Study on the Dimethyl Fumarate (DMF, Tecfidera®) Persistence of Remitting-relapsing Multiple Sclerosis (RR-MS) Patients Included in the French Patient Support Program (PSP) OroSEP
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 353
- 试验地点
- 62
- 主要终点
- Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months
研究概览
简要总结
The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without OroSEP patient support program (PSP), respectively.
The secondary objectives are: to compare oral DMF persistence at one month and three months in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the two groups; To describe the percentage of participants with treatment-related adverse events globally and by class of adverse events, in the two groups of participants; To assess the evolution of participants' anxiety globally and to compare it at inclusion and at six months in participants with and without OroSEP PSP, respectively; To describe participants' satisfaction regarding oral DMF initiation and follow-up globally at six months and to compare it in patients with and without OroSEP PSP, respectively;
For OroSEP PSP group: To assess participants' satisfaction regarding their participation in OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation in OroSEP PSP, after the last participant last visit of center.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the purpose and risks of the study and giving oral informed consent regarding TEC-ADHERE study and authorization to use protected health information (PHI) in accordance with national and local participant privacy regulations;
- •Diagnosis of RR-MS;
- •Initiating oral DMF according to Summary of Product Characteristics (SmPC) at the inclusion visit;
- •Expanded Disability Status Score (EDSS) under
排除标准
- •Participants with progressive form of Multiple Sclerosis (MS);
- •With memory or psychiatric disorders preventing them to complete questionnaires in the study.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Standard of Care (SoC) Group
SoC neurologists will include and follow-up all study participants who receive DMF according to their standard of care practice (non-coached participants).
干预措施: Dimethyl Fumarate (Drug)
OroSEP PSP (OPSP) Group
OPSP neurologists will include and follow-up all study participants who receive DMF according to their standard of care practice and the OroSEP PSP (coached participants).
干预措施: Dimethyl Fumarate (Drug)
OroSEP PSP (OPSP) Group
OPSP neurologists will include and follow-up all study participants who receive DMF according to their standard of care practice and the OroSEP PSP (coached participants).
干预措施: PSP (Other)
结局指标
主要结局
Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months
时间窗: 6 months
Persistence is defined as the percentage of participant still being treated by oral DMF at 6 months, according to routine visit.
次要结局
- Participant's Anxiety at Inclusion and at 6 Months(0 months and 6 months)
- Participant's Satisfaction Regarding Dimethyl Fumarate (DMF) Treatment at 6 Months(6 months)
- Percentage of Participants with Adverse Events (AEs)(up to 6 months)
- Participant's Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)(6 month)
- Neurologists' Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)(up to 6 months)
- Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months(1 month and 3 months)
- Percentage of Participant's with Adherence at 6 Months(6 months)
- Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months(3 month and 6 months)
- Percentage of Participants with Adverse Events (AEs) Related to Treatment(up to 6 months)
- Percentage of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation(up to 6 months)
- Percentage of Participants with Adverse Events (AEs) of Interest(up to 6 months)