CTRI/2009/091/000117已完成3 期
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 1,232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a). Aged 18 to 55 years old, inclusive at the time of informed consent.
- •b). Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- •c). Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •d). Must have relapsing-remitting disease course.
排除标准
- •a). Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- •b). Pregnant or nursing women
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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