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临床试验/NCT01186744
NCT01186744已完成3 期

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

Pfizer83 个研究点 分布在 3 个国家目标入组 666 人开始时间: 2010年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
666
试验地点
83
主要终点
Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Active Treatment (10 mg) BID / Placebo BID

Experimental

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

干预措施: CP-690,550 (Drug)

Active Treatment (5 mg) BID / Placebo BID

Experimental

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

干预措施: CP-690,550 (Drug)

Active Treatment (5 mg) BID

Experimental

Continuous active treatment (CP-690,550) for 56 weeks

干预措施: CP-690,550 (Drug)

Active Treatment (10 mg) BID

Experimental

Continuous active treatment (CP-690,550) for 56 weeks

干预措施: CP-690,550 (Drug)

结局指标

主要结局

Percentage of Participants Maintaining a Psoriasis Area and Severity Index 75 (PASI75) Response During the Double-Blind Treatment Withdrawal Period (Period B)

时间窗: Weeks 4, 8 12, and 16 (Period B)

The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response defined as at least a 75 percent (%) reduction in PASI relative to baseline.

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)

时间窗: Baseline and Weeks 4, 8, and 16 (Period C)

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).

Percentage of Participants Maintaining a Physician's Global Assessment (PGA) Response During the Double-Blind Treatment Withdrawal (Period B)

时间窗: Weeks 4, 8, 12, and 16 (Period B)

The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response defined as 0 (clear) or 1 (almost clear).

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)

时间窗: Baseline and Weeks 4, 8, and 16 (Period C)

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.

次要结局

  • 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)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants Maintaining Adequate PASI Response and Maintaining PGA Response (Clear or Almost Clear) During the Double-Blind Treatment Withdrawal (Period B)(Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B))
  • 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(Weeks 4, 8, and 16 (Period C))
  • Mean Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Median Time to PASI75 Response During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Median Time to Loss of Adequate Response During the Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • 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)(Week 24 (Period A) and Weeks 4, 8, 12, and 16 (Period B))
  • 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(Weeks 4, 8, and 16 (Period C))
  • 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(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline in Total Percent of Psoriatic BSA During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Mean Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Median Time to PGA Response of Clear or Almost Clear During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • 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)(Weeks 4 and 8 (Period B))
  • 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)(Weeks 4, 8, 12, and 16 (Period B))
  • Mean Change From Baseline in Total Percent of Psoriatic BSA During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participant Maintaining an Adequate Response During the Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • 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)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants With a PASI75 Response During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants With PGA Response of Clear or Almost Clear During Double-Blind Withdrawal Treatment (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Mean Total Percent of Psoriatic Body Surface Area (BSA) During Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Mean Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean PASI Score During Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • 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(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants With a PASI75 Response During Double-Blind Withdrawal Treatment (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants With PGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants With PGA Response of Clear or Almost Clear During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Mean PASI Score During Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Mean PASI Score During the CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-A in PASI Score During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants With a PASI75 Response During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline in Percent of Psoriatic BSA by Body Region During CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-B in PASI Score During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Mean PASI Component Scores During Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Mean PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Mean Change From Baseline in Total Percent of Psoriatic BSA During CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • 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)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants With ISI Score of 0 During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants Achieving an ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Median Time to ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-C in PASI Score During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean PASI Component Scores During the CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline in PASI Component Scores During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants Achieving at Least a 100% Reduction in PASI Relative to Baseline-A (PASI100) During Period A(Weeks 4, 8, 16, and 24 (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)(Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving ISI ≥2-Point Reduction During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-A in DLQI Score During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline in PASI Component Scores During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline in PASI Component Scores During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • 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)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving 100% Reduction in PASI Relative to Baseline-A (PASI100) During the CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-A in ISI Score During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants With ISI Score of 0 During CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving ISI ≥2-Point Reduction During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Median Time to ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants Achieving at Least a 50% Reduction in PASI Relative to Baseline-A (PASI50) During Period A(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants Achieving at Least a 90% Reduction in PASI Relative to Baseline-A (PASI90) During Period A(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants With a PASI Score ≥125% of the Baseline-A PASI Score During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Itch Severity Item (ISI) Score During the Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Mean ISI Score During the Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Mean Change From Baseline-C in ISI Score During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • ISI Score of ≤1 During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response(Weeks 4, 8, 16, and 24 (Period A))
  • Mean DLQI Score During the Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Mean Change From Baseline-B in DLQI Score During the Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Mean ISI Score During the CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-B in ISI Score During the Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Median Time to ISI Score of ≤1 During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • ISI Reduction (2-point Decrease in ISI Score) During the Initial CP-690,550 Treatment (Period A) - Percentage of Participants With a Response(Weeks 4, 8, 16, and 24 (Period A))
  • ISI Score of ≤1 During CP-690,550 Re-Treatment (Period C) - Percentage of Participants With a Response(Weeks 4, 8, and 16 (Period C))
  • Mean DLQI Score During the CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-C in DLQI Score During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-A in DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-B in DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants Achieving DLQI ≤1 Response During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C) - Percentage of Participant With a Response(Weeks 4, 8, and 16 (Period C))
  • Median Time to ISI Reduction (2-point Decrease in ISI Score) During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean Dermatology Life Quality Index (DLQI) Score During the Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-B Response During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • 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)(Baseline and Week 24 (Period A))
  • Mean DLQI Subscale Scores During the Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-C in DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving DLQI ≤1 Response During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants by DLQI Severity Category During the Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16, and 24 (Period A))
  • Median Time to DLQI ≥5-Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants With DLQI ≥5-Point Reduction From Baseline-A Response During CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)(Baseline and Week 56 (Period C))
  • Mean DLQI Subscale Scores During the Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • Mean DLQI Subscale Scores During the CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving DLQI ≤1 Response During CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-A Response During Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Percentage of Participants Achieving DLQI ≥5 Point Reduction From Baseline-C Response During CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-A in SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)(Week 24 (Period A))
  • Mean Change From Baseline-A in EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)(Week 24 (Period A))
  • Mean SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)(Baseline and Week 56 (Period C))
  • Percentage of Participants With PtGA Response of Clear or Almost Clear During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-A in SF-36 PCS and MCS Scores During the Initial CP-690,550 Treatment (Period A)(Week 24 (Period A))
  • Mean SF-36 Domain Scores During the Initial CP-690,550 Treatment (Period A)(Baseline and Week 24 (Period A))
  • Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During the Initial CP-690,550 Treatment (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-C in SF-36 PCS and MCS Scores During CP-690,550 Re-Treatment (Period C)(Week 56 (Period C))
  • Percentage of Participants in Each PtGA of Psoriasis Category During CP-690,550 Re-Treatment (Period C)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean Change From Baseline-C in SF-36 Domain Scores During CP-690,550 Re-Treatment (Period C)(Week 56 (Period C))
  • 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)(Baseline and Weeks 4, 8, and 16 (Period C))
  • Mean EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)(Baseline and Week 56 (Period C))
  • Mean EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)(Baseline and Week 56 (Period C))
  • Percentage of Participants in Each Patient Global Assessment (PtGA) of Psoriasis Category During the Initial CP-690,550 Treatment (Period A)(Baseline and Weeks 4, 8, 16 and 24 (Period A))
  • Mean Change From Baseline-A in EQ-5D Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)(Week 24 (Period A))
  • Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During Double-Blind Treatment Withdrawal (Period B)(Weeks 4, 8, 12, and 16 (Period B))
  • Percentage of Participants With Pustular, Erythrodermic, or Guttate Psoriasis During CP-690,550 Re-Treatment (Period C)(Weeks 4, 8, and 16 (Period C))
  • Percentage of Participants in Each PtGA of Psoriasis Category During Double-Blind Treatment Withdrawal (Period B)(Baseline and Weeks 4, 8, 12, and 16 (Period B))
  • 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(Weeks 4, 8, 12, and 16 (Period B))
  • Mean EuroQol 5 Dimensions (EQ-5D) Health State Profile Utility Score and VAS Scores During the Initial CP-690,550 Treatment Period (Period A)(Weeks 4, 8, 16, and 24 (Period A))
  • Mean Change From Baseline-C in EQ-5D Utility Score and VAS Scores During CP-690,550 Re-Treatment (Period C)(Week 56 (Period C))
  • Mean EQ-5D Domain Scores During the Initial CP-690,550 Treatment Period (Period A)(Baseline and Week 24 (Period A))
  • Mean Change From Baseline-C in EQ-5D Domain Scores During CP-690,550 Re-Treatment (Period C)(Week 56 (Period C))

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (83)

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