| Primary | Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) | The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.](streamdown:incomplete-link) | The Period B-Full Analysis Set (FAS-B) included all participants who were re-randomized at the end of Period A and received at least 1dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) or placebo at the beginning of Period B. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for CP-690,550 5 mg (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG003 | Placebo for 10 mg CP-690,550 | Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
| | Units | Counts |
|---|
| Participants | - OG00031
- OG00182
- OG00245
- OG003
|
| | Title | Denominators | Categories |
|---|
| Week 4 | | | Title | Measurements |
|---|
| - OG00090.3(72.9 to 96.8)
- OG00163.4(52.0 to 72.8)
- OG00291.1(78.0 to 96.6)
- OG003
|
|
| | 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 |
|---|
| | Log Rank | | 0.0008 | | | | | | 2-Sided | | | | | | | | Superiority or Other | | | | | Log Rank | | <0.0001 | |
|
| Primary | Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear). | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for CP-690,550 5 mg (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | |
|
| Primary | Percentage of Participants Achieving a PASI75 Response During CP-690,550 Re-Treatment (Period C) Among Those Who Had a Greater Than (>)50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) | The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response is defined as at least 75% reduction in PASI relative to Baseline/Day 1. Baseline defined as the last observation up to first dosing date in Period C. PASI responses at each period were relative to Baseline-A, where Baseline-A was defined as the last observation up to first dosing date in Period A.](streamdown:incomplete-link) | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID |
|
| Primary | Percentage of Participants Achieving a PGA Response of Clear or Almost Clear During CP-690,550 Re-treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe During Double-Blind Treatment Withdrawal (Period B) | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). | The Period C-Full Analysis Set (FAS-C) included all FAS-B participants who were advanced to the re-treatment period (Period C) during the 16 weeks of Period B and had received at least one dose of investigational drug (CP-690,550 5 mg BID or 10 mg BID) during Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A) | The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. PASI75 response defined as 75% reduction in PASI relative to baseline.](streamdown:incomplete-link) | The Period A-Full Analysis Set (FAS-A) included all participants who were randomized at baseline and received at least 1 dose of the randomized investigational drug (CP-690,550 5mg BID or 10 mg BID) during Period A. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A) | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear). | | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants Achieving Both a PASI50-75 Response and Dermatology Life Quality Index (DLQI) ≤5 Response During Initial CP-690,550 Treatment (Period A) | PASI50-75 response defined as a reduction of at least 50% but less than 75%. The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B) | Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B) | Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response. | | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | |
|
| Secondary | Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Period Between Week 24 and Week 32 (Period B) | The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. Weeks 4 and 8 are relative to the Period B baseline and are the same as Weeks 28 and 32, which are relative to Period A baseline. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion. | FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 8 of Period B. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4 and 8 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Percentage of Participants With PASI Score ≥125% of Baseline-A or New Type of Psoriasis (Pustular, Erythrodermic) During the Double-Blind Treatment Withdrawal (Period B) | The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI responses at each period are relative to Baseline-A where Baseline-A was defined as the last observation up to first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion. | FAS-B; Overall number (n) indicates the total number of participants with PASI Score ≥125% of baseline at least once during Weeks 4 to 16 of Period B. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | |
|
| Secondary | Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B) | Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Median Time to Loss of >50% of the Visit A4/Week 24 PASI Response and Loss of PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B) | | | Posted | | Median | 95% Confidence Interval | weeks | | Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG003 |
|
| Secondary | Percentage of Participants Regaining PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Median Time to Regain PASI75 and PGA Response (Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Among Participants Who Lost Both PASI75 Response and PGA Response (Clear or Almost Clear) at the Beginning of Period C | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. | | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Percentage of Participants Regaining PASI75 and PGA Response (PGA of Clear or Almost Clear) During CP-690,550 Re-Treatment (Period C) Who Had Lost Both PASI75 Response and PGA Response at the Beginning of Period C | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses at each period are relative to Baseline-A, where Baseline-A is defined as the last observation up to first dosing date in Period A. 95% confidence interval constructed using the normal approximation to the binomial distribution of one-sample proportion. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Median Time to PASI75 Response During CP-690,550 Re-Treatment (Period C) For Those Who Had a >50% Reduction of Visit A4/Week 24 PASI Response During Double-Blind Treatment Withdrawal (Period B) | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. | | Posted | | Median | 95% Confidence Interval | weeks | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Median Time to PGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PGA of Mild, Moderate, or Severe at the Beginning of Period C | | | Posted | | Median | 95% Confidence Interval | weeks | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | |
|
| Secondary | Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A) | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. Baseline defined as the last observation up to the first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B) | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion. | | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C) | PASI75 response defined as at least a 75% reduction in PASI relative to baseline. PASI responses in each period are relative to Baseline-A, where Baseline-A is defined as the last observation until first dosing date in Period A. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | |
|
| Secondary | Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A) | PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B) | PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of two-sample proportion. | | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
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| Secondary | Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C) | PGA response was defined as 0 (clear) or 1 (almost clear) on a 5-point scale where 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. 95% confidence interval is constructed using the normal approximation to the binomial distribution of one-sample proportion. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A) | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. | FAS-A; n equals the number of participants with an observation. | Posted | | Mean | Standard Error | percent psoriatic BSA | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B) | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | percent psoriatic BSA | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | |
|
| Secondary | Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C) | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | percent psoriatic BSA | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | |
|
| Secondary | Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A) | Baseline defined as the last observation up to first dosing date in Period A. | FAS-A; n equals number of participants with an observation | Posted | | Mean | Standard Error | percent change in psoriatic BSA | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B) | Baseline defined as the last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | percent change in psoriatic BSA | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
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| Secondary | Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C) | Baseline was defined as the last observation until first dosing date in Period C. | FAS-C; n equals number of participants with an observation | Posted | | Mean | Standard Error | percent change in psoriatic BSA | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A) | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. | FAS-A; n equals number of participants with an observation | Posted | | Mean | Standard Error | percent psoriatic BSA | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B) | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | percent psoriatic BSA | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | |
|
| Secondary | Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C) | Assessment of BSA with psoriasis performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The %surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | percent psoriatic BSA | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | |
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| Secondary | Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A) | Baseline defined as the last observation up to first dosing date in Period A. | FAS-A; n equals number of participants with an observation | Posted | | Mean | Standard Error | percent change in psoriatic BSA | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B) | Baseline defined as the last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | percent psoriatic BSA | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
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| Secondary | Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C) | Baseline defined as the last observation up to first dosing date in Period C. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | percent psoriatic BSA | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Mean PASI Score During Initial CP-690,550 Treatment (Period A) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. | | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean PASI Score During Double-Blind Treatment Withdrawal (Period B) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean PASI Score During the CP-690,550 Re-Treatment (Period C) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A. | | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-B defined as last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline-C defined as last observation up to first dosing date in Period C. | FAS-C; n equals number of participants with an observation | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B. | FAS-A; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) |
| |
| Secondary | Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B. | FAS-B; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C. | FAS-C; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B. | FAS-A; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) |
| |
| Secondary | Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period B. | FAS-B; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C) | Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI score can vary in increments of 0.1; higher scores represent greater severity of psoriasis. Baseline defined as last observation up to first dosing date in Period C. | FAS-C; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A | PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A | PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A | PASI quantifies the severity of psoriasis based on both lesion severity and the percent of BSA) affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of the body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During the CP-690,550 Re-Treatment (Period C) | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A. | FAS-C; n equals the number of participants with an observation | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During the CP-690,550 Re-Treatment (Period C) | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A. | FAS-C; n equals the number of participants with an observation | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C) | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A. | FAS-C; n equals the number of participants with an observation | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A) | PASI quantifies the severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by the investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head and neck, upper limbs, trunk, and lower limbs), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B) | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A. | FAS-B; n equals the number of participants with observations | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C) | PASI quantifies severity of psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite score by investigator of degree of erythema, induration, and scaling (scored separately) for each of 4 body regions (head/neck, upper limbs, trunk, lower limbs), with adjustment for percent of BSA involved for each body region and for proportion of body region to the whole body. PASI score can vary in increments of 0.1 and range from 0.0-72.0; higher scores representing greater severity of psoriasis. Baseline-A defined as last observation up to first dosing date in Period A. | FAS-C; n equals the number of participants with an observation | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean ISI Score During the CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. Baseline-A defined as the last observation up to first dosing date in Period A. | | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. Baseline-B defined as the last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | |
|
| Secondary | Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. Baseline-C defined as the last observation up to first dosing date in Period C. | FAS-C; n equals number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with a Baseline-A ISI greater than (>) 0, where Baseline-A is defined as the last observation up to first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with a Baseline-C ISI greater than (>) 0, where Baseline-C is defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with a Baseline-A ISI >1, where Baseline-A is defined as the last observation up to first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with a Baseline-A ISI ≥2, where Baseline-A is defined as the last observation up to first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with a Baseline-C ISI ≥2, where Baseline-C is defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with Baseline-A ISI >1, where Baseline-A was defined as the last observation before the first dosing date in Period A. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with a Baseline-C ISI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-A participants with Baseline-A ISI ≥2, where Baseline-A was defined as the last observation before the first dosing date in Period A. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with Baseline-C ISI ≥2, where Baseline-C defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) | The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends. | FAS-C participants with Baseline-C ISI >1, where Baseline-C defined as the last observation up to first dosing date in Period C. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean DLQI Score During the CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
|
| Secondary | Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | |
|
| Secondary | Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A. | | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C. | FAS-C; n equals number of participants with an observation | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). | | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
| |
| Secondary | Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
|
| Secondary | Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
|
| Secondary | Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-A defined as the last observation up to first dosing date in Period A. | | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-B defined as the last observation up to first dosing date in Period B. | FAS-B; n equals the number of participants with observations | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | |
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| Secondary | Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much); higher scores indicate poor quality of life. The DLQI can be analyzed under 6 subscales by combining questions and is categorized as follows: symptoms and feelings (maximum score=6); daily activities (maximum score=6); leisure (maximum score=6); work and school (maximum score=3); personal relationships (maximum score=6); and treatment (maximum score=3). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | scores on a scale | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | |
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| Secondary | Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-A participants with a Baseline-A DLQI ≥5, where Baseline-A is defined as the last observation up to first dosing date in Period A. n=participants with an observation. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-B participants with Baseline-B DLQI ≥5. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 |
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| Secondary | Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. Baseline-C defined as the last observation up to first dosing date in Period C. | FAS-C participants with Baseline-C DLQI ≥5 | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-A participants with a Baseline-A DLQI ≤1, where Baseline-A is defined as the last observation up to first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-B participants with Baseline-B DLQI >1 where Baseline-B defined as last observation up to first dosing date in Period B. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
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| Secondary | Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-C participants with a Baseline-C DLQI >1, where Baseline-C is defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Severity is measured using the following categories of scores: 0-1=no effect on patients' lives; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect. | | Posted | | Number | | percentage of participants | | Baseline and Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-A participants with Baseline-A DLQI ≥5, where Baseline-A was defined as the last observation before the first dosing date in Period A. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg (Period A) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C) | The DLQI is a general dermatology questionnaire that consists of 10 items that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | FAS-C participants with Baseline-C DLQI ≥5, where Baseline-C defined as the last observation up to first dosing date in Period C. | Posted | | Median | 95% Confidence Interval | weeks | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
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| Secondary | Mean Short-Form 36 (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores During the Initial CP-690,550 Treatment (Period A) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and standard deviations (SDs) of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life. | FAS-A; n=number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) |
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| Secondary | Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID |
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| Secondary | Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life. | | Posted | | Mean | Standard Error | scores on a scale | | Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A PCS score and MCS score are based on a normalized sum of the 8 scale scores; PCS/MCS summary concept score = (raw score*10) plus 50. Linear transformations were performed to transform scores to a mean of 50 and SDs of 10, in the general population. In norm-based scoring, each scale is scored to have same average (50)/SD (10). With this method anytime a scale score is below 50, health status is below average, and each point is one-tenth of a SD. Higher scores indicate a better health related quality of life. | | Posted | | Mean | Standard Error | scores on a scale | | Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | |
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| Secondary | Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. | FAS-A; n=number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 |
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| Secondary | Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-A defined as the last observation up to first dosing date in Period A. | FAS-A; n=number of participants with an observation | Posted | | Mean | Standard Error | scores on a scale | | Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C) | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, Role Limitations due to Physical Health Problems, Bodily Pain, Social Functioning, Mental Health, Role Limitations due to Emotional Problems, Vitality, and General Health Perceptions. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Higher scores indicate a better health related quality of life. Baseline-C defined as the last observation up to first dosing date in Period C. | | Posted | | Mean | Standard Error | scores on a scale | | Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 |
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| Secondary | Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A) | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe | | Posted | | Number | | percentage of participants | | Baseline and Weeks 4, 8, 16 and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B) | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. | FAS-B; n equals the number of participants with observations | Posted | | Number | | percentage of participants | | Baseline and Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
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| Secondary | Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C) | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. | | Posted | | Number | | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A) | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants With PtGA Response of Clear or Almost Clear During CP-690,550 Re-Treatment (Period C) Among Participants Who Had a PtGA of Mild, Moderate or Severe During CP-690,550 Treatment Withdrawal (Period B) | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline and Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | |
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| Secondary | Percentage of Participants Maintaining PtGA Response of Clear or Almost Clear During the Double-Blind Treatment Withdrawal (Period B) Among Participants Who Had a Response of Clear or Almost Clear at Beginning of Period B | The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5 point scale. The scale is scored as follows: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. Response defined as score of 0 or 1. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) |
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| Secondary | Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A) | 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. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. | FAS-A; n=number of participants with an observation. | Posted | | Mean | Standard Error | score on a scale | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C) | 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. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A) | 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. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-A defined as the last observation up to first dosing date in Period A. | FAS-A; n=number of participants with an observation | Posted | | Mean | Standard Error | scores on a scale | | Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C) | 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. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Baseline-C defined as the last observation up to first dosing date in Period C. | | Posted | | Mean | Standard Error | scores on a scale | | Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) |
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| Secondary | Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A) | 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. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). | FAS-A; n=number of participants with an observation. | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C) | 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. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). | FAS-C; n equals the number of participants with an observation | Posted | | Mean | Standard Error | score on a scale | | Baseline and Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
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| Secondary | Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A) | 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. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Baseline-A defined as the last observation up to first dosing date in Period A. | FAS-A; n=number of participants with an observation | Posted | | Mean | Standard Error | scores on a scale | | Week 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C) | 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. The score for each of the 5 dimensions can range from 1 to 3; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Baseline-C defined as the last observation up to first dosing date in Period C. | | Posted | | Mean | Standard Error | scores on a scale | | Week 56 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID |
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| Secondary | Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A) | | | Posted | | Number | | percentage of participants | | Weeks 4, 8, 16, and 24 (Period A) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period A) | Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment) | | OG001 | CP-690,550 10 mg BID (Period A) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) |
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| Secondary | Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B) | | | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, and 16 (Period B) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG001 | Placebo for 5 mg CP-690,550 BID (Period B) | Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG002 | CP-690,550 10 mg BID (Period B) | Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) | | OG003 | Placebo for 10 mg CP-690,550 BID (Period B) |
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| Secondary | Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C) | | | Posted | | Number | | percentage of participants | | Weeks 4, 8, and 16 (Period C) | | | | ID | Title | Description |
|---|
| OG000 | CP-690,550 5 mg BID / CP-690,550 5 mg BID | Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG001 | Placebo BID / CP-690,550 5 mg BID | Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG002 | CP-690,550 10 mg BID / CP-690,550 10 mg BID | Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment) | | OG003 | Placebo BID / CP-690,550 10 mg BID |
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