NCT00030966已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,200
- 试验地点
- 87
- 主要终点
- Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.
研究概览
简要总结
The purpose of this study is to determine if natalizumab in combination with AVONEX is safe and effective in delaying progression of individuals diagnosed with relapsing remitting Multiple Sclerosis (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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of MS as defined by McDonald et al, criteria, # 1- 4
- •Between the ages of 18 and 55, inclusive
- •Baseline EDSS score between 0.0 and 5.0, inclusive
- •Have been treated with Avonex for at least the 12 months prior to randomization
- •Have experienced at least one relapse (while on Avonex) within the 12 months prior to randomization.
- •Cranial MRI scan demonstrating lesions consistent with MS.
- •Have given written informed consent to participate in the study.
排除标准
- •Primary progressive, secondary progressive, or progressive relapsing MS.
- •MS relapse has occurred within 50 days of randomization
- •A clinically significant infectious illness within 30 days prior to randomization
- •History of, or abnormal lab result, indicative of significant disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent or Avonex for 116 weeks.
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- •Unable to perform the Timed 25-Foot Walk, 9HPT and PASAT 3
- •Abnormal blood tests at Screening Visit
研究组 & 干预措施
Group 1
Experimental
Adding natalizumab monthly infusion to Avonex weekly injection for up to 116 weeks.
干预措施: Natalizumab (Drug)
Group 2
Placebo Comparator
Adding placebo monthly infusion to Avonex weekly injection for up to 116 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS.
时间窗: 1 year and 2 years
次要结局
- If this combination reduces MRI lesions and the overall rate of clinical relapses(1 year and 2 years)
研究者
研究点 (87)
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