NCT00161655已完成4 期
A Multicenter, Open-label, Randomized, Pilot-study to Evaluate the Efficacy and Safety of the Combination of Etanercept (ETN) and Methotrexate and of Etanercept (ETN) Alone in Patients With Plaque Psoriasis Despite Methotrexate Therapy
Wyeth is now a wholly owned subsidiary of Pfizer8 个研究点 分布在 4 个国家目标入组 60 人开始时间: 2005年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.
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
- 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
- •Active plaque psoriasis involving >10% body surface area and/or minimal screening PASI score
- •Methotrexate >7.5 mg/week for the last 3 months
排除标准
- •Predominantly guttate, erythrodermic or pustular psoriasis
- •Other skin conditions than psoriasis
结局指标
主要结局
Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.
次要结局
- Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
- and 90. Time to clear or almost clear on PGA.
研究者
研究点 (8)
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