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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01186744
First received: August 20, 2010
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B) [ Time Frame: Weeks 4, 8 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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).

  • 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) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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).

  • 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) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.

  • Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    Adequate response defined as >50% reduction of the Visit A4/Week 24 (last visit in Period A) PASI response.

  • 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) [ Time Frame: Weeks 4 and 8 (Period B) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    Adequate PASI response defined as less than or equal to 50% reduction of the Visit A4/Week 24 PASI Response.

  • 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) [ Time Frame: Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

  • 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 [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

  • 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 [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    PASI75 response defined as at least a 75% reduction in PASI relative to baseline.

  • 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 [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
  • Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    Baseline defined as the last observation up to first dosing date in Period A.

  • Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    Baseline defined as the last observation up to first dosing date in Period B.

  • Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    Baseline was defined as the last observation until first dosing date in Period C.

  • Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    Baseline defined as the last observation up to first dosing date in Period A.

  • Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    Baseline defined as the last observation up to first dosing date in Period B.

  • Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    Baseline defined as the last observation up to first dosing date in Period C.

  • Mean PASI Score During Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean PASI Score During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean PASI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean ISI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean DLQI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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).

  • Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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).

  • Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Baseline and Week 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Week 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Week 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Week 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Baseline and Weeks 4, 8, 16 and 24 (Period A) ] [ Designated as safety issue: No ]
    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

  • Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Baseline and Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • 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) [ Time Frame: Baseline and Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
    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.

  • Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A) [ Time Frame: Week 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A) [ Time Frame: Baseline and Week 24 (Period A) ] [ Designated as safety issue: No ]
    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").

  • Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Baseline and Week 56 (Period C) ] [ Designated as safety issue: No ]
    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").

  • Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A) [ Time Frame: Week 24 (Period A) ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C) [ Time Frame: Week 56 (Period C) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A) [ Time Frame: Weeks 4, 8, 16, and 24 (Period A) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B) [ Time Frame: Weeks 4, 8, 12, and 16 (Period B) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C) [ Time Frame: Weeks 4, 8, and 16 (Period C) ] [ Designated as safety issue: No ]

Enrollment: 666
Study Start Date: September 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: CP-690,550
10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Experimental: Active Treatment (10 mg) BID
Continuous active treatment (CP-690,550) for 56 weeks
Drug: CP-690,550
10 mg oral BID
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
Drug: CP-690,550
5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
Experimental: Active Treatment (5 mg) BID
Continuous active treatment (CP-690,550) for 56 weeks
Drug: CP-690,550
5 mg oral BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186744

  Show 87 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01186744     History of Changes
Other Study ID Numbers: A3921111
Study First Received: August 20, 2010
Results First Received: January 27, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
OPT Retreatment
OPT
chronic
moderate
severe
treatment
safety
treatment withdrawal
retreatment
retreatment withdrawal
CP-690,550
Psoriasis Vulgaris
Plaque Psoriasis
tofacitinib
Xeljanz
nail psoriasis
Jak-inhibitor
oral treatment
Pruritus
Itch
DLQI
rebound
intermittent
retreat

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014