| Primary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3 | ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP). | Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed)=participants evaluable for this measure. | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00059.75
- OG00165.70
- OG00226.67
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Normal approximation for the difference in binomial proportions was used to test the superiority of each dose of CP-690,550 to placebo. | Normal approximation | | <0.0001 | A step-down procedure was used to control for multiple comparisons. In order for the comparison to 5 mg to be statistically significant, the comparison to 10 mg had to be statistically significant. | Percent difference | 39.04 | | | 2-Sided | 95 | 29.12 | 48.95 | | | | No | Superiority or Other | | |
|
| Primary | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Primary | Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3 | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2 | ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Week 2, Month 1, 2 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6 | ACR20 response: >= 20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3 | ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6 | ACR50 response: greater than or equal to >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3 | ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6 | ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | percentage of participants | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
|
| Secondary | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3 | DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. | FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6 | DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=<) 3.2 implied low disease activity, greater than (>) 3.2 to 5.1 implied moderate to high disease activity and less than (<) 2.6=remission. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 |
|
| Secondary | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6 | DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 |
|
| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
|
| Secondary | Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Patient Assessment of Arthritis Pain at Month 4, 5 and 6 | Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | mm | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg | |
|
| Secondary | Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6 | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | mm | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg | |
|
| Secondary | Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 2, Month 1, 2, 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6 | Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | mm | | Month 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
|
| Secondary | 36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | 36-Item Short-Form Health Survey (SF-36) at Month 6 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | |
|
| Secondary | Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. | FAS population. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Number | | participants | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Medical Outcome Study Sleep Scale (MOS-SS) at Month 6 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
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| Secondary | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg |
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| Secondary | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
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| Secondary | Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6 | FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg |
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| Secondary | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
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| Secondary | Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg |
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| Secondary | Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. | FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo |
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| Secondary | Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6 | Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used. Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale;higher score=higher medical cost. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
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| Secondary | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | events | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | events | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg |
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| 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. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | days | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
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| 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. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | days | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg |
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| Secondary | Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | hours per day | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
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| Secondary | Number of Hours Per Days as Assessed Using RA-HCRU at Month 6 | RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | hours per day | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg |
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| Secondary | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6 | Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. | | OG003 | Placebo, Then CP-690,550 10 mg |
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| Other Pre-specified | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | days | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Other Pre-specified | Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis | Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. | FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | | Number | | days | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
| |
| Secondary | Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]). | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Month 3 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo | Matching placebo tablet orally twice daily up to Month 3. |
|
| Secondary | Work Limitations Questionnaire (WLQ) Score at Month 6 | WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]). | FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each group respectively. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg | CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6. | | OG001 | CP-690,550 10 mg | CP-690,550 10 mg tablet orally twice daily up to Month 6. | | OG002 | Placebo, Then CP-690,550 5 mg | Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination. |
|