Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis (AMS04)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 13
- 主要终点
- Change in frequency of MBP-reactive Th17 cells
研究概览
简要总结
The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at multiple time points, prior to, and following the initiation of BAF312 or placebo treatment, in patients with Secondary Progressive Multiple Sclerosis (SPMS) who are enrolled in a clinical trial (NCT01665144) to evaluate the effectiveness and safety of BAF312.
详细描述
This study is complementary to a multi-center, randomized, double-blind,parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with SPMS (NCT01665144). Investigators will explore both immunological and neuroprotective mechanisms of BAF312 (siponimod), a novel agent in the setting of a SPMS clinical trial.
This study is part of a multi-center study, with the University of Michigan serving as the central site.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants enrolled in the multicenter, randomized, double-blind, parallel-group, placebo-controlled, variable treatment duration study comparing the efficacy and safety of BAF312 to placebo in patients with Secondary Progressive Multiple Sclerosis (SPMS) Protocol No. CBAF312A2304 (sponsored by Novartis). Refer to ClinicalTrials.gov record NCT
- •Subjects enrolled at one of the participating AMS04 study sites located in the United States.
- •Subject must be able to provide written informed consent.
排除标准
- •Subjects with severe bleeding disorders, platelet count less than (<)50,000/microliters (μL), and/or who are currently on full anticoagulant therapy will be excluded from the optional CSF collections.
结局指标
主要结局
Change in frequency of MBP-reactive Th17 cells
时间窗: From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).
Evaluation (BAF312 versus placebo) of dominant cytokines produced by myelin basic protein (MBP)-stimulated peripheral blood mononuclear cells (PBMCs), measured by ELISpot.
次要结局
- Change in frequency of polyclonal CD4+ Th17, Th1, Th2, and Treg cells(From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)
- Change in chemokine and cytokines levels(From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)
- Changes of clinical status and lymphocyte subgroups(From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)
- Change in Regulatory B Cells(From baseline to the follow-up time points (Open label phase + 6 months and OLP +12 months).)