A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,101
- 试验地点
- 120
- 主要终点
- Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
研究概览
简要总结
To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.
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
- •Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
- •Have plaque-type psoriasis covering at least 10% of total body surface area
- •Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis
排除标准
- •Non-plaque or drug induced forms of psoriasis
- •Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
- •Cannot discontinue phototherapy
- •Any uncontrolled significant medical condition
研究组 & 干预措施
CP 690,550 5 mg BID+Placebo BIW
干预措施: CP 690,550 5 mg (Drug)
CP 690,550 10 mg BID+Placebo BIW
干预措施: CP 690,550 10 mg (Drug)
Placebo BID+Etanercept 50 mg BIW
干预措施: Etanercept 50 mg (Biological)
Placebo BID+Placebo BIW
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
时间窗: Week 12
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 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12
时间窗: Week 12
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 was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.
次要结局
- Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment(Weeks 2, 4, and 8)
- Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment(Baseline and Weeks 2, 4, 8, and 12)
- Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment(Weeks 2, 4, and 8)
- Mean PASI Score During the 12-Week Double-Blind Treatment(Baseline and Weeks 2, 4, 8, and 12)
- Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Mean PASI Component Scores by Body Region During the 12-Week Double Blind Treatment(Baseline and Weeks 2, 4, 8, and 12)
- Mean Change From Baseline in PASI Component Scores by Body Region During the 12-Week Double Blind Treatment(Weeks 2, 4, 8, and 12)
- Percentage of Participants Who Achieved a 50% Reduction in PASI Relative to Baseline (PASI50) During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Median Time to PASI50 Response During the 12-Week Double-Blind Treatment(Baseline up to Week 12)
- Percentage of Participants Who Achieved a 90% Reduction in PASI Relative to Baseline (PASI90) During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Median Time to Achieve PASI75 Response During the 12-Week Double-Blind Treatment(Baseline up to Week 12)
- Mean Percentage of Total Psoriatic BSA During the 12-Week Double-Blind Treatment(Baseline and Weeks 2, 4, 8, and 12)
- Mean Percent Change From Baseline in Total Psoriatic BSA During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Percentage of Participants With a PASI Score Greater Than or Equal to (≥)125% of the Baseline PASI Score During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Mean Itch Severity Item (ISI) Score During the 12-Week Double-Blind Treatment(Baseline, Weeks 2, 4, 8, and 12)
- Mean Change From Baseline in ISI Score During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Percentage of Participants Achieving an ISI Score of 0 During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Mean Dermatology Life Quality Index (DLQI) Score During the 12-Week Double-Blind Treatment(Baseline and Weeks 4 and 12)
- Mean Change From Baseline in DLQI Score During the 12-Week Double-Blind Treatment(Weeks 4 and 12)
- Mean DLQI Subscale Scores During the 12-Week Double-Blind Treatment(Baseline and Weeks 4 and 12)
- Mean Change From Baseline in DLQI Subscale Scores During the 12-Week Double-Blind Treatment(Weeks 4 and 12)
- Percentage of Participants Achieving DLQI Response ≥5 During the 12-Week Double-Blind Treatment(Weeks 4 and 12)
- Percentage of Participants Achieving DLQI Response ≤1 During the 12-Week Double-Blind Treatment(Weeks 4 and 12)
- Mean SF-36 Domain Scores at Baseline and Week 12(Baseline and Week 12)
- Mean Change From Baseline in SF-36 MCS and PCS Scores(Week 12)
- Mean Change From Baseline in SF-36 Domain Scores(Week 12)
- Percentage of Participants in Each Patient Global Assessment of Psoriasis (PtGA) Category During the 12-Week Double-Blind Treatment(Baseline and Weeks 2, 4, and 8)
- Percentage of Participants With a PtGA Response During the 12-Week Double-Blind Treatment(Weeks 2, 4, 8, and 12)
- Median Time to DLQI Response(Weeks 4 and 12)
- Mean Short Form 36 (SF-36) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores at Baseline and Week 12(Baseline and Week 12)
- Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Category During the 12-Week Double-Blind Treatment(Week 12)
- Percentage of Participants Achieving PSSM Response of 'Very Satisfied' or 'Somewhat Satisfied' at Week 12(Week 12)
- Mean European Quality of Life 5 Dimension (EQ-5D) Health State Utility Score During the 12-Week Double-Blind Treatment(Baseline and Week 12)
- Least Squares (LS) Mean Change From Baseline in EQ-5D Health State Utility Score During the 12-Week Double-Blind Treatment(Week 12)
- Mean EQ-5D Visual Analog Score (VAS) During the 12-Week Double-Blind Treatment(Baseline and Week 12)
- Mean Change From Baseline in EQ-5D VAS at Week 12(Week 12)
- Dimension Health State EQ-5D Score During the 12-Week Double-Blind Treatment(Baseline and Week 12)
- Mean Change From Baseline in EQ-5D Dimension Health State Score at Week 12(Week 12)
- Percentage of Participants Interacting With Healthcare Professionals During the 12-Week Double-Blind Treatment(Baseline (BL) and Week 12)
- Percentage of Participants Reporting Healthcare Resource Use Events During the 12-Week Double-Blind Treatment(Week 12)
- Percentage of Participants Employed or Not Employed and the Impact of Psoriasis on Work(Baseline and Week 12)
- Percentage of Participants Reporting Work-Impacted Events During the 12-Week Double-Blind Treatment(Week 12)
- Mean Psoriasis Quality of Life 12 (PQOL-12) Score During the 12-Week Double-Blind Treatment(Baseline and Week 12)
- Mean Change From Baseline in PQOL-12 Score During the 12-Week Double-Blind Treatment(Week 12)