A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 752
- 试验地点
- 112
- 主要终点
- Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
研究概览
简要总结
The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.
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
- Single (Participant)
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
- •Inclusion Criteria:
- •18 years of age or older at time of consent
- •Active Psoriatic Arthritis
- •Clinically stable, plaque psoriasis involving more than 10% of the body surface area
排除标准
- •Exclusion Criteria:
- •Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
- •Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
- •Prior exposure to any TNF-inhibitor, including etanercept
研究组 & 干预措施
A
Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).
干预措施: etanercept (Drug)
B
Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24.
干预措施: etanercept (Drug)
B
Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis
时间窗: 12 weeks
The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.
次要结局
- Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)(12 and 24 weeks)