NCT00333034已完成3 期
A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis
Wyeth is now a wholly owned subsidiary of Pfizer23 个研究点 分布在 10 个国家目标入组 120 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 23
- 主要终点
- The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.
研究概览
简要总结
The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate
排除标准
- •Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.
结局指标
主要结局
The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.
次要结局
- The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,
- EQ5D, FACIT-F.
研究者
研究点 (23)
Loading locations...
相似试验
已完成
4 期
Evaluating Efficacy and Safety of Etanercept 50 mg Twice Weekly (BIW) in Rheumatoid Arthritis (RA) Subjects Who Are Sub-Optimal Responders to Etanercept 50 mg Once Weekly (QW)Rheumatoid ArthritisNCT00115219Amgen200
已完成
4 期
Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in SpainAnkylosing SpondylitisNCT00873730Wyeth is now a wholly owned subsidiary of Pfizer108
已完成
3 期
Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisAnkylosing SpondylitisNCT00421915Wyeth is now a wholly owned subsidiary of Pfizer84
已完成
2 期
Study Evaluating Etanercept in Moderate to Severe AsthmaAsthmaNCT00141791Wyeth is now a wholly owned subsidiary of Pfizer120
已完成
2 期
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary FibrosisPulmonary FibrosisNCT00063869Wyeth is now a wholly owned subsidiary of Pfizer88