Arthritis, Rheumatoid
Conditions
Keywords
randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy
Brief summary
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
Interventions
DRUGCP-690,550
Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
DRUGPlacebo
Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.
Exclusion criteria
* Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline, Month 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | Month 3 | ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis. |
| Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | Month 3 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Week 2, Month 1, 3 | ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6 | Month 4.5 and 6 | ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Week 2, Month 1, 3 | ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6 | Month 4.5, 6 | ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Baseline, Week 2, Month 1, 3 | DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Disease Activity Score Based on 28-Joints 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 the SJC and TJC using the 28 joints 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 and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline, Month 3 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. |
| Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | Month 6 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Week 2, Month 1, 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. |
| 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 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. |
| Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline, Week 2, Month 1, 3 | Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 4.5, 6 | Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline, Week 2, Month 1, 3 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly. |
| Patient Global Assessment (PtGA) of Arthritis Pain at Month 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 VAS, where 0 mm = very well and 100 mm = very poorly. |
| Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Baseline, Week 2, Month 1, 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 of Arthritis 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, Week 2, Month 1 and 3 | Baseline, Week 2, Month 1, 3 | SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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). |
| 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6 | SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, 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). |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline, Week 2, Month 1, 3 | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score\[RS\] minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute. |
| Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6 | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score\[RS\] minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Baseline, Week 2, Month 1, 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 optimal by choosing yes or no. Number of participants with optimal sleep is reported. |
| 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 optimal by choosing yes or no. Number of participants with optimal sleep is reported. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline, Month 3 | FACIT-Fatigue Scale (FS):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-FS 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. |
| 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 events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | Month 6 | FACIT-FS: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-FS 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 - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Baseline, Month 1, 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 - 5 Dimensions (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, 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 | 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 events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| Number of Days as Assessed Using RA-HCRU at Baseline and 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 were reported. |
| 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 were reported. |
| 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, hours affected per day and average number of hours missed work per day were reported. |
| Number of Hours Per Day as Assessed 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, hours affected per day and average number of hours missed work per day 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 10-point scale, where higher score indicated lower work performance. |
| Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | Month 6 | Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance. |
| Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 | Week 2, Month 1 | ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| 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 TJC; \>=20% improvement in SJC; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. |
| Work 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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]). |
| Work Limitations Questionnaire (WLQ) Score at 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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5, 6 | DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. |
| Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2, Month 1, 3 | DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3 | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. |
Countries
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Ireland, Italy, Puerto Rico, South Korea, Spain, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Month 6. | 133 |
| CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 6. | 134 |
| Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6. | 66 |
| Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6. | 66 |
| Total | 399 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 12 | 12 | 4 | 4 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy | 2 | 5 | 3 | 8 |
| Overall Study | Other | 1 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 8 | 3 | 4 |
| Overall Study | Withdrawal by Subject | 9 | 5 | 2 | 1 |
Baseline characteristics
| Characteristic | CP-690,550 5 mg | CP-690,550 10 mg | Placebo, Then CP-690,550 5 mg | Placebo, Then CP-690,550 10 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 11.5 | 55.1 years STANDARD_DEVIATION 11.3 | 54.3 years STANDARD_DEVIATION 11.7 | 54.5 years STANDARD_DEVIATION 11 | 55.0 years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 113 Participants | 116 Participants | 53 Participants | 53 Participants | 335 Participants |
| Sex: Female, Male Male | 20 Participants | 18 Participants | 13 Participants | 13 Participants | 64 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 | 37 / 133 | 43 / 134 | 46 / 132 | 35 / 199 | 30 / 200 |
| serious Total, serious adverse events | 2 / 133 | 2 / 134 | 6 / 132 | 8 / 199 | 8 / 200 |
Outcome results
Primary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n=132,134,132) | 1.60 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=117,125,118) | -0.41 Units on a scale | Standard Deviation 0.52 |
| CP-690,550 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n=132,134,132) | 1.50 Units on a scale | Standard Deviation 0.61 |
| 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=117,125,118) | -0.41 Units on a scale | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Baseline (n=132,134,132) | 1.63 Units on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | Change at Month 3 (n=117,125,118) | -0.17 Units on a scale | Standard Deviation 0.41 |
Comparison: Least squares mean difference (LS Mean Difference) and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.p-value: <0.000195% CI: [-0.38, -0.17]Mixed Models Analysis
Comparison: LS Mean Difference and corresponding 95% CI was calculated using a mixed effect repeated measure model with treatment, visit, treatment by visit interaction, and geographic region as fixed effects and participants as a random effect.p-value: <0.000195% CI: [-0.36, -0.15]Mixed Models Analysis
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 joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Month 3
Population: Full Analysis Set(FAS):all randomized participants who received at least 1 dose of study treatment, had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using Non-Responder Imputation(NRI). 'N' (Number of Participants Analyzed) signifies participants who were 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 | 41.67 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | 48.12 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | 24.43 percentage of participants |
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% confidence interval (CI) was evaluated for the difference in percentages.p-value: <0.000195% CI: [12.45, 34.92]Normal Approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.002495% CI: [6.06, 28.41]Normal Approximation
Primary
Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Time frame: Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CP-690,550 5 mg | Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 6.72 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 11.20 percentage of participants |
| Placebo | Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | 1.67 percentage of participants |
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 10 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.001795% CI: [3.54, 15.51]Normal Approximation
Comparison: Normal approximation for the difference in binomial proportions was used to test the superiority of CP-690,550 5 mg to placebo and 2-sided 95% CI was evaluated for the difference in percentages.p-value: 0.049695% CI: [0, 10.1]Normal Approximation
Secondary
36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Baseline, Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Bodily Pain (n=130,128,125) | 37.01 units on a scale | Standard Deviation 9.34 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Role Physical (n=130,128,125) | 36.71 units on a scale | Standard Deviation 10.23 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Physical Component Score (n=118,125,116) | 36.18 units on a scale | Standard Deviation 9.96 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1: Role Physical (n=124,123,123) | 38.25 units on a scale | Standard Deviation 10.06 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Physical Functioning (n=130,128,125) | 33.28 units on a scale | Standard Deviation 11.06 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Mental Component Score (n=118,125,116) | 46.40 units on a scale | Standard Deviation 11.87 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Physical Functioning (n=118,125,117) | 34.78 units on a scale | Standard Deviation 11.43 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline: Mental Component Score (n=133,134,132) | 42.82 units on a scale | Standard Deviation 12.69 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Physical Functioning (n=133,134,132) | 30.54 units on a scale | Standard Deviation 10.76 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Mental Health (n=124,123,123) | 44.13 units on a scale | Standard Deviation 11.68 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Mental Health (n=133,134,132) | 40.66 units on a scale | Standard Deviation 11.63 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Role Physical (n=133,134,132) | 33.66 units on a scale | Standard Deviation 10.21 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Physical Functioning (n=124,123,123) | 33.56 units on a scale | Standard Deviation 11.14 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3: Role Physical (n=118,125,117) | 38.40 units on a scale | Standard Deviation 10.49 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Role Emotional (n=133,134,132) | 37.58 units on a scale | Standard Deviation 14.08 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:General Health (n=133,134,132) | 35.84 units on a scale | Standard Deviation 9.5 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Role Emotional (n=124,123,123) | 41.05 units on a scale | Standard Deviation 13.23 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Social Functioning (n=133,134,132) | 37.40 units on a scale | Standard Deviation 13.1 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Vitality (n=133,134,132) | 39.71 units on a scale | Standard Deviation 9.87 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Mental Component Score (n=130,128,125) | 45.77 units on a scale | Standard Deviation 11.93 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Bodily Pain (n=118,125,117) | 39.25 units on a scale | Standard Deviation 9.78 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:General Health (n=124,123,123) | 38.09 units on a scale | Standard Deviation 9.32 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Physical Component Score (n=130,128,125) | 34.04 units on a scale | Standard Deviation 9.51 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:General Health (n=118,125,117) | 39.22 units on a scale | Standard Deviation 9.78 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Physical Component Score (n=124,123,123) | 34.88 units on a scale | Standard Deviation 9.24 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Mental Health (n=130,128,125) | 43.72 units on a scale | Standard Deviation 11.48 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Vitality (n=118,125,117) | 45.23 units on a scale | Standard Deviation 10.89 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Social Functioning (n=124,123,123) | 40.96 units on a scale | Standard Deviation 11.62 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Role Emotional (n=130,128,125) | 40.54 units on a scale | Standard Deviation 12.94 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Social Functioning (n=118,125,117) | 41.91 units on a scale | Standard Deviation 12.37 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Bodily Pain(n=124,123,123) | 37.50 units on a scale | Standard Deviation 9.45 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Social Functioning (n=130,128,125) | 41.18 units on a scale | Standard Deviation 12.79 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Role Emotional (n=118,125,116) | 41.21 units on a scale | Standard Deviation 12.57 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Mental Component Score (n=124,123,123) | 46.13 units on a scale | Standard Deviation 11.94 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Mental Health (n=118,125,117) | 44.58 units on a scale | Standard Deviation 11.95 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Vitality (n=124,123,123) | 44.33 units on a scale | Standard Deviation 9.35 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Vitality (n=130,128,125) | 43.02 units on a scale | Standard Deviation 10.18 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Bodily Pain (n=133,134,132) | 31.09 units on a scale | Standard Deviation 8.13 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Physical Component Score(n=133,134,132) | 30.72 units on a scale | Standard Deviation 9.29 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:General Health (n=130,128,125) | 37.38 units on a scale | Standard Deviation 8.52 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Physical Functioning (n=130,128,125) | 34.25 units on a scale | Standard Deviation 9.3 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Role Emotional (n=124,123,123) | 40.84 units on a scale | Standard Deviation 12.86 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Mental Health (n=124,123,123) | 46.18 units on a scale | Standard Deviation 11.64 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Physical Component Score (n=124,123,123) | 37.07 units on a scale | Standard Deviation 8.4 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Mental Component Score (n=124,123,123) | 47.28 units on a scale | Standard Deviation 12.47 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Physical Functioning (n=118,125,117) | 36.70 units on a scale | Standard Deviation 10.56 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3: Role Physical (n=118,125,117) | 40.19 units on a scale | Standard Deviation 10.95 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Bodily Pain (n=118,125,117) | 40.93 units on a scale | Standard Deviation 9.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:General Health (n=118,125,117) | 40.21 units on a scale | Standard Deviation 9.46 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Vitality (n=118,125,117) | 46.23 units on a scale | Standard Deviation 11.73 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Social Functioning (n=118,125,117) | 44.49 units on a scale | Standard Deviation 11.21 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Role Emotional (n=118,125,116) | 41.84 units on a scale | Standard Deviation 12.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Mental Health (n=118,125,117) | 45.83 units on a scale | Standard Deviation 11.59 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Physical Component Score (n=118,125,116) | 38.01 units on a scale | Standard Deviation 9.35 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Mental Component Score (n=118,125,116) | 47.37 units on a scale | Standard Deviation 12.01 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Physical Functioning (n=133,134,132) | 31.61 units on a scale | Standard Deviation 8.58 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Role Physical (n=133,134,132) | 34.08 units on a scale | Standard Deviation 9.67 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Bodily Pain (n=133,134,132) | 32.55 units on a scale | Standard Deviation 7.45 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:General Health (n=133,134,132) | 37.73 units on a scale | Standard Deviation 9.18 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Vitality (n=133,134,132) | 40.11 units on a scale | Standard Deviation 10.26 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Social Functioning (n=133,134,132) | 39.47 units on a scale | Standard Deviation 12.11 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Role Emotional (n=133,134,132) | 36.75 units on a scale | Standard Deviation 13.58 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Mental Health (n=133,134,132) | 41.91 units on a scale | Standard Deviation 11.99 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Physical Component Score(n=133,134,132) | 32.13 units on a scale | Standard Deviation 7.58 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline: Mental Component Score (n=133,134,132) | 43.24 units on a scale | Standard Deviation 12.81 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Social Functioning (n=124,123,123) | 44.12 units on a scale | Standard Deviation 11.65 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Role Physical (n=130,128,125) | 38.45 units on a scale | Standard Deviation 9.04 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Bodily Pain (n=130,128,125) | 38.42 units on a scale | Standard Deviation 7.7 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:General Health (n=130,128,125) | 38.57 units on a scale | Standard Deviation 8.61 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Vitality (n=130,128,125) | 43.89 units on a scale | Standard Deviation 10.71 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Social Functioning (n=130,128,125) | 42.29 units on a scale | Standard Deviation 11.29 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Role Emotional (n=130,128,125) | 40.62 units on a scale | Standard Deviation 11.99 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Mental Health (n=130,128,125) | 44.25 units on a scale | Standard Deviation 11.19 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Physical Component Score (n=130,128,125) | 35.69 units on a scale | Standard Deviation 7.74 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Mental Component Score (n=130,128,125) | 45.98 units on a scale | Standard Deviation 11.95 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Physical Functioning (n=124,123,123) | 35.64 units on a scale | Standard Deviation 10.06 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1: Role Physical (n=124,123,123) | 39.59 units on a scale | Standard Deviation 9.98 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Bodily Pain(n=124,123,123) | 40.02 units on a scale | Standard Deviation 8.42 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:General Health (n=124,123,123) | 39.82 units on a scale | Standard Deviation 9.25 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Vitality (n=124,123,123) | 45.65 units on a scale | Standard Deviation 11.47 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Role Emotional (n=118,125,116) | 36.16 units on a scale | Standard Deviation 14.5 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Mental Component Score (n=124,123,123) | 44.53 units on a scale | Standard Deviation 12.42 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Bodily Pain (n=130,128,125) | 33.77 units on a scale | Standard Deviation 7.8 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Physical Component Score(n=133,134,132) | 29.98 units on a scale | Standard Deviation 7.99 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Role Emotional (n=124,123,123) | 38.87 units on a scale | Standard Deviation 12.84 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:General Health (n=130,128,125) | 35.85 units on a scale | Standard Deviation 8.76 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Role Physical (n=133,134,132) | 32.53 units on a scale | Standard Deviation 9.66 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1: Role Physical (n=124,123,123) | 36.33 units on a scale | Standard Deviation 10.56 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Vitality (n=130,128,125) | 41.11 units on a scale | Standard Deviation 10.62 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Social Functioning (n=118,125,117) | 37.74 units on a scale | Standard Deviation 12.12 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Physical Component Score (n=124,123,123) | 32.72 units on a scale | Standard Deviation 9.18 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Social Functioning (n=130,128,125) | 38.08 units on a scale | Standard Deviation 12.18 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Vitality (n=118,125,117) | 40.30 units on a scale | Standard Deviation 11.71 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Social Functioning (n=124,123,123) | 39.00 units on a scale | Standard Deviation 12.49 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Role Emotional (n=130,128,125) | 37.69 units on a scale | Standard Deviation 13.49 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:General Health (n=118,125,117) | 35.30 units on a scale | Standard Deviation 9.3 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Bodily Pain(n=124,123,123) | 35.35 units on a scale | Standard Deviation 8.77 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Mental Health (n=130,128,125) | 42.07 units on a scale | Standard Deviation 12.31 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Bodily Pain (n=118,125,117) | 34.26 units on a scale | Standard Deviation 9.62 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Mental Health (n=124,123,123) | 42.89 units on a scale | Standard Deviation 11.92 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Vitality (n=133,134,132) | 38.41 units on a scale | Standard Deviation 10.77 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:General Health (n=133,134,132) | 34.82 units on a scale | Standard Deviation 8.67 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Physical Component Score (n=130,128,125) | 31.99 units on a scale | Standard Deviation 8.58 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Social Functioning (n=133,134,132) | 35.95 units on a scale | Standard Deviation 12.39 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Bodily Pain (n=133,134,132) | 31.95 units on a scale | Standard Deviation 7.7 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3: Role Physical (n=118,125,117) | 35.09 units on a scale | Standard Deviation 10.66 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Role Emotional (n=133,134,132) | 35.52 units on a scale | Standard Deviation 14.22 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Physical Functioning (n=133,134,132) | 28.32 units on a scale | Standard Deviation 9.3 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Vitality (n=124,123,123) | 41.85 units on a scale | Standard Deviation 11.5 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline:Mental Health (n=133,134,132) | 39.69 units on a scale | Standard Deviation 12.66 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Mental Component Score (n=130,128,125) | 43.57 units on a scale | Standard Deviation 12.74 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Mental Component Score (n=118,125,116) | 41.91 units on a scale | Standard Deviation 12.85 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Physical Functioning (n=118,125,117) | 30.54 units on a scale | Standard Deviation 10.67 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Baseline: Mental Component Score (n=133,134,132) | 41.34 units on a scale | Standard Deviation 13.25 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Physical Component Score (n=118,125,116) | 32.38 units on a scale | Standard Deviation 9.35 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:General Health (n=124,123,123) | 36.64 units on a scale | Standard Deviation 8.75 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Physical Functioning (n=130,128,125) | 30.25 units on a scale | Standard Deviation 10.3 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 3:Mental Health (n=118,125,117) | 40.89 units on a scale | Standard Deviation 12.46 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Month 1:Physical Functioning (n=124,123,123) | 31.01 units on a scale | Standard Deviation 10.15 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Baseline, Week 2, Month 1 and 3 | Week 2:Role Physical (n=130,128,125) | 36.05 units on a scale | Standard Deviation 10.48 |
Secondary
36-Item Short-Form Health Survey (SF-36) at Month 6
SF-36 is a standardized survey evaluating 8 domains (of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies 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 | Month 6:Mental Component Score | 47.41 units on a scale | Standard Deviation 12.32 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Bodily Pain | 41.53 units on a scale | Standard Deviation 9.61 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Functioning | 35.62 units on a scale | Standard Deviation 11.63 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Component Score | 37.78 units on a scale | Standard Deviation 9.2 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:General Health | 39.49 units on a scale | Standard Deviation 9.54 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6: Role Physical | 40.72 units on a scale | Standard Deviation 9.95 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Social Functioning | 44.05 units on a scale | Standard Deviation 10.93 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Health | 45.29 units on a scale | Standard Deviation 12.12 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Vitality | 46.49 units on a scale | Standard Deviation 9.82 |
| CP-690,550 5 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Role Emotional | 42.36 units on a scale | Standard Deviation 13.34 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Vitality | 47.59 units on a scale | Standard Deviation 10.93 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Role Emotional | 45.06 units on a scale | Standard Deviation 12.27 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Social Functioning | 44.66 units on a scale | Standard Deviation 11.92 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Health | 47.48 units on a scale | Standard Deviation 11.61 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6: Role Physical | 43.51 units on a scale | Standard Deviation 11.21 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Component Score | 48.83 units on a scale | Standard Deviation 12.65 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Component Score | 40.21 units on a scale | Standard Deviation 9.24 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:General Health | 41.68 units on a scale | Standard Deviation 10.35 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Functioning | 38.47 units on a scale | Standard Deviation 10.14 |
| CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Bodily Pain | 43.63 units on a scale | Standard Deviation 9.27 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Vitality | 45.09 units on a scale | Standard Deviation 12.26 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Functioning | 35.00 units on a scale | Standard Deviation 10.31 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6: Role Physical | 39.54 units on a scale | Standard Deviation 10.55 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Bodily Pain | 42.40 units on a scale | Standard Deviation 10.22 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:General Health | 38.95 units on a scale | Standard Deviation 9.51 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Social Functioning | 43.33 units on a scale | Standard Deviation 12.27 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Role Emotional | 41.07 units on a scale | Standard Deviation 13.18 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Health | 44.85 units on a scale | Standard Deviation 14.61 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Component Score | 37.84 units on a scale | Standard Deviation 9.59 |
| Placebo | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Component Score | 46.17 units on a scale | Standard Deviation 15.06 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Social Functioning | 40.38 units on a scale | Standard Deviation 11.11 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Health | 46.19 units on a scale | Standard Deviation 9.65 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Bodily Pain | 39.60 units on a scale | Standard Deviation 9.01 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6: Role Physical | 38.02 units on a scale | Standard Deviation 9.81 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Mental Component Score | 46.03 units on a scale | Standard Deviation 11.52 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Component Score | 35.43 units on a scale | Standard Deviation 8.69 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Vitality | 44.26 units on a scale | Standard Deviation 8.73 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Physical Functioning | 33.97 units on a scale | Standard Deviation 10.58 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:Role Emotional | 39.53 units on a scale | Standard Deviation 12.93 |
| Placebo, Then CP-690,550 10 mg | 36-Item Short-Form Health Survey (SF-36) at Month 6 | Month 6:General Health | 37.89 units on a scale | Standard Deviation 8.45 |
Secondary
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Baseline, Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Baseline (n=133,134,132) | 5.38 units on a scale | Standard Deviation 1 |
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Week 2 (n=127,125,124) | 4.46 units on a scale | Standard Deviation 1.23 |
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Month 1 (n=123,123,123) | 4.14 units on a scale | Standard Deviation 1.27 |
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Month 3 (n=118,124,118) | 3.74 units on a scale | Standard Deviation 1.31 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Month 3 (n=118,124,118) | 3.45 units on a scale | Standard Deviation 1.32 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Baseline (n=133,134,132) | 5.31 units on a scale | Standard Deviation 0.9 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Month 1 (n=123,123,123) | 3.92 units on a scale | Standard Deviation 1.19 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Week 2 (n=127,125,124) | 4.13 units on a scale | Standard Deviation 1.04 |
| Placebo | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Month 3 (n=118,124,118) | 4.78 units on a scale | Standard Deviation 1.34 |
| Placebo | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Week 2 (n=127,125,124) | 5.10 units on a scale | Standard Deviation 1.13 |
| Placebo | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Month 1 (n=123,123,123) | 4.92 units on a scale | Standard Deviation 1.2 |
| Placebo | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1 and 3 | Baseline (n=133,134,132) | 5.39 units on a scale | Standard Deviation 0.95 |
Secondary
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 6 (n=100,102,51,48) | 3.36 units on a scale | Standard Deviation 1.24 |
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 4.5 (n=112,113,56,51) | 3.43 units on a scale | Standard Deviation 1.25 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 4.5 (n=112,113,56,51) | 3.30 units on a scale | Standard Deviation 1.37 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 6 (n=100,102,51,48) | 3.07 units on a scale | Standard Deviation 1.18 |
| Placebo | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 6 (n=100,102,51,48) | 3.46 units on a scale | Standard Deviation 1.13 |
| Placebo | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 4.5 (n=112,113,56,51) | 3.57 units on a scale | Standard Deviation 1.15 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 4.5 (n=112,113,56,51) | 3.69 units on a scale | Standard Deviation 1.15 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4.5 and 6 | Month 6 (n=100,102,51,48) | 3.68 units on a scale | Standard Deviation 1.19 |
Secondary
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline (n=126,128,130) | 6.48 units on a scale | Standard Deviation 1.03 |
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Month 3 (n=112,121,110) | 4.58 units on a scale | Standard Deviation 1.39 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline (n=126,128,130) | 6.40 units on a scale | Standard Deviation 0.89 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Month 3 (n=112,121,110) | 4.26 units on a scale | Standard Deviation 1.48 |
| Placebo | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Baseline (n=126,128,130) | 6.47 units on a scale | Standard Deviation 0.98 |
| Placebo | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | Month 3 (n=112,121,110) | 5.56 units on a scale | Standard Deviation 1.45 |
Secondary
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 3.99 units on a scale | Standard Deviation 1.41 |
| CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 3.70 units on a scale | Standard Deviation 1.25 |
| Placebo | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 4.07 units on a scale | Standard Deviation 1.26 |
| Placebo, Then CP-690,550 10 mg | Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | 4.39 units on a scale | Standard Deviation 1.27 |
Secondary
Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 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 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Month 1 (n=122,121,120) | 0.56 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Baseline (n=131,134,129) | 0.38 units on a scale | Standard Deviation 0.34 |
| CP-690,550 5 mg | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Month 3 (n=117,123,117) | 0.55 units on a scale | Standard Deviation 0.3 |
| CP-690,550 10 mg | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Month 1 (n=122,121,120) | 0.63 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Baseline (n=131,134,129) | 0.47 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Month 3 (n=117,123,117) | 0.62 units on a scale | Standard Deviation 0.25 |
| Placebo | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Baseline (n=131,134,129) | 0.38 units on a scale | Standard Deviation 0.33 |
| Placebo | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Month 3 (n=117,123,117) | 0.43 units on a scale | Standard Deviation 0.35 |
| Placebo | Euro Quality of Life - 5 Dimensions (EQ-5D)- Health State Profile Utility Score at Baseline, Month 1 and 3 | Month 1 (n=122,121,120) | 0.49 units on a scale | Standard Deviation 0.3 |
Secondary
Euro Quality of Life - 5 Dimensions (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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP-690,550 5 mg | Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6 | 0.62 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg | Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6 | 0.68 units on a scale | Standard Deviation 0.24 |
| Placebo | Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6 | 0.60 units on a scale | Standard Deviation 0.24 |
| Placebo, Then CP-690,550 10 mg | Euro Quality of Life - 5 Dimensions (EQ-5D) - Health State Profile Utility Score at Month 6 | 0.55 units on a scale | Standard Deviation 0.29 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
FACIT-Fatigue Scale (FS):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-FS 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm 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=132,134,129) | 27.84 units on a scale | Standard Deviation 11.12 |
| CP-690,550 5 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Month 3 (n=118,125,117) | 33.30 units on a scale | Standard Deviation 11.72 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline (n=132,134,129) | 29.48 units on a scale | Standard Deviation 11.39 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Month 3 (n=118,125,117) | 33.66 units on a scale | Standard Deviation 12.27 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Baseline (n=132,134,129) | 26.98 units on a scale | Standard Deviation 11.52 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | Month 3 (n=118,125,117) | 27.93 units on a scale | Standard Deviation 12.36 |
Secondary
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
FACIT-FS: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-FS 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies 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 | 34.69 units on a scale | Standard Deviation 10.81 |
| CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 35.98 units on a scale | Standard Deviation 11.55 |
| Placebo | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 33.57 units on a scale | Standard Deviation 12.21 |
| Placebo, Then CP-690,550 10 mg | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | 31.63 units on a scale | Standard Deviation 10.16 |
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 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 4.5 (n=112,114,57,53) | 1.19 units on a scale | Standard Deviation 0.69 |
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 1.10 units on a scale | Standard Deviation 0.7 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 1.02 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 4.5 (n=112,114,57,53) | 1.10 units on a scale | Standard Deviation 0.7 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 4.5 (n=112,114,57,53) | 1.08 units on a scale | Standard Deviation 0.6 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 1.00 units on a scale | Standard Deviation 0.59 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 4.5 (n=112,114,57,53) | 1.26 units on a scale | Standard Deviation 0.75 |
| Placebo, Then CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 1.29 units on a scale | Standard Deviation 0.72 |
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty.
Time frame: Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Month 1 (n=123,123,123) | 1.37 units on a scale | Standard Deviation 0.68 |
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Week 2 (n=130,128,125) | 1.38 units on a scale | Standard Deviation 0.71 |
| CP-690,550 5 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Month 3 (n=118,125,118) | 1.20 units on a scale | Standard Deviation 0.72 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Month 1 (n=123,123,123) | 1.19 units on a scale | Standard Deviation 0.65 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Week 2 (n=130,128,125) | 1.28 units on a scale | Standard Deviation 0.58 |
| CP-690,550 10 mg | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Month 3 (n=118,125,118) | 1.10 units on a scale | Standard Deviation 0.66 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Week 2 (n=130,128,125) | 1.49 units on a scale | Standard Deviation 0.63 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Month 3 (n=118,125,118) | 1.44 units on a scale | Standard Deviation 0.72 |
| Placebo | Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, Month 1 and 3 | Month 1 (n=123,123,123) | 1.38 units on a scale | Standard Deviation 0.72 |
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score\[RS\] minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute.
Time frame: Baseline, Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Problem Summary (n=117,125,117) | 36.81 units on a scale | Standard Deviation 21.1 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Awakened Short of Breath (n=129,127,125) | 17.83 units on a scale | Standard Deviation 25.28 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Disturbance (n=133,133,129) | 47.43 units on a scale | Standard Deviation 28.39 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Snoring (n=124,122,120) | 36.13 units on a scale | Standard Deviation 33.42 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Disturbance (n=129,127,125) | 39.59 units on a scale | Standard Deviation 28.24 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Somnolence (n=117,125,117) | 30.14 units on a scale | Standard Deviation 23.53 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Quantity (n=124,123,123) | 6.59 units on a scale | Standard Deviation 1.34 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Quantity (n=129,127,124) | 6.40 units on a scale | Standard Deviation 1.57 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Disturbance (n=118,125,117) | 38.44 units on a scale | Standard Deviation 28.37 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Disturbance (n=124,123,123) | 39.12 units on a scale | Standard Deviation 28.16 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Snoring (n=128,125,122) | 36.25 units on a scale | Standard Deviation 34.21 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Quantity (n=132,131,129) | 6.47 units on a scale | Standard Deviation 1.55 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Adequacy (n=133,133,129) | 46.39 units on a scale | Standard Deviation 27.89 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Awakened Short of Breath (n=124,123,123) | 15.81 units on a scale | Standard Deviation 21.53 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Problem Summary (n=124,123,123) | 36.21 units on a scale | Standard Deviation 20.69 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Awakened Short of Breath (n=118,125,117) | 18.14 units on a scale | Standard Deviation 23.68 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Adequacy (n=124,123,123) | 49.84 units on a scale | Standard Deviation 28.31 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Overall Sleep Problem (n=124,123,123) | 37.23 units on a scale | Standard Deviation 20.7 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Snoring (n=131,131,127) | 42.14 units on a scale | Standard Deviation 31.89 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Overall Sleep Problem (n=133,132,129) | 43.10 units on a scale | Standard Deviation 21 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Adequacy (n=118,125,117) | 48.64 units on a scale | Standard Deviation 30.32 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Somnolence (n=133,132,129) | 36.39 units on a scale | Standard Deviation 22.47 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Snoring (n=118,123,117) | 36.44 units on a scale | Standard Deviation 32.83 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Overall Sleep Problem (n=117,125,117) | 37.23 units on a scale | Standard Deviation 20.72 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Problem Summary (n=129,127,125) | 36.87 units on a scale | Standard Deviation 20.84 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Awakened Short of Breath (n=133,133,130) | 16.99 units on a scale | Standard Deviation 24.56 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Somnolence (n=124,123,123) | 30.91 units on a scale | Standard Deviation 22.3 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Overall Sleep Problem (n=129,127,124) | 38.04 units on a scale | Standard Deviation 20.78 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Problem Summary (n=133,132,129) | 40.55 units on a scale | Standard Deviation 21.13 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Somnolence (n=129,127,124) | 31.78 units on a scale | Standard Deviation 21.85 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Adequacy (n=129,127,125) | 48.06 units on a scale | Standard Deviation 28.7 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Quantity (n=117,124,117) | 6.58 units on a scale | Standard Deviation 1.5 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Somnolence (n=117,125,117) | 31.31 units on a scale | Standard Deviation 23.68 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Problem Summary (n=133,132,129) | 39.87 units on a scale | Standard Deviation 18.03 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Overall Sleep Problem (n=133,132,129) | 41.57 units on a scale | Standard Deviation 17.88 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Adequacy (n=133,133,129) | 43.16 units on a scale | Standard Deviation 25.89 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Awakened Short of Breath (n=133,133,130) | 19.10 units on a scale | Standard Deviation 24.1 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Disturbance (n=133,133,129) | 43.20 units on a scale | Standard Deviation 24.83 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Quantity (n=132,131,129) | 6.44 units on a scale | Standard Deviation 1.35 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Snoring (n=131,131,127) | 37.10 units on a scale | Standard Deviation 33.75 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Somnolence (n=133,132,129) | 34.19 units on a scale | Standard Deviation 22.83 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Problem Summary (n=129,127,125) | 37.03 units on a scale | Standard Deviation 18.97 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Overall Sleep Problem (n=129,127,124) | 37.69 units on a scale | Standard Deviation 18.83 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Adequacy (n=129,127,125) | 44.17 units on a scale | Standard Deviation 28.35 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Awakened Short of Breath (n=129,127,125) | 17.32 units on a scale | Standard Deviation 21.58 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Disturbance (n=129,127,125) | 36.41 units on a scale | Standard Deviation 22.89 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Quantity (n=129,127,124) | 6.68 units on a scale | Standard Deviation 1.41 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Snoring (n=128,125,122) | 35.84 units on a scale | Standard Deviation 34.48 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Somnolence (n=129,127,124) | 32.18 units on a scale | Standard Deviation 23.47 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Problem Summary (n=124,123,123) | 34.53 units on a scale | Standard Deviation 20.08 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Overall Sleep Problem (n=124,123,123) | 35.40 units on a scale | Standard Deviation 19.94 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Adequacy (n=124,123,123) | 48.13 units on a scale | Standard Deviation 29.35 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Awakened Short of Breath (n=124,123,123) | 15.45 units on a scale | Standard Deviation 23.16 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Disturbance (n=124,123,123) | 34.82 units on a scale | Standard Deviation 25.12 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Quantity (n=124,123,123) | 6.80 units on a scale | Standard Deviation 1.43 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Snoring (n=124,122,120) | 34.10 units on a scale | Standard Deviation 32.8 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Problem Summary (n=117,125,117) | 35.68 units on a scale | Standard Deviation 19.36 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Somnolence (n=124,123,123) | 30.84 units on a scale | Standard Deviation 23.97 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Overall Sleep Problem (n=117,125,117) | 36.08 units on a scale | Standard Deviation 19.4 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Adequacy (n=118,125,117) | 48.56 units on a scale | Standard Deviation 29.04 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Awakened Short of Breath (n=118,125,117) | 19.68 units on a scale | Standard Deviation 24.09 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Disturbance (n=118,125,117) | 34.61 units on a scale | Standard Deviation 23.21 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Quantity (n=117,124,117) | 6.71 units on a scale | Standard Deviation 1.42 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Snoring (n=118,123,117) | 36.26 units on a scale | Standard Deviation 32.63 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Awakened Short of Breath (n=129,127,125) | 18.72 units on a scale | Standard Deviation 25.75 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Disturbance (n=118,125,117) | 43.27 units on a scale | Standard Deviation 26.45 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Snoring (n=124,122,120) | 41.50 units on a scale | Standard Deviation 33.12 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Somnolence (n=124,123,123) | 34.91 units on a scale | Standard Deviation 23.67 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Adequacy (n=129,127,125) | 42.72 units on a scale | Standard Deviation 26.77 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Awakened Short of Breath (n=133,133,130) | 21.54 units on a scale | Standard Deviation 26.19 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Somnolence (n=117,125,117) | 36.47 units on a scale | Standard Deviation 23.1 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Snoring (n=128,125,122) | 40.49 units on a scale | Standard Deviation 32.67 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Overall Sleep Problem (n=129,127,124) | 41.47 units on a scale | Standard Deviation 20.01 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Problem Summary (n=129,127,125) | 40.35 units on a scale | Standard Deviation 20.1 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Overall Sleep Problem (n=133,132,129) | 46.08 units on a scale | Standard Deviation 20.73 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Problem Summary (n=117,125,117) | 40.14 units on a scale | Standard Deviation 20.2 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Somnolence (n=133,132,129) | 38.55 units on a scale | Standard Deviation 23.6 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Quantity (n=117,124,117) | 6.27 units on a scale | Standard Deviation 1.49 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Overall Sleep Problem (n=117,125,117) | 42.00 units on a scale | Standard Deviation 20.41 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Snoring (n=131,131,127) | 40.00 units on a scale | Standard Deviation 33.62 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Adequacy (n=133,133,129) | 39.53 units on a scale | Standard Deviation 27.95 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Sleep Adequacy (n=118,125,117) | 43.68 units on a scale | Standard Deviation 27.47 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Quantity (n=132,131,129) | 6.33 units on a scale | Standard Deviation 1.46 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Overall Sleep Problem (n=124,123,123) | 38.79 units on a scale | Standard Deviation 20.58 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Problem Summary (n=124,123,123) | 37.37 units on a scale | Standard Deviation 20.42 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Problem Summary (n=133,132,129) | 44.65 units on a scale | Standard Deviation 20.56 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Adequacy (n=124,123,123) | 49.11 units on a scale | Standard Deviation 28.86 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Somnolence (n=129,127,124) | 36.45 units on a scale | Standard Deviation 23.18 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Awakened Short of Breath (n=118,125,117) | 17.95 units on a scale | Standard Deviation 24.27 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Awakened Short of Breath (n=124,123,123) | 19.84 units on a scale | Standard Deviation 26.3 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Quantity (n=129,127,124) | 6.48 units on a scale | Standard Deviation 1.75 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Baseline: Sleep Disturbance (n=133,133,129) | 47.98 units on a scale | Standard Deviation 27 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Disturbance (n=124,123,123) | 39.64 units on a scale | Standard Deviation 26.26 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Week 2: Sleep Disturbance (n=129,127,125) | 42.28 units on a scale | Standard Deviation 26.45 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 3: Snoring (n=118,123,117) | 41.37 units on a scale | Standard Deviation 31.92 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1 and 3 | Month 1: Sleep Quantity (n=124,123,123) | 6.43 units on a scale | Standard Deviation 1.42 |
Secondary
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem.Except adequacy,optimal sleep and quantity,higher scores=more impairment.Scores transformed(actual raw score\[RS\] minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Quantity | 6.56 units on a scale | Standard Deviation 1.45 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Awakened Short of Breath | 16.73 units on a scale | Standard Deviation 24.15 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Disturbance | 36.84 units on a scale | Standard Deviation 26.19 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Adequacy | 50.48 units on a scale | Standard Deviation 30.64 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Problem Summary | 35.32 units on a scale | Standard Deviation 21.46 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Snoring | 34.62 units on a scale | Standard Deviation 31.8 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Somnolence | 29.74 units on a scale | Standard Deviation 22.24 |
| CP-690,550 5 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Overall Sleep Problem | 35.75 units on a scale | Standard Deviation 20.68 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Somnolence | 26.14 units on a scale | Standard Deviation 19.4 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Adequacy | 52.75 units on a scale | Standard Deviation 28.46 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Awakened Short of Breath | 14.12 units on a scale | Standard Deviation 22.62 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Overall Sleep Problem | 32.92 units on a scale | Standard Deviation 18.33 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Disturbance | 33.88 units on a scale | Standard Deviation 23.51 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Quantity | 6.93 units on a scale | Standard Deviation 1.29 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Problem Summary | 32.03 units on a scale | Standard Deviation 18.42 |
| CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Snoring | 35.84 units on a scale | Standard Deviation 31.79 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Snoring | 37.96 units on a scale | Standard Deviation 31.95 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Problem Summary | 38.78 units on a scale | Standard Deviation 20.81 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Overall Sleep Problem | 39.73 units on a scale | Standard Deviation 20.85 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Adequacy | 43.47 units on a scale | Standard Deviation 30.99 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Somnolence | 30.61 units on a scale | Standard Deviation 22.56 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Awakened Short of Breath | 18.37 units on a scale | Standard Deviation 21.54 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Disturbance | 40.92 units on a scale | Standard Deviation 26.89 |
| Placebo | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Quantity | 6.27 units on a scale | Standard Deviation 1.29 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Disturbance | 35.10 units on a scale | Standard Deviation 25.26 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Adequacy | 50.42 units on a scale | Standard Deviation 26.89 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Somnolence | 33.19 units on a scale | Standard Deviation 20.09 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Problem Summary | 35.35 units on a scale | Standard Deviation 19.05 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Sleep Quantity | 6.80 units on a scale | Standard Deviation 1.26 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Snoring | 38.75 units on a scale | Standard Deviation 32.59 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Awakened Short of Breath | 17.92 units on a scale | Standard Deviation 21.13 |
| Placebo, Then CP-690,550 10 mg | Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | Month 6: Overall Sleep Problem | 36.02 units on a scale | Standard Deviation 18.45 |
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 were reported.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days on sick leave (n=17,22,28) | 19.76 days | Standard Deviation 25.59 |
| 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=1,0,2) | 12.00 days | — |
| 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=21,10,26) | 113.24 days | Standard Deviation 102.65 |
| 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=6,6,11) | 41.33 days | Standard Deviation 40.41 |
| 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=4,4,5) | 8.25 days | Standard Deviation 9.46 |
| 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=1,1,1) | 9.00 days | — |
| 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=36,40,32) | 50.72 days | Standard Deviation 63.36 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days devices/aids used (n=31,18,24) | 122.94 days | Standard Deviation 139.56 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: RA related devices/aids used (31,20,24) | 2.06 days | Standard Deviation 1.59 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: RA related devices/aids used (22,11,27) | 2.09 days | Standard Deviation 1.31 |
| 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=11,13,16) | 22.09 days | Standard Deviation 28.51 |
| 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=39,46,41) | 4.67 days | Standard Deviation 1.24 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospital length of stay (n=4,4,7) | 1.75 days | Standard Deviation 0.96 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Chores by family/friend (n=50,41,52) | 27.30 days | Standard Deviation 31.13 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Chores by housekeeper (n=20,18,24) | 13.35 days | Standard Deviation 20.32 |
| 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=19,29,28) | 26.58 days | Standard Deviation 30.3 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Chores by housekeeper (n=15,14,17) | 13.00 days | Standard Deviation 16.76 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Chores by family/friend (n=71,65,66) | 27.55 days | Standard Deviation 31.88 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days in nursing home (n=1,1,1) | 2.00 days | — |
| 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=33,47,37) | 4.94 days | Standard Deviation 1.09 |
| 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=4,4,5) | 9.25 days | Standard Deviation 7.89 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days in nursing home (n=1,1,1) | 28.00 days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days devices/aids used (n=31,18,24) | 100.28 days | Standard Deviation 122.82 |
| 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=39,46,41) | 4.83 days | Standard Deviation 1.29 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Chores by housekeeper (n=20,18,24) | 20.56 days | Standard Deviation 32.53 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Chores by family/friend (n=71,65,66) | 26.31 days | Standard Deviation 32.27 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days on sick leave (n=17,22,28) | 13.09 days | Standard Deviation 16.15 |
| 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=6,6,11) | 6.83 days | Standard Deviation 4.96 |
| 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=36,40,32) | 39.75 days | Standard Deviation 32.85 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: RA related devices/aids used (31,20,24) | 1.75 days | Standard Deviation 1.48 |
| 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=1,0,2) | NA days | — |
| 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=1,1,1) | 21.00 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=21,10,26) | 264.10 days | Standard Deviation 429.48 |
| 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=33,47,37) | 4.89 days | Standard Deviation 1.09 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Chores by housekeeper (n=15,14,17) | 16.93 days | Standard Deviation 31.22 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Chores by family/friend (n=50,41,52) | 24.24 days | Standard Deviation 32.54 |
| 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=11,13,16) | 6.62 days | Standard Deviation 4.94 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospital length of stay (n=4,4,7) | 7.00 days | Standard Deviation 7.57 |
| 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=19,29,28) | 17.76 days | Standard Deviation 23.98 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: RA related devices/aids used (22,11,27) | 3.00 days | Standard Deviation 4.45 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Chores by family/friend (n=71,65,66) | 27.38 days | Standard Deviation 30.75 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Days of part time work (n=4,4,5) | 8.20 days | Standard Deviation 11.12 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Days of work per week (n=33,47,37) | 4.65 days | Standard Deviation 1.06 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Chores by housekeeper (n=20,18,24) | 15.88 days | Standard Deviation 23.45 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospital length of stay (n=4,4,7) | 5.43 days | Standard Deviation 3.78 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days of work per week (n=39,46,41) | 4.90 days | Standard Deviation 1.18 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: RA related devices/aids used (22,11,27) | 2.04 days | Standard Deviation 1.26 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Chores by family/friend (n=50,41,52) | 25.19 days | Standard Deviation 36.03 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days devices/aids used (n=31,18,24) | 94.63 days | Standard Deviation 86.62 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Paid work, bothered by RA (n=36,40,32) | 31.00 days | Standard Deviation 30.79 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Paid work, bothered by RA (n=19,29,28) | 30.54 days | Standard Deviation 30.39 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: RA related devices/aids used (31,20,24) | 1.79 days | Standard Deviation 0.88 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Days on sick leave (n=11,13,16) | 13.69 days | Standard Deviation 20.16 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Hospital length of stay (n=1,0,2) | 11.00 days | Standard Deviation 12.73 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days of part time work (n=6,6,11) | 12.36 days | Standard Deviation 16.2 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days in nursing home (n=1,1,1) | 28.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Days in nursing home (n=1,1,1) | 21.00 days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Days on sick leave (n=17,22,28) | 23.71 days | Standard Deviation 31.28 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Chores by housekeeper (n=15,14,17) | 10.12 days | Standard Deviation 12.84 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Days devices/aids used (n=21,10,26) | 73.85 days | Standard Deviation 70.6 |
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 were reported.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of part time work (n=3,3,0,3) | 5.67 days | Standard Deviation 8.08 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: RA related devices/aids used (19,8,5,8) | 2.05 days | Standard Deviation 1.22 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital length of stay (n=2,1,2,1) | 32.00 days | Standard Deviation 33.94 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days devices/aids used (n=18,7,5,8) | 141.28 days | Standard Deviation 105.31 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of work per week (n=34,36,20,14) | 4.62 days | Standard Deviation 1.33 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Paid work, bothered by RA (n=21,19,12,11) | 25.00 days | Standard Deviation 32.76 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=32,23,18,19) | 28.91 days | Standard Deviation 32.1 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days in nursing home (n=2,0,0,2) | 21.50 days | Standard Deviation 0.71 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days on sick leave (n=7,10,5,5) | 21.00 days | Standard Deviation 31.86 |
| CP-690,550 5 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 12.75 days | Standard Deviation 13.21 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=32,23,18,19) | 18.83 days | Standard Deviation 26.97 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days devices/aids used (n=18,7,5,8) | 68.43 days | Standard Deviation 30.12 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital length of stay (n=2,1,2,1) | 3.00 days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of work per week (n=34,36,20,14) | 4.97 days | Standard Deviation 1 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 24.89 days | Standard Deviation 36.09 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of part time work (n=3,3,0,3) | 9.33 days | Standard Deviation 5.03 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days in nursing home (n=2,0,0,2) | NA days | — |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Paid work, bothered by RA (n=21,19,12,11) | 14.95 days | Standard Deviation 20.85 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days on sick leave (n=7,10,5,5) | 10.40 days | Standard Deviation 14.49 |
| CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: RA related devices/aids used (19,8,5,8) | 1.13 days | Standard Deviation 0.64 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days in nursing home (n=2,0,0,2) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=32,23,18,19) | 19.33 days | Standard Deviation 24.14 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of part time work (n=3,3,0,3) | NA days | — |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days devices/aids used (n=18,7,5,8) | 182.40 days | Standard Deviation 87.11 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: RA related devices/aids used (19,8,5,8) | 2.20 days | Standard Deviation 0.84 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days on sick leave (n=7,10,5,5) | 9.20 days | Standard Deviation 11.17 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of work per week (n=34,36,20,14) | 4.85 days | Standard Deviation 0.99 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital length of stay (n=2,1,2,1) | 25.00 days | Standard Deviation 21.21 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Paid work, bothered by RA (n=21,19,12,11) | 22.17 days | Standard Deviation 31.98 |
| Placebo | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 9.22 days | Standard Deviation 10.73 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: RA related devices/aids used (19,8,5,8) | 1.63 days | Standard Deviation 1.19 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital length of stay (n=2,1,2,1) | 24.00 days | — |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days in nursing home (n=2,0,0,2) | 13.50 days | Standard Deviation 2.12 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days devices/aids used (n=18,7,5,8) | 75.00 days | Standard Deviation 79.33 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of work per week (n=34,36,20,14) | 4.71 days | Standard Deviation 1.49 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 7.80 days | Standard Deviation 4.55 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=32,23,18,19) | 17.63 days | Standard Deviation 26.46 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days on sick leave (n=7,10,5,5) | 42.60 days | Standard Deviation 44.81 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Days of part time work (n=3,3,0,3) | 21.33 days | Standard Deviation 33.49 |
| Placebo, Then CP-690,550 10 mg | Number of Days as Assessed Using RA-HCRU at Month 6 | Month 6: Paid work, bothered by RA (n=21,19,12,11) | 19.64 days | Standard Deviation 21.73 |
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 events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospitalization (n=4,4,7) | 1.25 number of events | Standard Deviation 0.5 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Outpatient surgery (n=7,3,4) | 1.14 number of 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: Doctor visit (n=119,121,111) | 5.07 number of events | Standard Deviation 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: NM practitioner visits (n=4,6,5) | 5.75 number of events | Standard Deviation 4.35 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospital ER visit (n=14,5,9) | 1.79 number of events | Standard Deviation 1.53 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baselin:RA related NM visit (n=4,7,5) | 1.25 number of events | Standard Deviation 0.96 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Outpatient surgery (n=6,4,8) | 1.17 number of events | Standard Deviation 0.41 |
| 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 tests (n=34,32,32) | 1.85 number of events | Standard Deviation 1.02 |
| 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=117,120,111) | 1.46 number of events | Standard Deviation 0.91 |
| 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=15,6,9) | 0.67 number of events | Standard Deviation 0.9 |
| 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=35,33,34) | 0.71 number of events | Standard Deviation 0.83 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: RA related hospitalization (n=4,5,7) | 0.75 number of events | Standard Deviation 0.96 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: RA related outpatient surgery (n=6,5,9) | 0.33 number of events | Standard Deviation 0.82 |
| 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=89,99,93) | 3.30 number of events | Standard Deviation 2.91 |
| 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: NM practitioners visits (n=4,4,4) | 36.25 number of events | Standard Deviation 40.25 |
| 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=7,8,8) | 1.00 number of 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: Hospitalization (n=1,0,2) | 1.00 number of events | — |
| 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 tests (n=22,22,26) | 1.82 number of events | Standard Deviation 1.65 |
| 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=90,98,93) | 1.16 number of events | Standard Deviation 1.08 |
| 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=7,8,8) | 0.43 number of events | Standard Deviation 0.79 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: RA related diagnostic test (n=23,22,26) | 0.30 number of events | Standard Deviation 0.47 |
| 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=1,0,2) | 0.00 number of events | — |
| 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=7,3,4) | 0.43 number of events | Standard Deviation 0.79 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related NM visit (n=4,4,4) | 0.75 number of events | Standard Deviation 0.96 |
| 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=4,5,7) | 0.80 number of events | Standard Deviation 1.1 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baselin:RA related NM visit (n=4,7,5) | 0.57 number of events | Standard Deviation 0.53 |
| 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=1,0,2) | NA number of 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: Non-study diagnostic tests (n=34,32,32) | 2.06 number of events | Standard Deviation 1.72 |
| 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 NM visit (n=4,4,4) | 1.25 number of events | Standard Deviation 0.96 |
| 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=7,3,4) | 1.00 number of 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 hospitalization (n=1,0,2) | NA number of 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 outpatient surgery (n=6,5,9) | 0.80 number of events | Standard Deviation 0.84 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related outpatient surgery (n=7,3,4) | 0.67 number of events | Standard Deviation 1.15 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Hospital ER visit (n=7,8,8) | 1.38 number of events | Standard Deviation 1.06 |
| 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=119,121,111) | 5.09 number of events | Standard Deviation 5.1 |
| 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=90,98,93) | 0.82 number of events | Standard Deviation 0.65 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: RA related diagnostic test (n=35,33,34) | 0.79 number of events | Standard Deviation 1.14 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: NM practitioner visits (n=4,6,5) | 4.83 number of events | Standard Deviation 3.25 |
| 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=7,8,8) | 0.00 number of 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 diagnostic test (n=23,22,26) | 0.23 number of events | Standard Deviation 0.43 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospital ER visit (n=14,5,9) | 2.00 number of events | Standard Deviation 1.73 |
| 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=89,99,93) | 3.69 number of events | Standard Deviation 3.73 |
| 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=117,120,111) | 1.18 number of events | Standard Deviation 0.84 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Hospitalization (n=4,4,7) | 1.00 number of 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: RA related ER visit (n=15,6,9) | 0.67 number of 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: NM practitioners visits (n=4,4,4) | 5.00 number of events | Standard Deviation 2 |
| 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=6,4,8) | 1.00 number of 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: Non-study diagnostic tests (n=22,22,26) | 1.14 number of events | Standard Deviation 0.35 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: Outpatient surgery (n=6,4,8) | 1.00 number of 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 tests (n=34,32,32) | 1.69 number of 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 | Month 3: Non-study diagnostic tests (n=22,22,26) | 1.62 number of events | Standard Deviation 1.27 |
| 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=117,120,111) | 1.44 number of events | Standard Deviation 0.93 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3:RA related NM visit (n=4,4,4) | 1.25 number of events | Standard Deviation 0.96 |
| 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=15,6,9) | 0.89 number of events | Standard Deviation 0.93 |
| 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=35,33,34) | 0.82 number of 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 doctor visit (n=90,98,93) | 1.13 number of 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: RA related hospitalization (n=4,5,7) | 0.86 number of events | Standard Deviation 0.69 |
| 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=6,5,9) | 0.89 number of events | Standard Deviation 0.93 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baselin:RA related NM visit (n=4,7,5) | 1.00 number of events | Standard Deviation 1 |
| 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=89,99,93) | 4.04 number of events | Standard Deviation 4.59 |
| 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=7,8,8) | 0.75 number of events | Standard Deviation 1.39 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: NM practitioners visits (n=4,4,4) | 8.75 number of events | Standard Deviation 10.63 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3: Hospitalization (n=1,0,2) | 1.00 number of 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=7,3,4) | 1.00 number of events | Standard Deviation 1.15 |
| 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=1,0,2) | 0.00 number of 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: Doctor visit (n=119,121,111) | 4.58 number of events | Standard Deviation 3.82 |
| 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=7,8,8) | 1.38 number of events | Standard Deviation 0.74 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline: NM practitioner visits (n=4,6,5) | 21.40 number of events | Standard Deviation 29.75 |
| 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=14,5,9) | 1.22 number of events | Standard Deviation 0.44 |
| 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=7,3,4) | 1.00 number of 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: Hospitalization (n=4,4,7) | 1.14 number of events | Standard Deviation 0.38 |
| 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=23,22,26) | 0.35 number of events | Standard Deviation 0.56 |
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 events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related doctor visit (n=73,80,40,36) | 1.10 number of 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 | Month 6: RA related hospitalization (n=2,1,2,1) | 0.00 number of 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 | Month 6: NM practitioner visit (n=1,4,1,2) | 5.00 number of events | — |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Hospitalization (n=2,1,2,1) | 2.00 number of 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 | Month 6: Doctor visit (n=73,80,39,36) | 3.26 number of events | Standard Deviation 2.83 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6:RA related outpatient surgery (n=5,2,0,2) | 0.00 number of 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 | Month 6: Outpatient surgery (n=0,5,2,2) | NA number of events | — |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related diagnostic test (n=16,16,13,7) | 0.44 number of events | Standard Deviation 0.73 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related ER visit (n=4,7,3,1) | 0.00 number of 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 | Month6:RA related NM practitioner visit(n=1,4,1,2) | 1.00 number of events | — |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Non-study diagnostic test (n=15,16,13,7) | 2.07 number of events | Standard Deviation 2.02 |
| CP-690,550 5 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital ER visit (n=4,7,3,1) | 1.25 number of events | Standard Deviation 0.5 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Non-study diagnostic test (n=15,16,13,7) | 1.19 number of events | Standard Deviation 0.54 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related doctor visit (n=73,80,40,36) | 0.86 number of events | Standard Deviation 0.76 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related diagnostic test (n=16,16,13,7) | 0.00 number of 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 | Month 6: RA related ER visit (n=4,7,3,1) | 0.00 number of 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 | Month 6: NM practitioner visit (n=1,4,1,2) | 15.50 number of events | Standard Deviation 10.63 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital ER visit (n=4,7,3,1) | 1.43 number of events | Standard Deviation 0.79 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month6:RA related NM practitioner visit(n=1,4,1,2) | 2.00 number of events | Standard Deviation 1.63 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6:RA related outpatient surgery (n=5,2,0,2) | 2.00 number of 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 | Month 6: Outpatient surgery (n=0,5,2,2) | 1.00 number of 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 | Month 6: Doctor visit (n=73,80,39,36) | 3.84 number of events | Standard Deviation 4.25 |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related hospitalization (n=2,1,2,1) | 0.00 number of events | — |
| CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Hospitalization (n=2,1,2,1) | 1.00 number of events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month6:RA related NM practitioner visit(n=1,4,1,2) | 0.00 number of events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Doctor visit (n=73,80,39,36) | 3.64 number of events | Standard Deviation 4.03 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: NM practitioner visit (n=1,4,1,2) | 20.00 number of events | — |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Hospital ER visit (n=4,7,3,1) | 1.67 number of events | Standard Deviation 1.15 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Hospitalization (n=2,1,2,1) | 1.00 number of events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Outpatient surgery (n=0,5,2,2) | 2.50 number of events | Standard Deviation 0.71 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Non-study diagnostic test (n=15,16,13,7) | 1.85 number of events | Standard Deviation 0.99 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related doctor visit (n=73,80,40,36) | 0.85 number of events | Standard Deviation 0.83 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related ER visit (n=4,7,3,1) | 0.00 number of events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related diagnostic test (n=16,16,13,7) | 0.31 number of events | Standard Deviation 0.85 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related hospitalization (n=2,1,2,1) | 0.00 number of events | Standard Deviation 0 |
| Placebo | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6:RA related outpatient surgery (n=5,2,0,2) | NA number of 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 | Month 6: RA related diagnostic test (n=16,16,13,7) | 0.29 number of events | Standard Deviation 0.49 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Non-study diagnostic test (n=15,16,13,7) | 1.14 number of events | Standard Deviation 0.38 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: Outpatient surgery (n=0,5,2,2) | 1.50 number of events | Standard Deviation 0.71 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month6:RA related NM practitioner visit(n=1,4,1,2) | 1.00 number of events | Standard Deviation 1.41 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: RA related hospitalization (n=2,1,2,1) | 2.00 number of 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 | Month 6: Hospitalization (n=2,1,2,1) | 1.00 number of 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 | Month 6: Hospital ER visit (n=4,7,3,1) | 1.00 number of 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 | Month 6: Doctor visit (n=73,80,39,36) | 4.97 number of events | Standard Deviation 6.73 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6:RA related outpatient surgery (n=5,2,0,2) | 0.00 number of 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 | Month 6: RA related ER visit (n=4,7,3,1) | 0.00 number of 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 | Month 6: RA related doctor visit (n=73,80,40,36) | 1.00 number of events | Standard Deviation 0.96 |
| Placebo, Then CP-690,550 10 mg | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | Month 6: NM practitioner visit (n=1,4,1,2) | 4.00 number of events | Standard Deviation 0 |
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, hours affected per day and average number of hours missed work per day were reported.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Missed work due to RA (n=4,4,5) | 3.00 hours per day | Standard Deviation 2 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Work done (n=34,46,37) | 7.97 hours per day | Standard Deviation 4.72 |
| 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=6,6,11) | 2.67 hours per day | Standard Deviation 1.97 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Work done (n=39,45,41) | 9.41 hours per day | Standard Deviation 8.52 |
| 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=3,1,3) | 4.00 hours per day | Standard Deviation 3.46 |
| 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=2,2,5) | 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: Home healthcare services (n=2,1,4) | 5.00 hours per day | Standard Deviation 4.24 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Chores by family/friend (n=50,41,49) | 3.50 hours per day | Standard Deviation 3.72 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Chores by housekeeper (n=19,18,23) | 4.68 hours per day | Standard Deviation 3.23 |
| 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=3,1,3) | 1.33 hours per day | Standard Deviation 0.58 |
| 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=15,14,17) | 4.00 hours per day | Standard Deviation 2.2 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Chores by family/friend (n=71,63,66) | 2.85 hours per day | Standard Deviation 1.89 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Work done (n=34,46,37) | 9.20 hours per day | Standard Deviation 8.52 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Home healthcare services (n=2,1,4) | 3.00 hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Work done (n=39,45,41) | 8.18 hours per day | Standard Deviation 7.18 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Chores by housekeeper (n=19,18,23) | 3.83 hours per day | Standard Deviation 1.54 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Chores by family/friend (n=71,63,66) | 4.44 hours per day | Standard Deviation 11.21 |
| 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=6,6,11) | 3.17 hours per day | Standard Deviation 2.23 |
| 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=2,2,5) | 0.50 hours per day | Standard Deviation 0.71 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Home healthcare services (n=3,1,3) | 2.00 hours per day | — |
| 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=15,14,17) | 3.71 hours per day | Standard Deviation 1.14 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Chores by family/friend (n=50,41,49) | 2.83 hours per day | Standard Deviation 2.57 |
| 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=4,4,5) | 6.25 hours per day | Standard Deviation 6.18 |
| 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=3,1,3) | 1.00 hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Chores by housekeeper (n=19,18,23) | 4.78 hours per day | Standard Deviation 2.37 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Missed work due to RA (n=4,4,5) | 7.80 hours per day | Standard Deviation 9.12 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Chores by housekeeper (n=15,14,17) | 5.41 hours per day | Standard Deviation 5.26 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Work done (n=39,45,41) | 8.98 hours per day | Standard Deviation 7.35 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Work done (n=34,46,37) | 7.76 hours per day | Standard Deviation 1.98 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Chores by family/friend (n=50,41,49) | 4.00 hours per day | Standard Deviation 5.34 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Home healthcare services (n=2,1,4) | 7.25 hours per day | Standard Deviation 11.18 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: RA related home HC services (n=2,2,5) | 0.80 hours per day | Standard Deviation 0.84 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Missed work due to RA (n=6,6,11) | 7.55 hours per day | Standard Deviation 7.31 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: RA related home HC services (n=3,1,3) | 1.67 hours per day | Standard Deviation 0.58 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Month 3: Home healthcare services (n=3,1,3) | 9.33 hours per day | Standard Deviation 12.7 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | Baseline: Chores by family/friend (n=71,63,66) | 3.42 hours per day | Standard Deviation 2.61 |
Secondary
Number of Hours Per Day as Assessed 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, hours affected per day and average number of hours missed work per day were reported.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=31,22,18,19) | 3.16 hours per day | Standard Deviation 2.57 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 2.88 hours per day | Standard Deviation 2.36 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Work done (n=34,36,20,14) | 7.53 hours per day | Standard Deviation 2.19 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Home healthcare services (n=0,2,0,0) | NA hours per day | — |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Missed work due to RA (n=3,3,0,3) | 4.00 hours per day | Standard Deviation 0 |
| CP-690,550 5 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: RA related home HC services (n=0,2,0,0) | NA hours per day | — |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Missed work due to RA (n=3,3,0,3) | 2.67 hours per day | Standard Deviation 1.15 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: RA related home HC services (n=0,2,0,0) | 1.00 hours per day | Standard Deviation 0 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Home healthcare services (n=0,2,0,0) | 2.00 hours per day | Standard Deviation 1.41 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Work done (n=34,36,20,14) | 10.36 hours per day | Standard Deviation 9.85 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 3.78 hours per day | Standard Deviation 1.2 |
| CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=31,22,18,19) | 2.05 hours per day | Standard Deviation 1.05 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 5.00 hours per day | Standard Deviation 3.28 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Missed work due to RA (n=3,3,0,3) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=31,22,18,19) | 2.72 hours per day | Standard Deviation 1.67 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Home healthcare services (n=0,2,0,0) | NA hours per day | — |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Work done (n=34,36,20,14) | 7.65 hours per day | Standard Deviation 2.16 |
| Placebo | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: RA related home HC services (n=0,2,0,0) | NA hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: RA related home HC services (n=0,2,0,0) | NA hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by housekeeper (n=8,9,9,5) | 5.00 hours per day | Standard Deviation 1.58 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Home healthcare services (n=0,2,0,0) | NA hours per day | — |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Chores by family/friend (n=31,22,18,19) | 3.63 hours per day | Standard Deviation 5.58 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Missed work due to RA (n=3,3,0,3) | 2.00 hours per day | Standard Deviation 1.73 |
| Placebo, Then CP-690,550 10 mg | Number of Hours Per Day as Assessed RA-HCRU at Month 6 | Month 6: Work done (n=34,36,20,14) | 10.21 hours per day | Standard Deviation 8.78 |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Time frame: Baseline, Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Baseline (n= 133, 134, 132) | 53 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Week 2 (n= 130, 128, 126) | 52 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Month 1 (n= 124, 123, 124) | 59 participants |
| CP-690,550 5 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Month 3 (n= 118, 125, 118) | 53 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Month 3 (n= 118, 125, 118) | 56 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Baseline (n= 133, 134, 132) | 59 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Month 1 (n= 124, 123, 124) | 58 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Week 2 (n= 130, 128, 126) | 62 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Month 3 (n= 118, 125, 118) | 47 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Week 2 (n= 130, 128, 126) | 50 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Month 1 (n= 124, 123, 124) | 53 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Week 2, Month 1, and 3 | Baseline (n= 133, 134, 132) | 48 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 optimal by choosing yes or no. Number of participants with optimal sleep is reported.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies 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 | 50 participants |
| CP-690,550 10 mg | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 57 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | 21 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 | 24 participants |
Secondary
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Baseline, Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline (n=127,128,131) | 65.73 units on a scale | Standard Deviation 22.79 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 3 (n=119,124,116) | 38.91 units on a scale | Standard Deviation 27.11 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Week 2 (n=130,128,125) | 49.79 units on a scale | Standard Deviation 26.6 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 1 (n=124,122,123) | 45.59 units on a scale | Standard Deviation 26.02 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Week 2 (n=130,128,125) | 42.35 units on a scale | Standard Deviation 22.11 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 1 (n=124,122,123) | 39.09 units on a scale | Standard Deviation 24.05 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 3 (n=119,124,116) | 37.72 units on a scale | Standard Deviation 26.99 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline (n=127,128,131) | 60.10 units on a scale | Standard Deviation 23.16 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 3 (n=119,124,116) | 53.40 units on a scale | Standard Deviation 26.52 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline (n=127,128,131) | 60.74 units on a scale | Standard Deviation 23.5 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Week 2 (n=130,128,125) | 55.88 units on a scale | Standard Deviation 23.85 |
| Placebo | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 1 (n=124,122,123) | 52.29 units on a scale | Standard Deviation 25.65 |
Secondary
Patient Assessment of Arthritis Pain at Month 4.5 and 6
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 38.93 units on a scale | Standard Deviation 26.4 |
| CP-690,550 5 mg | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 34.38 units on a scale | Standard Deviation 25.33 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 29.56 units on a scale | Standard Deviation 22.77 |
| CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 35.01 units on a scale | Standard Deviation 24.6 |
| Placebo | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 33.11 units on a scale | Standard Deviation 23.44 |
| Placebo | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 31.37 units on a scale | Standard Deviation 24.76 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 40.62 units on a scale | Standard Deviation 26.67 |
| Placebo, Then CP-690,550 10 mg | Patient Assessment of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 40.71 units on a scale | Standard Deviation 25.88 |
Secondary
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 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 VAS, where 0 mm = very well and 100 mm = very poorly.
Time frame: Baseline, Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline (n=127,128,131) | 64.69 units on a scale | Standard Deviation 23.22 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Week 2 (n=130,128,124) | 48.24 units on a scale | Standard Deviation 25.54 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 1 (n=124,123,123) | 44.86 units on a scale | Standard Deviation 25.62 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 3 (n=119,125,118) | 41.23 units on a scale | Standard Deviation 27.06 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 3 (n=119,125,118) | 37.23 units on a scale | Standard Deviation 25.65 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline (n=127,128,131) | 58.79 units on a scale | Standard Deviation 23.59 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 1 (n=124,123,123) | 38.35 units on a scale | Standard Deviation 23.38 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Week 2 (n=130,128,124) | 41.75 units on a scale | Standard Deviation 21.79 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 3 (n=119,125,118) | 52.85 units on a scale | Standard Deviation 25.64 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Week 2 (n=130,128,124) | 57.70 units on a scale | Standard Deviation 23.77 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Month 1 (n=124,123,123) | 51.39 units on a scale | Standard Deviation 26.01 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1 and 3 | Baseline (n=127,128,131) | 61.87 units on a scale | Standard Deviation 22.92 |
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 VAS, where 0 mm = very well and 100 mm = very poorly.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 34.59 units on a scale | Standard Deviation 24.82 |
| CP-690,550 5 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 37.40 units on a scale | Standard Deviation 24.65 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 31.25 units on a scale | Standard Deviation 23.25 |
| CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 36.01 units on a scale | Standard Deviation 25.46 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 34.38 units on a scale | Standard Deviation 23.47 |
| Placebo | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 34.88 units on a scale | Standard Deviation 23.84 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 4.5 (n=112,115,56,53) | 38.79 units on a scale | Standard Deviation 26.17 |
| Placebo, Then CP-690,550 10 mg | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4.5 and 6 | Month 6 (n=104,103,51,49) | 38.61 units on a scale | Standard Deviation 22.27 |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6
ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies 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 6 | 51.52 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 4.5 | 54.55 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 4.5 | 47.37 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 | 54.89 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6 | Month 4.5 | 50.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4.5 and 6 | Month 6 | 45.45 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 | 40.00 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 4.5 | 46.15 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1
ACR20 response: \>=20% improvement in TJC; \>=20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies 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 and Month 1 | Week 2 | 27.69 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 | Month 1 | 42.42 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 | Week 2 | 32.81 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 | Month 1 | 44.36 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 | Week 2 | 16.67 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2 and Month 1 | Month 1 | 27.48 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6
ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4.5 and 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies 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 4.5 | 28.79 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 | 37.12 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 | 30.08 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 4.5 | 28.57 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6 | Month 4.5 | 30.30 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4.5 and 6 | Month 6 | 28.79 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 4.5 | 20.00 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 | 20.00 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3
ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies 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 and 3 | Month 1 | 12.88 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Week 2 | 7.69 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Month 3 | 26.52 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Month 1 | 17.29 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Week 2 | 5.47 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Month 3 | 27.82 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Week 2 | 1.59 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Month 3 | 8.40 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1 and 3 | Month 1 | 6.11 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 TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies 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 4.5 | 10.61 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 | 15.91 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 | 15.79 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 4.5 | 12.78 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6 | Month 4.5 | 12.12 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4.5 and 6 | Month 6 | 10.61 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 4.5 | 7.69 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 | 9.23 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3
ACR70 response: \>=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Missing values due to participant dropping due to any reason were imputed using NRI. Here 'N' (Number of Participants Analyzed) signifies 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 and 3 | Month 1 | 7.58 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Week 2 | 2.31 percentage of participants |
| CP-690,550 5 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Month 3 | 13.64 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Month 1 | 6.77 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Week 2 | 2.34 percentage of participants |
| CP-690,550 10 mg | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Month 3 | 10.53 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Week 2 | 0.00 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Month 3 | 1.53 percentage of participants |
| Placebo | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1 and 3 | Month 1 | 0.00 percentage of participants |
Secondary
Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 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, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Baseline (n=126,128,131) | 65.38 units on a scale | Standard Deviation 18.21 |
| CP-690,550 5 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Week 2 (n=129,128,123) | 46.51 units on a scale | Standard Deviation 23.38 |
| CP-690,550 5 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Month 1 (n=123,122,123) | 39.88 units on a scale | Standard Deviation 22.19 |
| CP-690,550 5 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Month 3 (n=117,124,116) | 34.94 units on a scale | Standard Deviation 25.22 |
| CP-690,550 10 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Month 3 (n=117,124,116) | 30.64 units on a scale | Standard Deviation 22.2 |
| CP-690,550 10 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Baseline (n=126,128,131) | 58.68 units on a scale | Standard Deviation 19.42 |
| CP-690,550 10 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Month 1 (n=123,122,123) | 36.28 units on a scale | Standard Deviation 21.52 |
| CP-690,550 10 mg | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Week 2 (n=129,128,123) | 41.29 units on a scale | Standard Deviation 20.58 |
| Placebo | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Month 3 (n=117,124,116) | 44.08 units on a scale | Standard Deviation 23.53 |
| Placebo | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Week 2 (n=129,128,123) | 51.36 units on a scale | Standard Deviation 21.87 |
| Placebo | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Month 1 (n=123,122,123) | 47.67 units on a scale | Standard Deviation 20.84 |
| Placebo | Physician Global Assessment of Arthritis at Baseline, Week 2, Month 1 and 3 | Baseline (n=126,128,131) | 64.36 units on a scale | Standard Deviation 16.7 |
Secondary
Physician Global Assessment of Arthritis 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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 4.5 (n=110,114,55,53) | 27.50 units on a scale | Standard Deviation 18.87 |
| CP-690,550 5 mg | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 6 (n=101,101,51,48) | 24.17 units on a scale | Standard Deviation 18.55 |
| CP-690,550 10 mg | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 6 (n=101,101,51,48) | 19.65 units on a scale | Standard Deviation 17.15 |
| CP-690,550 10 mg | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 4.5 (n=110,114,55,53) | 26.12 units on a scale | Standard Deviation 22.28 |
| Placebo | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 4.5 (n=110,114,55,53) | 28.67 units on a scale | Standard Deviation 19.77 |
| Placebo | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 6 (n=101,101,51,48) | 23.55 units on a scale | Standard Deviation 18.3 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 4.5 (n=110,114,55,53) | 28.17 units on a scale | Standard Deviation 21.5 |
| Placebo, Then CP-690,550 10 mg | Physician Global Assessment of Arthritis at Month 4.5 and 6 | Month 6 (n=101,101,51,48) | 23.75 units on a scale | Standard Deviation 16.2 |
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: MIDS (n=42,54,56) | 28.44 units on a scale | Standard Deviation 24.35 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: WLI (n=43,56,44) | 8.30 units on a scale | Standard Deviation 6.57 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: WLI (n=44,57,57) | 10.51 units on a scale | Standard Deviation 6.07 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: PDS (n=43,55,55) | 49.44 units on a scale | Standard Deviation 28.49 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: TMS (n=42,54,48) | 43.96 units on a scale | Standard Deviation 26.39 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: MIDS (n=40,54,44) | 27.82 units on a scale | Standard Deviation 28.8 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: PDS (n=40,51,43) | 52.08 units on a scale | Standard Deviation 30.74 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: ODS (n=41,50,52) | 41.95 units on a scale | Standard Deviation 31.5 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: ODS (n=39,51,43) | 26.30 units on a scale | Standard Deviation 29.16 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: TMS (n=38,50,42) | 36.09 units on a scale | Standard Deviation 26.83 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: TMS (n=42,54,48) | 48.53 units on a scale | Standard Deviation 25.03 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: PDS (n=40,51,43) | 47.20 units on a scale | Standard Deviation 26.39 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: MIDS (n=40,54,44) | 28.60 units on a scale | Standard Deviation 27.34 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: ODS (n=39,51,43) | 30.78 units on a scale | Standard Deviation 26.12 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: WLI (n=43,56,44) | 8.73 units on a scale | Standard Deviation 6.11 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: TMS (n=38,50,42) | 36.47 units on a scale | Standard Deviation 26.72 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: PDS (n=43,55,55) | 48.95 units on a scale | Standard Deviation 21.5 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: MIDS (n=42,54,56) | 31.79 units on a scale | Standard Deviation 23.66 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: ODS (n=41,50,52) | 37.30 units on a scale | Standard Deviation 25.74 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: WLI (n=44,57,57) | 10.27 units on a scale | Standard Deviation 5.71 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: ODS (n=39,51,43) | 42.67 units on a scale | Standard Deviation 28.97 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: TMS (n=38,50,42) | 47.62 units on a scale | Standard Deviation 29.23 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: MIDS (n=42,54,56) | 34.36 units on a scale | Standard Deviation 27.68 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: MIDS (n=40,54,44) | 37.22 units on a scale | Standard Deviation 28.7 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: WLI (n=44,57,57) | 10.99 units on a scale | Standard Deviation 5.96 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: ODS (n=41,50,52) | 40.20 units on a scale | Standard Deviation 25.89 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: TMS (n=42,54,48) | 50.91 units on a scale | Standard Deviation 28.08 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: WLI (n=43,56,44) | 11.67 units on a scale | Standard Deviation 6.29 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Month 3: PDS (n=40,51,43) | 42.31 units on a scale | Standard Deviation 24.32 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | Baseline: PDS (n=43,55,55) | 51.86 units on a scale | Standard Deviation 25.25 |
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 (TMS)(5-items); Physical Demands scale (PDS) (6-item); Mental-Interpersonal Demands Scale (MIDS) (9-items); Output Demands Scale (ODS) (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: TMS (n=39,42,23,18) | 26.96 units on a scale | Standard Deviation 29.72 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: PDS (n=38,42,24,18) | 47.53 units on a scale | Standard Deviation 36.97 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: MIDS (n=40,45,24,19) | 18.50 units on a scale | Standard Deviation 26.9 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: WLI (n=40,45,24,19) | 6.87 units on a scale | Standard Deviation 6.53 |
| CP-690,550 5 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: ODS (n=39,44,24,19) | 21.32 units on a scale | Standard Deviation 27.74 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: WLI (n=40,45,24,19) | 8.78 units on a scale | Standard Deviation 7.07 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: MIDS (n=40,45,24,19) | 29.84 units on a scale | Standard Deviation 29.03 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: ODS (n=39,44,24,19) | 29.20 units on a scale | Standard Deviation 29 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: TMS (n=39,42,23,18) | 30.77 units on a scale | Standard Deviation 27.83 |
| CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: PDS (n=38,42,24,18) | 44.65 units on a scale | Standard Deviation 30.6 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: ODS (n=39,44,24,19) | 30.50 units on a scale | Standard Deviation 31.94 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: PDS (n=38,42,24,18) | 40.94 units on a scale | Standard Deviation 27.82 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: TMS (n=39,42,23,18) | 32.50 units on a scale | Standard Deviation 30.79 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: WLI (n=40,45,24,19) | 9.27 units on a scale | Standard Deviation 7.06 |
| Placebo | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: MIDS (n=40,45,24,19) | 31.95 units on a scale | Standard Deviation 32.26 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: TMS (n=39,42,23,18) | 32.73 units on a scale | Standard Deviation 25.1 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: MIDS (n=40,45,24,19) | 30.68 units on a scale | Standard Deviation 32.09 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: ODS (n=39,44,24,19) | 33.68 units on a scale | Standard Deviation 28.02 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: WLI (n=40,45,24,19) | 9.62 units on a scale | Standard Deviation 7.41 |
| Placebo, Then CP-690,550 10 mg | Work Limitations Questionnaire (WLQ) Score at Month 6 | Month 6: PDS (n=38,42,24,18) | 47.15 units on a scale | Standard Deviation 29.47 |
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 10-point scale, where higher score indicated lower work performance.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline (n=73,76,72) | 4.27 units on a scale | Standard Deviation 3.2 |
| 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=63,72,73) | 3.52 units on a scale | Standard Deviation 3.24 |
| 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=73,76,72) | 4.38 units on a scale | Standard Deviation 3.12 |
| 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=63,72,73) | 3.51 units on a scale | Standard Deviation 4.73 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Baseline (n=73,76,72) | 4.65 units on a scale | Standard Deviation 3.23 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Month 3 (n=63,72,73) | 4.04 units on a scale | Standard Deviation 3.37 |
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 10-point scale, where higher score indicated lower work performance.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies 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 | 3.27 units on a scale | Standard Deviation 2.94 |
| CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 2.63 units on a scale | Standard Deviation 2.75 |
| Placebo | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 3.33 units on a scale | Standard Deviation 3.22 |
| Placebo, Then CP-690,550 10 mg | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | 4.83 units on a scale | Standard Deviation 3.33 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at 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.
Time frame: Baseline, Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Work disabled due to RA (n=83,77,79) | 1.46 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Performed part time work (n=96,100,96) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3:Non study diagnostic tests (n=116,125,117) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Sick leave due to RA (n=104,109,100) | 1.83 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline:Non-study diagnostic tests(n=133,134,130) | 1.74 units on a scale | Standard Deviation 0.44 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Lost job/retired early (n=83,77,80) | 1.58 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Performed part time work (n=103,108,100) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Sick leave due to RA (n=95,100,97) | 1.88 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Had outpatient surgeries (n=116,125,117) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Performed paid work (n=102,109,98) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: In nursing home (n=133,134,130) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Hospitalization (n=116,124,117) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Unable to do chores (n=130,130,126) | 1.37 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Admitted for overnight stay (n=16,6,9) | 0.19 units on a scale | Standard Deviation 0.54 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Admitted for overnight stay (n=7,8,8) | 0.29 units on a scale | Standard Deviation 0.76 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Chores by housekeeper (n=130,134,130) | 1.85 units on a scale | Standard Deviation 0.36 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Work disabled due to RA (n=67,67,69) | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Treated in ER (n=116,125,117) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Chores by family/friends (n=131,134,130) | 1.44 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Home HC services (n=133,134,130) | 1.98 units on a scale | Standard Deviation 0.12 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Seen any doctor (n=117,125,117) | 1.23 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Treated in ER (n=133,134,130) | 1.89 units on a scale | Standard Deviation 0.32 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Unable to work due to RA (n=68,66,71) | 1.41 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Home healthcare services (n=2,2,5) | 1.50 units on a scale | Standard Deviation 0.71 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Lost job/retired early (n=67,68,69) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline:Required aids/devices (n=133,134,130) | 1.77 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Unable to do chores (n=112,120,113) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Retired (n=68,66,72) | 1.56 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Seen NM practitioner (n=133,134,130) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Hospitalization (n=133,134,130) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Feel well enough to work (n=68,67,70) | 1.82 units on a scale | Standard Deviation 0.38 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Currently employed (n=132,134,130) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Seen any doctor (n=133,133,130) | 1.11 units on a scale | Standard Deviation 0.31 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Currently employed (n=115,125,117) | 1.70 units on a scale | Standard Deviation 0.46 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Feel well enough to work (n=84,78,83) | 1.85 units on a scale | Standard Deviation 0.36 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Chores by family/friends (n=116,122,116) | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Seen NM practitioner (n=116,125,117) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Retired (n=85,80,86) | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Performed paid work (n=96,99,97) | 1.78 units on a scale | Standard Deviation 0.42 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Required aids/devices (n=116,125,117) | 1.81 units on a scale | Standard Deviation 0.39 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Had outpatient surgeries (n=133,134,130) | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Home HC services (n=116,123,117) | 1.97 units on a scale | Standard Deviation 0.16 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Unable to work due to RA (n=84,77,83) | 1.36 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Chores by housekeeper (n=116,122,117) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: In nursing home (n=116,125,117) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Currently employed (n=132,134,130) | 1.66 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Seen any doctor (n=133,133,130) | 1.09 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Treated in ER (n=133,134,130) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Admitted for overnight stay (n=16,6,9) | 0.17 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Hospitalization (n=133,134,130) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Had outpatient surgeries (n=133,134,130) | 1.97 units on a scale | Standard Deviation 0.17 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: In nursing home (n=133,134,130) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Home HC services (n=133,134,130) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline:Required aids/devices (n=133,134,130) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Seen NM practitioner (n=133,134,130) | 1.96 units on a scale | Standard Deviation 0.21 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Feel well enough to work (n=84,78,83) | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Retired (n=85,80,86) | 1.43 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Lost job/retired early (n=83,77,80) | 1.69 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Unable to work due to RA (n=84,77,83) | 1.48 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Work disabled due to RA (n=83,77,79) | 1.55 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Sick leave due to RA (n=104,109,100) | 1.80 units on a scale | Standard Deviation 0.4 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Performed part time work (n=103,108,100) | 1.94 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Performed paid work (n=102,109,98) | 1.63 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Unable to do chores (n=130,130,126) | 1.42 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Chores by housekeeper (n=130,134,130) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Chores by family/friends (n=131,134,130) | 1.49 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Seen any doctor (n=117,125,117) | 1.21 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Treated in ER (n=116,125,117) | 1.94 units on a scale | Standard Deviation 0.25 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Admitted for overnight stay (n=7,8,8) | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Hospitalization (n=116,124,117) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Had outpatient surgeries (n=116,125,117) | 1.98 units on a scale | Standard Deviation 0.15 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Currently employed (n=115,125,117) | 1.62 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Performed part time work (n=96,100,96) | 1.94 units on a scale | Standard Deviation 0.24 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline:Non-study diagnostic tests(n=133,134,130) | 1.75 units on a scale | Standard Deviation 0.43 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Home healthcare services (n=2,2,5) | 0.50 units on a scale | Standard Deviation 0.71 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3:Non study diagnostic tests (n=116,125,117) | 1.82 units on a scale | Standard Deviation 0.38 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: In nursing home (n=116,125,117) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Home HC services (n=116,123,117) | 1.99 units on a scale | Standard Deviation 0.09 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Required aids/devices (n=116,125,117) | 1.91 units on a scale | Standard Deviation 0.28 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Seen NM practitioner (n=116,125,117) | 1.97 units on a scale | Standard Deviation 0.18 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Feel well enough to work (n=68,67,70) | 1.78 units on a scale | Standard Deviation 0.42 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Retired (n=68,66,72) | 1.36 units on a scale | Standard Deviation 0.48 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Lost job/retired early (n=67,68,69) | 1.69 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Unable to work due to RA (n=68,66,71) | 1.53 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Work disabled due to RA (n=67,67,69) | 1.57 units on a scale | Standard Deviation 0.5 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Sick leave due to RA (n=95,100,97) | 1.86 units on a scale | Standard Deviation 0.35 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Performed paid work (n=96,99,97) | 1.69 units on a scale | Standard Deviation 0.47 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Unable to do chores (n=112,120,113) | 1.63 units on a scale | Standard Deviation 0.49 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Chores by housekeeper (n=116,122,117) | 1.89 units on a scale | Standard Deviation 0.32 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Chores by family/friends (n=116,122,116) | 1.66 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3:Non study diagnostic tests (n=116,125,117) | 1.77 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Unable to work due to RA (n=84,77,83) | 1.40 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Chores by family/friends (n=116,122,116) | 1.53 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: In nursing home (n=116,125,117) | 1.99 units on a scale | Standard Deviation 0.09 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Lost job/retired early (n=83,77,80) | 1.55 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Sick leave due to RA (n=95,100,97) | 1.82 units on a scale | Standard Deviation 0.38 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Home HC services (n=116,123,117) | 1.97 units on a scale | Standard Deviation 0.16 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Retired (n=85,80,86) | 1.49 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Had outpatient surgeries (n=133,134,130) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Required aids/devices (n=116,125,117) | 1.76 units on a scale | Standard Deviation 0.43 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Feel well enough to work (n=84,78,83) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Performed part time work (n=96,100,96) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Seen NM practitioner (n=116,125,117) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Currently employed (n=132,134,130) | 1.68 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Currently employed (n=115,125,117) | 1.68 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Seen NM practitioner (n=133,134,130) | 1.96 units on a scale | Standard Deviation 0.19 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Hospitalization (n=133,134,130) | 1.95 units on a scale | Standard Deviation 0.23 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Feel well enough to work (n=68,67,70) | 1.83 units on a scale | Standard Deviation 0.38 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline:Required aids/devices (n=133,134,130) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Chores by housekeeper (n=116,122,117) | 1.85 units on a scale | Standard Deviation 0.35 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Retired (n=68,66,72) | 1.53 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Chores by family/friends (n=131,134,130) | 1.48 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Home healthcare services (n=2,2,5) | 0.80 units on a scale | Standard Deviation 0.84 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Seen any doctor (n=117,125,117) | 1.21 units on a scale | Standard Deviation 0.41 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Chores by housekeeper (n=130,134,130) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Admitted for overnight stay (n=16,6,9) | 0.33 units on a scale | Standard Deviation 0.71 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Treated in ER (n=116,125,117) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Unable to do chores (n=130,130,126) | 1.27 units on a scale | Standard Deviation 0.45 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Lost job/retired early (n=67,68,69) | 1.59 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Admitted for overnight stay (n=7,8,8) | 0.13 units on a scale | Standard Deviation 0.35 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Performed paid work (n=102,109,98) | 1.65 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Home HC services (n=133,134,130) | 1.96 units on a scale | Standard Deviation 0.19 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Hospitalization (n=116,124,117) | 1.98 units on a scale | Standard Deviation 0.13 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Performed part time work (n=103,108,100) | 1.88 units on a scale | Standard Deviation 0.33 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Seen any doctor (n=133,133,130) | 1.15 units on a scale | Standard Deviation 0.35 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Had outpatient surgeries (n=116,125,117) | 1.97 units on a scale | Standard Deviation 0.18 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Unable to work due to RA (n=68,66,71) | 1.44 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: In nursing home (n=133,134,130) | 1.99 units on a scale | Standard Deviation 0.09 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Performed paid work (n=96,99,97) | 1.67 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Unable to do chores (n=112,120,113) | 1.45 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Treated in ER (n=133,134,130) | 1.93 units on a scale | Standard Deviation 0.25 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Month 3: Work disabled due to RA (n=67,67,69) | 1.54 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Sick leave due to RA (n=104,109,100) | 1.71 units on a scale | Standard Deviation 0.46 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline: Work disabled due to RA (n=83,77,79) | 1.48 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 | Baseline:Non-study diagnostic tests(n=133,134,130) | 1.74 units on a scale | Standard Deviation 0.44 |
Secondary
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
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 included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Admitted for overnight stay (n=5,7,3,1) | 0.20 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: Required aids/devices (n=103,102,50,48) | 1.82 units on a scale | Standard Deviation 0.39 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Home HC services (n=101,102,50,49) | 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: Hospitalization (n=102,102,50,49) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed part time work (n=85,84,40,36) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: In nursing home (n=103,102,50,49) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-study diagnostic test(n=103,102,50,49) | 1.85 units on a scale | Standard Deviation 0.35 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Had outpatient surgeries (n=103,102,50,49) | 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: Chores by family/friends (n=103,99,50,49) | 1.69 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: Sick leave due to RA (n=85,84,41,37) | 1.92 units on a scale | Standard Deviation 0.28 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Work disabled due to RA (n=61,53,27,32) | 1.57 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: Unable to work due to RA (n=62,55,27,32) | 1.48 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: Unable to do chores (n=101,98,49,48) | 1.65 units on a scale | Standard Deviation 0.48 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Lost job/retired early (n=62,54,27,32) | 1.71 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: Seen any doctor (n=102,101,50,49) | 1.29 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=103,99,50,49) | 1.92 units on a scale | Standard Deviation 0.27 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Retired (n=62,56,28,31) | 1.45 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: Feel well enough to work (n=62,57,27,32) | 1.81 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: Treated in ER (n=103,102,50,49) | 1.96 units on a scale | Standard Deviation 0.19 |
| CP-690,550 5 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed paid work (n=83,84,40,36) | 1.71 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: Currently employed (n=103,102,50,49) | 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: Seen NM practitioner (n=103,102,50,49) | 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: Admitted for overnight stay (n=5,7,3,1) | 0.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Currently employed (n=103,102,50,49) | 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: Feel well enough to work (n=62,57,27,32) | 1.68 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: Lost job/retired early (n=62,54,27,32) | 1.74 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: Unable to do chores (n=101,98,49,48) | 1.73 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: Seen any doctor (n=102,101,50,49) | 1.22 units on a scale | Standard Deviation 0.41 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Treated in ER (n=103,102,50,49) | 1.93 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: Hospitalization (n=102,102,50,49) | 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:Had outpatient surgeries (n=103,102,50,49) | 1.95 units on a scale | Standard Deviation 0.22 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-study diagnostic test(n=103,102,50,49) | 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: In nursing home (n=103,102,50,49) | 2.00 units on a scale | Standard Deviation 0 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Home HC services (n=101,102,50,49) | 1.98 units on a scale | Standard Deviation 0.14 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Required aids/devices (n=103,102,50,48) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Seen NM practitioner (n=103,102,50,49) | 1.96 units on a scale | Standard Deviation 0.2 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Retired (n=62,56,28,31) | 1.36 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: Unable to work due to RA (n=62,55,27,32) | 1.67 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: Work disabled due to RA (n=61,53,27,32) | 1.70 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: Sick leave due to RA (n=85,84,41,37) | 1.88 units on a scale | Standard Deviation 0.33 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed part time work (n=85,84,40,36) | 1.95 units on a scale | Standard Deviation 0.21 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed paid work (n=83,84,40,36) | 1.75 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: Chores by housekeeper (n=103,99,50,49) | 1.91 units on a scale | Standard Deviation 0.29 |
| CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Chores by family/friends (n=103,99,50,49) | 1.77 units on a scale | Standard Deviation 0.42 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Admitted for overnight stay (n=5,7,3,1) | 1.33 units on a scale | Standard Deviation 1.15 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Required aids/devices (n=103,102,50,48) | 1.90 units on a scale | Standard Deviation 0.3 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Unable to do chores (n=101,98,49,48) | 1.51 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Seen NM practitioner (n=103,102,50,49) | 1.98 units on a scale | Standard Deviation 0.14 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Treated in ER (n=103,102,50,49) | 1.94 units on a scale | Standard Deviation 0.24 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Seen any doctor (n=102,101,50,49) | 1.20 units on a scale | Standard Deviation 0.4 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Chores by housekeeper (n=103,99,50,49) | 1.82 units on a scale | Standard Deviation 0.39 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Home HC services (n=101,102,50,49) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Unable to work due to RA (n=62,55,27,32) | 1.56 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Chores by family/friends (n=103,99,50,49) | 1.62 units on a scale | Standard Deviation 0.49 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Work disabled due to RA (n=61,53,27,32) | 1.56 units on a scale | Standard Deviation 0.51 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Lost job/retired early (n=62,54,27,32) | 1.59 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Sick leave due to RA (n=85,84,41,37) | 1.88 units on a scale | Standard Deviation 0.33 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Retired (n=62,56,28,31) | 1.43 units on a scale | Standard Deviation 0.5 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-study diagnostic test(n=103,102,50,49) | 1.74 units on a scale | Standard Deviation 0.44 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed part time work (n=85,84,40,36) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Had outpatient surgeries (n=103,102,50,49) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Feel well enough to work (n=62,57,27,32) | 1.70 units on a scale | Standard Deviation 0.47 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Hospitalization (n=102,102,50,49) | 1.96 units on a scale | Standard Deviation 0.2 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: In nursing home (n=103,102,50,49) | 2.00 units on a scale | Standard Deviation 0 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed paid work (n=83,84,40,36) | 1.65 units on a scale | Standard Deviation 0.48 |
| Placebo | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Currently employed (n=103,102,50,49) | 1.60 units on a scale | Standard Deviation 0.49 |
| 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=61,53,27,32) | 1.50 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=102,102,50,49) | 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: Required aids/devices (n=103,102,50,48) | 1.83 units on a scale | Standard Deviation 0.38 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Treated in ER (n=103,102,50,49) | 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=103,99,50,49) | 1.90 units on a scale | Standard Deviation 0.31 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: In nursing home (n=103,102,50,49) | 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: Seen NM practitioner (n=103,102,50,49) | 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: Sick leave due to RA (n=85,84,41,37) | 1.86 units on a scale | Standard Deviation 0.35 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Currently employed (n=103,102,50,49) | 1.71 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: Seen any doctor (n=102,101,50,49) | 1.27 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: Feel well enough to work (n=62,57,27,32) | 1.88 units on a scale | Standard Deviation 0.34 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6:Non-study diagnostic test(n=103,102,50,49) | 1.86 units on a scale | Standard Deviation 0.35 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Unable to do chores (n=101,98,49,48) | 1.44 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: Retired (n=62,56,28,31) | 1.39 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: Admitted for overnight stay (n=5,7,3,1) | 0.00 units on a scale | — |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Performed paid work (n=83,84,40,36) | 1.64 units on a scale | Standard Deviation 0.49 |
| Placebo, Then CP-690,550 10 mg | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Month 6: Chores by family/friends (n=103,99,50,49) | 1.55 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 part time work (n=85,84,40,36) | 1.92 units on a scale | Standard Deviation 0.28 |
| 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=62,55,27,32) | 1.41 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=62,54,27,32) | 1.44 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: Home HC services (n=101,102,50,49) | 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:Had outpatient surgeries (n=103,102,50,49) | 1.96 units on a scale | Standard Deviation 0.2 |
Other Pre-specified
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Month 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3: DAS28-4 (ESR) <2.6 | 8 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3: DAS28-4 (ESR) <=3.2 | 17 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3: DAS28-4 (ESR) <2.6 | 14 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3: DAS28-4 (ESR) <=3.2 | 28 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3: DAS28-4 (ESR) <2.6 | 2 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 3 | Month 3: DAS28-4 (ESR) <=3.2 | 6 participants |
Other Pre-specified
Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission.
Time frame: Month 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4(ESR) <2.6 | 13 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4 (ESR) <=3.2 | 35 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4 (ESR) <=3.2 | 37 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4(ESR) <2.6 | 20 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4(ESR) <2.6 | 7 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4 (ESR) <=3.2 | 11 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4(ESR) <2.6 | 2 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 6 | Month 6: DAS28-4 (ESR) <=3.2 | 11 participants |
Other Pre-specified
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Month 4.5, 6
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <2.6 | 31 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <=3.2 | 50 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <2.6 | 35 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <=3.2 | 57 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <=3.2 | 57 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <2.6 | 36 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <=3.2 | 59 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <2.6 | 42 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <2.6 | 11 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <=3.2 | 21 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <=3.2 | 23 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <2.6 | 14 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <=3.2 | 19 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <=3.2 | 19 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 4.5: DAS28-3(CRP) <2.6 | 12 participants |
| Placebo, Then CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Month 4.5 and 6 | Month 6: DAS28-3(CRP) <2.6 | 9 participants |
Other Pre-specified
Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (CRP) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Week 2, Month 1, 3
Population: FAS included all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline measurement. Here 'N' (Number of Participants Analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants who were evaluable at specified time points for each arm group, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2: DAS28-3(CRP) <2.6 (n=127,125,124) | 8 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124) | 19 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 1: DAS28-3(CRP) <2.6 (n=132,133,131) | 14 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131) | 27 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 3: DAS28-3(CRP) <2.6 (n=132,133,131) | 27 participants |
| CP-690,550 5 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131) | 45 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131) | 57 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2: DAS28-3(CRP) <2.6 (n=127,125,124) | 12 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131) | 42 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 3: DAS28-3(CRP) <2.6 (n=132,133,131) | 35 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124) | 23 participants |
| CP-690,550 10 mg | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 1: DAS28-3(CRP) <2.6 (n=132,133,131) | 7 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2: DAS28-3(CRP) <=3.2 (n=127,125,124) | 4 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 1: DAS28-3(CRP) <2.6 (n=132,133,131) | 3 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 3: DAS28-3(CRP) <=3.2 (n=132,133,131) | 13 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 1: DAS28-3(CRP) <=3.2 (n=132,133,131) | 11 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Week 2: DAS28-3(CRP) <2.6 (n=127,125,124) | 2 participants |
| Placebo | Number of Participants With Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 and Less Than or Equal to 3.2 at Week 2, Month 1 and 3 | Month 3: DAS28-3(CRP) <2.6 (n=132,133,131) | 6 participants |