 15.00 days | — |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days aids/devices used | 126.67 days | Standard Deviation 125.26 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days aids/devices used | 118.05 days | Standard Deviation 99.31 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 20.49 days | Standard Deviation 29.77 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related aids used | 2.25 days | Standard Deviation 1.06 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of part time work | 6.60 days | Standard Deviation 4.1 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 9.40 days | Standard Deviation 6.99 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of work per week | 5.13 days | Standard Deviation 1 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:days on sick leave due to RA | 17.47 days | Standard Deviation 28.41 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:paid work, bothered by RA | 16.82 days | Standard Deviation 22.67 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:days on sick leave due to RA | 16.93 days | Standard Deviation 23.97 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | 16.65 days | Standard Deviation 23.82 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of part time work | 4.33 days | Standard Deviation 3.01 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:days on sick leave due to RA | 19.33 days | Standard Deviation 27.95 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of part-time work | 5.56 days | Standard Deviation 6.82 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: paid work, bothered by RA | 21.95 days | Standard Deviation 27.3 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of work per week | 5.10 days | Standard Deviation 1.02 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:paid work, bothered by RA | 19.31 days | Standard Deviation 21.34 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related aids used | 1.50 days | Standard Deviation 0.83 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related aids used | 2.15 days | Standard Deviation 1.52 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 13.09 days | Standard Deviation 25.89 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 6.90 days | Standard Deviation 8.28 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days aids/devices used | 137.85 days | Standard Deviation 150.03 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | 22.04 days | Standard Deviation 30.72 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital length of stay | 10.43 days | Standard Deviation 8.62 |
| CP-690,550 5 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days in nursing home | 2.00 days | — |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of part time work | 3.00 days | Standard Deviation 2.83 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital length of stay | 9.25 days | Standard Deviation 3.59 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days in nursing home | 54.00 days | Standard Deviation 50.91 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days aids/devices used | 231.00 days | Standard Deviation 190.27 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related aids used | 1.89 days | Standard Deviation 1.96 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of work per week | 4.95 days | Standard Deviation 1.01 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:days on sick leave due to RA | 10.14 days | Standard Deviation 9.94 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of part-time work | 12.17 days | Standard Deviation 10.11 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:paid work, bothered by RA | 16.23 days | Standard Deviation 22.36 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 24.36 days | Standard Deviation 35.96 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | 20.11 days | Standard Deviation 27.19 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital length of stay | 13.67 days | Standard Deviation 9.42 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days aids/devices used | 169.50 days | Standard Deviation 157.29 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related aids used | 2.25 days | Standard Deviation 1.67 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of work per week | 5.01 days | Standard Deviation 0.99 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:days on sick leave due to RA | 6.09 days | Standard Deviation 5.87 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of part time work | 6.80 days | Standard Deviation 4.66 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:paid work, bothered by RA | 16.30 days | Standard Deviation 22.6 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 21.75 days | Standard Deviation 33.15 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 21.30 days | Standard Deviation 30.38 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospital length of stay | 21.00 days | Standard Deviation 10.65 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days in nursing home | 21.00 days | — |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days aids/devices used | 178.20 days | Standard Deviation 178.98 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related aids used | 1.82 days | Standard Deviation 2.09 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of work per week | 5.03 days | Standard Deviation 1.01 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:days on sick leave due to RA | 3.25 days | Standard Deviation 2.5 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: paid work, bothered by RA | 9.17 days | Standard Deviation 9.5 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 4.75 days | Standard Deviation 2.99 |
| CP-690,550 10 mg BID | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | 12.18 days | Standard Deviation 21.46 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days aids/devices used | 65.75 days | Standard Deviation 16.5 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospital length of stay | 6.00 days | Standard Deviation 2.83 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | 17.74 days | Standard Deviation 25.33 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital length of stay | 9.00 days | Standard Deviation 8.49 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days in nursing home | 15.50 days | Standard Deviation 7.78 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 7.40 days | Standard Deviation 3.58 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: paid work, bothered by RA | 16.95 days | Standard Deviation 17.31 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days aids/devices used | 136.50 days | Standard Deviation 87 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:paid work, bothered by RA | 21.10 days | Standard Deviation 26.11 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days in nursing home | 20.00 days | — |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related aids used | 1.50 days | Standard Deviation 1 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of part-time work | 16.00 days | Standard Deviation 15.56 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | 17.21 days | Standard Deviation 26.87 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of work per week | 5.15 days | Standard Deviation 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:days on sick leave due to RA | 2.75 days | Standard Deviation 1.49 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 4.00 days | Standard Deviation 2 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:days on sick leave due to RA | 4.20 days | Standard Deviation 1.64 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:days on sick leave due to RA | 7.25 days | Standard Deviation 12.46 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of part time work | 31.00 days | Standard Deviation 41.01 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days of work per week | 5.00 days | Standard Deviation 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: days of work per week | 5.05 days | Standard Deviation 0.93 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:paid work, bothered by RA | 19.35 days | Standard Deviation 25.33 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related aids used | 2.50 days | Standard Deviation 1 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related aids used | 1.50 days | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 3.83 days | Standard Deviation 2.48 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: days aids/devices used | 159.50 days | Standard Deviation 41 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: days of part time work | 19.00 days | Standard Deviation 30.69 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 27.37 days | Standard Deviation 35.36 |
| MTX 10, 15, or 20 mg, Weekly | Number of Days as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital length of stay | 33.33 days | Standard Deviation 11.55 |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 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 and Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: doctor visits | 3.45 events | Standard Deviation 2.99 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:non-medical practitioner visits | 10.40 events | Standard Deviation 14.05 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: doctor visits | 2.57 events | Standard Deviation 3.64 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related doctor visits | 0.99 events | Standard Deviation 0.77 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: doctor visits | 4.81 events | Standard Deviation 5.57 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related non-medical visits | 0.67 events | Standard Deviation 0.82 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospital ER visits | 1.83 events | Standard Deviation 1.34 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related hospitalization | 1.27 events | Standard Deviation 0.55 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:non-medical practitioner visits | 10.33 events | Standard Deviation 15.13 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related ER visits | 0.33 events | Standard Deviation 0.65 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospital ER visit | 2.13 events | Standard Deviation 2.73 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related diagnostic tests | 0.18 events | Standard Deviation 0.39 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: non-study diagnostic tests | 1.32 events | Standard Deviation 0.64 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related hospitalization | 0.25 events | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: outpatient surgery | 2.56 events | Standard Deviation 3.24 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: outpatient surgery | 1.25 events | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related doctor visits | 1.55 events | Standard Deviation 1.07 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: outpatient surgery | 1.50 events | Standard Deviation 1.22 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related outpatient surgery | 0.33 events | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA related diagnostic tests | 0.26 events | Standard Deviation 0.63 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL:non-study diagnostic tests | 2.25 events | Standard Deviation 1.6 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related ER visits | 1.12 events | Standard Deviation 0.86 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related diagnostic tests | 1.20 events | Standard Deviation 1.22 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:RA-related non-medical visits | 1.20 events | Standard Deviation 1.3 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related ER visits | 0.07 events | Standard Deviation 0.26 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: non-medical practitioner visits | 23.82 events | Standard Deviation 56.1 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: non-study diagnostic tests | 1.73 events | Standard Deviation 1.39 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospital ER visits | 1.36 events | Standard Deviation 0.84 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related non-medical visits | 1.00 events | Standard Deviation 0.82 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospitalization | 1.03 events | Standard Deviation 0.16 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related doctor visits | 0.82 events | Standard Deviation 0.72 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:RA-related outpatient surgery | 0.14 events | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: doctor visits | 4.37 events | Standard Deviation 3.86 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related doctor visits | 1.46 events | Standard Deviation 0.95 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospital ER visit | 1.49 events | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related ER visits | 1.00 events | Standard Deviation 0.83 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related hospitalization | 1.24 events | Standard Deviation 0.69 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: outpatient surgery | 2.13 events | Standard Deviation 2.61 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related outpatient surgery | 0.80 events | Standard Deviation 0.86 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL:non-study diagnostic tests | 2.05 events | Standard Deviation 1.27 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related diagnostic tests | 1.21 events | Standard Deviation 1.21 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: non-medical practitioner visits | 10.07 events | Standard Deviation 19.72 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related non-medical visits | 1.13 events | Standard Deviation 0.81 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: doctor visits | 3.44 events | Standard Deviation 3.12 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related doctor visits | 0.96 events | Standard Deviation 0.62 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospital ER visits | 1.94 events | Standard Deviation 2.08 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related ER visits | 0.13 events | Standard Deviation 0.34 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related hospitalization | 0.33 events | Standard Deviation 0.58 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: outpatient surgery | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: non-study diagnostic tests | 1.33 events | Standard Deviation 0.73 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related diagnostic tests | 0.27 events | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:non-medical practitioner visits | 4.50 events | Standard Deviation 2.43 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related non-medical visits | 1.00 events | Standard Deviation 0.63 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: doctor visits | 2.48 events | Standard Deviation 2.82 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related doctor visits | 0.74 events | Standard Deviation 0.64 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospital ER visits | 1.22 events | Standard Deviation 0.73 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related ER visits | 0.26 events | Standard Deviation 0.65 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospitalization | 2.29 events | Standard Deviation 3.4 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related hospitalization | 0.14 events | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: outpatient surgery | 1.43 events | Standard Deviation 0.79 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: non-study diagnostic tests | 1.54 events | Standard Deviation 1 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA related diagnostic tests | 0.12 events | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:non-medical practitioner visits | 5.50 events | Standard Deviation 6.36 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:RA-related non-medical visits | 1.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: doctor visits | 3.57 events | Standard Deviation 2.94 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:non-medical practitioner visits | 4.75 events | Standard Deviation 1.26 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: doctor visits | 2.12 events | Standard Deviation 1.72 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related non-medical visits | 1.14 events | Standard Deviation 0.69 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: non-study diagnostic tests | 1.47 events | Standard Deviation 0.94 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related doctor visits | 0.74 events | Standard Deviation 0.54 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: non-medical practitioner visits | 8.57 events | Standard Deviation 11.13 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospital ER visit | 1.38 events | Standard Deviation 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospital ER visits | 5.33 events | Standard Deviation 5.86 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related diagnostic tests | 1.09 events | Standard Deviation 0.91 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: doctor visits | 4.82 events | Standard Deviation 5.31 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related ER visits | 1.00 events | Standard Deviation 1 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL:non-study diagnostic tests | 1.75 events | Standard Deviation 1.18 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA related diagnostic tests | 0.35 events | Standard Deviation 0.79 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: hospitalization | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related doctor visits | 1.56 events | Standard Deviation 0.96 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related hospitalization | 0.75 events | Standard Deviation 0.96 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: outpatient surgery | 1.25 events | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:RA-related non-medical visits | 1.25 events | Standard Deviation 1.26 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: outpatient surgery | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related hospitalization | 0.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: outpatient surgery | 1.25 events | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospitalization | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related hospitalization | 1.13 events | Standard Deviation 0.55 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: non-study diagnostic tests | 1.57 events | Standard Deviation 1.02 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related ER visits | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: hospitalization | 1.05 events | Standard Deviation 0.21 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related diagnostic tests | 0.21 events | Standard Deviation 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: hospital ER visits | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6:RA-related outpatient surgery | 0.25 events | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:non-medical practitioner visits | 9.00 events | Standard Deviation 7.07 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: RA-related doctor visits | 1.03 events | Standard Deviation 0.72 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related ER visits | 1.13 events | Standard Deviation 1.02 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related non-medical visits | 2.00 events | Standard Deviation 0 |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related doctor visits | 0.83 events | Standard Deviation 0.6 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related doctor visit | 0.78 events | Standard Deviation 0.74 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: doctor visit | 2.19 events | Standard Deviation 1.81 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: doctor visits | 2.27 events | Standard Deviation 2.17 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital ER visit | 1.60 events | Standard Deviation 1.35 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related non-medical visits | 2.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related ER visit | 0.20 events | Standard Deviation 0.63 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related hospitalization | 0.29 events | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-medical practitioner visits | 16.00 events | Standard Deviation 19.8 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospitalization | 2.33 events | Standard Deviation 2.31 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-medical practitioner visits | 20.67 events | Standard Deviation 3.06 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related diagnostic tests | 0.08 events | Standard Deviation 0.39 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 3.25 events | Standard Deviation 4.5 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 1.48 events | Standard Deviation 0.77 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: outpatient surgery | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related outpatient surgery | 0.33 events | Standard Deviation 0.82 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital ER visit | 1.06 events | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related outpatient surgery | 0.11 events | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related non-medical visits | 0.67 events | Standard Deviation 1.15 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 1.61 events | Standard Deviation 1.05 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA related diagnostic tests | 0.11 events | Standard Deviation 0.32 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related ER visits | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related diagnostic tests | 0.13 events | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related ER visit | 0.13 events | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24 hospital ER visits | 1.40 events | Standard Deviation 0.7 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-medical practitioner visits | 17.00 events | Standard Deviation 18.38 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related doctor visit | 0.77 events | Standard Deviation 0.61 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:RA-related non-medical visits | 1.00 events | Standard Deviation 1.41 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic tests | 1.50 events | Standard Deviation 0.83 |
| CP-690,550 5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: doctor visits | 2.17 events | Standard Deviation 1.91 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24 hospital ER visits | 1.33 events | Standard Deviation 0.65 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: doctor visit | 2.19 events | Standard Deviation 1.72 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related doctor visit | 0.74 events | Standard Deviation 0.7 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital ER visit | 1.13 events | Standard Deviation 0.35 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related ER visit | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: outpatient surgery | 1.50 events | Standard Deviation 1.07 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related outpatient surgery | 0.13 events | Standard Deviation 0.35 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 1.34 events | Standard Deviation 0.57 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related diagnostic tests | 0.22 events | Standard Deviation 0.57 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-medical practitioner visits | 13.33 events | Standard Deviation 6.43 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:RA-related non-medical visits | 1.33 events | Standard Deviation 1.15 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: doctor visits | 2.21 events | Standard Deviation 1.83 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related doctor visit | 0.82 events | Standard Deviation 0.66 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital ER visit | 1.89 events | Standard Deviation 1.36 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related ER visit | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospitalization | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related hospitalization | 0.67 events | Standard Deviation 1.03 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | 2.14 events | Standard Deviation 1.68 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related outpatient surgery | 0.14 events | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 1.85 events | Standard Deviation 1.43 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related diagnostic tests | 0.19 events | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-medical practitioner visits | 18.00 events | Standard Deviation 16.25 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related non-medical visits | 1.50 events | Standard Deviation 1.91 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: doctor visits | 2.78 events | Standard Deviation 3.8 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related doctor visits | 0.76 events | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related ER visits | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospitalization | 1.25 events | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related hospitalization | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 2.00 events | Standard Deviation 2.24 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic tests | 1.29 events | Standard Deviation 0.53 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA related diagnostic tests | 0.03 events | Standard Deviation 0.18 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-medical practitioner visits | 3.50 events | Standard Deviation 1.91 |
| CP-690,550 10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related non-medical visits | 1.00 events | Standard Deviation 1.15 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: doctor visits | 2.75 events | Standard Deviation 2.03 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: doctor visits | 2.93 events | Standard Deviation 3.02 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related ER visit | 0.20 events | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related doctor visits | 0.93 events | Standard Deviation 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related diagnostic tests | 0.36 events | Standard Deviation 0.67 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24 hospital ER visits | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 1.18 events | Standard Deviation 0.4 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related doctor visit | 0.89 events | Standard Deviation 0.77 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related ER visits | 1.33 events | Standard Deviation 1.15 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related outpatient surgery | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:non-study diagnostic tests | 1.40 events | Standard Deviation 0.51 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: hospitalization | 1.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: outpatient surgery | 1.33 events | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospital ER visit | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related hospitalization | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: outpatient surgery | 3.00 events | Standard Deviation 2.65 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: RA-related hospitalization | 0.50 events | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related hospitalization | 0.67 events | Standard Deviation 1.15 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: doctor visit | 2.22 events | Standard Deviation 1.62 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 1.50 events | Standard Deviation 0.8 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospitalization | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: outpatient surgery | 3.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related diagnostic tests | 0.08 events | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related ER visit | 0.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: hospitalization | 1.00 events | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:non-medical practitioner visits | 4.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: hospital ER visit | 1.40 events | Standard Deviation 0.89 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA related diagnostic tests | 0.27 events | Standard Deviation 0.59 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related non-medical visits | 0.00 events | — |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: RA-related doctor visit | 0.80 events | Standard Deviation 0.65 |
| MTX 10, 15, or 20 mg, Weekly | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:RA-related outpatient surgery | 2.00 events | — |
Secondary
Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6
RA-HCRU assessed healthcare (HC) usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Time frame: Baseline and Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by housekeeper | 4.85 hours per day | Standard Deviation 2.31 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related home HC services | 1.00 hours per day | Standard Deviation 0.82 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: work done | 8.53 hours per day | Standard Deviation 5.33 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: missed work due to RA | 4.36 hours per day | Standard Deviation 4.98 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: home healthcare services | 1.50 hours per day | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by family | 4.26 hours per day | Standard Deviation 4.56 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: home healthcare services | 0.00 hours per day | — |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related home HC services | 0.00 hours per day | — |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: work done | 8.53 hours per day | Standard Deviation 4.7 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: missed work due to RA | 4.11 hours per day | Standard Deviation 2.51 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 4.50 hours per day | Standard Deviation 2.43 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by family | 3.44 hours per day | Standard Deviation 3.77 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: home healthcare services | 5.00 hours per day | Standard Deviation 6.08 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related home HC services | 0.67 hours per day | Standard Deviation 0.58 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: work done | 7.97 hours per day | Standard Deviation 2.84 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: missed work due to RA | 4.14 hours per day | Standard Deviation 2.67 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 4.93 hours per day | Standard Deviation 2.7 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by family | 3.86 hours per day | Standard Deviation 2.84 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related home HC services | 0.83 hours per day | Standard Deviation 0.75 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: home healthcare services | 1.25 hours per day | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by family | 3.28 hours per day | Standard Deviation 2.29 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: work done | 8.25 hours per day | Standard Deviation 4.02 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: missed work due to RA | 4.11 hours per day | Standard Deviation 3.44 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: home healthcare services | 4.50 hours per day | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: missed work due to RA | 5.62 hours per day | Standard Deviation 13.58 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 5.40 hours per day | Standard Deviation 4.61 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 5.17 hours per day | Standard Deviation 2.92 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by housekeeper | 6.46 hours per day | Standard Deviation 9.83 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: work done | 8.55 hours per day | Standard Deviation 5.23 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: RA-related home HC services | 2.00 hours per day | Standard Deviation 2.83 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by family | 3.92 hours per day | Standard Deviation 4.23 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: work done | 8.29 hours per day | Standard Deviation 4.4 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by family | 3.35 hours per day | Standard Deviation 3.5 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: home healthcare services | 2.20 hours per day | Standard Deviation 1.64 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3:RA-related home HC services | 0.25 hours per day | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: missed work due to RA | 8.86 hours per day | Standard Deviation 15.72 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by family | 4.08 hours per day | Standard Deviation 4.01 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: work done | 7.85 hours per day | Standard Deviation 1.47 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: work done | 8.33 hours per day | Standard Deviation 3.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by family | 4.22 hours per day | Standard Deviation 6.14 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: missed work due to RA | 5.58 hours per day | Standard Deviation 7.95 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 4.00 hours per day | Standard Deviation 2.55 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: missed work due to RA | 6.33 hours per day | Standard Deviation 5.75 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: home healthcare services | 1.00 hours per day | Standard Deviation 1 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 3: chores by family | 3.61 hours per day | Standard Deviation 4.19 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: RA-related home HC services | 1.33 hours per day | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: work done | 7.68 hours per day | Standard Deviation 1.81 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: missed work due to RA | 6.21 hours per day | Standard Deviation 8.96 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | BL: chores by housekeeper | 4.75 hours per day | Standard Deviation 2.45 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 4.80 hours per day | Standard Deviation 2.2 |
Secondary
Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24
RA-HCRU assessed HC usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done, and work missed were reported.
Time frame: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: home healthcare services | 2.00 hours per day | — |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18:RA-related home HC services | 0.00 hours per day | — |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: work done | 8.18 hours per day | Standard Deviation 3.73 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: missed work due to RA | 2.25 hours per day | Standard Deviation 1.28 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: work done | 8.63 hours per day | Standard Deviation 4.69 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: missed work due to RA | 3.00 hours per day | Standard Deviation 2.53 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: work done | 8.38 hours per day | Standard Deviation 3.9 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 3.74 hours per day | Standard Deviation 4.42 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 5.60 hours per day | Standard Deviation 1.34 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 8.50 hours per day | Standard Deviation 8.63 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 6.64 hours per day | Standard Deviation 4.67 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:RA-related home HC services | 0.00 hours per day | Standard Deviation 0 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: missed work due to RA | 6.50 hours per day | Standard Deviation 6.61 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | 3.44 hours per day | Standard Deviation 3.66 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | 2.97 hours per day | Standard Deviation 2.14 |
| CP-690,550 5 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: home healthcare services | 2.00 hours per day | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: work done | 7.84 hours per day | Standard Deviation 2.36 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: home healthcare services | 25.00 hours per day | Standard Deviation 32.53 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12:RA-related home HC services | 0.00 hours per day | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: work done | 7.99 hours per day | Standard Deviation 3.59 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: missed work due to RA | 4.83 hours per day | Standard Deviation 5.34 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 4.60 hours per day | Standard Deviation 2.29 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | 3.29 hours per day | Standard Deviation 2.4 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: work done | 8.32 hours per day | Standard Deviation 4.16 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: missed work due to RA | 1.80 hours per day | Standard Deviation 1.64 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 4.92 hours per day | Standard Deviation 2.94 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 3.70 hours per day | Standard Deviation 3.28 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:home healthcare services | 2.67 hours per day | Standard Deviation 1.15 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related home HC services | 0.00 hours per day | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: missed work due to RA | 2.00 hours per day | Standard Deviation 0 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 5.25 hours per day | Standard Deviation 2.93 |
| CP-690,550 10 mg BID | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | 2.81 hours per day | Standard Deviation 2.22 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by housekeeper | 4.33 hours per day | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: RA-related home HC services | 2.00 hours per day | — |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: work done | 8.02 hours per day | Standard Deviation 1.45 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by family | 3.19 hours per day | Standard Deviation 2.25 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: work done | 8.02 hours per day | Standard Deviation 1.48 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: chores by housekeeper | 3.80 hours per day | Standard Deviation 1.92 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: work done | 8.34 hours per day | Standard Deviation 4.32 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: missed work due to RA | 4.50 hours per day | Standard Deviation 7.72 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by housekeeper | 4.33 hours per day | Standard Deviation 3.01 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: missed work due to RA | 2.50 hours per day | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 12: missed work due to RA | 3.50 hours per day | Standard Deviation 0.71 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 18: chores by family | 3.44 hours per day | Standard Deviation 2.57 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24: chores by family | 3.75 hours per day | Standard Deviation 3.19 |
| MTX 10, 15, or 20 mg, Weekly | Number of Hours Per Day as Assessed Using RA-HCRU at Months 12, 18, and 24 | Month 24:home healthcare services | 2.00 hours per day | — |
Secondary
Patient Assessment of Arthritis Pain
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 and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 15 | 24.25 mm | Standard Deviation 20.39 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 6 | 27.07 mm | Standard Deviation 21.21 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 21 | 23.30 mm | Standard Deviation 19.86 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 12 | 26.09 mm | Standard Deviation 21.29 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 9 | 26.11 mm | Standard Deviation 20.35 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Baseline | 59.06 mm | Standard Deviation 23.87 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 2 | 31.97 mm | Standard Deviation 22.94 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 1 | 36.62 mm | Standard Deviation 23.72 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 18 | 23.66 mm | Standard Deviation 19.29 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 3 | 29.41 mm | Standard Deviation 21.53 |
| CP-690,550 5 mg BID | Patient Assessment of Arthritis Pain | Month 24 | 23.03 mm | Standard Deviation 19.8 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 9 | 23.76 mm | Standard Deviation 21.24 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Baseline | 61.37 mm | Standard Deviation 23.14 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 1 | 32.78 mm | Standard Deviation 23.31 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 2 | 30.33 mm | Standard Deviation 23.66 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 3 | 27.07 mm | Standard Deviation 21.54 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 6 | 24.22 mm | Standard Deviation 21.53 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 12 | 22.64 mm | Standard Deviation 20.15 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 15 | 23.72 mm | Standard Deviation 21.97 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 18 | 22.72 mm | Standard Deviation 21.78 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 21 | 22.85 mm | Standard Deviation 21.79 |
| CP-690,550 10 mg BID | Patient Assessment of Arthritis Pain | Month 24 | 21.09 mm | Standard Deviation 19.32 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 21 | 29.18 mm | Standard Deviation 21.46 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 15 | 29.85 mm | Standard Deviation 22.94 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 2 | 39.74 mm | Standard Deviation 23.72 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Baseline | 58.77 mm | Standard Deviation 23.58 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 18 | 27.81 mm | Standard Deviation 20.66 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 1 | 46.34 mm | Standard Deviation 24.47 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 9 | 31.22 mm | Standard Deviation 22.5 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 6 | 30.94 mm | Standard Deviation 22.87 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 24 | 27.52 mm | Standard Deviation 20.28 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 12 | 29.91 mm | Standard Deviation 20.76 |
| MTX 10, 15, or 20 mg, Weekly | Patient Assessment of Arthritis Pain | Month 3 | 36.83 mm | Standard Deviation 21.99 |
Secondary
Patient Global Assessment of Arthritis
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS where 0=very well and 100=very poorly.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 15 | 25.19 mm | Standard Deviation 20.12 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 6 | 28.37 mm | Standard Deviation 21.23 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 21 | 24.72 mm | Standard Deviation 20.93 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 12 | 26.72 mm | Standard Deviation 20.84 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 9 | 26.73 mm | Standard Deviation 20.38 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Baseline | 60.20 mm | Standard Deviation 24.56 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 2 | 31.91 mm | Standard Deviation 22.9 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 1 | 38.27 mm | Standard Deviation 24.83 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 18 | 24.76 mm | Standard Deviation 19.93 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 3 | 30.36 mm | Standard Deviation 21.78 |
| CP-690,550 5 mg BID | Patient Global Assessment of Arthritis | Month 24 | 24.42 mm | Standard Deviation 21.43 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 9 | 24.98 mm | Standard Deviation 22.3 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Baseline | 60.88 mm | Standard Deviation 22.65 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 1 | 32.63 mm | Standard Deviation 23.09 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 2 | 28.94 mm | Standard Deviation 22.63 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 3 | 28.60 mm | Standard Deviation 22.21 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 6 | 24.84 mm | Standard Deviation 21.61 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 12 | 24.38 mm | Standard Deviation 22.34 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 15 | 23.79 mm | Standard Deviation 21.96 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 18 | 24.38 mm | Standard Deviation 22.59 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 21 | 23.86 mm | Standard Deviation 21.52 |
| CP-690,550 10 mg BID | Patient Global Assessment of Arthritis | Month 24 | 23.61 mm | Standard Deviation 20.86 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 21 | 30.19 mm | Standard Deviation 21.15 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 15 | 32.26 mm | Standard Deviation 22.79 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 2 | 41.29 mm | Standard Deviation 22.73 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Baseline | 57.71 mm | Standard Deviation 24.3 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 18 | 29.31 mm | Standard Deviation 20.91 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 1 | 46.15 mm | Standard Deviation 22.82 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 9 | 32.79 mm | Standard Deviation 22.42 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 6 | 32.12 mm | Standard Deviation 21.92 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 24 | 28.81 mm | Standard Deviation 20.54 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 12 | 32.40 mm | Standard Deviation 21.69 |
| MTX 10, 15, or 20 mg, Weekly | Patient Global Assessment of Arthritis | Month 3 | 37.43 mm | Standard Deviation 21.2 |
Secondary
Percentage of Participants Achieving an ACR20 Response
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 1 | 49.32 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 2 | 63.59 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 3 | 69.92 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 6 | 71.27 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 9 | 72.09 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 12 | 67.75 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 15 | 68.83 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 18 | 64.23 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 21 | 65.04 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 24 | 64.23 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 21 | 62.18 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 1 | 58.27 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 12 | 71.57 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 9 | 73.60 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 2 | 71.57 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 24 | 64.21 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 18 | 65.99 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 3 | 77.92 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 15 | 66.24 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR20 Response | Month 6 | 76.14 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 18 | 46.74 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 6 | 50.54 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 9 | 55.43 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 12 | 51.09 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 21 | 45.11 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 15 | 47.28 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 1 | 21.20 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 24 | 42.39 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 2 | 42.39 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR20 Response | Month 3 | 51.63 percentage of participants |
Secondary
Percentage of Participants Achieving an ACR50 Response
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 15 | 50.68 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 3 | 40.11 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 18 | 47.97 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 21 | 49.05 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 1 | 17.98 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 24 | 49.32 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 6 | 46.61 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 2 | 32.61 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 9 | 49.86 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 12 | 49.86 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 15 | 54.31 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 6 | 56.35 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 12 | 55.58 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 18 | 51.78 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 3 | 50.00 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 1 | 27.99 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 21 | 50.51 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 9 | 56.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 24 | 49.24 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR50 Response | Month 2 | 40.10 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 24 | 28.26 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 1 | 3.80 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 2 | 11.41 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 3 | 20.11 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 6 | 26.63 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 9 | 35.33 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 12 | 33.70 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 15 | 33.15 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 18 | 30.43 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR50 Response | Month 21 | 30.43 percentage of participants |
Secondary
Percentage of Participants Achieving an ACR70 Response
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 1, 2, 3, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 9 | 29.23 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 24 | 34.15 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 15 | 30.05 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 12 | 28.69 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 1 | 5.22 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 21 | 32.24 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 3 | 19.95 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 2 | 16.16 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 18 | 32.24 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 12 | 37.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 1 | 9.23 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 2 | 23.02 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 3 | 26.60 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 9 | 37.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 15 | 37.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 18 | 36.57 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 21 | 36.83 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants Achieving an ACR70 Response | Month 24 | 37.60 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 3 | 5.49 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 1 | 0.55 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 18 | 15.93 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 2 | 3.30 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 24 | 15.38 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 12 | 15.38 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 9 | 13.19 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 21 | 17.58 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants Achieving an ACR70 Response | Month 15 | 17.03 percentage of participants |
Secondary
Percentage of Participants With an ACR70 Response Sustained at Least 6 Months
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 6, 9, 12, 15, 18, 21, and 24
Population: FAS, no imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With an ACR70 Response Sustained at Least 6 Months | 28.42 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With an ACR70 Response Sustained at Least 6 Months | 38.54 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With an ACR70 Response Sustained at Least 6 Months | 13.98 percentage of participants |
Secondary
Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 15 | 65.30 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 2 | 69.13 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 21 | 62.30 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 9 | 73.50 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 12 | 68.03 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 3 | 72.95 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 6 | 74.32 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 18 | 64.21 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 1 | 64.38 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 24 | 60.11 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 6 | 77.81 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 9 | 73.21 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 15 | 67.86 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 1 | 73.91 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 2 | 79.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 3 | 80.36 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 12 | 71.43 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 18 | 64.80 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 21 | 65.05 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 24 | 65.05 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 1 | 45.65 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 15 | 51.63 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 3 | 65.22 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 18 | 48.91 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 9 | 61.41 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 24 | 46.74 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 6 | 63.04 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 2 | 61.41 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 21 | 46.74 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.22 Improvement in HAQ-DI Score | Month 12 | 58.70 percentage of participants |
Secondary
Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 15 | 61.20 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 18 | 59.84 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 21 | 58.74 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 24 | 56.83 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 1 | 54.79 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 2 | 62.30 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 3 | 65.57 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 6 | 69.67 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 9 | 69.13 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 12 | 65.03 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 21 | 61.22 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 24 | 62.76 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 9 | 69.39 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 1 | 65.73 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 2 | 73.21 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 3 | 74.23 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 12 | 67.35 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 15 | 65.31 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 6 | 73.21 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 18 | 63.27 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 6 | 53.80 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 12 | 52.72 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 2 | 47.83 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 24 | 43.48 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 15 | 47.83 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 9 | 53.26 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 18 | 46.20 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 1 | 32.61 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 21 | 44.02 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.3 Improvement in HAQ-DI Score | Month 3 | 54.89 percentage of participants |
Secondary
Percentage of Participants With at Least 0.5 Improvement in HAQ-DI
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, 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, and 3=unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. 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: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 1 | 47.95 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 3 | 60.66 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 2 | 55.46 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 24 | 53.28 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 6 | 63.11 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 9 | 65.30 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 12 | 59.56 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 15 | 58.20 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 18 | 56.28 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 21 | 55.19 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 18 | 60.71 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 1 | 55.75 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 2 | 67.86 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 9 | 65.05 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 6 | 68.88 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 3 | 69.64 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 21 | 58.16 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 12 | 63.01 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 24 | 59.44 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 15 | 60.71 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 1 | 26.09 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 24 | 37.50 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 6 | 48.91 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 9 | 47.28 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 18 | 41.30 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 12 | 45.65 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 2 | 39.67 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 21 | 41.85 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 3 | 43.48 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With at Least 0.5 Improvement in HAQ-DI | Month 15 | 44.57 percentage of participants |
Secondary
Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits
ACR20 response: ≥20% improvement in TJC or SJC and ≥20% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS, no imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 2 consecutive visits | 8.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 3 consecutive visits | 8.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 4 consecutive visits | 5.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 8 consecutive visits | 9.4 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 9 consecutive visits | 9.7 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 6 consecutive visits | 6.7 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 7 consecutive visits | 6.7 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 10 consecutive visits | 23.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 5 consecutive visits | 7.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 6 consecutive visits | 6.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 10 consecutive visits | 30.5 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 8 consecutive visits | 4.5 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 7 consecutive visits | 6.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 9 consecutive visits | 11.6 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 2 consecutive visits | 6.5 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 3 consecutive visits | 11.1 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 5 consecutive visits | 4.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 4 consecutive visits | 6.8 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 7 consecutive visits | 5.9 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 3 consecutive visits | 14.5 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 2 consecutive visits | 7.5 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 8 consecutive visits | 5.4 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 10 consecutive visits | 4.8 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 4 consecutive visits | 10.2 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 6 consecutive visits | 4.8 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 5 consecutive visits | 5.4 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR20 Response by Number of Consecutive Visits | 9 consecutive visits | 9.7 percentage of participants |
Secondary
Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits
ACR50 response: ≥50% improvement in TJC or SJC and ≥50% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS, no imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 7 consecutive visits | 6.2 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 4 consecutive visits | 6.4 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 2 consecutive visits | 9.9 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 9 consecutive visits | 5.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 6 consecutive visits | 4.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 3 consecutive visits | 10.7 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 8 consecutive visits | 5.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 5 consecutive visits | 9.7 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 10 consecutive visits | 5.9 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 6 consecutive visits | 4.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 7 consecutive visits | 6.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 9 consecutive visits | 8.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 8 consecutive visits | 7.1 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 10 consecutive visits | 11.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 2 consecutive visits | 9.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 5 consecutive visits | 5.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 3 consecutive visits | 9.1 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 4 consecutive visits | 7.3 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 2 consecutive visits | 9.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 4 consecutive visits | 5.4 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 5 consecutive visits | 3.2 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 10 consecutive visits | 1.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 3 consecutive visits | 8.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 6 consecutive visits | 5.4 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 7 consecutive visits | 5.9 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 8 consecutive visits | 2.2 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR50 Response by Number of Consecutive Visits | 9 consecutive visits | 1.6 percentage of participants |
Secondary
Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits
ACR70 response: ≥70% improvement in TJC or SJC and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of HAQ), and 5) CRP.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS, no imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 8 consecutive visits | 2.9 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 9 consecutive visits | 3.2 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 3 consecutive visits | 5.9 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 7 consecutive visits | 2.9 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 10 consecutive visits | 1.3 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 4 consecutive visits | 5.4 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 2 consecutive visits | 10.7 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 6 consecutive visits | 3.8 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 5 consecutive visits | 4.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 2 consecutive visits | 8.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 6 consecutive visits | 3.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 7 consecutive visits | 4.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 8 consecutive visits | 4.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 10 consecutive visits | 2.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 5 consecutive visits | 5.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 3 consecutive visits | 7.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 9 consecutive visits | 5.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 4 consecutive visits | 6.0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 10 consecutive visits | 0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 7 consecutive visits | 2.7 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 8 consecutive visits | NA percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 9 consecutive visits | 1.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 2 consecutive visits | 5.9 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 3 consecutive visits | 3.8 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 4 consecutive visits | 4.3 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 6 consecutive visits | 1.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of ACR70 Response by Number of Consecutive Visits | 5 consecutive visits | 1.6 percentage of participants |
Secondary
Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS, no imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 2 consecutive visits | 10.2 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 8 consecutive visits | 3.2 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 10 consecutive visits | 1.3 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 3 consecutive visits | 8.6 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 4 consecutive visits | 6.4 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 5 consecutive visits | 5.1 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 6 consecutive visits | 5.4 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 7 consecutive visits | 4.0 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 9 consecutive visits | 4.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 2 consecutive visits | 10.6 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 6 consecutive visits | 4.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 3 consecutive visits | 8.6 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 7 consecutive visits | 7.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 10 consecutive visits | 2.8 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 8 consecutive visits | 6.5 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 4 consecutive visits | 7.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 9 consecutive visits | 7.6 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 5 consecutive visits | 5.5 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 9 consecutive visits | NA percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 2 consecutive visits | 7.0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 5 consecutive visits | 4.3 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 3 consecutive visits | 7.0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 4 consecutive visits | 3.8 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 6 consecutive visits | 1.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 7 consecutive visits | 1.6 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 10 consecutive visits | NA percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-3(CRP) <2.6 by Number of Consecutive Visits | 8 consecutive visits | 1.1 percentage of participants |
Secondary
Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS, no imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 7 consecutive visits | 1.9 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 8 consecutive visits | NA percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 10 consecutive visits | NA percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 9 consecutive visits | NA percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 2 consecutive visits | 6.2 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 4 consecutive visits | 4.0 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 3 consecutive visits | 5.4 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 5 consecutive visits | NA percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 6 consecutive visits | 2.4 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 2 consecutive visits | 7.6 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 3 consecutive visits | 5.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 4 consecutive visits | 4.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 8 consecutive visits | 2.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 9 consecutive visits | 2.5 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 10 consecutive visits | NA percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 5 consecutive visits | 1.3 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 6 consecutive visits | 2.0 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 7 consecutive visits | 3.0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 8 consecutive visits | 0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 5 consecutive visits | 1.6 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 3 consecutive visits | 2.7 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 6 consecutive visits | NA percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 2 consecutive visits | 4.3 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 7 consecutive visits | NA percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 10 consecutive visits | 0 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 9 consecutive visits | 1.1 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Consecutive Visits of DAS28-4(ESR) <2.6 by Number of Consecutive Visits | 4 consecutive visits | 3.2 percentage of participants |
Secondary
Percentage of Participants With DAS28-3(CRP) <2.6
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 18 | 38.42 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 9 | 36.24 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 3 | 25.89 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 15 | 37.60 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 12 | 36.51 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 1 | 7.38 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 2 | 20.44 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 21 | 37.06 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 6 | 31.34 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 24 | 38.42 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 12 | 49.49 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 1 | 14.14 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 2 | 28.68 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 3 | 37.82 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 6 | 47.21 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 9 | 45.69 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 15 | 49.24 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 18 | 44.67 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 21 | 44.67 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 24 | 43.91 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 6 | 15.22 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 1 | 2.72 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 18 | 19.02 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 3 | 9.78 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 2 | 5.43 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 24 | 18.48 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 12 | 20.65 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 9 | 17.39 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 21 | 17.39 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) <2.6 | Month 15 | 19.57 percentage of participants |
Secondary
Percentage of Participants With DAS28-3(CRP) ≤3.2
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28-3(CRP) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-3(CRP) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 9 | 52.04 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 18 | 52.59 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 1 | 16.67 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 21 | 52.59 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 24 | 52.32 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 12 | 52.59 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 2 | 35.42 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 15 | 53.41 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 3 | 40.33 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 6 | 47.68 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 9 | 60.41 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 2 | 47.97 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 18 | 56.09 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 6 | 62.69 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 12 | 64.97 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 21 | 55.84 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 1 | 33.16 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 3 | 56.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 24 | 56.85 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 15 | 58.88 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 24 | 29.35 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 12 | 32.61 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 15 | 29.89 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 1 | 5.98 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 2 | 14.13 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 3 | 19.57 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 6 | 27.72 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 18 | 25.00 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 21 | 28.26 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) ≤3.2 | Month 9 | 33.15 percentage of participants |
Secondary
Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement)
DAS28-3(CRP) was calculated from the SJC and TJC using 28-joints count and CRP (mg/L). Total score range: 0 to approximately 10, higher score indicated more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from baseline \[BL\]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 1 | 71.86 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 2 | 80.11 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 3 | 83.65 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 6 | 82.83 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 15 | 75.20 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 18 | 73.02 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 21 | 69.48 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 24 | 68.94 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 9 | 80.38 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 12 | 76.29 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 24 | 69.80 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 12 | 78.68 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 15 | 73.35 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 18 | 71.57 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 21 | 69.29 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 1 | 80.46 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 2 | 85.79 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 9 | 82.74 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 3 | 89.34 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 6 | 85.03 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 3 | 68.48 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 2 | 58.15 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 12 | 60.87 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 24 | 49.46 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 1 | 37.50 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 15 | 59.24 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 6 | 64.13 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 21 | 50.54 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 18 | 55.98 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-3(CRP) Response (Good or Moderate Improvement) | Month 9 | 64.13 percentage of participants |
Secondary
Percentage of Participants With DAS28-4(ESR) <2.6
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 3 | 13.74 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 24 | 20.76 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 9 | 16.37 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 2 | 9.06 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 1 | 2.07 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 18 | 16.96 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 15 | 16.37 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 6 | 14.62 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 21 | 18.42 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 12 | 18.71 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 1 | 5.69 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 15 | 24.19 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 18 | 19.89 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 21 | 21.42 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 24 | 22.31 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 12 | 23.39 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 2 | 12.90 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 3 | 17.47 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 6 | 21.77 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 9 | 23.66 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 21 | 8.77 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 12 | 11.70 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 3 | 4.68 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 18 | 11.11 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 9 | 9.94 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 6 | 7.60 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 1 | 0.00 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 24 | 9.94 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 15 | 12.87 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) <2.6 | Month 2 | 2.35 percentage of participants |
Secondary
Percentage of Participants With DAS28-4(ESR) ≤3.2
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28-4(ESR) ≤3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4(ESR) \<2.6 = remission.
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 18 | 32.16 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 2 | 18.42 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 3 | 25.15 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 21 | 34.21 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 24 | 34.80 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 1 | 7.40 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 6 | 27.78 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 9 | 29.24 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 12 | 33.33 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 15 | 33.04 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 21 | 38.17 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 12 | 41.13 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 24 | 36.02 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 1 | 14.09 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 6 | 38.17 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 15 | 40.86 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 9 | 39.78 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 2 | 25.81 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 3 | 30.38 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 18 | 35.22 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 18 | 16.37 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 21 | 16.37 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 3 | 9.94 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 15 | 18.13 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 24 | 15.79 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 12 | 18.71 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 2 | 4.71 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 1 | 2.99 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 9 | 18.13 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) ≤3.2 | Month 6 | 14.04 percentage of participants |
Secondary
Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement)
DAS28-4(ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and patient's global assessment of disease activity (participant rated arthritis activity assessment). Total score range: 0 to approximately 10, higher score=more disease activity. DAS28 categorical responses define a good (absolute: \<3.2 or \>1.2 improvement from BL), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: \>5.1 or \<0.6 change from BL).
Time frame: Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS (NRI); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 15 | 74.85 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 18 | 70.18 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 21 | 69.88 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 2 | 74.27 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 24 | 68.71 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 6 | 78.95 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 9 | 78.36 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 1 | 62.43 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 12 | 76.61 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 3 | 80.41 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 12 | 79.57 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 15 | 73.12 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 3 | 88.17 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 6 | 84.14 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 2 | 82.26 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 21 | 69.89 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 18 | 70.97 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 9 | 81.72 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 24 | 69.62 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 1 | 74.25 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 24 | 49.12 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 1 | 33.53 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 2 | 50.00 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 3 | 66.67 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 6 | 60.82 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 9 | 61.40 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 12 | 59.65 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 18 | 52.05 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 15 | 56.73 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With DAS28-4(ESR) Response (Good or Moderate Improvement) | Month 21 | 48.54 percentage of participants |
Secondary
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). A increase of less than or equal to (≤)0.5 in mTSS is considered to be no progression in the mTSS.
Time frame: Months 6, 12, and 24
Population: FAS (LEP); 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 12 | 82.42 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 6 | 87.07 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 24 | 79.89 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 12 | 87.67 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 6 | 89.25 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 24 | 83.65 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 6 | 73.65 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 24 | 64.91 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24 | Month 12 | 69.01 percentage of participants |
Secondary
Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. An increase of ≤0.5 in Erosion Score is considered to be 'no worsening' in the Erosion Score.
Time frame: Months 6, 12, and 24
Population: FAS (LEP)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 12 | 88.47 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 6 | 91.67 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 24 | 85.34 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 12 | 90.88 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 6 | 93.01 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 24 | 88.20 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 6 | 81.44 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 24 | 70.18 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With no Worsening in Erosion Score (Increase ≤0.5) at Months 6, 12, and 24 | Month 12 | 74.85 percentage of participants |
Secondary
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
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: Months 1, 2, 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 2 | 57.06 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 12 | 58.10 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 6 | 61.76 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 1 | 55.31 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 24 | 61.74 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 18 | 63.03 percentage of participants |
| CP-690,550 5 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 3 | 58.71 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 6 | 58.04 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 1 | 55.22 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 2 | 55.41 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 3 | 60.05 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 12 | 58.43 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 18 | 62.37 percentage of participants |
| CP-690,550 10 mg BID | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 24 | 55.87 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 12 | 50.00 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 2 | 48.88 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 24 | 55.66 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 18 | 52.59 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 6 | 58.23 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 3 | 51.74 percentage of participants |
| MTX 10, 15, or 20 mg, Weekly | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Month 1 | 51.09 percentage of participants |
Secondary
Physician Global Assessment of Arthritis
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 and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 24 | 15.31 mm | Standard Deviation 14.14 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 15 | 16.65 mm | Standard Deviation 14.03 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 2 | 27.84 mm | Standard Deviation 18.26 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 18 | 16.47 mm | Standard Deviation 12.7 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 21 | 15.73 mm | Standard Deviation 12.73 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 1 | 36.70 mm | Standard Deviation 19.24 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 3 | 25.06 mm | Standard Deviation 17.1 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Baseline | 61.97 mm | Standard Deviation 16.45 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 6 | 22.19 mm | Standard Deviation 17.31 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 9 | 18.68 mm | Standard Deviation 15.09 |
| CP-690,550 5 mg BID | Physician Global Assessment of Arthritis | Month 12 | 17.63 mm | Standard Deviation 15.09 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 12 | 14.19 mm | Standard Deviation 12.63 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 3 | 22.80 mm | Standard Deviation 16.36 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 15 | 14.97 mm | Standard Deviation 13.13 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 9 | 16.61 mm | Standard Deviation 15.01 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 1 | 33.05 mm | Standard Deviation 18.32 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 18 | 14.02 mm | Standard Deviation 12.51 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 2 | 25.80 mm | Standard Deviation 17.62 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 6 | 18.32 mm | Standard Deviation 14.74 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 21 | 14.61 mm | Standard Deviation 13.39 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Month 24 | 14.42 mm | Standard Deviation 13.63 |
| CP-690,550 10 mg BID | Physician Global Assessment of Arthritis | Baseline | 60.50 mm | Standard Deviation 16.93 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 24 | 20.04 mm | Standard Deviation 15.54 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Baseline | 59.25 mm | Standard Deviation 17.7 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 1 | 45.52 mm | Standard Deviation 19.73 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 2 | 37.19 mm | Standard Deviation 18.61 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 3 | 32.07 mm | Standard Deviation 17.28 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 6 | 27.25 mm | Standard Deviation 16.8 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 9 | 23.65 mm | Standard Deviation 16.55 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 12 | 22.22 mm | Standard Deviation 15.3 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 15 | 23.29 mm | Standard Deviation 17.36 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 18 | 20.19 mm | Standard Deviation 14.74 |
| MTX 10, 15, or 20 mg, Weekly | Physician Global Assessment of Arthritis | Month 21 | 20.01 mm | Standard Deviation 14.02 |
Secondary
SF-36 Domain Scores
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).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Role Emotional | 41.84 units on a scale | Standard Deviation 11.82 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 General Health Perception | 44.92 units on a scale | Standard Deviation 8.93 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Mental Health | 46.21 units on a scale | Standard Deviation 11.29 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Physical Functioning | 38.24 units on a scale | Standard Deviation 11.05 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Role Emotional | 43.07 units on a scale | Standard Deviation 10.93 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 General Health Perception | 43.86 units on a scale | Standard Deviation 9.43 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Role Physical | 43.27 units on a scale | Standard Deviation 9.42 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Role Emotional | 43.36 units on a scale | Standard Deviation 11.02 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Social Functioning | 41.33 units on a scale | Standard Deviation 10.45 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Role Physical | 42.37 units on a scale | Standard Deviation 9.83 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Role Emotional | 42.38 units on a scale | Standard Deviation 11.44 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Vitality | 49.24 units on a scale | Standard Deviation 10.9 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Role Physical | 41.30 units on a scale | Standard Deviation 9.85 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Role Emotional | 43.49 units on a scale | Standard Deviation 11.12 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 General Health Perception | 43.11 units on a scale | Standard Deviation 9.19 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Role Physical | 39.05 units on a scale | Standard Deviation 9.74 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline Mental Health | 38.87 units on a scale | Standard Deviation 11.88 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Social Functioning | 43.56 units on a scale | Standard Deviation 10.89 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline Role Physical | 33.54 units on a scale | Standard Deviation 9.64 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 General Health Perception | 44.75 units on a scale | Standard Deviation 8.78 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Mental Health | 45.85 units on a scale | Standard Deviation 11.12 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Physical Functioning | 43.45 units on a scale | Standard Deviation 10.29 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Mental Health | 43.56 units on a scale | Standard Deviation 11.28 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 General Health Perception | 41.69 units on a scale | Standard Deviation 9.37 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Physical Functioning | 43.01 units on a scale | Standard Deviation 10.65 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Physical Functioning | 39.91 units on a scale | Standard Deviation 10.77 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Vitality | 51.18 units on a scale | Standard Deviation 9.48 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Physical Functioning | 43.06 units on a scale | Standard Deviation 10.32 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Physical Functioning | 40.62 units on a scale | Standard Deviation 10.98 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Mental Health | 46.37 units on a scale | Standard Deviation 11.64 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Mental Health | 44.57 units on a scale | Standard Deviation 12.34 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Physical Functioning | 36.41 units on a scale | Standard Deviation 10.45 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Mental Health | 46.78 units on a scale | Standard Deviation 10.82 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Mental Health | 45.78 units on a scale | Standard Deviation 11.73 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline General Health Perception | 38.02 units on a scale | Standard Deviation 9.03 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Mental Health | 46.48 units on a scale | Standard Deviation 10.87 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Vitality | 51.29 units on a scale | Standard Deviation 9.74 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Mental Health | 46.54 units on a scale | Standard Deviation 11.33 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Physical Functioning | 41.05 units on a scale | Standard Deviation 11.03 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Vitality | 50.10 units on a scale | Standard Deviation 10.37 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Physical Functioning | 42.67 units on a scale | Standard Deviation 10.84 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Physical Functioning | 41.72 units on a scale | Standard Deviation 11.2 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Bodily Pain | 46.24 units on a scale | Standard Deviation 9.46 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Vitality | 50.81 units on a scale | Standard Deviation 9.45 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Social Functioning | 44.75 units on a scale | Standard Deviation 10.2 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline Vitality | 41.87 units on a scale | Standard Deviation 9.9 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Bodily Pain | 46.42 units on a scale | Standard Deviation 9.3 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline Physical Functioning | 30.21 units on a scale | Standard Deviation 9.47 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Bodily Pain | 45.72 units on a scale | Standard Deviation 9.26 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Social Functioning | 45.21 units on a scale | Standard Deviation 9.97 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Vitality | 50.35 units on a scale | Standard Deviation 10.09 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Bodily Pain | 45.97 units on a scale | Standard Deviation 9.38 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Social Functioning | 45.37 units on a scale | Standard Deviation 9.47 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Bodily Pain | 44.14 units on a scale | Standard Deviation 8.73 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Bodily Pain | 45.32 units on a scale | Standard Deviation 9.32 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Social Functioning | 45.43 units on a scale | Standard Deviation 10 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Mental Health | 46.47 units on a scale | Standard Deviation 10.53 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Role Emotional | 42.19 units on a scale | Standard Deviation 11.43 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Vitality | 50.52 units on a scale | Standard Deviation 10.05 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Bodily Pain | 44.37 units on a scale | Standard Deviation 8.9 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Bodily Pain | 44.44 units on a scale | Standard Deviation 8.87 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Social Functioning | 46.09 units on a scale | Standard Deviation 9.56 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 General Health Perception | 45.03 units on a scale | Standard Deviation 9.08 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Bodily Pain | 42.78 units on a scale | Standard Deviation 9.09 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Social Functioning | 46.39 units on a scale | Standard Deviation 9.32 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 General Health Perception | 44.78 units on a scale | Standard Deviation 9.23 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Bodily Pain | 40.54 units on a scale | Standard Deviation 8.47 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Social Functioning | 46.22 units on a scale | Standard Deviation 9.05 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Vitality | 50.43 units on a scale | Standard Deviation 10.35 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline Bodily Pain | 33.29 units on a scale | Standard Deviation 8.11 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Social Functioning | 46.52 units on a scale | Standard Deviation 9.11 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Vitality | 47.94 units on a scale | Standard Deviation 9.98 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 24 Role Physical | 44.73 units on a scale | Standard Deviation 9.34 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Basline Role Emotional | 34.01 units on a scale | Standard Deviation 13.32 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 General Health Perception | 44.24 units on a scale | Standard Deviation 9.18 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 21 Role Physical | 44.51 units on a scale | Standard Deviation 9.18 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 1 Role Emotional | 39.21 units on a scale | Standard Deviation 12.35 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Vitality | 51.40 units on a scale | Standard Deviation 9.84 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 18 Role Physical | 44.44 units on a scale | Standard Deviation 90.4 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 2 Role Emotional | 40.59 units on a scale | Standard Deviation 12.21 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 General Health Perception | 44.00 units on a scale | Standard Deviation 9.48 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 15 Role Physical | 44.46 units on a scale | Standard Deviation 9.41 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 3 Role Emotional | 41.55 units on a scale | Standard Deviation 11.59 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 General Health Perception | 44.17 units on a scale | Standard Deviation 9.32 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 12 Role Physical | 43.67 units on a scale | Standard Deviation 9.36 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 6 Role Emotional | 41.95 units on a scale | Standard Deviation 11.69 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Baseline Social Functioning | 36.41 units on a scale | Standard Deviation 11.32 |
| CP-690,550 5 mg BID | SF-36 Domain Scores | Month 9 Role Physical | 42.78 units on a scale | Standard Deviation 9.6 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 General Health Perception | 43.18 units on a scale | Standard Deviation 9.19 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline Vitality | 41.63 units on a scale | Standard Deviation 10.01 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Vitality | 48.99 units on a scale | Standard Deviation 9.55 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Vitality | 49.68 units on a scale | Standard Deviation 10.47 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Vitality | 50.59 units on a scale | Standard Deviation 10 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Vitality | 50.69 units on a scale | Standard Deviation 10.27 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Vitality | 51.34 units on a scale | Standard Deviation 10.17 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Vitality | 51.96 units on a scale | Standard Deviation 9.5 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Vitality | 51.23 units on a scale | Standard Deviation 9.89 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline Social Functioning | 36.66 units on a scale | Standard Deviation 11.06 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Social Functioning | 44.13 units on a scale | Standard Deviation 9.85 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Social Functioning | 43.78 units on a scale | Standard Deviation 10.44 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Vitality | 51.83 units on a scale | Standard Deviation 9.62 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Vitality | 51.68 units on a scale | Standard Deviation 9.86 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Vitality | 52.00 units on a scale | Standard Deviation 10.12 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Social Functioning | 44.60 units on a scale | Standard Deviation 10.49 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Social Functioning | 46.18 units on a scale | Standard Deviation 9.68 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Social Functioning | 46.46 units on a scale | Standard Deviation 9.5 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Social Functioning | 46.88 units on a scale | Standard Deviation 9.45 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Role Emotional | 44.29 units on a scale | Standard Deviation 10.85 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Social Functioning | 46.99 units on a scale | Standard Deviation 9.25 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Social Functioning | 46.82 units on a scale | Standard Deviation 9.34 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Social Functioning | 47.22 units on a scale | Standard Deviation 9.61 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Social Functioning | 47.76 units on a scale | Standard Deviation 9.27 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Basline Role Emotional | 34.69 units on a scale | Standard Deviation 13.06 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Role Emotional | 41.31 units on a scale | Standard Deviation 11.72 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Role Emotional | 41.60 units on a scale | Standard Deviation 11.62 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Role Emotional | 42.18 units on a scale | Standard Deviation 11.43 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Role Emotional | 43.80 units on a scale | Standard Deviation 10.75 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Role Emotional | 44.08 units on a scale | Standard Deviation 10.85 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Role Emotional | 44.72 units on a scale | Standard Deviation 10.98 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Role Emotional | 44.00 units on a scale | Standard Deviation 10.91 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Role Emotional | 44.53 units on a scale | Standard Deviation 10.65 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Role Emotional | 45.27 units on a scale | Standard Deviation 11.02 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Mental Health | 46.48 units on a scale | Standard Deviation 11.07 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline Mental Health | 39.51 units on a scale | Standard Deviation 11.76 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Mental Health | 45.59 units on a scale | Standard Deviation 10.92 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Physical Functioning | 41.39 units on a scale | Standard Deviation 10.84 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Mental Health | 45.27 units on a scale | Standard Deviation 11.43 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Mental Health | 45.71 units on a scale | Standard Deviation 11.86 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Physical Functioning | 42.79 units on a scale | Standard Deviation 10.83 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Physical Functioning | 43.45 units on a scale | Standard Deviation 10.23 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Physical Functioning | 44.29 units on a scale | Standard Deviation 10.17 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Physical Functioning | 44.03 units on a scale | Standard Deviation 10.58 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Mental Health | 47.31 units on a scale | Standard Deviation 10.93 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Mental Health | 47.43 units on a scale | Standard Deviation 10.68 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Mental Health | 47.16 units on a scale | Standard Deviation 10.71 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Mental Health | 48.05 units on a scale | Standard Deviation 10.17 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Mental Health | 48.06 units on a scale | Standard Deviation 10.74 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Physical Functioning | 44.30 units on a scale | Standard Deviation 10.64 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Physical Functioning | 44.25 units on a scale | Standard Deviation 10.31 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Physical Functioning | 44.55 units on a scale | Standard Deviation 10.4 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline Role Physical | 34.11 units on a scale | Standard Deviation 9.35 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Role Physical | 41.30 units on a scale | Standard Deviation 9.28 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Role Physical | 42.73 units on a scale | Standard Deviation 9.58 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Role Physical | 43.51 units on a scale | Standard Deviation 9.43 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Role Physical | 44.46 units on a scale | Standard Deviation 9.82 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Role Physical | 45.04 units on a scale | Standard Deviation 9.47 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Role Physical | 45.81 units on a scale | Standard Deviation 9.39 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Role Physical | 45.90 units on a scale | Standard Deviation 9.47 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Role Physical | 45.27 units on a scale | Standard Deviation 9.3 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Role Physical | 45.77 units on a scale | Standard Deviation 9.45 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Role Physical | 46.20 units on a scale | Standard Deviation 9.04 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline Bodily Pain | 33.27 units on a scale | Standard Deviation 7.25 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Bodily Pain | 42.81 units on a scale | Standard Deviation 8.57 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Bodily Pain | 44.15 units on a scale | Standard Deviation 9.19 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 Bodily Pain | 44.79 units on a scale | Standard Deviation 9.35 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 Bodily Pain | 46.05 units on a scale | Standard Deviation 9.47 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 Bodily Pain | 46.40 units on a scale | Standard Deviation 9.58 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 Bodily Pain | 47.17 units on a scale | Standard Deviation 9.25 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 Bodily Pain | 47.18 units on a scale | Standard Deviation 9.34 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 Bodily Pain | 47.38 units on a scale | Standard Deviation 9.31 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 Bodily Pain | 47.43 units on a scale | Standard Deviation 9.34 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Bodily Pain | 47.66 units on a scale | Standard Deviation 9.42 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline General Health Perception | 37.24 units on a scale | Standard Deviation 8.55 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 General Health Perception | 42.40 units on a scale | Standard Deviation 8.78 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 2 Physical Functioning | 40.41 units on a scale | Standard Deviation 10.82 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 3 General Health Perception | 43.72 units on a scale | Standard Deviation 8.99 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 6 General Health Perception | 44.32 units on a scale | Standard Deviation 9.24 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 9 General Health Perception | 44.53 units on a scale | Standard Deviation 9.73 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 12 General Health Perception | 45.06 units on a scale | Standard Deviation 9.35 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 Mental Health | 48.18 units on a scale | Standard Deviation 10.69 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Baseline Physical Functioning | 31.57 units on a scale | Standard Deviation 9.86 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 1 Physical Functioning | 38.68 units on a scale | Standard Deviation 10.31 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 15 General Health Perception | 45.14 units on a scale | Standard Deviation 9.4 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 18 General Health Perception | 45.00 units on a scale | Standard Deviation 9.6 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 21 General Health Perception | 45.02 units on a scale | Standard Deviation 9.73 |
| CP-690,550 10 mg BID | SF-36 Domain Scores | Month 24 General Health Perception | 45.14 units on a scale | Standard Deviation 9.41 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Role Emotional | 39.15 units on a scale | Standard Deviation 11.72 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 General Health Perception | 41.35 units on a scale | Standard Deviation 8.07 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Role Physical | 41.28 units on a scale | Standard Deviation 9.28 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Role Emotional | 38.30 units on a scale | Standard Deviation 11.87 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Vitality | 44.83 units on a scale | Standard Deviation 9.67 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Role Physical | 41.17 units on a scale | Standard Deviation 9.35 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Role Emotional | 36.93 units on a scale | Standard Deviation 12.1 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 General Health Perception | 42.53 units on a scale | Standard Deviation 8.11 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Role Physical | 42.31 units on a scale | Standard Deviation 10.15 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Basline Role Emotional | 34.69 units on a scale | Standard Deviation 12.57 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Vitality | 48.21 units on a scale | Standard Deviation 10.18 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Role Physical | 42.72 units on a scale | Standard Deviation 9.72 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Social Functioning | 43.87 units on a scale | Standard Deviation 10.38 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Physical Functioning | 32.82 units on a scale | Standard Deviation 10.09 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Role Physical | 41.83 units on a scale | Standard Deviation 10.15 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Social Functioning | 44.49 units on a scale | Standard Deviation 9.98 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 General Health Perception | 42.09 units on a scale | Standard Deviation 8.51 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline Bodily Pain | 33.80 units on a scale | Standard Deviation 7.53 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Social Functioning | 44.44 units on a scale | Standard Deviation 10.94 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Vitality | 48.83 units on a scale | Standard Deviation 8.94 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Bodily Pain | 37.54 units on a scale | Standard Deviation 7.55 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Social Functioning | 42.96 units on a scale | Standard Deviation 10.84 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 General Health Perception | 42.15 units on a scale | Standard Deviation 9.92 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Bodily Pain | 38.93 units on a scale | Standard Deviation 7.89 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 General Health Perception | 42.74 units on a scale | Standard Deviation 8.3 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Bodily Pain | 40.61 units on a scale | Standard Deviation 8.19 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Social Functioning | 43.22 units on a scale | Standard Deviation 9.94 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Vitality | 48.52 units on a scale | Standard Deviation 9.79 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Bodily Pain | 42.36 units on a scale | Standard Deviation 8.66 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Role Emotional | 40.90 units on a scale | Standard Deviation 11.62 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Vitality | 48.03 units on a scale | Standard Deviation 9.87 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Bodily Pain | 42.62 units on a scale | Standard Deviation 8.32 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Social Functioning | 45.08 units on a scale | Standard Deviation 9.71 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline Vitality | 41.77 units on a scale | Standard Deviation 9.56 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Bodily Pain | 42.47 units on a scale | Standard Deviation 8.85 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Social Functioning | 44.15 units on a scale | Standard Deviation 10.42 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Mental Health | 45.95 units on a scale | Standard Deviation 10.96 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Bodily Pain | 42.72 units on a scale | Standard Deviation 9.75 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Social Functioning | 42.52 units on a scale | Standard Deviation 9.75 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Vitality | 47.06 units on a scale | Standard Deviation 9.11 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Bodily Pain | 43.35 units on a scale | Standard Deviation 9.25 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Role Emotional | 41.12 units on a scale | Standard Deviation 11.81 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 General Health Perception | 42.75 units on a scale | Standard Deviation 8.65 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Physical Functioning | 39.66 units on a scale | Standard Deviation 9.7 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Physical Functioning | 38.52 units on a scale | Standard Deviation 10.34 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Bodily Pain | 43.70 units on a scale | Standard Deviation 9.47 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Physical Functioning | 38.85 units on a scale | Standard Deviation 10.12 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Vitality | 49.26 units on a scale | Standard Deviation 10.59 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Mental Health | 45.41 units on a scale | Standard Deviation 11.36 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Physical Functioning | 37.61 units on a scale | Standard Deviation 10.17 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline Physical Functioning | 32.04 units on a scale | Standard Deviation 9.57 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 12 Mental Health | 44.78 units on a scale | Standard Deviation 11.25 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Mental Health | 44.09 units on a scale | Standard Deviation 10.55 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Bodily Pain | 43.37 units on a scale | Standard Deviation 9.43 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Mental Health | 44.38 units on a scale | Standard Deviation 11.92 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Mental Health | 43.35 units on a scale | Standard Deviation 10.34 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Vitality | 48.93 units on a scale | Standard Deviation 10.48 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Mental Health | 44.95 units on a scale | Standard Deviation 12.62 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Mental Health | 42.83 units on a scale | Standard Deviation 10.84 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Vitality | 45.51 units on a scale | Standard Deviation 9.53 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Mental Health | 46.03 units on a scale | Standard Deviation 12.31 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Physical Functioning | 36.12 units on a scale | Standard Deviation 9.97 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline General Health Perception | 37.63 units on a scale | Standard Deviation 8.6 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Physical Functioning | 39.01 units on a scale | Standard Deviation 10.9 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Physical Functioning | 35.29 units on a scale | Standard Deviation 10.26 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Social Functioning | 41.36 units on a scale | Standard Deviation 10.28 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Physical Functioning | 39.32 units on a scale | Standard Deviation 10.57 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline Mental Health | 39.75 units on a scale | Standard Deviation 11.3 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 General Health Perception | 42.69 units on a scale | Standard Deviation 9.06 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Physical Functioning | 39.85 units on a scale | Standard Deviation 10.74 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Mental Health | 44.06 units on a scale | Standard Deviation 11.85 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 General Health Perception | 39.58 units on a scale | Standard Deviation 8.69 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline Role Physical | 33.98 units on a scale | Standard Deviation 9.42 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Role Emotional | 41.14 units on a scale | Standard Deviation 11.68 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Social Functioning | 40.12 units on a scale | Standard Deviation 10.72 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 1 Role Physical | 36.39 units on a scale | Standard Deviation 9.36 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 21 Role Emotional | 41.25 units on a scale | Standard Deviation 12.14 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 24 Vitality | 49.07 units on a scale | Standard Deviation 9.94 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 Role Physical | 38.43 units on a scale | Standard Deviation 9.33 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 18 Role Emotional | 42.43 units on a scale | Standard Deviation 11.81 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 2 General Health Perception | 40.68 units on a scale | Standard Deviation 8.1 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 3 Role Physical | 39.37 units on a scale | Standard Deviation 9.67 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 Role Emotional | 39.83 units on a scale | Standard Deviation 12.09 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Baseline Social Functioning | 37.64 units on a scale | Standard Deviation 11.32 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Role Physical | 40.78 units on a scale | Standard Deviation 9.76 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 6 Role Emotional | 40.34 units on a scale | Standard Deviation 12.72 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 15 General Health Perception | 41.85 units on a scale | Standard Deviation 8.4 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Domain Scores | Month 9 Role Physical | 40.80 units on a scale | Standard Deviation 9.66 |
Secondary
SF-36 Physical Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 2 | 40.98 units on a scale | Standard Deviation 8.44 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 21 | 45.06 units on a scale | Standard Deviation 8.36 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 24 | 44.95 units on a scale | Standard Deviation 8.76 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 3 | 42.25 units on a scale | Standard Deviation 8.57 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 12 | 43.65 units on a scale | Standard Deviation 8.68 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Baseline | 32.92 units on a scale | Standard Deviation 7.36 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 6 | 42.82 units on a scale | Standard Deviation 8.42 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 18 | 44.53 units on a scale | Standard Deviation 8.42 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 1 | 33.81 units on a scale | Standard Deviation 8.47 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 9 | 42.96 units on a scale | Standard Deviation 8.69 |
| CP-690,550 5 mg BID | SF-36 Physical Component Score | Month 15 | 44.54 units on a scale | Standard Deviation 8.83 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 9 | 44.77 units on a scale | Standard Deviation 8.8 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 12 | 45.72 units on a scale | Standard Deviation 8.43 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 18 | 45.50 units on a scale | Standard Deviation 8.95 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 1 | 40.61 units on a scale | Standard Deviation 8.11 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 21 | 45.56 units on a scale | Standard Deviation 8.84 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 24 | 45.78 units on a scale | Standard Deviation 8.5 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 2 | 42.52 units on a scale | Standard Deviation 8.38 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 3 | 43.35 units on a scale | Standard Deviation 8.53 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 6 | 44.34 units on a scale | Standard Deviation 8.79 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Baseline | 33.20 units on a scale | Standard Deviation 7.33 |
| CP-690,550 10 mg BID | SF-36 Physical Component Score | Month 15 | 45.62 units on a scale | Standard Deviation 8.78 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 24 | 41.53 units on a scale | Standard Deviation 8.3 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 15 | 41.02 units on a scale | Standard Deviation 8.27 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Baseline | 33.58 units on a scale | Standard Deviation 7.82 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 1 | 35.40 units on a scale | Standard Deviation 8.28 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 2 | 37.51 units on a scale | Standard Deviation 8.22 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 3 | 38.60 units on a scale | Standard Deviation 8.01 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 6 | 40.37 units on a scale | Standard Deviation 8.11 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 9 | 40.30 units on a scale | Standard Deviation 7.97 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 12 | 41.27 units on a scale | Standard Deviation 8.05 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 18 | 41.15 units on a scale | Standard Deviation 8.5 |
| MTX 10, 15, or 20 mg, Weekly | SF-36 Physical Component Score | Month 21 | 41.67 units on a scale | Standard Deviation 8.44 |
Secondary
Short Form 36 (SF-36) Mental Component Score
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 15 | 47.40 units on a scale | Standard Deviation 10.31 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 1 | 44.90 units on a scale | Standard Deviation 11.4 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 18 | 47.64 units on a scale | Standard Deviation 10.32 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 21 | 46.93 units on a scale | Standard Deviation 10.85 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 9 | 46.91 units on a scale | Standard Deviation 10.74 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 24 | 47.32 units on a scale | Standard Deviation 10.23 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 2 | 45.95 units on a scale | Standard Deviation 12.1 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 3 | 46.82 units on a scale | Standard Deviation 11.21 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Baseline | 40.48 units on a scale | Standard Deviation 12 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 12 | 47.04 units on a scale | Standard Deviation 10.67 |
| CP-690,550 5 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 6 | 47.08 units on a scale | Standard Deviation 10.97 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 2 | 46.09 units on a scale | Standard Deviation 11.28 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 15 | 48.04 units on a scale | Standard Deviation 10.13 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 3 | 46.59 units on a scale | Standard Deviation 11.33 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 18 | 48.25 units on a scale | Standard Deviation 9.86 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 1 | 46.70 units on a scale | Standard Deviation 10.78 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 9 | 48.04 units on a scale | Standard Deviation 10.42 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 21 | 48.50 units on a scale | Standard Deviation 10.04 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 6 | 47.55 units on a scale | Standard Deviation 10.26 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 12 | 48.05 units on a scale | Standard Deviation 9.99 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Month 24 | 48.96 units on a scale | Standard Deviation 10.36 |
| CP-690,550 10 mg BID | Short Form 36 (SF-36) Mental Component Score | Baseline | 40.73 units on a scale | Standard Deviation 11.73 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 24 | 46.42 units on a scale | Standard Deviation 10.62 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Baseline | 40.93 units on a scale | Standard Deviation 11.27 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 1 | 43.98 units on a scale | Standard Deviation 10.71 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 3 | 45.27 units on a scale | Standard Deviation 10.42 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 6 | 45.73 units on a scale | Standard Deviation 12.06 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 9 | 46.86 units on a scale | Standard Deviation 10.85 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 12 | 45.71 units on a scale | Standard Deviation 11.01 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 15 | 45.03 units on a scale | Standard Deviation 11.75 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 18 | 46.76 units on a scale | Standard Deviation 11.49 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 21 | 46.70 units on a scale | Standard Deviation 11.66 |
| MTX 10, 15, or 20 mg, Weekly | Short Form 36 (SF-36) Mental Component Score | Month 2 | 44.35 units on a scale | Standard Deviation 10.48 |
Secondary
Swollen Joints Count (SJC)
Sixty-six (66) joints were assessed by a blinded joint assessor for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 66 joints assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), MCP (I, II, III, IV, V), thumb IP, PIP (II, III, IV, V), DIP (II, III, IV, V); lower extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), MTP (I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 15 | 2.63 swollen joints | Standard Deviation 6.35 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 6 | 4.70 swollen joints | Standard Deviation 7.4 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 21 | 2.28 swollen joints | Standard Deviation 4.12 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 12 | 3.30 swollen joints | Standard Deviation 6.12 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 9 | 3.83 swollen joints | Standard Deviation 5.67 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Baseline | 16.27 swollen joints | Standard Deviation 9.24 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 2 | 6.84 swollen joints | Standard Deviation 7.74 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 1 | 9.90 swollen joints | Standard Deviation 9.6 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 18 | 2.44 swollen joints | Standard Deviation 4.07 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 3 | 5.81 swollen joints | Standard Deviation 8.76 |
| CP-690,550 5 mg BID | Swollen Joints Count (SJC) | Month 24 | 2.00 swollen joints | Standard Deviation 3.7 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 9 | 3.22 swollen joints | Standard Deviation 5.93 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Baseline | 15.58 swollen joints | Standard Deviation 8.37 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 1 | 8.02 swollen joints | Standard Deviation 7.03 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 2 | 5.69 swollen joints | Standard Deviation 6.29 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 3 | 4.32 swollen joints | Standard Deviation 5.53 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 6 | 3.69 swollen joints | Standard Deviation 6.05 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 12 | 2.88 swollen joints | Standard Deviation 6.77 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 15 | 3.00 swollen joints | Standard Deviation 7.95 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 18 | 2.25 swollen joints | Standard Deviation 5.28 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 21 | 2.02 swollen joints | Standard Deviation 4 |
| CP-690,550 10 mg BID | Swollen Joints Count (SJC) | Month 24 | 2.29 swollen joints | Standard Deviation 6.44 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 21 | 3.47 swollen joints | Standard Deviation 4.14 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 15 | 4.92 swollen joints | Standard Deviation 8.21 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 2 | 9.97 swollen joints | Standard Deviation 9.05 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Baseline | 16.76 swollen joints | Standard Deviation 10.27 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 18 | 3.91 swollen joints | Standard Deviation 4.85 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 1 | 12.56 swollen joints | Standard Deviation 9.4 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 9 | 4.83 swollen joints | Standard Deviation 6.74 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 6 | 6.30 swollen joints | Standard Deviation 7.12 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 24 | 3.38 swollen joints | Standard Deviation 4.26 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 12 | 5.17 swollen joints | Standard Deviation 9.44 |
| MTX 10, 15, or 20 mg, Weekly | Swollen Joints Count (SJC) | Month 3 | 7.88 swollen joints | Standard Deviation 7.98 |
Secondary
Tender Joints Count (TJC)
Sixty-eight (68) joints were assessed by a blinded joint assessor to determine the number of joints considered tender or painful. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not assessed. 68 joints to be assessed were: upper body (temporomandibular, sternoclavicular, acromioclavicular); upper extremity: shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V); lower extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 15 | 5.55 tender joints | Standard Deviation 9.15 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 6 | 8.71 tender joints | Standard Deviation 11.04 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 21 | 4.60 tender joints | Standard Deviation 6.87 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 12 | 6.60 tender joints | Standard Deviation 9.78 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 9 | 7.31 tender joints | Standard Deviation 10.45 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Baseline | 25.65 tender joints | Standard Deviation 13.81 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 2 | 12.12 tender joints | Standard Deviation 12.31 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 1 | 15.75 tender joints | Standard Deviation 12.98 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 18 | 5.12 tender joints | Standard Deviation 7.15 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 3 | 10.03 tender joints | Standard Deviation 11.52 |
| CP-690,550 5 mg BID | Tender Joints Count (TJC) | Month 24 | 4.50 tender joints | Standard Deviation 6.75 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 9 | 6.14 tender joints | Standard Deviation 10.11 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Baseline | 25.12 tender joints | Standard Deviation 13.51 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 1 | 13.66 tender joints | Standard Deviation 12.61 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 2 | 10.67 tender joints | Standard Deviation 12.31 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 3 | 8.61 tender joints | Standard Deviation 10.67 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 6 | 6.59 tender joints | Standard Deviation 10.28 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 12 | 5.46 tender joints | Standard Deviation 10.16 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 15 | 5.17 tender joints | Standard Deviation 9.79 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 18 | 4.46 tender joints | Standard Deviation 7.98 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 21 | 4.19 tender joints | Standard Deviation 6.4 |
| CP-690,550 10 mg BID | Tender Joints Count (TJC) | Month 24 | 4.66 tender joints | Standard Deviation 8.52 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 21 | 7.07 tender joints | Standard Deviation 9.68 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 15 | 8.23 tender joints | Standard Deviation 10.5 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 2 | 16.39 tender joints | Standard Deviation 14.16 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Baseline | 25.41 tender joints | Standard Deviation 15.03 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 18 | 6.97 tender joints | Standard Deviation 8.74 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 1 | 20.07 tender joints | Standard Deviation 14.83 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 9 | 8.82 tender joints | Standard Deviation 11.27 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 6 | 11.99 tender joints | Standard Deviation 13.34 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 24 | 6.01 tender joints | Standard Deviation 6.81 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 12 | 9.13 tender joints | Standard Deviation 12.67 |
| MTX 10, 15, or 20 mg, Weekly | Tender Joints Count (TJC) | Month 3 | 14.05 tender joints | Standard Deviation 14.13 |
Secondary
WLQ Work Loss Index Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Baseline and Months 3, 6, and 12
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | WLQ Work Loss Index Score | Baseline | 11.00 units on a scale | Standard Deviation 5.93 |
| CP-690,550 5 mg BID | WLQ Work Loss Index Score | Month 6 | 7.72 units on a scale | Standard Deviation 5.74 |
| CP-690,550 5 mg BID | WLQ Work Loss Index Score | Month 12 | 7.89 units on a scale | Standard Deviation 6.07 |
| CP-690,550 5 mg BID | WLQ Work Loss Index Score | Month 3 | 8.05 units on a scale | Standard Deviation 6.25 |
| CP-690,550 10 mg BID | WLQ Work Loss Index Score | Baseline | 11.21 units on a scale | Standard Deviation 6.08 |
| CP-690,550 10 mg BID | WLQ Work Loss Index Score | Month 3 | 7.60 units on a scale | Standard Deviation 6.43 |
| CP-690,550 10 mg BID | WLQ Work Loss Index Score | Month 6 | 6.49 units on a scale | Standard Deviation 5.62 |
| CP-690,550 10 mg BID | WLQ Work Loss Index Score | Month 12 | 5.88 units on a scale | Standard Deviation 5.31 |
| MTX 10, 15, or 20 mg, Weekly | WLQ Work Loss Index Score | Month 6 | 7.29 units on a scale | Standard Deviation 5.69 |
| MTX 10, 15, or 20 mg, Weekly | WLQ Work Loss Index Score | Baseline | 10.55 units on a scale | Standard Deviation 6.24 |
| MTX 10, 15, or 20 mg, Weekly | WLQ Work Loss Index Score | Month 3 | 8.32 units on a scale | Standard Deviation 5.78 |
| MTX 10, 15, or 20 mg, Weekly | WLQ Work Loss Index Score | Month 12 | 6.47 units on a scale | Standard Deviation 5.9 |
Secondary
Work Limitation Questionnaire (WLQ) Score
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Time frame: Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Mental Demands | 22.99 units on a scale | Standard Deviation 25.59 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Output Demands | 22.85 units on a scale | Standard Deviation 24.6 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Physical Demands | 47.87 units on a scale | Standard Deviation 33.29 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Time Management | 31.47 units on a scale | Standard Deviation 27.99 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Physical Demands | 51.18 units on a scale | Standard Deviation 23.02 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Time Management | 30.82 units on a scale | Standard Deviation 29.76 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Physical Demands | 48.11 units on a scale | Standard Deviation 31.33 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Output Demands | 25.65 units on a scale | Standard Deviation 25.74 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 9: Time Management | 70.00 units on a scale | — |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Mental Demands | 19.24 units on a scale | Standard Deviation 23.15 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Output Demands | 24.55 units on a scale | Standard Deviation 24.47 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Output Demands | 26.46 units on a scale | Standard Deviation 26.26 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Mental Demands | 31.29 units on a scale | Standard Deviation 24.72 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Mental Demands | 22.01 units on a scale | Standard Deviation 24.05 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Physical Demands | 50.13 units on a scale | Standard Deviation 31.81 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Physical Demands | 8.33 units on a scale | — |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Time Management | 29.18 units on a scale | Standard Deviation 28.16 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Physical Demands | 50.79 units on a scale | Standard Deviation 34.51 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Output Demands | 40.77 units on a scale | Standard Deviation 27.36 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Mental Demands | 29.63 units on a scale | Standard Deviation 26.98 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Time Management | 23.19 units on a scale | Standard Deviation 25.28 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 1: Time Management | 40.00 units on a scale | — |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Time Management | 67.50 units on a scale | Standard Deviation 17.68 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Output Demands | 31.67 units on a scale | Standard Deviation 27.54 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Time Management | 28.17 units on a scale | Standard Deviation 29.38 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Output Demands | 0.00 units on a scale | — |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Physical Demands | 62.50 units on a scale | Standard Deviation 29.17 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Mental Demands | 5.56 units on a scale | — |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Physical Demands | 51.10 units on a scale | Standard Deviation 35.26 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 2: Time Management | 25.00 units on a scale | Standard Deviation 35.36 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Mental Demands | 19.44 units on a scale | Standard Deviation 22.7 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Time Management | 46.41 units on a scale | Standard Deviation 25.59 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Time Management | 5.00 units on a scale | — |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Output Demands | 22.98 units on a scale | Standard Deviation 25.23 |
| CP-690,550 5 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Mental Demands | 23.84 units on a scale | Standard Deviation 26.67 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Physical Demands | 33.33 units on a scale | Standard Deviation 57.74 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Time Management | 47.79 units on a scale | Standard Deviation 28.29 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Physical Demands | 50.99 units on a scale | Standard Deviation 25.47 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Mental Demands | 33.84 units on a scale | Standard Deviation 26.72 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Baseline: Output Demands | 40.50 units on a scale | Standard Deviation 28.07 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 1: Time Management | 37.50 units on a scale | Standard Deviation 53.03 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Output Demands | 82.50 units on a scale | Standard Deviation 24.75 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Time Management | 21.06 units on a scale | Standard Deviation 25.37 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Physical Demands | 45.94 units on a scale | Standard Deviation 36.65 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Mental Demands | 17.25 units on a scale | Standard Deviation 23.29 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 24: Output Demands | 19.39 units on a scale | Standard Deviation 24.03 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 2: Time Management | 15.00 units on a scale | — |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Time Management | 29.02 units on a scale | Standard Deviation 29.19 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Physical Demands | 45.77 units on a scale | Standard Deviation 32.86 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Mental Demands | 22.50 units on a scale | Standard Deviation 27.28 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 3: Output Demands | 25.63 units on a scale | Standard Deviation 28.3 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Physical Demands | 45.76 units on a scale | Standard Deviation 35.45 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Time Management | 25.11 units on a scale | Standard Deviation 28.08 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Mental Demands | 18.00 units on a scale | Standard Deviation 24.11 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 6: Output Demands | 20.31 units on a scale | Standard Deviation 23.33 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 9: Time Management | 35.00 units on a scale | Standard Deviation 33.91 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Time Management | 24.43 units on a scale | Standard Deviation 28.49 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Physical Demands | 46.42 units on a scale | Standard Deviation 37.18 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Mental Demands | 15.11 units on a scale | Standard Deviation 21.94 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 12: Output Demands | 17.36 units on a scale | Standard Deviation 22.98 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Time Management | 8.33 units on a scale | Standard Deviation 14.43 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Mental Demands | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 15: Output Demands | 6.67 units on a scale | Standard Deviation 11.55 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Time Management | 22.16 units on a scale | Standard Deviation 26.77 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Physical Demands | 43.14 units on a scale | Standard Deviation 37.06 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Mental Demands | 17.51 units on a scale | Standard Deviation 23.83 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 18: Output Demands | 19.83 units on a scale | Standard Deviation 25.37 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Time Management | 60.00 units on a scale | Standard Deviation 35.36 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Physical Demands | 27.08 units on a scale | Standard Deviation 20.62 |
| CP-690,550 10 mg BID | Work Limitation Questionnaire (WLQ) Score | Month 21: Mental Demands | 87.50 units on a scale | Standard Deviation 17.68 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 24: Output Demands | 20.02 units on a scale | Standard Deviation 23.85 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 18: Mental Demands | 17.78 units on a scale | Standard Deviation 22.99 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 12: Mental Demands | 17.21 units on a scale | Standard Deviation 21.88 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Baseline: Time Management | 47.26 units on a scale | Standard Deviation 28.19 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 12: Output Demands | 21.49 units on a scale | Standard Deviation 26.87 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 24: Mental Demands | 17.50 units on a scale | Standard Deviation 24.04 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 21: Physical Demands | 62.50 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 15: Time Management | 75.00 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 1: Time Management | 40.00 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 24: Time Management | 25.11 units on a scale | Standard Deviation 25.07 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 18: Output Demands | 22.63 units on a scale | Standard Deviation 26.31 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 15: Mental Demands | 37.50 units on a scale | Standard Deviation 53.03 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 21: Output Demands | 45.00 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 15: Physical Demands | 54.17 units on a scale | Standard Deviation 25.34 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 15: Output Demands | 48.33 units on a scale | Standard Deviation 44.78 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Baseline: Output Demands | 38.34 units on a scale | Standard Deviation 28.09 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 21: Time Management | 80.00 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 6: Physical Demands | 46.46 units on a scale | Standard Deviation 30.78 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 18: Time Management | 25.09 units on a scale | Standard Deviation 28.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 6: Time Management | 27.87 units on a scale | Standard Deviation 25.18 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 3: Output Demands | 27.77 units on a scale | Standard Deviation 26.38 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Baseline: Mental Demands | 28.57 units on a scale | Standard Deviation 26.35 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 6: Mental Demands | 20.29 units on a scale | Standard Deviation 23.9 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 3: Mental Demands | 22.66 units on a scale | Standard Deviation 24.71 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 24: Physical Demands | 43.75 units on a scale | Standard Deviation 33.06 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 6: Output Demands | 24.66 units on a scale | Standard Deviation 25.38 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 3: Physical Demands | 54.47 units on a scale | Standard Deviation 28.36 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 18: Physical Demands | 43.93 units on a scale | Standard Deviation 33.15 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 9: Time Management | 62.92 units on a scale | Standard Deviation 32.12 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 3: Time Management | 34.76 units on a scale | Standard Deviation 27.7 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Baseline: Physical Demands | 50.15 units on a scale | Standard Deviation 25.54 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 12: Time Management | 25.86 units on a scale | Standard Deviation 25.57 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 2: Time Management | 95.00 units on a scale | Standard Deviation 8.66 |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 21: Mental Demands | 25.00 units on a scale | — |
| MTX 10, 15, or 20 mg, Weekly | Work Limitation Questionnaire (WLQ) Score | Month 12: Physical Demands | 39.98 units on a scale | Standard Deviation 32.42 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Months 3, 6, 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 18 | 2.33 units on a scale | Standard Deviation 2.63 |
| CP-690,550 5 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 6 | 2.97 units on a scale | Standard Deviation 3.58 |
| CP-690,550 5 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 24 | 2.47 units on a scale | Standard Deviation 2.63 |
| CP-690,550 5 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Baseline | 4.94 units on a scale | Standard Deviation 3.26 |
| CP-690,550 5 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 12 | 2.69 units on a scale | Standard Deviation 2.75 |
| CP-690,550 5 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 3 | 3.59 units on a scale | Standard Deviation 2.92 |
| CP-690,550 10 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 12 | 2.08 units on a scale | Standard Deviation 2.38 |
| CP-690,550 10 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 3 | 3.25 units on a scale | Standard Deviation 3.78 |
| CP-690,550 10 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 24 | 2.35 units on a scale | Standard Deviation 2.75 |
| CP-690,550 10 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 18 | 2.11 units on a scale | Standard Deviation 2.47 |
| CP-690,550 10 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Baseline | 4.71 units on a scale | Standard Deviation 3.07 |
| CP-690,550 10 mg BID | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 6 | 2.27 units on a scale | Standard Deviation 2.58 |
| MTX 10, 15, or 20 mg, Weekly | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 24 | 2.52 units on a scale | Standard Deviation 2.68 |
| MTX 10, 15, or 20 mg, Weekly | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Baseline | 4.57 units on a scale | Standard Deviation 3.15 |
| MTX 10, 15, or 20 mg, Weekly | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 3 | 3.57 units on a scale | Standard Deviation 2.8 |
| MTX 10, 15, or 20 mg, Weekly | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 6 | 3.04 units on a scale | Standard Deviation 2.75 |
| MTX 10, 15, or 20 mg, Weekly | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 12 | 2.94 units on a scale | Standard Deviation 3.85 |
| MTX 10, 15, or 20 mg, Weekly | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU | Month 18 | 2.11 units on a scale | Standard Deviation 2.38 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Baseline and Months 3 and 6
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: required aids/devices | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: treated in ER | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: unable to work due to RA | 1.56 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: treated in ER | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL:admitted for overnight stay | 0.24 units on a scale | Standard Deviation 0.56 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: home healthcare services | 2.00 units on a scale | Standard Deviation 0.05 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: lost job/retired early | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: hospitalized | 1.89 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: outpatient surgery | 1.99 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: any outpatient surgery | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: home healthcare services | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: work disabled due to RA | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: non-study diagnostic tests | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: sick leave due to RA | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: treated in ER | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: in a nursing home | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: currently employed | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: home healthcare services | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: retired | 1.56 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: required aids/devices | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: used aids/devices | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: in nursing home | 2.00 units on a scale | Standard Deviation 0.05 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: non-medical practitioner | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: sick leave due to RA | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: feel well enough to work | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: currently employed | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: performed paid work | 1.77 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: non-medical practitioner | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: feel well enough to work | 1.78 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: performed part-time work | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: non-study diagnostic tests | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: unable to work due to RA | 1.45 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: chores by family/friends | 1.78 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: unable to work due to RA | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: Lost job/retired early | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: performed paid work | 1.69 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3:hospitalization | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: work disabled due to RA | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: currently employed | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6:admitted for overnight stay | 0.36 units on a scale | Standard Deviation 0.74 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: retired | 1.60 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: unable to do chores | 1.69 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: lost job/retired early | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: sick leave due to RA | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: performed part-time work | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: Hospitalization | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: performed part time work | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: non-study diagnostic test | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: performed paid work | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: in nursing home | 2.00 units on a scale | Standard Deviation 0.05 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: work disabled due to RA | 1.68 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: unable to do chores | 1.41 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: seen any doctor | 1.12 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: chores by family/friends | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: chores by housekeeper | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: feel well enough to work | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3:admitted for overnight stay | 0.08 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: chores by family/friends | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: seen any doctor | 1.40 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: retired | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: seen any doctor | 1.36 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: unable to do chores | 1.79 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: seen any doctor | 1.30 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: treated in ER | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6:admitted for overnight stay | 0.21 units on a scale | Standard Deviation 0.54 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3:admitted for overnight stay | 0.06 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3:hospitalization | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: sick leave due to RA | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: non-study diagnostic tests | 1.90 units on a scale | Standard Deviation 0.31 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: in nursing home | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: performed part-time work | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: home healthcare services | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: in nursing home | 2.00 units on a scale | Standard Deviation 0.05 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: required aids/devices | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: non-medical practitioner | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: performed paid work | 1.82 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: currently employed | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: treated in ER | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: feel well enough to work | 1.58 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: unable to work due to RA | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: unable to do chores | 1.81 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: lost job/retired early | 1.79 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: work disabled due to RA | 1.68 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: retired | 1.59 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: sick leave due to RA | 1.90 units on a scale | Standard Deviation 0.31 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: home healthcare services | 1.99 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: performed part-time work | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: performed paid work | 1.72 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: chores by family/friends | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: unable to do chores | 1.71 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: chores by family/friends | 1.71 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: seen any doctor | 1.13 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: seen any doctor | 1.39 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: treated in ER | 1.91 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: required aids/devices | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL:admitted for overnight stay | 0.31 units on a scale | Standard Deviation 0.83 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: Hospitalization | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: hospitalized | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: any outpatient surgery | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: non-study diagnostic tests | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: in a nursing home | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: home healthcare services | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: currently employed | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: used aids/devices | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: non-medical practitioner | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: currently employed | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: feel well enough to work | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: feel well enough to work | 1.78 units on a scale | Standard Deviation 0.42 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: unable to work due to RA | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: Lost job/retired early | 1.81 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: unable to work due to RA | 1.66 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: work disabled due to RA | 1.58 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: retired | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: sick leave due to RA | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: lost job/retired early | 1.81 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: performed part time work | 1.88 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: performed paid work | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: unable to do chores | 1.40 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: work disabled due to RA | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: chores by housekeeper | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: non-study diagnostic test | 1.88 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: chores by family/friends | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: retired | 1.57 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: unable to do chores | 1.44 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: treated in ER | 1.98 units on a scale | Standard Deviation 0.14 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6:admitted for overnight stay | 1.33 units on a scale | Standard Deviation 1.15 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: Hospitalization | 1.97 units on a scale | Standard Deviation 0.16 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: outpatient surgery | 1.97 units on a scale | Standard Deviation 0.16 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: non-study diagnostic test | 1.89 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: in nursing home | 1.99 units on a scale | Standard Deviation 0.08 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: home healthcare services | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: required aids/devices | 1.95 units on a scale | Standard Deviation 0.22 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: non-medical practitioner | 1.97 units on a scale | Standard Deviation 0.16 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: currently employed | 1.55 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: feel well enough to work | 1.65 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: unable to work due to RA | 1.52 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: lost job/retired early | 1.78 units on a scale | Standard Deviation 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: work disabled due to RA | 1.68 units on a scale | Standard Deviation 0.47 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: retired | 1.52 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: sick leave due to RA | 1.89 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: performed part-time work | 1.95 units on a scale | Standard Deviation 0.22 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: performed paid work | 1.69 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: unable to do chores | 1.70 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: chores by housekeeper | 1.94 units on a scale | Standard Deviation 0.24 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: chores by family/friends | 1.71 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: seen any doctor | 1.12 units on a scale | Standard Deviation 0.32 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: treated in ER | 1.91 units on a scale | Standard Deviation 0.28 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL:admitted for overnight stay | 0.25 units on a scale | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: hospitalized | 1.88 units on a scale | Standard Deviation 0.33 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: any outpatient surgery | 1.98 units on a scale | Standard Deviation 0.15 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: non-study diagnostic tests | 1.69 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: in a nursing home | 1.98 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: home healthcare services | 1.98 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: used aids/devices | 1.91 units on a scale | Standard Deviation 0.29 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: non-medical practitioner | 1.96 units on a scale | Standard Deviation 0.19 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: currently employed | 1.54 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: feel well enough to work | 1.78 units on a scale | Standard Deviation 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: unable to work due to RA | 1.42 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: Lost job/retired early | 1.77 units on a scale | Standard Deviation 0.43 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: work disabled due to RA | 1.59 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: retired | 1.53 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: sick leave due to RA | 1.74 units on a scale | Standard Deviation 0.44 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: performed part time work | 1.83 units on a scale | Standard Deviation 0.38 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: performed paid work | 1.57 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 6: seen any doctor | 1.35 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: chores by housekeeper | 1.93 units on a scale | Standard Deviation 0.26 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | BL: chores by family/friends | 1.49 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: seen any doctor | 1.30 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: treated in ER | 1.98 units on a scale | Standard Deviation 0.13 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3:admitted for overnight stay | 0.33 units on a scale | Standard Deviation 0.58 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3:hospitalization | 1.99 units on a scale | Standard Deviation 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: outpatient surgery | 1.99 units on a scale | Standard Deviation 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: non-study diagnostic tests | 1.92 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: in nursing home | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: home healthcare services | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: required aids/devices | 1.92 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.11 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: currently employed | 1.53 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: feel well enough to work | 1.67 units on a scale | Standard Deviation 0.47 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: unable to work due to RA | 1.50 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: lost job/retired early | 1.83 units on a scale | Standard Deviation 0.38 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: work disabled due to RA | 1.67 units on a scale | Standard Deviation 0.47 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: retired | 1.54 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: sick leave due to RA | 1.85 units on a scale | Standard Deviation 0.36 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: performed part-time work | 1.92 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: performed paid work | 1.66 units on a scale | Standard Deviation 0.47 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: unable to do chores | 1.54 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: chores by housekeeper | 1.89 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Months 3 and 6 | Month 3: chores by family/friends | 1.58 units on a scale | Standard Deviation 0.5 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, non-medical practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, overnight stay, home healthcare services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.
Time frame: Months 12, 18, and 24
Population: FAS; 'n' (number of participants analyzed) signifies participants who were evaluable for this measure at a given timepoint for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: retired | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: seen any doctor | 1.45 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: treated in ER | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month12:admitted for overnight stay | 0.19 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: hospitalized | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12:any outpatient surgery | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 1.90 units on a scale | Standard Deviation 0.3 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: in a nursing home | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: home healthcare services | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: used aids/devices | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: currently employed | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: feel well enough to work | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: unable to work due to RA | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: Lost job/retired early | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: work disabled due to RA | 1.66 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: sick leave due to RA | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: performed part time work | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: performed paid work | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: unable to do chores | 1.79 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: chores by housekeeper | 1.96 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: chores by family/friends | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: seen any doctor | 1.43 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: treated in ER | 1.96 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month18:admitted for overnight stay | 0.60 units on a scale | Standard Deviation 0.97 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18:hospitalization | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: in nursing home | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: home healthcare services | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: required aids/devices | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: currently employed | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: feel well enough to work | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: unable to work due to RA | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: lost job/retired early | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: work disabled due to RA | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: retired | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: sick leave due to RA | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: performed part-time work | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: performed paid work | 1.78 units on a scale | Standard Deviation 0.41 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: unable to do chores | 1.84 units on a scale | Standard Deviation 0.36 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: chores by housekeeper | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: chores by family/friends | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: seen any doctor | 1.46 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: treated in ER | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month24:admitted for overnight stay | 0.20 units on a scale | Standard Deviation 0.63 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: Hospitalization | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24:non-study diagnostic test | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: in nursing home | 2.00 units on a scale | Standard Deviation 0.06 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: home healthcare services | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: required aids/devices | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: currently employed | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: feel well enough to work | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: unable to work due to RA | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: lost job/retired early | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: work disabled due to RA | 1.75 units on a scale | Standard Deviation 0.43 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: retired | 1.47 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: sick leave due to RA | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: performed part-time work | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: performed paid work | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: unable to do chores | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: chores by housekeeper | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: chores by family/friends | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: feel well enough to work | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: seen any doctor | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: seen any doctor | 1.44 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: non-medical practitioner | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: feel well enough to work | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: treated in ER | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: unable to work due to RA | 1.72 units on a scale | Standard Deviation 0.45 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: in nursing home | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month12:admitted for overnight stay | 0.25 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18:hospitalization | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: treated in ER | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: hospitalized | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: lost job/retired early | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: seen any doctor | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12:any outpatient surgery | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: home healthcare services | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: retired | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 1.88 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: work disabled due to RA | 1.78 units on a scale | Standard Deviation 0.42 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month24:admitted for overnight stay | 0.67 units on a scale | Standard Deviation 0.98 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: in a nursing home | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: performed part-time work | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: unable to work due to RA | 1.75 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: home healthcare services | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: retired | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: used aids/devices | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: required aids/devices | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: Hospitalization | 1.99 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: sick leave due to RA | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month18:admitted for overnight stay | 0.33 units on a scale | Standard Deviation 0.71 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: currently employed | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: currently employed | 1.54 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: chores by family/friends | 1.88 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: feel well enough to work | 1.56 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: performed part-time work | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: outpatient surgery | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: unable to work due to RA | 1.73 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.12 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: lost job/retired early | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: Lost job/retired early | 1.81 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: performed paid work | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: sick leave due to RA | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: work disabled due to RA | 1.73 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: treated in ER | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: retired | 1.52 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24:non-study diagnostic test | 1.89 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: sick leave due to RA | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: unable to do chores | 1.84 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: currently employed | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: performed part time work | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: unable to do chores | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: chores by housekeeper | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: performed paid work | 1.84 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: required aids/devices | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: in nursing home | 1.99 units on a scale | Standard Deviation 0.08 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: unable to do chores | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: work disabled due to RA | 1.77 units on a scale | Standard Deviation 0.42 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: chores by family/friends | 1.89 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: chores by housekeeper | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: performed paid work | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: chores by housekeeper | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: chores by family/friends | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg BID | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: home healthcare services | 1.99 units on a scale | Standard Deviation 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: chores by family/friends | 1.79 units on a scale | Standard Deviation 0.41 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: seen any doctor | 1.41 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: home healthcare services | 1.99 units on a scale | Standard Deviation 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: treated in ER | 1.96 units on a scale | Standard Deviation 0.2 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month18:admitted for overnight stay | 0.40 units on a scale | Standard Deviation 0.89 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18:hospitalization | 1.97 units on a scale | Standard Deviation 0.16 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: required aids/devices | 1.96 units on a scale | Standard Deviation 0.19 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: outpatient surgery | 1.97 units on a scale | Standard Deviation 0.16 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: performed part-time work | 1.95 units on a scale | Standard Deviation 0.21 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18:non-study diagnostic tests | 1.90 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: in nursing home | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: non-medical practitioner | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: home healthcare services | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: chores by housekeeper | 1.97 units on a scale | Standard Deviation 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: required aids/devices | 1.97 units on a scale | Standard Deviation 0.18 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: non-medical practitioner | 1.99 units on a scale | Standard Deviation 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: currently employed | 1.55 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: currently employed | 1.55 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: feel well enough to work | 1.67 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: unable to work due to RA | 1.59 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: feel well enough to work | 1.65 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: lost job/retired early | 1.80 units on a scale | Standard Deviation 0.4 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: performed paid work | 1.75 units on a scale | Standard Deviation 0.44 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: work disabled due to RA | 1.66 units on a scale | Standard Deviation 0.48 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: retired | 1.48 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: unable to work due to RA | 1.52 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: sick leave due to RA | 1.95 units on a scale | Standard Deviation 0.22 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: chores by family/friends | 1.81 units on a scale | Standard Deviation 0.39 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: performed part-time work | 1.98 units on a scale | Standard Deviation 0.14 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: performed paid work | 1.79 units on a scale | Standard Deviation 0.41 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: lost job/retired early | 1.81 units on a scale | Standard Deviation 0.39 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: unable to do chores | 1.78 units on a scale | Standard Deviation 0.42 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: chores by housekeeper | 1.95 units on a scale | Standard Deviation 0.22 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 18: chores by family/friends | 1.84 units on a scale | Standard Deviation 0.37 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: work disabled due to RA | 1.70 units on a scale | Standard Deviation 0.46 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: seen any doctor | 1.41 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: seen any doctor | 1.47 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: treated in ER | 1.96 units on a scale | Standard Deviation 0.19 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: unable to do chores | 1.80 units on a scale | Standard Deviation 0.4 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month12:admitted for overnight stay | 0.20 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: hospitalized | 1.99 units on a scale | Standard Deviation 0.12 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: treated in ER | 1.97 units on a scale | Standard Deviation 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12:any outpatient surgery | 1.98 units on a scale | Standard Deviation 0.15 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12:non-study diagnostic tests | 1.92 units on a scale | Standard Deviation 0.27 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: in a nursing home | 1.99 units on a scale | Standard Deviation 0.09 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month24:admitted for overnight stay | 0.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: home healthcare services | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: retired | 1.52 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: used aids/devices | 1.97 units on a scale | Standard Deviation 0.17 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: non-medical practitioner | 2.00 units on a scale | Standard Deviation 0 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: Hospitalization | 1.98 units on a scale | Standard Deviation 0.14 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: currently employed | 1.53 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: feel well enough to work | 1.61 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: unable to work due to RA | 1.61 units on a scale | Standard Deviation 0.49 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: outpatient surgery | 1.99 units on a scale | Standard Deviation 0.1 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: Lost job/retired early | 1.80 units on a scale | Standard Deviation 0.4 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: work disabled due to RA | 1.73 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: retired | 1.42 units on a scale | Standard Deviation 0.5 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: sick leave due to RA | 1.93 units on a scale | Standard Deviation 0.26 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24:non-study diagnostic test | 1.86 units on a scale | Standard Deviation 0.35 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: performed part time work | 1.97 units on a scale | Standard Deviation 0.16 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: sick leave due to RA | 1.90 units on a scale | Standard Deviation 0.31 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: performed paid work | 1.72 units on a scale | Standard Deviation 0.45 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: unable to do chores | 1.79 units on a scale | Standard Deviation 0.41 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 24: in nursing home | 1.98 units on a scale | Standard Deviation 0.14 |
| MTX 10, 15, or 20 mg, Weekly | Work Productivity and Healthcare Resource Utilization (HCRU) at Months 12, 18, and 24 | Month 12: chores by housekeeper | 1.96 units on a scale | Standard Deviation 0.19 |