A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 345
- 试验地点
- 9
- 主要终点
- To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS
研究概览
简要总结
The primary objective of this study is to determine whether combination treatment (adding methylprednisolone to Avonex) reduces progression of disability over 4 years compared to Avonex alone. The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.
详细描述
Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone (MP). Patients will receive MP as 500 mg po for 3 days every month or matching placebo. The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time.
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
- •Informed consent
- •Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
- •Disability EDSS score of 4.0 or less at baseline
- •Clinical activity as defined by at least one relapse in the last year
排除标准
- •Relapse in the month prior to enrolment
- •Treatment with immunosuppressive drugs for MS
- •History of major depression
- •Former severe reactions to corticosteroids
- •Pregnant women
- •Diabetes mellitus, and drug or alcohol dependency
- •Known or suspected allergy to trial products
研究组 & 干预措施
1
interferon-beta-1a in combination with methylprednisolone
干预措施: Interferon-beta-1a (Avonex) plus methylprednisolone (Drug)
2
interferon-beta-1a in combination with placebo
干预措施: Interferon-beta-1a (Avonex) plus methylprednisolone (Drug)
结局指标
主要结局
To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS
时间窗: 4 years
次要结局
未报告次要终点