A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab (REMICADE�) Induction Therapy in Patients With Plaque-type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 249
- 主要终点
- Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with plaque-type psoriasis.
详细描述
The purpose of this study is to investigate the safety and possible usefulness of infliximab therapy for patients with severe plaque psoriasis. In a previous small study of infliximab in 33 patients with psoriasis, about 80% of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions, while 20% of patients who received placebo showed improvement. The patients will receive infusions of infliximab either 3 or 5 mg/kg or placebo at weeks 0,2,6. Patients who have significant psoriasis at week 26 will receive an additional infusion.
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
- •Must be 18 years of age or older at time of enrollment
- •may be male or female
- •Have had a diagnosis of plaque-type psoriasis at least 6 months prior to screening
- •Have plaque-type psoriasis covering at least 10% of total BSA at baseline
- •Have previously received PUVA and/or other systemic treatment for psoriasis
排除标准
- •Have non-plaque forms of psoriasis
- •Have a history of drug-induced psoriasis
- •Are pregnant, nursing, or planning pregnancy within 12 months of enrollment
- •Have had any previous treatment with infliximab or any therapeutic agent
结局指标
主要结局
Proportion of patients achieving a = 75% improvement in PASI score from baseline at week 10
次要结局
- The proportion of patients positive for antibodies to infliximab;The proportion of patients with infusion reactions at week 26;The proportion of infliximab-treated patients with infusion reaction at week 26 by antibodies to infliximab status at week 26