The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
研究概览
简要总结
The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
- •Female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (SPC) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
排除标准
- •Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
- •Antibiotic treatment in the last month prior to study entry.
- •Scheduled alteration of diet, including the use of probiotics.
- •NOTE: Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
dimethyl fumarate
As prescribed by the Investigator according to the local Summary of Product Characteristics.
干预措施: dimethyl fumarate (Drug)
injectable MS DMT
As prescribed by the Investigator according to the local Summary of Product Characteristics.
干预措施: injectable MS DMT (Drug)
结局指标
主要结局
Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
时间窗: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
次要结局
- Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences.(Upon GI symptoms and week 12)
- Change in gut microbiota composition between DMF treated participants that do or do not develop GI AEs as measured by an increase in the Gastrointestinal Symptom Rating Scale (GSRS) score.(Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points)
- Changes in gut microbiota composition in participants treated with DMF compared to participants treated with an alternative injectable multiple sclerosis (MS) disease modifying therapies (DMT)(Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points)
- Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.(Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points)