NCT00195507已完成4 期
A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects With Psoriasis
Wyeth is now a wholly owned subsidiary of Pfizer127 个研究点 分布在 7 个国家目标入组 720 人开始时间: 2004年12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
- 720
- 试验地点
- 127
- 主要终点
- Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
研究概览
简要总结
This study will provide a direct comparison of 'continuous therapy' and 'intermittent therapy' with withdrawal and retreatment upon return of psoriasis.
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
- •Stable, active plaque psoriasis
- •Failure to respond to the following systemic therapies: Methotrexate, Cyclosporine, PUVA or Fumarate
排除标准
- •Evidence of skin conditions other than psoriasis that would interfere with evaluations of the effect of the study
- •Systemic psoriasis therapy within 28 days prior
结局指标
主要结局
Physician Global Assessment of Psoriasis (PGA) Score - Mean Value Over 54 Weeks
时间窗: 54 weeks
Physician Global Assessment of Psoriasis (PGA) is a 7-point scale used to assess severity of psoriatic plaques (1=severe psoriasis, 7=clear).
次要结局
- Patient Global Assessment of Psoriasis Score - Percentage of Improvement From Baseline(54 weeks)
- Time to Achieve a Physician Global Assessment of Psoriasis Score of "Clear" or "Almost Clear"(54 weeks)
- Number of Patients With Survey Response of "Somewhat Satisfied" or Better(54 weeks)
研究者
研究点 (127)
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