A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Proportion of participants with persistent anti-natalizumab antibodies
研究概览
简要总结
The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have documented diagnosis of RMS at screening.
- •Must fall within the therapeutic indications stated in the locally approved label for natalizumab.
- •Must have an EDSS score from 0 to 6.5, inclusive.
排除标准
- •Any prior use of natalizumab.
- •Positive for anti-natalizumab antibodies at screening.
- •Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
natalizumab
natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44)
干预措施: natalizumab (Drug)
结局指标
主要结局
Proportion of participants with persistent anti-natalizumab antibodies
时间窗: 48 weeks
Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit.
次要结局
- Proportion of participants with transient anti-natalizumab antibodies(48 weeks)
- Proportion of participants with post-injection adverse events (AEs)(48 weeks)
- Proportion of participants with clinical relapse(48 weeks)
- Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.(48 weeks)
- Proportion of Participants that experience Adverse Events and Serious Adverse Events(up to 56 weeks)