NCT00237887已完成3 期
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 1,212
- 主要终点
- Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score
研究概览
简要总结
A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic 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
- 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
- •Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- •Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
- •Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections
排除标准
- •Subject had previously received anti-TNF therapy.
- •Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
- •Subject cannot avoid excessive sun exposure
- •Subject is taking or requires oral or injectable corticosteroids
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
结局指标
主要结局
Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score
时间窗: Week 16
次要结局
- Safety parameters
研究者
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