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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01186744
Registration number
NCT01186744
Ethics application status
Date submitted
20/08/2010
Date registered
23/08/2010
Date last updated
26/12/2018
Titles & IDs
Public title
A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
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Scientific title
A Phase 3, Multi-Site, Randomized, Mixed-Blind, Parallel-Group Treatment Withdrawal And Re-Treatment Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
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Secondary ID [1]
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A3921111
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Treatment: Drugs - CP-690,550
Experimental: Active Treatment (10 mg) BID / Placebo BID - Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks
Experimental: Active Treatment (10 mg) BID - Continuous active treatment (CP-690,550) for 56 weeks
Experimental: Active Treatment (5 mg) BID / Placebo BID - Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks
Experimental: Active Treatment (5 mg) BID - Continuous active treatment (CP-690,550) for 56 weeks
Treatment: Drugs: CP-690,550
10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Treatment: Drugs: CP-690,550
10 mg oral BID
Treatment: Drugs: CP-690,550
5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Treatment: Drugs: CP-690,550
5 mg oral BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
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Assessment method [1]
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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.
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Timepoint [1]
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Weeks 4, 8 12, and 16 (Period B)
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Primary outcome [2]
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Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)
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Assessment method [2]
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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).
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Timepoint [2]
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Weeks 4, 8, 12, and 16 (Period B)
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Primary outcome [3]
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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)
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Weeks 4, 8, and 16 (Period C)
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Primary outcome [4]
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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)
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [1]
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Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)
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Assessment method [1]
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0
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.
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Timepoint [1]
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Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [2]
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Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)
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Assessment method [2]
0
0
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).
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Timepoint [2]
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Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [3]
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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)
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Assessment method [3]
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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.
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Timepoint [3]
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Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [4]
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Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
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Assessment method [4]
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Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.
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Timepoint [4]
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Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [5]
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Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)
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Assessment method [5]
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Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.
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Timepoint [5]
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Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [6]
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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)
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Assessment method [6]
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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.
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Timepoint [6]
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Weeks 4 and 8 (Period B)
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Secondary outcome [7]
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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)
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Assessment method [7]
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0
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.
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Timepoint [7]
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Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [8]
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Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)
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Assessment method [8]
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Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.
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Timepoint [8]
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Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [9]
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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)
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Assessment method [9]
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0
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Timepoint [9]
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Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [10]
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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
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Assessment method [10]
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PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [10]
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Weeks 4, 8, and 16 (Period C)
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Secondary outcome [11]
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0
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
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Assessment method [11]
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0
PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [11]
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Weeks 4, 8, and 16 (Period C)
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Secondary outcome [12]
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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
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Assessment method [12]
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0
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.
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Timepoint [12]
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Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [13]
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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)
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Assessment method [13]
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PASI75 response defined as at least a 75% reduction in PASI relative to baseline.
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Timepoint [13]
0
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Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [14]
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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
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Assessment method [14]
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0
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Timepoint [14]
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Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [15]
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Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)
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Assessment method [15]
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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.
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Timepoint [15]
0
0
Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [16]
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0
Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)
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Assessment method [16]
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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.
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Timepoint [16]
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Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [17]
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Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)
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Assessment method [17]
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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.
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Timepoint [17]
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Weeks 4, 8, and 16 (Period C)
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Secondary outcome [18]
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Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
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Assessment method [18]
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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.
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Timepoint [18]
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Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [19]
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0
Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)
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Assessment method [19]
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0
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.
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Timepoint [19]
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Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [20]
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0
Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)
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Assessment method [20]
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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.
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Timepoint [20]
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Weeks 4, 8, and 16 (Period C)
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Secondary outcome [21]
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Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)
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Assessment method [21]
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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.
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Timepoint [21]
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0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [22]
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Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
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Assessment method [22]
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0
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.
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Timepoint [22]
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0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [23]
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0
Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
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Assessment method [23]
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0
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.
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Timepoint [23]
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0
Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [24]
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0
Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)
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Assessment method [24]
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0
Baseline defined as the last observation up to first dosing date in Period A.
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Timepoint [24]
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0
Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [25]
0
0
Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)
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Assessment method [25]
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0
Baseline defined as the last observation up to first dosing date in Period B.
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Timepoint [25]
0
0
Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [26]
0
0
Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)
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Assessment method [26]
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0
Baseline was defined as the last observation until first dosing date in Period C.
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Timepoint [26]
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Weeks 4, 8, and 16 (Period C)
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Secondary outcome [27]
0
0
Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
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Assessment method [27]
0
0
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.
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Timepoint [27]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [28]
0
0
Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
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Assessment method [28]
0
0
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.
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Timepoint [28]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [29]
0
0
Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
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Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [30]
0
0
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)
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Assessment method [30]
0
0
Baseline defined as the last observation up to first dosing date in Period A.
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Timepoint [30]
0
0
Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [31]
0
0
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)
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Assessment method [31]
0
0
Baseline defined as the last observation up to first dosing date in Period B.
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Timepoint [31]
0
0
Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [32]
0
0
Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)
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Assessment method [32]
0
0
Baseline defined as the last observation up to first dosing date in Period C.
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Timepoint [32]
0
0
Weeks 4, 8, and 16 (Period C)
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Secondary outcome [33]
0
0
Mean PASI Score During Initial CP-690,550 Treatment (Period A)
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Assessment method [33]
0
0
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.
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Timepoint [33]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
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Secondary outcome [34]
0
0
Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [34]
0
0
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.
Query!
Timepoint [34]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
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Secondary outcome [35]
0
0
Mean PASI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [35]
0
0
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.
Query!
Timepoint [35]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
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Secondary outcome [36]
0
0
Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)
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Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [37]
0
0
Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [38]
0
0
Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [39]
0
0
Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [39]
0
0
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.
Query!
Timepoint [39]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [40]
0
0
Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [40]
0
0
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.
Query!
Timepoint [40]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [41]
0
0
Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [41]
0
0
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.
Query!
Timepoint [41]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [42]
0
0
Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [42]
0
0
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.
Query!
Timepoint [42]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [43]
0
0
Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [43]
0
0
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.
Query!
Timepoint [43]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [44]
0
0
Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [44]
0
0
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.
Query!
Timepoint [44]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [45]
0
0
Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A
Query!
Assessment method [45]
0
0
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.
Query!
Timepoint [45]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [46]
0
0
Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A
Query!
Assessment method [46]
0
0
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.
Query!
Timepoint [46]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [47]
0
0
Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A
Query!
Assessment method [47]
0
0
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.
Query!
Timepoint [47]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [48]
0
0
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)
Query!
Assessment method [48]
0
0
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.
Query!
Timepoint [48]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [49]
0
0
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)
Query!
Assessment method [49]
0
0
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.
Query!
Timepoint [49]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [50]
0
0
Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [50]
0
0
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.
Query!
Timepoint [50]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [51]
0
0
Percentage of Participants With a PASI Score =125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [51]
0
0
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.
Query!
Timepoint [51]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [52]
0
0
Percentage of Participants With a PASI Score =125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [52]
0
0
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.
Query!
Timepoint [52]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [53]
0
0
Percentage of Participants With a PASI Score =125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [53]
0
0
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.
Query!
Timepoint [53]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [54]
0
0
Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [54]
0
0
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.
Query!
Timepoint [54]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [55]
0
0
Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [55]
0
0
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.
Query!
Timepoint [55]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [56]
0
0
Mean ISI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [56]
0
0
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.
Query!
Timepoint [56]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [57]
0
0
Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [57]
0
0
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.
Query!
Timepoint [57]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [58]
0
0
Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [58]
0
0
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.
Query!
Timepoint [58]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [59]
0
0
Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [59]
0
0
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.
Query!
Timepoint [59]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [60]
0
0
Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [60]
0
0
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.
Query!
Timepoint [60]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [61]
0
0
Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [61]
0
0
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.
Query!
Timepoint [61]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [62]
0
0
Percentage of Participants Achieving ISI Score of =1 During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [62]
0
0
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.
Query!
Timepoint [62]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [63]
0
0
Percentage of Participants Achieving an ISI Score of =1 During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [63]
0
0
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.
Query!
Timepoint [63]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [64]
0
0
Percentage of Participants Achieving ISI =2-Point Reduction During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [64]
0
0
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.
Query!
Timepoint [64]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [65]
0
0
Percentage of Participants Achieving ISI =2-Point Reduction During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [65]
0
0
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.
Query!
Timepoint [65]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [66]
0
0
ISI Score of =1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
Query!
Assessment method [66]
0
0
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.
Query!
Timepoint [66]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [67]
0
0
Median Time to ISI Score of =1 During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [67]
0
0
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.
Query!
Timepoint [67]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [68]
0
0
ISI Score of =1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response
Query!
Assessment method [68]
0
0
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.
Query!
Timepoint [68]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [69]
0
0
Median Time to ISI Score of =1 During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [69]
0
0
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.
Query!
Timepoint [69]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [70]
0
0
ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response
Query!
Assessment method [70]
0
0
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.
Query!
Timepoint [70]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [71]
0
0
Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [71]
0
0
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.
Query!
Timepoint [71]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [72]
0
0
ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response
Query!
Assessment method [72]
0
0
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.
Query!
Timepoint [72]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [73]
0
0
Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [73]
0
0
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.
Query!
Timepoint [73]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [74]
0
0
Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [74]
0
0
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.
Query!
Timepoint [74]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [75]
0
0
Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [75]
0
0
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.
Query!
Timepoint [75]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [76]
0
0
Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [76]
0
0
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.
Query!
Timepoint [76]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [77]
0
0
Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [77]
0
0
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.
Query!
Timepoint [77]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [78]
0
0
Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [78]
0
0
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.
Query!
Timepoint [78]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [79]
0
0
Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [79]
0
0
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.
Query!
Timepoint [79]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [80]
0
0
Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [80]
0
0
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).
Query!
Timepoint [80]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [81]
0
0
Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [81]
0
0
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).
Query!
Timepoint [81]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [82]
0
0
Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [82]
0
0
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).
Query!
Timepoint [82]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [83]
0
0
Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [83]
0
0
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.
Query!
Timepoint [83]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [84]
0
0
Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [84]
0
0
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.
Query!
Timepoint [84]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [85]
0
0
Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [85]
0
0
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.
Query!
Timepoint [85]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [86]
0
0
Percentage of Participants Achieving DLQI =5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [86]
0
0
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.
Query!
Timepoint [86]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [87]
0
0
Percentage of Participants Achieving DLQI =5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [87]
0
0
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.
Query!
Timepoint [87]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [88]
0
0
Percentage of Participants Achieving DLQI =5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [88]
0
0
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.
Query!
Timepoint [88]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [89]
0
0
Percentage of Participants Achieving DLQI =1 Response During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [89]
0
0
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.
Query!
Timepoint [89]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [90]
0
0
Percentage of Participants Achieving DLQI =1 Response During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [90]
0
0
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.
Query!
Timepoint [90]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [91]
0
0
Percentage of Participants Achieving DLQI =1 Response During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [91]
0
0
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.
Query!
Timepoint [91]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [92]
0
0
Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [92]
0
0
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.
Query!
Timepoint [92]
0
0
Baseline and Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [93]
0
0
Percentage of Participants With DLQI =5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [93]
0
0
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.
Query!
Timepoint [93]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [94]
0
0
Median Time to DLQI =5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [94]
0
0
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.
Query!
Timepoint [94]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [95]
0
0
Percentage of Participants With DLQI =5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [95]
0
0
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.
Query!
Timepoint [95]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [96]
0
0
Median Time to DLQI =5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [96]
0
0
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.
Query!
Timepoint [96]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [97]
0
0
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)
Query!
Assessment method [97]
0
0
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.
Query!
Timepoint [97]
0
0
Baseline and Week 24 (Period A)
Query!
Secondary outcome [98]
0
0
Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [98]
0
0
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.
Query!
Timepoint [98]
0
0
Baseline and Week 56 (Period C)
Query!
Secondary outcome [99]
0
0
Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [99]
0
0
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.
Query!
Timepoint [99]
0
0
Week 24 (Period A)
Query!
Secondary outcome [100]
0
0
Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [100]
0
0
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.
Query!
Timepoint [100]
0
0
Week 56 (Period C)
Query!
Secondary outcome [101]
0
0
Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [101]
0
0
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.
Query!
Timepoint [101]
0
0
Baseline and Week 24 (Period A)
Query!
Secondary outcome [102]
0
0
Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [102]
0
0
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.
Query!
Timepoint [102]
0
0
Baseline and Week 56 (Period C)
Query!
Secondary outcome [103]
0
0
Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [103]
0
0
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.
Query!
Timepoint [103]
0
0
Week 24 (Period A)
Query!
Secondary outcome [104]
0
0
Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [104]
0
0
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.
Query!
Timepoint [104]
0
0
Week 56 (Period C)
Query!
Secondary outcome [105]
0
0
Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [105]
0
0
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
Query!
Timepoint [105]
0
0
Baseline and Weeks 4, 8, 16 and 24 (Period A)
Query!
Secondary outcome [106]
0
0
Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [106]
0
0
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.
Query!
Timepoint [106]
0
0
Baseline and Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [107]
0
0
Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [107]
0
0
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.
Query!
Timepoint [107]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [108]
0
0
Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [108]
0
0
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.
Query!
Timepoint [108]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [109]
0
0
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)
Query!
Assessment method [109]
0
0
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.
Query!
Timepoint [109]
0
0
Baseline and Weeks 4, 8, and 16 (Period C)
Query!
Secondary outcome [110]
0
0
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
Query!
Assessment method [110]
0
0
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.
Query!
Timepoint [110]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [111]
0
0
Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
Query!
Assessment method [111]
0
0
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.
Query!
Timepoint [111]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [112]
0
0
Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [112]
0
0
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.
Query!
Timepoint [112]
0
0
Baseline and Week 56 (Period C)
Query!
Secondary outcome [113]
0
0
Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)
Query!
Assessment method [113]
0
0
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.
Query!
Timepoint [113]
0
0
Week 24 (Period A)
Query!
Secondary outcome [114]
0
0
Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [114]
0
0
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.
Query!
Timepoint [114]
0
0
Week 56 (Period C)
Query!
Secondary outcome [115]
0
0
Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
Query!
Assessment method [115]
0
0
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").
Query!
Timepoint [115]
0
0
Baseline and Week 24 (Period A)
Query!
Secondary outcome [116]
0
0
Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [116]
0
0
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").
Query!
Timepoint [116]
0
0
Baseline and Week 56 (Period C)
Query!
Secondary outcome [117]
0
0
Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)
Query!
Assessment method [117]
0
0
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.
Query!
Timepoint [117]
0
0
Week 24 (Period A)
Query!
Secondary outcome [118]
0
0
Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [118]
0
0
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.
Query!
Timepoint [118]
0
0
Week 56 (Period C)
Query!
Secondary outcome [119]
0
0
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)
Query!
Assessment method [119]
0
0
Query!
Timepoint [119]
0
0
Weeks 4, 8, 16, and 24 (Period A)
Query!
Secondary outcome [120]
0
0
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)
Query!
Assessment method [120]
0
0
Query!
Timepoint [120]
0
0
Weeks 4, 8, 12, and 16 (Period B)
Query!
Secondary outcome [121]
0
0
Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)
Query!
Assessment method [121]
0
0
Query!
Timepoint [121]
0
0
Weeks 4, 8, and 16 (Period C)
Query!
Eligibility
Key inclusion criteria
- 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at
least 12 months prior to first dose of study drug;
- Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's
Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at
least 10% of body surface area;
- No evidence of active or latent or inadequately treated infection with Tuberculosis or
other serious infections.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Non-plaque or drug induced forms of psoriasis;
- Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot
discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
- Any uncontrolled significant medical condition.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/01/2013
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
666
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Dr. Glenn & Partners - Kogarah
Query!
Recruitment hospital [2]
0
0
Premier Dermatology - Kogarah
Query!
Recruitment hospital [3]
0
0
Skin and Cancer Foundation - Carlton
Query!
Recruitment hospital [4]
0
0
Uniradiology - Carlton
Query!
Recruitment hospital [5]
0
0
Emeritus Research - Malvern East
Query!
Recruitment hospital [6]
0
0
Malvern Diagnostic Imaging - Malvern
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
3053 - Carlton
Query!
Recruitment postcode(s) [3]
0
0
3145 - Malvern East
Query!
Recruitment postcode(s) [4]
0
0
3144 - Malvern
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Jersey
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oregon
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Rhode Island
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
West Virginia
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
C1114aap
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Ciudad Autonoma de Buenos Aires
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
RJ
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
SP
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Pleven
Query!
Country [27]
0
0
Bulgaria
Query!
State/province [27]
0
0
Sofia
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
British Columbia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Newfoundland and Labrador
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Ontario
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Quebec
Query!
Country [32]
0
0
Denmark
Query!
State/province [32]
0
0
Aarhus C
Query!
Country [33]
0
0
Denmark
Query!
State/province [33]
0
0
Hellerup
Query!
Country [34]
0
0
Denmark
Query!
State/province [34]
0
0
Svendborg
Query!
Country [35]
0
0
Finland
Query!
State/province [35]
0
0
Tampere
Query!
Country [36]
0
0
Greece
Query!
State/province [36]
0
0
Aathens
Query!
Country [37]
0
0
Greece
Query!
State/province [37]
0
0
Ioannina
Query!
Country [38]
0
0
Greece
Query!
State/province [38]
0
0
Thessaloniki
Query!
Country [39]
0
0
Netherlands
Query!
State/province [39]
0
0
Beek
Query!
Country [40]
0
0
Slovakia
Query!
State/province [40]
0
0
Bratislava
Query!
Country [41]
0
0
Slovakia
Query!
State/province [41]
0
0
Trnava
Query!
Country [42]
0
0
United Kingdom
Query!
State/province [42]
0
0
Leytonstone
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
Warwickshire
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5
mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and
subsequent withdrawal of active treatment at various timepoints during the 16 week double
blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP
690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and
subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID
and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are
candidates for systemic therapy or phototherapy.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01186744
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01186744
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