A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 5,487
- 试验地点
- 3
- 主要终点
- The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)
研究概览
简要总结
The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.
详细描述
Patients aged 12 to under 18 may be included where enrollment of pediatric patients in this study is considered observational and is permissible by local regulations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl fumarate (DMF) under routine clinical care are eligible to participate in the study.
排除标准
- •Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid esters), or compounded fumarates.
- •Patients participating in other clinical studies.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
dimethyl fumarate (DMF)
Patients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care
干预措施: dimethyl fumarate (Drug)
结局指标
主要结局
The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)
时间窗: Up to 5 years
The number of participants that experience Serious Adverse Events (SAEs)
时间窗: Up to 5 years
次要结局
- Primary reasons for discontinuation of dimethyl fumarate (DMF) use(Up to 5 years)
- Duration of dimethyl fumarate (DMF) use(Up to 5 years)
- dimethyl fumarate (DMF) dosing frequency(Up to 5 years)
- Frequency of relapses over time(Up to 5 years)
- Disease progression as measured by Expanded Disability Status Scale (EDSS) over time(Up to 5 years)
- Multiple Sclerosis Impact Scale-29 Items (MSIS-29) physical multiple sclerosis (MS) impact score(Up to 5 years)
- Multiple Sclerosis Impact Scale-29 Items (MSIS-29) psychological multiple sclerosis (MS) impact score(Up to 5 years)
- EuroQol-5 Dimensions (5 Level) (EQ-5D-5L) index score(Up to 5 years)
- EuroQol Visual Analogue Scale (EQ VAS) (0-100 scale)(Up to 5 years)
- Modified Fatigue Impact Scale-5 (MFIS-5) total score(Up to 5 years)
- Work Productivity and Activity Impairment questionnaire: Multiple Sclerosis, Version 2.0 (WPAI-MS) impairment percentages(Up to 5 years)
- Health Care Resource Consumption Questionnaire(Up to 5 years)