NCT00679731已完成3 期
A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis
AbbVie (prior sponsor, Abbott)43 个研究点 分布在 14 个国家目标入组 317 人开始时间: 2008年4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
- 317
- 试验地点
- 43
- 主要终点
- Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24
研究概览
简要总结
This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.
详细描述
This study is only being conducted in the EU and Canada
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 anti-IL 12
研究组 & 干预措施
A
Experimental
ABT-874
干预措施: ABT-874 (Drug)
B
Active Comparator
Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 24
时间窗: Week 24
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 24
时间窗: Week 24
Proportion of subjects who achieve a PASI 75 response relative to baseline at Week 52
时间窗: Week 52
The proportion of subjects who achieve a PGA score of 0 or 1 at Week 52
时间窗: Week 52
次要结局
- Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 24(Week 24)
- Changes from Baseline in the DLQI total score at Week 24(Week 24)
- Proportion of subjects who achieve a PASI 100 response relative to baseline at Week 52(Week 52)
- Changes from Baseline in the DLQI total score at Week 52(Week 52)
研究者
研究点 (43)
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