Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate SURV-SEP
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Number of patients with a relapse and/or progressive worsening of disease (EDSS score)
研究概览
简要总结
The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.
Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.
It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.
The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient 18 years old and more
- •with multiple sclerosis according to the criteria of Mac Donald 2010 : relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP)
- •for which treatment with dimethyl-fumarate has been prescribed
- •followed at the Rothschild Foundation in the Neurology Department
- •having given written consent to participation in the study
排除标准
- •pregnant or breastfeeding woman
- •patient with a measure of legal protection
- •subject unaffiliated insurance
研究组 & 干预措施
Patient with recurring-remitting MS
干预措施: Dimethyl fumarate (Drug)
结局指标
主要结局
Number of patients with a relapse and/or progressive worsening of disease (EDSS score)
时间窗: After one year of treatment
次要结局
未报告次要终点