NCT03302442已完成不适用
Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Relapse within first year of treatment
研究概览
简要总结
The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMS Patients with an EDSS score ranging between 0 and 5.5, who initiated either DMF or Teriflunomide before 1/01/2016 and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation Patients who had consent to OFSEP registry Naive patient or treated with prior first line treatment : interferon, glatiramer acetate
排除标准
- •Patient with progressive multiple sclerosis
- •Patients with prior second line Patient with no MRI or EDSS score within the year before DMF or Teriflunomide initiation.
结局指标
主要结局
Relapse within first year of treatment
时间窗: 12 months
Proportion of patients experimenting at least one relapse within the first year of treatment
次要结局
- Occurrence of clinical event at Two years(24 months)
- Progression of disability(12 months and 24 months)
- Radiological disease activity(12 months and 24 months)
- Adverse drug reaction(12 months and 24 months)
研究者
研究点 (1)
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