A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab 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
- 900
- 试验地点
- 53
- 主要终点
- The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years.
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in 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 50 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 (McDonald et al., 2001)
- •Between the ages of 18 and 50, inclusive.
- •Baseline EDSS score between 0.0 and 5.0, inclusive.
- •Have experienced at least one relapse within the 12 months prior to randomization.
- •Cranial MRI scan demonstrating lesion(s) 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,in the opinion of the investigator, within 50 days prior to randomization and/or the subject has not stabilized from a previous relapse.
- •A clinically significant infectious illness within 30 days prior to randomization.
- •History of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of a recombinant humanized antibody immunomodulating agent 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
- •Abnormal blood tests performed at the Screening Visit.
研究组 & 干预措施
Group 1
Natalizumab 300 mg, IV
干预措施: Natalizumab (Drug)
Group 2
Placebo IV infusion
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years.
时间窗: 1 year and 2 years
次要结局
- Reduction in MRI changes and clinical relapses(1 year)