A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine 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
- 入组人数
- 1,234
- 试验地点
- 1
- 主要终点
- Proportion of Subjects Relapsed
研究概览
简要总结
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.
The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
- •Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-
- •Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- •Must have relapsing-remitting disease course.
排除标准
- •Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
- •Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
- •Pregnant or nursing women.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Participants received two placebo capsules orally three times daily (TID)
干预措施: Placebo (Drug)
BG00012 240 mg Twice Daily (BID)
Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
干预措施: BG00012 (Drug)
BG00012 240 mg 3 Times Daily (TID)
Participants received two 120 mg BG00012 capsules orally three times daily (TID)
干预措施: BG00012 (Drug)
结局指标
主要结局
Proportion of Subjects Relapsed
时间窗: 2 years
A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurolgic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.
次要结局
- Number of Gadolinium-enhancing T1-weighted Lesions(2 years)
- Number of Subjects With Gadolinium (Gd)-Enhancing Lesions(2 years)
- Number of New or Newly Enlarging T2 Hyperintense Lesions(2 years)
- Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)(2 years)
- Annualized Relapse Rate(2 years)