An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 912
- 主要终点
- Subject incidence of adverse events, including infectious episodes
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)
排除标准
- •Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
- •Pregnant or breast-feeding females
- •Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
研究组 & 干预措施
50 mg
50 mg once weekly
干预措施: Etanercept (Drug)
100 mg
50 mg twice weekly
干预措施: Etanercept (Drug)
结局指标
主要结局
Subject incidence of adverse events, including infectious episodes
时间窗: 72 weeks
Changes from baseline in laboratory values
时间窗: 72 weeks
次要结局
- Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study(72 weeks)
- Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis(72 weeks)
- Patient Global Assessment of psoriasis(72 weeks)
- Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores(72 weeks)
- Changes from baseline in SF-36 Health Survey scores(72 weeks)