NCT00338754已完成2 期
A Phase 2/3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Adalimumab in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 160
- 试验地点
- 8
- 主要终点
- Proportion of subjects with clinical response relative to Baseline PASI score
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was age 20 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, and had moderate to severe plaque psoriasis
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 UVA, UVB or PUVA phototherapy
- •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 with clinical response relative to Baseline PASI score
次要结局
- QoLs
- Clinical response indicators
- Safety parameters
研究者
研究点 (8)
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