A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis.Acronym: ADVANCE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen Idec
- 入组人数
- 1,500
- 试验地点
- 21
- 主要终点
- To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo.
研究概览
简要总结
This study is a multicenter, randomized, double-blind, parallel- group, placebo- controlled study to evaluate the efficacy and safety of PEGylated Interferon Beta-1a (BIIB017) (125 mcg SC) in two dosing frequencies (every 2 weeks and every 4 weeks) in subjects with relapsing multiple sclerosis. The study will be conducted in approximately 30 countries and approximately 225 sites globally. Approximately 1260 subjects are planned to participate in this trial. The primary outcome measure is to determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo. The secondary outcomes are to determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability. India has contributed 170 patients and all the patients are in the follow up phase of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 65.00 Day(s)（—）
- 性别
- All
入选标准
- •Aged 18 to 65 years old, inclusive, at the time of informed consent.
- •Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-
- •Must have an EDSS score between 0.0 and 5.
- •Must have experienced at least 2 relapses that have been medically documented within the last 3 years with one occurring in the last 12 months.
排除标准
- •Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- •Pregnant or nursing women Other protocol-defined, Inclusion/ exclusion criteria may apply.
结局指标
主要结局
To determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year compared to placebo.
时间窗: 1 year
次要结局
- To determine whether BIIB017, at 1 year when compared with placebo, is effective in reducing the total number new brain lesions, reducing the proportion of subjects who relapsed, improving quality of life, and slowing the progression of disability.(1 year)