A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

Amgen0 个研究点目标入组 600 人开始时间: 2003年6月1日最近更新: 2013年5月15日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Amgen
入组人数: 600
主要终点: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.

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: 否

入选标准

•Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period

排除标准

•Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

结局指标

主要结局

Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

次要结局

Dermatology Live Quality Index (DLQI) response at week 12
Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
Serious adverse events and infections during long-term therapy
Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
Psoriasis pain (VAS) at week 12
PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Adverse events, infections injection site reactions during long-term therapy

研究者

发起方

Amgen

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

3 期

Study Evaluating Etanercept Treatment of Patients With Ankylosing SpondylitisAnkylosing Spondylitis

NCT00421915Wyeth is now a wholly owned subsidiary of Pfizer84

已完成

3 期

Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With PsoriasisPsoriasis

NCT00333034Wyeth is now a wholly owned subsidiary of Pfizer120

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 Arthritis

NCT00115219Amgen200

已完成

3 期

Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid ArthritisArthritis, Rheumatoid

NCT00445770Pfizer550

已完成

2 期

Etanercept With Tacrolimus for PsoriasisPsoriasis

NCT00134394University of Medicine and Dentistry of New Jersey20