NCT00691964已完成3 期
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
AbbVie (prior sponsor, Abbott)35 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 35
- 主要终点
- Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
研究概览
简要总结
Compare the efficacy of ABT-874 versus etanercept in subjects with moderate to severe plaque 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
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of Psoriasis for 6 mo.
- •BSA 10%, PASI 12 or above, PGA 3 or above
排除标准
- •Previous exposure to either etanercept or ABT-874
研究组 & 干预措施
A
Experimental
干预措施: ABT-874 (Biological)
B
Active Comparator
干预措施: etanercept (Biological)
C
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Proportion of subjects who achieve a PGA of 0 or 1 response relative to baseline at Week 12
时间窗: 12 Weeks
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 12
时间窗: 12 Weeks
次要结局
- Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 12(12 Weeks)
研究者
研究点 (35)
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