Arthritis, Rheumatoid
Conditions
Keywords
Antirheumatic Agents Clinical Trial
Brief summary
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.
Interventions
DRUGCP-690,550
5mg CP-690,550 BID PO for 6 months
DRUGPlacebo
Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria. * The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory * Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity. * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. * Patient has washed out of all DMARDs other that antimalarials
Exclusion criteria
* Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3.0 x 109/L; 3. Absolute neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/L * History of any other autoimmune rheumatic disease other than Sjogren's syndrome * No malignancy or history of malignancy. * History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | Month 3 | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline, Month 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | Month 3 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Week 2, Month 1, 2, 3 | ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 4, 5, 6 | ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Week 2, Month 1, 2, 3 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 4, 5, 6 | ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline, Month 3 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | Month 6 | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Baseline, Week 2, Month 1, 2, 3 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 4, 5, 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Baseline, Week 2, Month 1, 2, 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 4, 5, 6 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty. |
| Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline, Week 2, Month 1, 2, 3 | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain. |
| Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 4, 5, 6 | Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline, Week 2, Month 1, 2, 3 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4, 5, 6 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. |
| Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline, Week 2, Month 1, 2, 3 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4, 5, 6 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. |
| 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline, Month 3 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. |
| 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. |
| Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline, Month 3 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline, Month 3 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. |
| Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Month 6 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline, Month 3 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | Month 6 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. |
| Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Baseline, Month 3 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 | Month 6 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline, Month 3 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. |
| Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline, Month 3 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of 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 Month 3 | Baseline, Month 3 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends. |
| Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline, Month 3 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Month 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline, Month 3 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline, Month 3 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]). |
| Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]). |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | Month 6 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Week 2, Month 1, 2 | ACR20 response: \>= 20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 4, 5, 6 | ACR20 response: \>= 20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 2 weeks | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain. |
| Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 2 weeks | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. |
Countries
Brazil, Bulgaria, Chile, Colombia, Czechia, Dominican Republic, Germany, India, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Russia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | 243 |
| CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6. | 245 |
| Placebo, Then CP-690,550 5 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | 61 |
| Placebo, Then CP-690,550 10 mg Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination. | 61 |
| Total | 610 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 9 | 3 | 2 |
| Overall Study | Death | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 1 | 1 | 3 | 4 |
| Overall Study | Other | 1 | 2 | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 8 | 1 | 1 |
| Overall Study | Randomized but not treated | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 0 | 2 |
Baseline characteristics
| Characteristic | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg | Total |
|---|---|---|---|---|---|
| Age Continuous | 52.2 Years STANDARD_DEVIATION 11.5 | 52.4 Years STANDARD_DEVIATION 11.7 | 50.7 Years STANDARD_DEVIATION 12.8 | 48.8 Years STANDARD_DEVIATION 11.9 | 51.8 Years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 207 Participants | 216 Participants | 54 Participants | 51 Participants | 528 Participants |
| Sex: Female, Male Male | 36 Participants | 29 Participants | 7 Participants | 10 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 80 / 243 | 84 / 245 | 40 / 122 | 37 / 304 | 48 / 306 |
| serious Total, serious adverse events | 1 / 243 | 5 / 245 | 6 / 122 | 6 / 304 | 6 / 306 |
Outcome results
Primary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n=240,241,122) | 1.53 units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n=237,227,109) | -0.48 units on a scale | Standard Deviation 0.66 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n=240,241,122) | 1.50 units on a scale | Standard Deviation 0.64 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n=237,227,109) | -0.54 units on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n=240,241,122) | 1.53 units on a scale | Standard Deviation 0.65 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n=237,227,109) | -0.18 units on a scale | Standard Deviation 0.61 |
Comparison: p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.p-value: <0.000195% CI: [-0.5, -0.27]Linear mixed effect model
Comparison: p-value was calculated using linear mixed effect model. The fixed effects of treatment, visit, and treatment-by-visit interaction were included, along with participant as random effect.p-value: <0.000195% CI: [-0.43, -0.2]Linear mixed effect model
Primary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Month 3
Population: Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | 59.75 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | 65.70 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | 26.67 percentage of participants |
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.p-value: <0.000195% CI: [29.12, 48.95]Normal approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo.p-value: <0.000195% CI: [23.04, 43.13]Normal approximation
Primary
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.
Time frame: Month 3
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 6.11 percentage of participants |
| CP-690,550 10 mg | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 10.05 percentage of participants |
| Placebo | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 4.81 percentage of participants |
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.p-value: 0.072895% CI: [-0.49, 10.96]Normal Approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690550 to placebo.p-value: 0.619395% CI: [-3.85, 6.46]Normal Approximation
Secondary
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Mental Health (n=235,224,108) | 44.33 units on a scale | Standard Deviation 11.5 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:General health perception(n=239,243,122) | 34.86 units on a scale | Standard Deviation 8.72 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Physical functioning (n=239,243,122) | 30.09 units on a scale | Standard Deviation 9.31 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Bodily Pain (n=235,224,108) | 40.56 units on a scale | Standard Deviation 9.38 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Mental Component (n=239,243,122) | 41.36 units on a scale | Standard Deviation 11.68 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Bodily Pain (n=239,243,122) | 32.41 units on a scale | Standard Deviation 7.57 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Social Functioning(n=235,224,108) | 41.62 units on a scale | Standard Deviation 10.9 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Physical Component (n=239,243,122) | 31.23 units on a scale | Standard Deviation 8.03 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Physical Component (n=233,224,107) | 38.03 units on a scale | Standard Deviation 9.18 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Role Physical (n=233,224,107) | 38.90 units on a scale | Standard Deviation 9.41 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Physical functioning(n=235,224,108) | 36.13 units on a scale | Standard Deviation 10.44 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:General health perception(n=235,224,108) | 39.52 units on a scale | Standard Deviation 9.37 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Mental Health (n=239,243,122) | 40.05 units on a scale | Standard Deviation 11.49 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Mental Component (n=233,224,107) | 45.21 units on a scale | Standard Deviation 11.65 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Vitality (n=235,224,108) | 47.36 units on a scale | Standard Deviation 10.69 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Role Emotional (n=239,243,122) | 34.26 units on a scale | Standard Deviation 12.63 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Social Functioning (n=239,243,122) | 36.78 units on a scale | Standard Deviation 11.04 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Role Emotional (n=233,224,107) | 38.76 units on a scale | Standard Deviation 12.13 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Vitality (n=239,243,122) | 41.22 units on a scale | Standard Deviation 10.06 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Role Physical (n=239,243,122) | 32.84 units on a scale | Standard Deviation 8.87 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:General health perception(n=235,224,108) | 41.50 units on a scale | Standard Deviation 9.78 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Physical functioning (n=239,243,122) | 30.51 units on a scale | Standard Deviation 8.76 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Role Physical (n=239,243,122) | 33.45 units on a scale | Standard Deviation 8.69 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Social Functioning (n=239,243,122) | 36.07 units on a scale | Standard Deviation 11.27 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Bodily Pain (n=239,243,122) | 32.74 units on a scale | Standard Deviation 7.55 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Mental Health (n=239,243,122) | 40.50 units on a scale | Standard Deviation 12.57 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Role Emotional (n=239,243,122) | 36.70 units on a scale | Standard Deviation 13.03 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Vitality (n=239,243,122) | 41.04 units on a scale | Standard Deviation 10.27 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:General health perception(n=239,243,122) | 35.71 units on a scale | Standard Deviation 8.86 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Mental Component (n=239,243,122) | 42.19 units on a scale | Standard Deviation 12.44 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Physical Component (n=239,243,122) | 31.37 units on a scale | Standard Deviation 7.39 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Physical functioning(n=235,224,108) | 37.05 units on a scale | Standard Deviation 10.58 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Role Physical (n=233,224,107) | 40.45 units on a scale | Standard Deviation 9.9 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Social Functioning(n=235,224,108) | 43.25 units on a scale | Standard Deviation 9.95 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Bodily Pain (n=235,224,108) | 43.08 units on a scale | Standard Deviation 9.5 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Mental Health (n=235,224,108) | 45.13 units on a scale | Standard Deviation 11.25 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Role Emotional (n=233,224,107) | 40.84 units on a scale | Standard Deviation 11.57 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Vitality (n=235,224,108) | 49.03 units on a scale | Standard Deviation 9.86 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Mental Component (n=233,224,107) | 46.58 units on a scale | Standard Deviation 10.81 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Physical Component (n=233,224,107) | 39.69 units on a scale | Standard Deviation 9.31 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Role Physical (n=239,243,122) | 33.33 units on a scale | Standard Deviation 8.97 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Bodily Pain (n=235,224,108) | 36.35 units on a scale | Standard Deviation 8.81 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Vitality (n=239,243,122) | 40.13 units on a scale | Standard Deviation 9.82 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Physical Component (n=233,224,107) | 34.58 units on a scale | Standard Deviation 8.94 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Mental Health (n=235,224,108) | 40.73 units on a scale | Standard Deviation 10.73 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Role Emotional (n=239,243,122) | 35.17 units on a scale | Standard Deviation 13.11 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Mental Component (n=233,224,107) | 41.13 units on a scale | Standard Deviation 10.9 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Role Emotional (n=233,224,107) | 36.08 units on a scale | Standard Deviation 12.66 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Mental Health (n=239,243,122) | 38.43 units on a scale | Standard Deviation 12.36 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Physical functioning (n=239,243,122) | 31.41 units on a scale | Standard Deviation 9.66 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Vitality (n=235,224,108) | 42.23 units on a scale | Standard Deviation 9.75 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Bodily Pain (n=239,243,122) | 32.77 units on a scale | Standard Deviation 7.67 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Physical functioning(n=235,224,108) | 32.93 units on a scale | Standard Deviation 10.63 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Physical Component (n=239,243,122) | 32.21 units on a scale | Standard Deviation 8.35 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Social Functioning (n=239,243,122) | 35.16 units on a scale | Standard Deviation 10.34 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Role Physical (n=233,224,107) | 35.19 units on a scale | Standard Deviation 9.72 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:Mental Component (n=239,243,122) | 39.87 units on a scale | Standard Deviation 11.62 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:General health perception(n=235,224,108) | 37.22 units on a scale | Standard Deviation 8.75 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Month 3:Social Functioning(n=235,224,108) | 36.14 units on a scale | Standard Deviation 10.04 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | Baseline:General health perception(n=239,243,122) | 34.70 units on a scale | Standard Deviation 9 |
Secondary
36-Item Short-Form Health Survey (SF-36) at Month 6
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Time frame: Month 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical functioning | 36.99 units on a scale | Standard Deviation 10.07 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Physical | 39.85 units on a scale | Standard Deviation 9.57 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Social Functioning | 42.36 units on a scale | Standard Deviation 10.6 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Bodily Pain | 41.80 units on a scale | Standard Deviation 9.55 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental Health | 43.98 units on a scale | Standard Deviation 12.18 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Emotional | 40.37 units on a scale | Standard Deviation 11.32 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Vitality | 47.47 units on a scale | Standard Deviation 10.58 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | General health perception | 41.05 units on a scale | Standard Deviation 9.24 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental component | 45.43 units on a scale | Standard Deviation 11.58 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical component | 39.24 units on a scale | Standard Deviation 8.42 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Social Functioning | 42.98 units on a scale | Standard Deviation 10.15 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental component | 46.08 units on a scale | Standard Deviation 10.44 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Bodily Pain | 43.67 units on a scale | Standard Deviation 9.54 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental Health | 45.05 units on a scale | Standard Deviation 11.01 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Emotional | 41.03 units on a scale | Standard Deviation 11.47 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Vitality | 48.89 units on a scale | Standard Deviation 10.29 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical component | 40.89 units on a scale | Standard Deviation 9.04 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | General health perception | 42.58 units on a scale | Standard Deviation 9.84 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical functioning | 38.43 units on a scale | Standard Deviation 10.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Physical | 40.93 units on a scale | Standard Deviation 9.5 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | General health perception | 38.99 units on a scale | Standard Deviation 8.73 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Vitality | 45.08 units on a scale | Standard Deviation 9.5 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical component | 37.89 units on a scale | Standard Deviation 9.56 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical functioning | 35.74 units on a scale | Standard Deviation 10.23 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Bodily Pain | 40.80 units on a scale | Standard Deviation 9.36 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Emotional | 39.04 units on a scale | Standard Deviation 12.93 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental component | 43.29 units on a scale | Standard Deviation 12.37 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Physical | 38.25 units on a scale | Standard Deviation 9.73 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental Health | 42.14 units on a scale | Standard Deviation 11.9 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Social Functioning | 39.57 units on a scale | Standard Deviation 11.45 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental Health | 47.03 units on a scale | Standard Deviation 10.62 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | General health perception | 40.42 units on a scale | Standard Deviation 10.83 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Emotional | 42.66 units on a scale | Standard Deviation 12.1 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical component | 37.06 units on a scale | Standard Deviation 9.14 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Vitality | 47.88 units on a scale | Standard Deviation 9.19 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Role Physical | 38.97 units on a scale | Standard Deviation 9.06 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Social Functioning | 43.39 units on a scale | Standard Deviation 9.78 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Bodily Pain | 42.19 units on a scale | Standard Deviation 9.46 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Physical functioning | 35.26 units on a scale | Standard Deviation 9.98 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Mental component | 48.76 units on a scale | Standard Deviation 11.06 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Week 2, Month 1, 2, 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 238, 233, 109) | 4.02 units on a scale | Standard Deviation 1.26 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 236, 115) | 4.41 units on a scale | Standard Deviation 1.12 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 239, 242, 121) | 5.68 units on a scale | Standard Deviation 0.9 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 234, 231, 118) | 4.79 units on a scale | Standard Deviation 1.12 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 3.89 units on a scale | Standard Deviation 1.27 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 236, 115) | 3.99 units on a scale | Standard Deviation 1.26 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 239, 242, 121) | 5.60 units on a scale | Standard Deviation 0.91 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 234, 231, 118) | 4.42 units on a scale | Standard Deviation 1.11 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 238, 233, 109) | 3.64 units on a scale | Standard Deviation 1.27 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 3.59 units on a scale | Standard Deviation 1.27 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 4.68 units on a scale | Standard Deviation 1.27 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 238, 233, 109) | 4.85 units on a scale | Standard Deviation 1.36 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 239, 242, 121) | 5.56 units on a scale | Standard Deviation 0.85 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 236, 115) | 4.98 units on a scale | Standard Deviation 1.25 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 234, 231, 118) | 5.30 units on a scale | Standard Deviation 1.13 |
Secondary
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Month 4, 5, 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 4 (n= 235, 222, 54, 48) | 3.65 units on a scale | Standard Deviation 1.24 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 6 (n= 228, 215, 53, 50) | 3.48 units on a scale | Standard Deviation 1.23 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 5 (n= 231, 219, 55, 50) | 3.54 units on a scale | Standard Deviation 1.26 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 4 (n= 235, 222, 54, 48) | 3.26 units on a scale | Standard Deviation 1.22 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 6 (n= 228, 215, 53, 50) | 3.11 units on a scale | Standard Deviation 1.26 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 5 (n= 231, 219, 55, 50) | 3.12 units on a scale | Standard Deviation 1.24 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 5 (n= 231, 219, 55, 50) | 3.53 units on a scale | Standard Deviation 1.25 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 4 (n= 235, 222, 54, 48) | 3.89 units on a scale | Standard Deviation 1.19 |
| Placebo | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 6 (n= 228, 215, 53, 50) | 3.56 units on a scale | Standard Deviation 1.32 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 4 (n= 235, 222, 54, 48) | 3.50 units on a scale | Standard Deviation 1.28 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 6 (n= 228, 215, 53, 50) | 3.12 units on a scale | Standard Deviation 1.34 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | Month 5 (n= 231, 219, 55, 50) | 3.34 units on a scale | Standard Deviation 1.26 |
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline (n= 236, 234, 115) | 6.71 units on a scale | Standard Deviation 0.93 |
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Month 3 (n= 229, 219, 104) | 4.78 units on a scale | Standard Deviation 1.37 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline (n= 236, 234, 115) | 6.70 units on a scale | Standard Deviation 0.94 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Month 3 (n= 229, 219, 104) | 4.55 units on a scale | Standard Deviation 1.39 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline (n= 236, 234, 115) | 6.65 units on a scale | Standard Deviation 0.93 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Month 3 (n= 229, 219, 104) | 5.54 units on a scale | Standard Deviation 1.46 |
Secondary
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.
Time frame: Month 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 4.33 units on a scale | Standard Deviation 1.39 |
| CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 4.01 units on a scale | Standard Deviation 1.38 |
| Placebo | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 4.31 units on a scale | Standard Deviation 1.34 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 3.98 units on a scale | Standard Deviation 1.5 |
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Baseline (n= 240, 243, 122) | 0.41 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Month 3 (n= 237, 227, 108) | 0.60 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Baseline (n= 240, 243, 122) | 0.39 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Month 3 (n= 237, 227, 108) | 0.66 units on a scale | Standard Deviation 0.23 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Baseline (n= 240, 243, 122) | 0.42 units on a scale | Standard Deviation 0.31 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | Month 3 (n= 237, 227, 108) | 0.51 units on a scale | Standard Deviation 0.31 |
Secondary
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Month 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 | 0.63 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 | 0.68 units on a scale | Standard Deviation 0.22 |
| Placebo | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 | 0.58 units on a scale | Standard Deviation 0.29 |
| Placebo, Then CP-690,550 10 mg | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 | 0.65 units on a scale | Standard Deviation 0.21 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline (n= 240, 243, 122) | 27.90 units on a scale | Standard Deviation 10.7 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Month 3 (n= 237, 227, 109) | 34.40 units on a scale | Standard Deviation 10.65 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline (n= 240, 243, 122) | 27.72 units on a scale | Standard Deviation 11.15 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Month 3 (n= 237, 227, 109) | 35.42 units on a scale | Standard Deviation 9.75 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline (n= 240, 243, 122) | 27.17 units on a scale | Standard Deviation 10.88 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Month 3 (n= 237, 227, 109) | 30.06 units on a scale | Standard Deviation 10.87 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Time frame: Month 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 34.58 units on a scale | Standard Deviation 10.69 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 36.30 units on a scale | Standard Deviation 10.1 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 33.63 units on a scale | Standard Deviation 9.29 |
| Placebo, Then CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 36.46 units on a scale | Standard Deviation 9.27 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Time frame: Baseline, Week 2, Month 1, 2, 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 240, 241, 122) | 1.53 units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 1.05 units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 1.18 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 1.05 units on a scale | Standard Deviation 0.7 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 240, 239, 119) | 1.27 units on a scale | Standard Deviation 0.62 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 0.97 units on a scale | Standard Deviation 0.68 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 240, 241, 122) | 1.50 units on a scale | Standard Deviation 0.64 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 240, 239, 119) | 1.21 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 1.09 units on a scale | Standard Deviation 0.66 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 0.97 units on a scale | Standard Deviation 0.69 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 240, 239, 119) | 1.43 units on a scale | Standard Deviation 0.64 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 1.40 units on a scale | Standard Deviation 0.68 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 240, 241, 122) | 1.53 units on a scale | Standard Deviation 0.65 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 1.35 units on a scale | Standard Deviation 0.73 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 1.40 units on a scale | Standard Deviation 0.64 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Time frame: Month 4, 5, 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 0.97 units on a scale | Standard Deviation 0.66 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 0.94 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 0.95 units on a scale | Standard Deviation 0.69 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 0.88 units on a scale | Standard Deviation 0.68 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 0.86 units on a scale | Standard Deviation 0.67 |
| CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 0.87 units on a scale | Standard Deviation 0.69 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 1.04 units on a scale | Standard Deviation 0.59 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 1.08 units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 1.05 units on a scale | Standard Deviation 0.63 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 1.09 units on a scale | Standard Deviation 0.65 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 1.00 units on a scale | Standard Deviation 0.66 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 1.03 units on a scale | Standard Deviation 0.64 |
Secondary
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:adequacy(n=236,229,109) | 51.69 units on a scale | Standard Deviation 28.77 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:snoring(n=236,229,109) | 32.63 units on a scale | Standard Deviation 29.61 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:adequacy(n=239,243,122) | 45.44 units on a scale | Standard Deviation 27.25 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:sleep disturbance(n=236,229,109) | 36.58 units on a scale | Standard Deviation 24.67 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:somnolence(n=236,229,109) | 30.28 units on a scale | Standard Deviation 21.28 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:overall sleep problem(n=236,228,109) | 35.53 units on a scale | Standard Deviation 19.3 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:sleep problem summary(n=239,242,122) | 40.59 units on a scale | Standard Deviation 18.98 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:sleep problem summary(n=236,228,109) | 34.46 units on a scale | Standard Deviation 19.89 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:awaken short of breath(n=236,228,109) | 15.93 units on a scale | Standard Deviation 21.29 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:quantity(n=237,228,109) | 6.77 units on a scale | Standard Deviation 1.63 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:somnolence(n=239,243,122) | 37.21 units on a scale | Standard Deviation 22.47 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:sleep disturbance(n=238,242,122) | 44.44 units on a scale | Standard Deviation 24.11 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:quantity(n=240,243,122) | 6.53 units on a scale | Standard Deviation 1.56 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:overall sleep problem(n=238,242,122) | 42.45 units on a scale | Standard Deviation 18.38 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:snoring(n=238,243,121) | 35.71 units on a scale | Standard Deviation 31.07 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:awaken short of breath(n=239,243,122) | 18.16 units on a scale | Standard Deviation 23.76 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:quantity(n=240,243,122) | 6.38 units on a scale | Standard Deviation 1.63 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:overall sleep problem(n=238,242,122) | 43.09 units on a scale | Standard Deviation 20.41 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:sleep problem summary(n=239,242,122) | 42.38 units on a scale | Standard Deviation 21.01 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:somnolence(n=239,243,122) | 37.64 units on a scale | Standard Deviation 21.76 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:sleep disturbance(n=238,242,122) | 43.33 units on a scale | Standard Deviation 26.18 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:awaken short of breath(n=239,243,122) | 20.91 units on a scale | Standard Deviation 25.47 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:adequacy(n=239,243,122) | 42.63 units on a scale | Standard Deviation 27.37 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:overall sleep problem(n=236,228,109) | 33.29 units on a scale | Standard Deviation 19.96 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:sleep problem summary(n=236,228,109) | 33.25 units on a scale | Standard Deviation 20.16 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:somnolence(n=236,229,109) | 30.45 units on a scale | Standard Deviation 21.26 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:snoring(n=236,229,109) | 25.85 units on a scale | Standard Deviation 27.57 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:snoring(n=238,243,121) | 30.29 units on a scale | Standard Deviation 30.5 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:quantity(n=237,228,109) | 6.89 units on a scale | Standard Deviation 1.45 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:sleep disturbance(n=236,229,109) | 32.58 units on a scale | Standard Deviation 24.27 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:awaken short of breath(n=236,228,109) | 16.23 units on a scale | Standard Deviation 21.69 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:adequacy(n=236,229,109) | 52.93 units on a scale | Standard Deviation 27.75 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:adequacy(n=236,229,109) | 44.40 units on a scale | Standard Deviation 27.67 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:snoring(n=238,243,121) | 30.25 units on a scale | Standard Deviation 31.42 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:somnolence(n=239,243,122) | 36.56 units on a scale | Standard Deviation 21.29 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:sleep problem summary(n=236,228,109) | 40.55 units on a scale | Standard Deviation 22.02 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:snoring(n=236,229,109) | 27.52 units on a scale | Standard Deviation 29.79 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:sleep problem summary(n=239,242,122) | 45.98 units on a scale | Standard Deviation 21.85 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:awaken short of breath(n=236,228,109) | 22.20 units on a scale | Standard Deviation 24.99 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:quantity(n=237,228,109) | 6.78 units on a scale | Standard Deviation 1.47 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:overall sleep problem(n=236,228,109) | 41.13 units on a scale | Standard Deviation 21.31 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:overall sleep problem(n=238,242,122) | 47.32 units on a scale | Standard Deviation 21.24 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:adequacy(n=239,243,122) | 40.08 units on a scale | Standard Deviation 28.36 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:sleep disturbance(n=236,229,109) | 41.16 units on a scale | Standard Deviation 27.4 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3:somnolence(n=236,229,109) | 35.66 units on a scale | Standard Deviation 23.01 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:awaken short of breath(n=239,243,122) | 24.92 units on a scale | Standard Deviation 29.35 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:quantity(n=240,243,122) | 6.37 units on a scale | Standard Deviation 1.74 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline:sleep disturbance(n=238,242,122) | 51.27 units on a scale | Standard Deviation 25.89 |
Secondary
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute.
Time frame: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Awaken short of breath | 15.55 units on a scale | Standard Deviation 21.67 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep disturbance | 35.75 units on a scale | Standard Deviation 25.11 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep problem summary | 35.17 units on a scale | Standard Deviation 18.81 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Adequacy(n=229,214,54,50) | 48.52 units on a scale | Standard Deviation 27.41 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Somnolence | 30.26 units on a scale | Standard Deviation 21.01 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Snoring | 35.28 units on a scale | Standard Deviation 31.04 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Overall sleep problem | 35.68 units on a scale | Standard Deviation 18.8 |
| CP-690,550 5 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Quantity | 6.64 units on a scale | Standard Deviation 1.45 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Snoring | 27.79 units on a scale | Standard Deviation 28.24 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Quantity | 6.87 units on a scale | Standard Deviation 1.71 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Adequacy(n=229,214,54,50) | 53.04 units on a scale | Standard Deviation 29.14 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep disturbance | 33.38 units on a scale | Standard Deviation 23.91 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Somnolence | 29.42 units on a scale | Standard Deviation 20.64 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Overall sleep problem | 33.33 units on a scale | Standard Deviation 19.19 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep problem summary | 33.33 units on a scale | Standard Deviation 19.66 |
| CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Awaken short of breath | 15.70 units on a scale | Standard Deviation 21.41 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep problem summary | 37.41 units on a scale | Standard Deviation 20.3 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Overall sleep problem | 37.29 units on a scale | Standard Deviation 19.26 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Somnolence | 31.36 units on a scale | Standard Deviation 19.75 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Snoring | 26.30 units on a scale | Standard Deviation 28.5 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Quantity | 6.65 units on a scale | Standard Deviation 1.52 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep disturbance | 37.80 units on a scale | Standard Deviation 23.96 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Awaken short of breath | 21.11 units on a scale | Standard Deviation 21.43 |
| Placebo | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Adequacy(n=229,214,54,50) | 49.44 units on a scale | Standard Deviation 29.36 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Snoring | 29.20 units on a scale | Standard Deviation 27.47 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Somnolence | 29.60 units on a scale | Standard Deviation 21.56 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Adequacy(n=229,214,54,50) | 49.00 units on a scale | Standard Deviation 27.94 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Awaken short of breath | 23.20 units on a scale | Standard Deviation 25.67 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep problem summary | 35.87 units on a scale | Standard Deviation 20.8 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Quantity | 6.64 units on a scale | Standard Deviation 1.27 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Overall sleep problem | 35.64 units on a scale | Standard Deviation 21.2 |
| Placebo, Then CP-690,550 10 mg | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Sleep disturbance | 33.80 units on a scale | Standard Deviation 25.83 |
Secondary
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days of work per week(n=68,79,41) | 5.00 days | Standard Deviation 0.93 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Paid work, bothered by RA(n=69,68,37) | 33.87 days | Standard Deviation 31.01 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospital length of stay(n=14,19,7) | 15.43 days | Standard Deviation 12.33 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related aids used(n=27,20,14) | 1.81 days | Standard Deviation 1.36 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Chores by housekeeper(n=33,43,22) | 17.30 days | Standard Deviation 24.67 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related aids used(n=38,31,20) | 2.21 days | Standard Deviation 1.47 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days devices/aids used(n=27,20,14) | 109.93 days | Standard Deviation 107.85 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Chores by family(n=139,131,84) | 29.54 days | Standard Deviation 31.72 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Chores by family(n=81,82,55) | 25.72 days | Standard Deviation 31.12 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days in nursing home(n=0,1,1) | NA days | — |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospital length of stay(n=2,6,2) | 7.50 days | Standard Deviation 6.36 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Paid work, bothered by RA(n=44,44,30) | 21.70 days | Standard Deviation 26.22 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days of work per week(n=72,84,43) | 5.08 days | Standard Deviation 1.04 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Chores by housekeeper(n=26,19,23) | 7.73 days | Standard Deviation 8.43 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days of part time work(n=10,11,9) | 12.70 days | Standard Deviation 20.97 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days on sick leave(n=33,34,25) | 25.12 days | Standard Deviation 33.23 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days devices/aids used(n=37,31,20) | 118.95 days | Standard Deviation 134.74 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days on sick leave(n=13,17,10) | 15.00 days | Standard Deviation 23.59 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days of part time work(n=20,25,12) | 15.65 days | Standard Deviation 22.74 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days in nursing home(n=4,2,1) | 23.25 days | Standard Deviation 2.63 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Paid work, bothered by RA(n=44,44,30) | 19.39 days | Standard Deviation 23.1 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospital length of stay(n=14,19,7) | 9.63 days | Standard Deviation 7.27 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days in nursing home(n=4,2,1) | 16.50 days | Standard Deviation 6.36 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days devices/aids used(n=37,31,20) | 85.52 days | Standard Deviation 95.38 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related aids used(n=38,31,20) | 1.90 days | Standard Deviation 1.33 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days of work per week(n=72,84,43) | 4.92 days | Standard Deviation 1.17 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days on sick leave(n=33,34,25) | 10.91 days | Standard Deviation 18.15 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days of part time work(n=20,25,12) | 20.44 days | Standard Deviation 26.71 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Paid work, bothered by RA(n=69,68,37) | 28.15 days | Standard Deviation 29.06 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Chores by housekeeper(n=33,43,22) | 16.63 days | Standard Deviation 25.99 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Chores by family(n=139,131,84) | 27.85 days | Standard Deviation 34.8 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospital length of stay(n=2,6,2) | 6.33 days | Standard Deviation 7.12 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days in nursing home(n=0,1,1) | 2.0 days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days devices/aids used(n=27,20,14) | 89.50 days | Standard Deviation 89.98 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related aids used(n=27,20,14) | 1.50 days | Standard Deviation 0.95 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days of work per week(n=68,79,41) | 5.05 days | Standard Deviation 1.19 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days on sick leave(n=13,17,10) | 14.82 days | Standard Deviation 23.32 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days of part time work(n=10,11,9) | 19.09 days | Standard Deviation 25.07 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Chores by housekeeper(n=26,19,23) | 6.32 days | Standard Deviation 5.73 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Chores by family(n=81,82,55) | 27.29 days | Standard Deviation 33.02 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days in nursing home(n=4,2,1) | 10.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related aids used(n=27,20,14) | 1.93 days | Standard Deviation 1.21 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days of part time work(n=20,25,12) | 12.42 days | Standard Deviation 10.57 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Chores by family(n=81,82,55) | 27.00 days | Standard Deviation 30.37 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days of work per week(n=68,79,41) | 4.88 days | Standard Deviation 1.17 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days on sick leave(n=33,34,25) | 22.40 days | Standard Deviation 29.72 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Chores by housekeeper(n=26,19,23) | 18.13 days | Standard Deviation 25.19 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days on sick leave(n=13,17,10) | 19.60 days | Standard Deviation 27.68 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days of work per week(n=72,84,43) | 5.02 days | Standard Deviation 0.96 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospital length of stay(n=14,19,7) | 4.29 days | Standard Deviation 2.81 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days of part time work(n=10,11,9) | 6.22 days | Standard Deviation 5.7 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related aids used(n=38,31,20) | 1.45 days | Standard Deviation 0.69 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospital length of stay(n=2,6,2) | 12.00 days | Standard Deviation 2.83 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Chores by family(n=139,131,84) | 22.12 days | Standard Deviation 27.36 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Days devices/aids used(n=37,31,20) | 55.90 days | Standard Deviation 56.66 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days in nursing home(n=0,1,1) | 10.0 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Chores by housekeeper(n=33,43,22) | 14.55 days | Standard Deviation 22.32 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Paid work, bothered by RA(n=44,44,30) | 26.50 days | Standard Deviation 27.03 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Days devices/aids used(n=27,20,14) | 94.68 days | Standard Deviation 111.05 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Paid work, bothered by RA(n=69,68,37) | 38.30 days | Standard Deviation 27.52 |
Secondary
Number of Days as Assessed Using RA-HCRU at Month 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: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Paid work, bothered by RA(n=34,32,14,12) | 21.09 days | Standard Deviation 25.89 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days devices/aids used(n=24,13,6,4) | 97.17 days | Standard Deviation 116.84 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 20.38 days | Standard Deviation 27.42 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of work per week(n=65,75,22,21) | 4.95 days | Standard Deviation 0.84 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | RA related aids used(n=25,12,6,4) | 1.48 days | Standard Deviation 1.23 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=25,13,8,1) | 16.32 days | Standard Deviation 24.4 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of part time work(n=11,6,3,2) | 15.00 days | Standard Deviation 25.46 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days in nursing home(n=1,1,0,0) | 24.00 days | — |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Hospital length of stay(n=5,3,2,2) | 13.60 days | Standard Deviation 18.28 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days on sick leave(n=10,10,3,2) | 21.10 days | Standard Deviation 27.23 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of work per week(n=65,75,22,21) | 5.16 days | Standard Deviation 0.99 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Paid work, bothered by RA(n=34,32,14,12) | 12.72 days | Standard Deviation 17.5 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Hospital length of stay(n=5,3,2,2) | 7.67 days | Standard Deviation 5.86 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days in nursing home(n=1,1,0,0) | 15.00 days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days devices/aids used(n=24,13,6,4) | 53.85 days | Standard Deviation 52.29 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | RA related aids used(n=25,12,6,4) | 1.67 days | Standard Deviation 0.98 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days on sick leave(n=10,10,3,2) | 15.50 days | Standard Deviation 27.71 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of part time work(n=11,6,3,2) | 8.50 days | Standard Deviation 5.68 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=25,13,8,1) | 20.23 days | Standard Deviation 31.76 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 28.09 days | Standard Deviation 32.55 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Days on sick leave(n=10,10,3,2) | 9.00 days | Standard Deviation 5.2 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of work per week(n=65,75,22,21) | 5.09 days | Standard Deviation 1.15 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Hospital length of stay(n=5,3,2,2) | 13.50 days | Standard Deviation 14.85 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 11.58 days | Standard Deviation 18.35 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=25,13,8,1) | 8.50 days | Standard Deviation 11.78 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Days in nursing home(n=1,1,0,0) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Paid work, bothered by RA(n=34,32,14,12) | 26.14 days | Standard Deviation 29.98 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | RA related aids used(n=25,12,6,4) | 2.17 days | Standard Deviation 1.83 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of part time work(n=11,6,3,2) | 5.00 days | Standard Deviation 3 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Days devices/aids used(n=24,13,6,4) | 101.50 days | Standard Deviation 106.85 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of part time work(n=11,6,3,2) | 4.00 days | Standard Deviation 4.24 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days of work per week(n=65,75,22,21) | 4.71 days | Standard Deviation 1.19 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days on sick leave(n=10,10,3,2) | 47.50 days | Standard Deviation 60.1 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Hospital length of stay(n=5,3,2,2) | 1.50 days | Standard Deviation 0.71 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 27.38 days | Standard Deviation 30.61 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days in nursing home(n=1,1,0,0) | NA days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Paid work, bothered by RA(n=34,32,14,12) | 15.92 days | Standard Deviation 18.8 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Days devices/aids used(n=24,13,6,4) | 72.25 days | Standard Deviation 113.1 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=25,13,8,1) | 90.00 days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | RA related aids used(n=25,12,6,4) | 1.75 days | Standard Deviation 0.96 |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Outpatient surgery(n=6,11,2) | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related doctor visit (n=192,205,100) | 1.26 events | Standard Deviation 0.81 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospital ER visit(n=13,18,10) | 1.15 events | Standard Deviation 0.38 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related ER visit(n=12,18,10) | 0.75 events | Standard Deviation 0.75 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospitalization(n=14,19,7) | 1.07 events | Standard Deviation 0.27 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related hospitalization(n=14,19,8) | 1.00 events | Standard Deviation 0.55 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Doctor visit(n=193,204,102) | 4.38 events | Standard Deviation 4.5 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related outpatient surgery(n=6,11,3) | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Non-study diagnostic test(n=39,51,17) | 1.69 events | Standard Deviation 1.22 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related diagnostic test(n=41,52,19) | 0.61 events | Standard Deviation 0.67 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Non-medical practitioner visit(n=8,2,2) | 12.00 events | Standard Deviation 12.99 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related non-medical visit(n=8,2,2) | 1.13 events | Standard Deviation 0.64 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Doctor visit(n=141,137,66) | 3.60 events | Standard Deviation 2.4 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related doctor visit(n=142,138,66) | 0.83 events | Standard Deviation 0.67 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospital ER visit(n=14,14,8) | 1.21 events | Standard Deviation 0.8 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related ER visit(n=14,13,8) | 0.14 events | Standard Deviation 0.53 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospitalization(n=2,6,2) | 1.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related hospitalization(n=2,7,2) | 0.50 events | Standard Deviation 0.71 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Outpatient surgery(n=7,5,2) | 1.14 events | Standard Deviation 0.38 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related outpatient surgery(n=7,5,2) | 0.29 events | Standard Deviation 0.76 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Non-study diagnostic test(n=27,25,13) | 1.26 events | Standard Deviation 0.81 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related diagnostic test(n=30,26,14) | 0.13 events | Standard Deviation 0.35 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Non-medical practitioner visit(n=4,1,0) | 10.75 events | Standard Deviation 6.99 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related non-medical visit(n=4,1,0) | 0.25 events | Standard Deviation 0.5 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related diagnostic test(n=30,26,14) | 0.15 events | Standard Deviation 0.37 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Doctor visit(n=193,204,102) | 3.85 events | Standard Deviation 4.07 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Doctor visit(n=141,137,66) | 3.64 events | Standard Deviation 3.44 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospitalization(n=2,6,2) | 1.17 events | Standard Deviation 0.41 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related doctor visit (n=192,205,100) | 1.18 events | Standard Deviation 0.85 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Non-medical practitioner visit(n=8,2,2) | 7.00 events | Standard Deviation 7.07 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Non-study diagnostic test(n=27,25,13) | 1.60 events | Standard Deviation 0.82 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospital ER visit(n=13,18,10) | 1.61 events | Standard Deviation 1.29 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related doctor visit(n=142,138,66) | 0.81 events | Standard Deviation 0.81 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Non-medical practitioner visit(n=4,1,0) | 7.00 events | — |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related ER visit(n=12,18,10) | 0.50 events | Standard Deviation 0.62 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related diagnostic test(n=41,52,19) | 0.83 events | Standard Deviation 0.94 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related hospitalization(n=2,7,2) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospitalization(n=14,19,7) | 1.11 events | Standard Deviation 0.32 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospital ER visit(n=14,14,8) | 1.29 events | Standard Deviation 0.47 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related non-medical visit(n=8,2,2) | 1.50 events | Standard Deviation 0.71 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related hospitalization(n=14,19,8) | 0.84 events | Standard Deviation 0.6 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Non-study diagnostic test(n=39,51,17) | 1.94 events | Standard Deviation 1.22 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related non-medical visit(n=4,1,0) | 2.00 events | — |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Outpatient surgery(n=6,11,2) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related ER visit(n=14,13,8) | 0.15 events | Standard Deviation 0.55 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Outpatient surgery(n=7,5,2) | 1.60 events | Standard Deviation 0.89 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related outpatient surgery(n=6,11,3) | 0.55 events | Standard Deviation 0.82 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related outpatient surgery(n=7,5,2) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related outpatient surgery(n=6,11,3) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Non-study diagnostic test(n=39,51,17) | 1.59 events | Standard Deviation 1.06 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related diagnostic test(n=41,52,19) | 0.95 events | Standard Deviation 0.97 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Non-medical practitioner visit(n=8,2,2) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related outpatient surgery(n=7,5,2) | 1.00 events | Standard Deviation 1.41 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related non-medical visit(n=8,2,2) | 0.50 events | Standard Deviation 0.71 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Non-medical practitioner visit(n=4,1,0) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Doctor visit(n=141,137,66) | 4.00 events | Standard Deviation 3.12 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related doctor visit(n=142,138,66) | 0.92 events | Standard Deviation 0.81 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Non-study diagnostic test(n=27,25,13) | 1.54 events | Standard Deviation 0.78 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospital ER visit(n=14,14,8) | 1.50 events | Standard Deviation 0.76 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related non-medical visit(n=4,1,0) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related ER visit(n=14,13,8) | 0.25 events | Standard Deviation 0.46 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Doctor visit(n=193,204,102) | 3.56 events | Standard Deviation 2.73 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related doctor visit (n=192,205,100) | 1.33 events | Standard Deviation 0.89 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Hospitalization(n=2,6,2) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospital ER visit(n=13,18,10) | 1.40 events | Standard Deviation 0.7 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related diagnostic test(n=30,26,14) | 0.21 events | Standard Deviation 0.43 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related ER visit(n=12,18,10) | 0.80 events | Standard Deviation 0.92 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Hospitalization(n=14,19,7) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related hospitalization(n=2,7,2) | 0.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:RA related hospitalization(n=14,19,8) | 0.88 events | Standard Deviation 0.64 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline:Outpatient surgery(n=6,11,2) | 1.00 events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:Outpatient surgery(n=7,5,2) | 1.00 events | Standard Deviation 0 |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related diagnostic test(n=29,34,6,6) | 0.45 events | Standard Deviation 0.87 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related non-medical visit(n=0,2,0,0) | NA events | — |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related outpatient surgery(n=3,12,0,2) | 0.00 events | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Doctor visit(n=159,152,39,36) | 3.22 events | Standard Deviation 2.54 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-study diagnostic test(n=24,33,7,5) | 2.04 events | Standard Deviation 1.55 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospital ER visit(n=16,13,3,2) | 1.06 events | Standard Deviation 0.25 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related ER visit(n=16,12,3,2) | 0.13 events | Standard Deviation 0.34 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related doctor visit(n=159,152,39,36) | 0.92 events | Standard Deviation 0.7 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-medical practitioner visit(n=0,2,0,0) | NA events | — |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospitalization(n=5,3,2,2) | 1.20 events | Standard Deviation 0.45 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related hospitalization(n=5,3,2,2) | 0.20 events | Standard Deviation 0.45 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Outpatient surgery(n=3,10,0,2) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related doctor visit(n=159,152,39,36) | 0.83 events | Standard Deviation 0.73 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Outpatient surgery(n=3,10,0,2) | 1.50 events | Standard Deviation 1.58 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related ER visit(n=16,12,3,2) | 0.08 events | Standard Deviation 0.28 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-study diagnostic test(n=24,33,7,5) | 1.39 events | Standard Deviation 0.75 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related diagnostic test(n=29,34,6,6) | 0.29 events | Standard Deviation 0.52 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related outpatient surgery(n=3,12,0,2) | 0.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Doctor visit(n=159,152,39,36) | 3.69 events | Standard Deviation 3.18 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related hospitalization(n=5,3,2,2) | 0.33 events | Standard Deviation 0.58 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospitalization(n=5,3,2,2) | 1.00 events | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospital ER visit(n=16,13,3,2) | 1.25 events | Standard Deviation 0.45 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related non-medical visit(n=0,2,0,0) | 0.50 events | Standard Deviation 0.71 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-medical practitioner visit(n=0,2,0,0) | 3.00 events | Standard Deviation 1.41 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related outpatient surgery(n=3,12,0,2) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Doctor visit(n=159,152,39,36) | 3.00 events | Standard Deviation 2.29 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related doctor visit(n=159,152,39,36) | 1.05 events | Standard Deviation 0.6 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospital ER visit(n=16,13,3,2) | 3.00 events | Standard Deviation 1.73 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related ER visit(n=16,12,3,2) | 1.67 events | Standard Deviation 2.08 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospitalization(n=5,3,2,2) | 1.50 events | Standard Deviation 0.71 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related hospitalization(n=5,3,2,2) | 0.50 events | Standard Deviation 0.71 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Outpatient surgery(n=3,10,0,2) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-study diagnostic test(n=24,33,7,5) | 2.57 events | Standard Deviation 1.62 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related diagnostic test(n=29,34,6,6) | 0.67 events | Standard Deviation 0.82 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-medical practitioner visit(n=0,2,0,0) | NA events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related non-medical visit(n=0,2,0,0) | NA events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related hospitalization(n=5,3,2,2) | 0.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospitalization(n=5,3,2,2) | 1.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Doctor visit(n=159,152,39,36) | 3.69 events | Standard Deviation 2.25 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related diagnostic test(n=29,34,6,6) | 0.33 events | Standard Deviation 0.52 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related ER visit(n=16,12,3,2) | 0.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Hospital ER visit(n=16,13,3,2) | 1.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related non-medical visit(n=0,2,0,0) | NA events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-medical practitioner visit(n=0,2,0,0) | NA events | — |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related outpatient surgery(n=3,12,0,2) | 0.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Outpatient surgery(n=3,10,0,2) | 1.00 events | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA related doctor visit(n=159,152,39,36) | 0.92 events | Standard Deviation 0.69 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Non-study diagnostic test(n=24,33,7,5) | 1.20 events | Standard Deviation 0.45 |
Secondary
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Home healthcare services(n=1,4,1) | 2.00 hours per day | — |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:RA related home HC services(n=2,4,1) | 1.50 hours per day | Standard Deviation 0.71 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Work done(n=71,85,43) | 7.66 hours per day | Standard Deviation 1.87 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Missed work due to RA(n=19,25,12) | 3.47 hours per day | Standard Deviation 2.67 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Chores by housekeeper(n=33,43,22) | 5.64 hours per day | Standard Deviation 4.06 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Chores by family(n=139,131,82) | 3.99 hours per day | Standard Deviation 4.02 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Home healthcare services(n=2,0,1) | 2.50 hours per day | Standard Deviation 2.12 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:RA related home HC services(n=2,0,1) | 0.50 hours per day | Standard Deviation 0.71 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Work done(n=66,79,41) | 8.20 hours per day | Standard Deviation 7.28 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Missed work due to RA(n=10,9,9) | 2.20 hours per day | Standard Deviation 1.55 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Chores by housekeeper(n=27,19,23) | 5.74 hours per day | Standard Deviation 4.7 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Chores by family(n=79,82,54) | 3.09 hours per day | Standard Deviation 1.96 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Chores by family(n=79,82,54) | 3.82 hours per day | Standard Deviation 6.91 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Home healthcare services(n=1,4,1) | 3.75 hours per day | Standard Deviation 5.5 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Home healthcare services(n=2,0,1) | NA hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Work done(n=66,79,41) | 7.68 hours per day | Standard Deviation 2.37 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:RA related home HC services(n=2,4,1) | 2.25 hours per day | Standard Deviation 2.5 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Chores by family(n=139,131,82) | 3.32 hours per day | Standard Deviation 2.89 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Chores by housekeeper(n=27,19,23) | 5.21 hours per day | Standard Deviation 4.89 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Work done(n=71,85,43) | 8.60 hours per day | Standard Deviation 6.12 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:RA related home HC services(n=2,0,1) | NA hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Chores by housekeeper(n=33,43,22) | 4.67 hours per day | Standard Deviation 2.07 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Missed work due to RA(n=19,25,12) | 10.84 hours per day | Standard Deviation 24.54 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Missed work due to RA(n=10,9,9) | 3.67 hours per day | Standard Deviation 1.41 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Missed work due to RA(n=19,25,12) | 6.17 hours per day | Standard Deviation 12.29 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Chores by housekeeper(n=33,43,22) | 5.86 hours per day | Standard Deviation 3.06 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Missed work due to RA(n=10,9,9) | 9.56 hours per day | Standard Deviation 19.04 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Chores by family(n=139,131,82) | 4.85 hours per day | Standard Deviation 6.88 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Home healthcare services(n=2,0,1) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:RA related home HC services(n=2,0,1) | 0.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Chores by housekeeper(n=27,19,23) | 5.91 hours per day | Standard Deviation 4.75 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Home healthcare services(n=1,4,1) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:RA related home HC services(n=2,4,1) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Work done(n=66,79,41) | 8.85 hours per day | Standard Deviation 5.34 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline:Work done(n=71,85,43) | 8.95 hours per day | Standard Deviation 5.2 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3:Chores by family(n=79,82,54) | 3.69 hours per day | Standard Deviation 3.82 |
Secondary
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
Time frame: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Home healthcare services(n=3,1,1,1) | 4.00 hours per day | Standard Deviation 1 |
| CP-690,550 5 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | RA related home healthcare services(3,1,2,1) | 1.00 hours per day | Standard Deviation 1 |
| CP-690,550 5 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Work done(n=65,75,22,21) | 8.38 hours per day | Standard Deviation 5.53 |
| CP-690,550 5 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Missed work due to RA(n=11,7,3,2) | 2.73 hours per day | Standard Deviation 2.53 |
| CP-690,550 5 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=24,14,8,1) | 5.13 hours per day | Standard Deviation 2.49 |
| CP-690,550 5 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 3.11 hours per day | Standard Deviation 2.18 |
| CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 2.86 hours per day | Standard Deviation 1.8 |
| CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Missed work due to RA(n=11,7,3,2) | 2.57 hours per day | Standard Deviation 1.72 |
| CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Home healthcare services(n=3,1,1,1) | 1.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Work done(n=65,75,22,21) | 8.43 hours per day | Standard Deviation 4.16 |
| CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | RA related home healthcare services(3,1,2,1) | 1.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=24,14,8,1) | 10.57 hours per day | Standard Deviation 22.97 |
| Placebo | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | RA related home healthcare services(3,1,2,1) | 0.00 hours per day | Standard Deviation 0 |
| Placebo | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Work done(n=65,75,22,21) | 7.23 hours per day | Standard Deviation 2.11 |
| Placebo | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Missed work due to RA(n=11,7,3,2) | 2.67 hours per day | Standard Deviation 2.31 |
| Placebo | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 3.29 hours per day | Standard Deviation 2.84 |
| Placebo | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=24,14,8,1) | 5.00 hours per day | Standard Deviation 2.45 |
| Placebo | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Home healthcare services(n=3,1,1,1) | 0.00 hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by housekeeper(n=24,14,8,1) | 8.00 hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Chores by family(n=74,64,24,13) | 4.69 hours per day | Standard Deviation 6.46 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | RA related home healthcare services(3,1,2,1) | 0.00 hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Missed work due to RA(n=11,7,3,2) | 1.50 hours per day | Standard Deviation 2.12 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Home healthcare services(n=3,1,1,1) | 1.00 hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | Work done(n=65,75,22,21) | 8.29 hours per day | Standard Deviation 1.79 |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time frame: Baseline, Month 3
Population: FAS population. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline(n=241,243,122) | 96 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3(n=238,229,109) | 113 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline(n=241,243,122) | 98 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3(n=238,229,109) | 117 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Baseline(n=241,243,122) | 45 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Month 3(n=238,229,109) | 52 participants |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Time frame: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 105 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 107 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 23 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 25 participants |
Secondary
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time frame: Baseline, Week 2, Month 1, 2, 3
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 36.39 mm | Standard Deviation 23.29 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 40.68 mm | Standard Deviation 23.04 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 241, 243, 122) | 61.35 mm | Standard Deviation 22.27 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 239, 239, 119) | 45.92 mm | Standard Deviation 22.87 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 237, 228, 108) | 34.93 mm | Standard Deviation 23.73 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 36.86 mm | Standard Deviation 24.46 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 241, 243, 122) | 62.03 mm | Standard Deviation 23.63 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 239, 239, 119) | 42.13 mm | Standard Deviation 25.06 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 31.66 mm | Standard Deviation 24.38 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 237, 228, 108) | 31.37 mm | Standard Deviation 24.35 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 237, 228, 108) | 49.84 mm | Standard Deviation 25.1 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 52.38 mm | Standard Deviation 26.09 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 241, 243, 122) | 61.79 mm | Standard Deviation 21.27 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 52.47 mm | Standard Deviation 24.59 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 239, 239, 119) | 55.61 mm | Standard Deviation 23.63 |
Secondary
Patient Assessment of Arthritis Pain at Month 4, 5 and 6
Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time frame: Month 4, 5, 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 33.18 mm | Standard Deviation 23.02 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 32.60 mm | Standard Deviation 23.55 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 32.63 mm | Standard Deviation 23.07 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 29.70 mm | Standard Deviation 23.21 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 27.89 mm | Standard Deviation 23.17 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 29.10 mm | Standard Deviation 22.24 |
| Placebo | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 34.05 mm | Standard Deviation 23.48 |
| Placebo | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 34.27 mm | Standard Deviation 24.53 |
| Placebo | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 33.96 mm | Standard Deviation 24.62 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 35.47 mm | Standard Deviation 25.28 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 32.28 mm | Standard Deviation 23.79 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 35.06 mm | Standard Deviation 24.82 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.
Time frame: Baseline, Week 2, Month 1, 2, 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 36.29 mm | Standard Deviation 22.2 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 39.63 mm | Standard Deviation 22.36 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 240, 243, 122) | 61.66 mm | Standard Deviation 22 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 108) | 35.90 mm | Standard Deviation 23.61 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 240, 239, 119) | 46.34 mm | Standard Deviation 22.36 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 240, 239, 119) | 41.32 mm | Standard Deviation 24.9 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 240, 243, 122) | 63.46 mm | Standard Deviation 23.23 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 37.69 mm | Standard Deviation 23.94 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 32.56 mm | Standard Deviation 23.47 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 108) | 32.78 mm | Standard Deviation 23.75 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 108) | 50.48 mm | Standard Deviation 25.82 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 233, 110) | 53.05 mm | Standard Deviation 26.04 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 240, 243, 122) | 62.63 mm | Standard Deviation 21.91 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 53.23 mm | Standard Deviation 24.01 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 240, 239, 119) | 55.95 mm | Standard Deviation 23.79 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.
Time frame: Month 4, 5, 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 33.59 mm | Standard Deviation 22.44 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 32.56 mm | Standard Deviation 23.09 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 34.59 mm | Standard Deviation 23.37 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 29.69 mm | Standard Deviation 22.25 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 29.52 mm | Standard Deviation 22.89 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 29.37 mm | Standard Deviation 22.13 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 32.88 mm | Standard Deviation 21.43 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 35.27 mm | Standard Deviation 23.77 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 33.51 mm | Standard Deviation 24 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 223, 55, 49) | 36.45 mm | Standard Deviation 25.92 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 228, 216, 54, 50) | 32.89 mm | Standard Deviation 23.78 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 33.96 mm | Standard Deviation 25.02 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6
ACR20 response: \>= 20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4, 5, 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 4 | 69.29 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 6 | 69.29 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 5 | 68.46 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 4 | 69.01 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 6 | 71.07 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 5 | 69.83 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 5 | 61.67 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 4 | 51.67 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 6 | 58.33 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 4 | 61.67 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 6 | 56.67 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | Month 5 | 63.33 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2
ACR20 response: \>= 20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1, 2
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Month 1 | 46.47 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Week 2 | 29.58 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Month 2 | 56.85 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Month 1 | 52.07 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Week 2 | 39.17 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Month 2 | 60.74 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Week 2 | 11.76 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Month 2 | 25.83 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | Month 1 | 21.67 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6
ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 4, 5, 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 4 | 37.34 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 6 | 41.91 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 5 | 39.42 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 4 | 42.98 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 6 | 46.69 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 5 | 45.45 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 5 | 36.67 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 4 | 28.33 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 6 | 33.33 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 4 | 28.33 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 6 | 33.33 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | Month 5 | 35.00 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
ACR50 response: greater than or equal to \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Month 1, 2, 3
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Week 2 | 5.83 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 1 | 17.43 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 2 | 26.14 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 3 | 31.12 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 3 | 36.78 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Week 2 | 12.92 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 2 | 33.88 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 1 | 23.97 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 3 | 12.50 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 1 | 4.17 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Month 2 | 5.83 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | Week 2 | 4.20 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Month 4, 5, 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 4 | 19.92 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 6 | 21.99 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 5 | 21.16 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 4 | 26.03 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 6 | 29.34 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 5 | 28.51 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 5 | 18.33 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 4 | 13.33 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 6 | 20.00 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 4 | 15.00 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 6 | 21.67 percentage of participants |
| Placebo, Then CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | Month 5 | 18.33 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Month 1, 2, 3
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Week 2 | 2.08 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 1 | 4.98 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 2 | 9.96 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 3 | 15.35 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 3 | 20.25 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Week 2 | 4.58 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 2 | 19.01 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 1 | 9.09 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 3 | 5.83 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 1 | 1.67 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Month 2 | 3.33 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | Week 2 | 0.00 percentage of participants |
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Baseline, Week 2, Month 1, 2, 3
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 232, 110) | 32.06 mm | Standard Deviation 20.81 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 35.89 mm | Standard Deviation 18.91 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 241, 243, 122) | 61.46 mm | Standard Deviation 16.93 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 239, 240, 119) | 43.43 mm | Standard Deviation 17.69 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 29.20 mm | Standard Deviation 19.98 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 33.99 mm | Standard Deviation 20.37 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 241, 243, 122) | 60.84 mm | Standard Deviation 16.84 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 239, 240, 119) | 40.47 mm | Standard Deviation 19.73 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 232, 110) | 26.75 mm | Standard Deviation 19.23 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 24.47 mm | Standard Deviation 18.42 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 3 (n= 238, 229, 109) | 42.05 mm | Standard Deviation 23.58 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 2 (n= 240, 232, 110) | 44.45 mm | Standard Deviation 23.62 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Baseline (n= 241, 243, 122) | 62.22 mm | Standard Deviation 16.85 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Month 1 (n= 237, 240, 116) | 46.98 mm | Standard Deviation 22.29 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Week 2 (n= 239, 240, 119) | 52.15 mm | Standard Deviation 19.25 |
Secondary
Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Time frame: Month 4, 5, 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 23.26 mm | Standard Deviation 18.12 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 221, 54, 49) | 25.30 mm | Standard Deviation 18.56 |
| CP-690,550 5 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 23.60 mm | Standard Deviation 17.63 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 20.99 mm | Standard Deviation 16.13 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 221, 54, 49) | 21.21 mm | Standard Deviation 16.46 |
| CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 20.61 mm | Standard Deviation 16.27 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 26.16 mm | Standard Deviation 19.55 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 221, 54, 49) | 27.48 mm | Standard Deviation 19.8 |
| Placebo | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 24.74 mm | Standard Deviation 17.93 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 5 (n= 231, 221, 55, 50) | 25.90 mm | Standard Deviation 19.85 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 4 (n= 235, 221, 54, 49) | 25.86 mm | Standard Deviation 20.32 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Month 6 (n= 229, 216, 54, 50) | 21.54 mm | Standard Deviation 17.51 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]).
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Time management(n=118, 119, 62) | 50.84 units on a scale | Standard Deviation 26.52 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Physical demands(n=117, 119, 66) | 51.84 units on a scale | Standard Deviation 22.44 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Mental demands(n=119,120,66) | 31.04 units on a scale | Standard Deviation 24.05 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Output demands(n=114, 116, 63) | 39.70 units on a scale | Standard Deviation 24.76 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Work loss index(n=124, 122, 67) | 10.82 units on a scale | Standard Deviation 5.21 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Time management(n=94, 89, 45) | 37.65 units on a scale | Standard Deviation 29.03 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Physical demands(n=98, 90, 46) | 51.89 units on a scale | Standard Deviation 29.32 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Mental demands(n=100, 93, 47) | 24.64 units on a scale | Standard Deviation 27.02 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Output demands(n=96, 90, 45) | 27.03 units on a scale | Standard Deviation 24.44 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Work loss index(n=102, 98, 49) | 8.48 units on a scale | Standard Deviation 5.6 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Output demands(n=96, 90, 45) | 28.31 units on a scale | Standard Deviation 29.37 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Time management(n=118, 119, 62) | 48.98 units on a scale | Standard Deviation 27.17 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Time management(n=94, 89, 45) | 34.63 units on a scale | Standard Deviation 29.91 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Work loss index(n=124, 122, 67) | 11.95 units on a scale | Standard Deviation 6.2 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Physical demands(n=117, 119, 66) | 49.24 units on a scale | Standard Deviation 27.51 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Work loss index(n=102, 98, 49) | 8.05 units on a scale | Standard Deviation 6.63 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Mental demands(n=100, 93, 47) | 24.62 units on a scale | Standard Deviation 29.12 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Mental demands(n=119,120,66) | 36.14 units on a scale | Standard Deviation 28.41 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Physical demands(n=98, 90, 46) | 46.48 units on a scale | Standard Deviation 30.17 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Output demands(n=114, 116, 63) | 44.85 units on a scale | Standard Deviation 30.23 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Mental demands(n=100, 93, 47) | 28.54 units on a scale | Standard Deviation 26.4 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Output demands(n=114, 116, 63) | 45.30 units on a scale | Standard Deviation 28.11 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Work loss index(n=124, 122, 67) | 12.16 units on a scale | Standard Deviation 5.92 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Time management(n=94, 89, 45) | 41.32 units on a scale | Standard Deviation 23.28 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Output demands(n=96, 90, 45) | 33.41 units on a scale | Standard Deviation 23.28 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Physical demands(n=98, 90, 46) | 46.71 units on a scale | Standard Deviation 24.78 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Time management(n=118, 119, 62) | 48.74 units on a scale | Standard Deviation 26.44 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3:Work loss index(n=102, 98, 49) | 9.29 units on a scale | Standard Deviation 5.66 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Physical demands(n=117, 119, 66) | 51.21 units on a scale | Standard Deviation 25.33 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline:Mental demands(n=119,120,66) | 38.69 units on a scale | Standard Deviation 27.76 |
Secondary
Work Limitations Questionnaire (WLQ) Score at Month 6
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0\[no loss\] to 100\[complete loss of work\]).
Time frame: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Output demands (n= 80, 81, 26, 23) | 25.04 units on a scale | Standard Deviation 24.29 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Physical demands (n=85, 81, 26, 25) | 45.37 units on a scale | Standard Deviation 29.86 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Work loss index (n= 85, 85, 26, 27) | 7.85 units on a scale | Standard Deviation 5.64 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Mental demands (n= 81, 82, 25, 26) | 22.66 units on a scale | Standard Deviation 25.71 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Time management (n=80, 81, 25, 23) | 36.27 units on a scale | Standard Deviation 29.22 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Mental demands (n= 81, 82, 25, 26) | 21.61 units on a scale | Standard Deviation 29.09 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Output demands (n= 80, 81, 26, 23) | 26.30 units on a scale | Standard Deviation 29.4 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Work loss index (n= 85, 85, 26, 27) | 7.60 units on a scale | Standard Deviation 6.49 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Physical demands (n=85, 81, 26, 25) | 45.17 units on a scale | Standard Deviation 34.14 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Time management (n=80, 81, 25, 23) | 30.42 units on a scale | Standard Deviation 28.39 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Mental demands (n= 81, 82, 25, 26) | 25.84 units on a scale | Standard Deviation 24.54 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Time management (n=80, 81, 25, 23) | 34.40 units on a scale | Standard Deviation 25.59 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Physical demands (n=85, 81, 26, 25) | 57.16 units on a scale | Standard Deviation 27.63 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Output demands (n= 80, 81, 26, 23) | 28.65 units on a scale | Standard Deviation 23.9 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Work loss index (n= 85, 85, 26, 27) | 9.07 units on a scale | Standard Deviation 5.22 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Output demands (n= 80, 81, 26, 23) | 35.05 units on a scale | Standard Deviation 29.32 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Physical demands (n=85, 81, 26, 25) | 50.33 units on a scale | Standard Deviation 31.74 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Time management (n=80, 81, 25, 23) | 39.86 units on a scale | Standard Deviation 30.64 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Mental demands (n= 81, 82, 25, 26) | 29.77 units on a scale | Standard Deviation 29.64 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Work loss index (n= 85, 85, 26, 27) | 9.23 units on a scale | Standard Deviation 6.26 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Month 3
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline (n=146, 174, 79) | 5.59 units on a scale | Standard Deviation 3.17 |
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3 (n=138, 148, 75) | 3.39 units on a scale | Standard Deviation 2.85 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline (n=146, 174, 79) | 5.61 units on a scale | Standard Deviation 6.42 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3 (n=138, 148, 75) | 3.43 units on a scale | Standard Deviation 2.88 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline (n=146, 174, 79) | 5.41 units on a scale | Standard Deviation 2.94 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3 (n=138, 148, 75) | 4.57 units on a scale | Standard Deviation 2.94 |
Secondary
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Time frame: Month 6
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 3.22 units on a scale | Standard Deviation 2.85 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 3.18 units on a scale | Standard Deviation 3 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 3.21 units on a scale | Standard Deviation 2.8 |
| Placebo, Then CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 3.94 units on a scale | Standard Deviation 3.22 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time frame: Baseline, Month 3
Population: FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Treated in emergency room(n=236,229,109) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Home healthcare services(n=235,239,119) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Feel well enough to work(n=108,93,50) | 1.72 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Seen any doctor(n=235,228,109) | 1.42 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Required aids/devices(n=236,239,119) | 1.84 units on a scale | Standard Deviation 0.37 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: In nursing home(n=236,229,109) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Chores by housekeeper(n=235,239,119) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Non-medical practitioner(n=236,239,120) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Chores by housekeeper(n=235,229,108) | 1.88 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Unable to do chores(n=235,238,118) | 1.36 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Currently employed(n=236,239,120) | 1.69 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Unable to work due to RA(n=107,98,52) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Performed paid work(n=191,204,99) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Feel well enough to work(n=111,90,57) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Hospitalization(n=236,228,109) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Performed part time work(n=192,202,98) | 1.89 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Unable to work due to RA(n=111,93,59) | 1.37 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Unable to do chores(n=231,227,107) | 1.60 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Lost job/retired early(n=107,92,49) | 1.68 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Sick leave due to RA(n=191,202,99) | 1.82 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Lost job/retired early(n=110,92,58) | 1.61 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Work disabled due to RA(n=109,92,49) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Retired(n=116,99,59) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Work disabled due to RA(n=111,91,58) | 1.54 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Seen any doctor(n=236,239,119) | 1.19 units on a scale | Standard Deviation 0.39 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Non-medical practitioner(n=236,229,109) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Performed paid work(n=179,184,88) | 1.75 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Treated in emergency room(n=236,239,120) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Non-study diagnostic test(n=236,228,109) | 1.87 units on a scale | Standard Deviation 0.33 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Performed part time work(n=181,180,88) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Admitted for overnight stay (n=13,18,10) | 0.15 units on a scale | Standard Deviation 0.55 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Required aids/devices(n=235,228,109) | 1.89 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Sick leave due to RA(n=180,183,88) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Hospitalization(n=236,239,120) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Chores by family/friends(n=235,239,118) | 1.40 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Retired(n=115,107,51) | 1.52 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Outpatient surgery(n=236,239,120 | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Home healthcare services(n=236,228,108) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Outpatient surgery(n=236,229,109) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Non-study diagnostic test(n=235,239,120) | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Currently employed(n=236,228,109) | 1.71 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Admitted for overnight stay (n=14,14,8) | 0.29 units on a scale | Standard Deviation 0.61 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:In nursing home(n=236,239,120) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Chores by family/friends(n=234,229,108) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Work disabled due to RA(n=111,91,58) | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Performed part time work(n=192,202,98) | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Non-study diagnostic test(n=236,228,109) | 1.88 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: In nursing home(n=236,229,109) | 2.00 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Lost job/retired early(n=107,92,49) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Work disabled due to RA(n=109,92,49) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Currently employed(n=236,228,109) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Feel well enough to work(n=108,93,50) | 1.69 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Unable to work due to RA(n=107,98,52) | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Seen any doctor(n=236,239,119) | 1.15 units on a scale | Standard Deviation 0.36 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Treated in emergency room(n=236,239,120) | 1.92 units on a scale | Standard Deviation 0.26 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Admitted for overnight stay (n=13,18,10) | 0.17 units on a scale | Standard Deviation 0.51 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Hospitalization(n=236,239,120) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Outpatient surgery(n=236,239,120 | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Non-study diagnostic test(n=235,239,120) | 1.78 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:In nursing home(n=236,239,120) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Home healthcare services(n=235,239,119) | 1.98 units on a scale | Standard Deviation 0.13 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Required aids/devices(n=236,239,119) | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Non-medical practitioner(n=236,239,120) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Currently employed(n=236,239,120) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Feel well enough to work(n=111,90,57) | 1.83 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Unable to work due to RA(n=111,93,59) | 1.29 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Performed paid work(n=191,204,99) | 1.66 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Lost job/retired early(n=110,92,58) | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Retired(n=116,99,59) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Sick leave due to RA(n=191,202,99) | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Unable to do chores(n=235,238,118) | 1.32 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Chores by housekeeper(n=235,239,119) | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Chores by family/friends(n=235,239,118) | 1.44 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Seen any doctor(n=235,228,109) | 1.41 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Treated in emergency room(n=236,229,109) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Admitted for overnight stay (n=14,14,8) | 0.43 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Hospitalization(n=236,228,109) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Outpatient surgery(n=236,229,109) | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Retired(n=115,107,51) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Sick leave due to RA(n=180,183,88) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Performed part time work(n=181,180,88) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Performed paid work(n=179,184,88) | 1.76 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Unable to do chores(n=231,227,107) | 1.63 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Chores by housekeeper(n=235,229,108) | 1.92 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Chores by family/friends(n=234,229,108) | 1.64 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Home healthcare services(n=236,228,108) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Required aids/devices(n=235,228,109) | 1.91 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Non-medical practitioner(n=236,229,109) | 2.00 units on a scale | Standard Deviation 0.07 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Required aids/devices(n=235,228,109) | 1.87 units on a scale | Standard Deviation 0.34 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Seen any doctor(n=235,228,109) | 1.39 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:In nursing home(n=236,239,120) | 1.99 units on a scale | Standard Deviation 0.09 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Chores by housekeeper(n=235,229,108) | 1.79 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Treated in emergency room(n=236,229,109) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Non-study diagnostic test(n=235,239,120) | 1.83 units on a scale | Standard Deviation 0.37 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Currently employed(n=236,228,109) | 1.62 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Admitted for overnight stay (n=14,14,8) | 0.50 units on a scale | Standard Deviation 0.93 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: In nursing home(n=236,229,109) | 1.99 units on a scale | Standard Deviation 0.1 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Hospitalization(n=236,228,109) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Outpatient surgery(n=236,239,120 | 1.98 units on a scale | Standard Deviation 0.16 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Chores by family/friends(n=234,229,108) | 1.49 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3:Outpatient surgery(n=236,229,109) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Work disabled due to RA(n=109,92,49) | 1.47 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Hospitalization(n=236,239,120) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Sick leave due to RA(n=180,183,88) | 1.89 units on a scale | Standard Deviation 0.32 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Retired(n=115,107,51) | 1.53 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Admitted for overnight stay (n=13,18,10) | 0.20 units on a scale | Standard Deviation 0.63 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Non-study diagnostic test(n=236,228,109) | 1.87 units on a scale | Standard Deviation 0.34 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Treated in emergency room(n=236,239,120) | 1.92 units on a scale | Standard Deviation 0.28 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Home healthcare services(n=236,228,108) | 1.99 units on a scale | Standard Deviation 0.1 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Performed part time work(n=181,180,88) | 1.90 units on a scale | Standard Deviation 0.3 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Seen any doctor(n=236,239,119) | 1.17 units on a scale | Standard Deviation 0.38 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Lost job/retired early(n=107,92,49) | 1.59 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Work disabled due to RA(n=111,91,58) | 1.52 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Lost job/retired early(n=110,92,58) | 1.55 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Performed paid work(n=179,184,88) | 1.65 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Retired(n=116,99,59) | 1.49 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Unable to work due to RA(n=111,93,59) | 1.41 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Unable to work due to RA(n=107,98,52) | 1.35 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Sick leave due to RA(n=191,202,99) | 1.74 units on a scale | Standard Deviation 0.44 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Feel well enough to work(n=111,90,57) | 1.86 units on a scale | Standard Deviation 0.35 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Performed part time work(n=192,202,98) | 1.88 units on a scale | Standard Deviation 0.33 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Currently employed(n=236,239,120) | 1.64 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Performed paid work(n=191,204,99) | 1.62 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Non-medical practitioner(n=236,239,120) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Non-medical practitioner(n=236,229,109) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Unable to do chores(n=235,238,118) | 1.30 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Required aids/devices(n=236,239,119) | 1.83 units on a scale | Standard Deviation 0.38 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Unable to do chores(n=231,227,107) | 1.39 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Chores by housekeeper(n=235,239,119) | 1.81 units on a scale | Standard Deviation 0.4 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Month 3: Feel well enough to work(n=108,93,50) | 1.86 units on a scale | Standard Deviation 0.35 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Chores by family/friends(n=235,239,118) | 1.29 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Baseline:Home healthcare services(n=235,239,119) | 1.99 units on a scale | Standard Deviation 0.09 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
Time frame: Month 6
Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Treated in emergency room(n=229,216,54,50) | 1.93 units on a scale | Standard Deviation 0.26 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to do chores(n=229,214,52,50) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Diagnostic test(n=229,216,54,50) | 1.87 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Outpatient surgery(n=229,216,54,50) | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Admitted for overnight stay (n=16,13,3,2) | 0.25 units on a scale | Standard Deviation 0.58 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Home healthcare services(n=229,216,54,49) | 1.99 units on a scale | Standard Deviation 0.11 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Hospitalization(n=229,216,54,50) | 1.98 units on a scale | Standard Deviation 1.15 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by family/friends(n=229,216,54,50) | 1.67 units on a scale | Standard Deviation 0.47 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed paid work(n=172,169,39,41) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed part time work(n=173,170,40,41) | 1.93 units on a scale | Standard Deviation 0.25 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Required aids/devices(n=229,216,54,50) | 1.89 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Sick leave due to RA(n=175,169,41,41) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Retired(n=126,110,25,23) | 1.51 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Work disabled due to RA(n=125,103,24,23) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-medical practitioner(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:In nursing home(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0.07 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Lost job/retired early(n=126,102,24,23) | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Feel well enough to work(n=124,101,24,22) | 1.73 units on a scale | Standard Deviation 0.45 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Seen any doctor(n=227,216,54,50) | 1.30 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by housekeeper(n=229,216,54,50) | 1.89 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to work due to RA(n=123,105,24,24) | 1.50 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Currently employed(n=229,216,54,50) | 1.71 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Required aids/devices(n=229,216,54,50) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Diagnostic test(n=229,216,54,50) | 1.84 units on a scale | Standard Deviation 0.37 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Home healthcare services(n=229,216,54,49) | 2.00 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-medical practitioner(n=229,216,54,50) | 1.99 units on a scale | Standard Deviation 0.1 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Seen any doctor(n=227,216,54,50) | 1.30 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Treated in emergency room(n=229,216,54,50) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Admitted for overnight stay (n=16,13,3,2) | 0.23 units on a scale | Standard Deviation 0.44 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Hospitalization(n=229,216,54,50) | 1.99 units on a scale | Standard Deviation 1.12 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Outpatient surgery(n=229,216,54,50) | 1.94 units on a scale | Standard Deviation 0.23 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Currently employed(n=229,216,54,50) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Feel well enough to work(n=124,101,24,22) | 1.66 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:In nursing home(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0.07 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to work due to RA(n=123,105,24,24) | 1.46 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Lost job/retired early(n=126,102,24,23) | 1.63 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Work disabled due to RA(n=125,103,24,23) | 1.54 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Retired(n=126,110,25,23) | 1.45 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Sick leave due to RA(n=175,169,41,41) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed part time work(n=173,170,40,41) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed paid work(n=172,169,39,41) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to do chores(n=229,214,52,50) | 1.69 units on a scale | Standard Deviation 0.46 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by housekeeper(n=229,216,54,50) | 1.94 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by family/friends(n=229,216,54,50) | 1.70 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Lost job/retired early(n=126,102,24,23) | 1.54 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Seen any doctor(n=227,216,54,50) | 1.28 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to do chores(n=229,214,52,50) | 1.54 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to work due to RA(n=123,105,24,24) | 1.54 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-medical practitioner(n=229,216,54,50) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:In nursing home(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Work disabled due to RA(n=125,103,24,23) | 1.54 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Required aids/devices(n=229,216,54,50) | 1.89 units on a scale | Standard Deviation 0.32 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by family/friends(n=229,216,54,50) | 1.54 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Retired(n=126,110,25,23) | 1.56 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Hospitalization(n=229,216,54,50) | 1.96 units on a scale | Standard Deviation 1.19 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by housekeeper(n=229,216,54,50) | 1.85 units on a scale | Standard Deviation 0.36 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Sick leave due to RA(n=175,169,41,41) | 1.93 units on a scale | Standard Deviation 0.26 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed part time work(n=173,170,40,41) | 1.93 units on a scale | Standard Deviation 0.27 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Home healthcare services(n=229,216,54,49) | 1.96 units on a scale | Standard Deviation 0.19 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Admitted for overnight stay (n=16,13,3,2) | 1.33 units on a scale | Standard Deviation 2.31 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed paid work(n=172,169,39,41) | 1.64 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Outpatient surgery(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Treated in emergency room(n=229,216,54,50) | 1.94 units on a scale | Standard Deviation 0.23 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Diagnostic test(n=229,216,54,50) | 1.87 units on a scale | Standard Deviation 0.34 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Feel well enough to work(n=124,101,24,22) | 1.71 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Currently employed(n=229,216,54,50) | 1.59 units on a scale | Standard Deviation 0.5 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Diagnostic test(n=229,216,54,50) | 1.88 units on a scale | Standard Deviation 0.33 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:In nursing home(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by family/friends(n=229,216,54,50) | 1.74 units on a scale | Standard Deviation 0.44 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Feel well enough to work(n=124,101,24,22) | 1.73 units on a scale | Standard Deviation 0.46 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Sick leave due to RA(n=175,169,41,41) | 1.95 units on a scale | Standard Deviation 0.22 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Home healthcare services(n=229,216,54,49) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Chores by housekeeper(n=229,216,54,50) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to work due to RA(n=123,105,24,24) | 1.42 units on a scale | Standard Deviation 0.5 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed paid work(n=172,169,39,41) | 1.73 units on a scale | Standard Deviation 0.45 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Unable to do chores(n=229,214,52,50) | 1.70 units on a scale | Standard Deviation 0.46 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Currently employed(n=229,216,54,50) | 1.58 units on a scale | Standard Deviation 0.5 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Lost job/retired early(n=126,102,24,23) | 1.57 units on a scale | Standard Deviation 0.51 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Required aids/devices(n=229,216,54,50) | 1.92 units on a scale | Standard Deviation 0.27 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Performed part time work(n=173,170,40,41) | 1.95 units on a scale | Standard Deviation 0.22 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-medical practitioner(n=229,216,54,50) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Work disabled due to RA(n=125,103,24,23) | 1.43 units on a scale | Standard Deviation 0.51 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Admitted for overnight stay (n=16,13,3,2) | 1.00 units on a scale | Standard Deviation 1.41 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Seen any doctor(n=227,216,54,50) | 1.28 units on a scale | Standard Deviation 0.45 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Outpatient surgery(n=229,216,54,50) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Retired(n=126,110,25,23) | 1.48 units on a scale | Standard Deviation 0.51 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Hospitalization(n=229,216,54,50) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Treated in emergency room(n=229,216,54,50) | 1.96 units on a scale | Standard Deviation 0.2 |
Other Pre-specified
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Time frame: 2 weeks
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 3 days |
| CP-690,550 10 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 3 days |
| Placebo | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | 3 days |
Other Pre-specified
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.
Time frame: 2 weeks
Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 3 days |
| CP-690,550 10 mg | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 3 days |
| Placebo | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | 3 days |