NCT01930708已完成4 期
A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,114
- 试验地点
- 1
- 主要终点
- Annualized Relapse Rate (ARR)
研究概览
简要总结
The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.
The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.
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
- •Have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) and satisfy the approved therapeutic indication for DMF (per the local DMF product information).
- •Must be naïve to DMF, Fumaderm®, and other compounded fumarates, and to MS therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab.
- •Have a recent complete blood count (CBC) that does not preclude the subject's participation in the study, in the judgment of the Investigator.
排除标准
- •Are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
- •Have major comorbid conditions that preclude participation in the study, as determined by the Investigator.
- •Are pregnant, unless DMF is clearly needed and the potential benefit of DMF to the subjects justifies the potential risk to the fetus, in the judgment of the Investigator (in all countries except Austria). In Austria, pregnant subjects are excluded from participation in the study.
- •Are women of childbearing potential and are not using appropriate contraception (per the local DMF product information) as determined by the Investigator.
- •Women who are breastfeeding may be excluded (per the local DMF product information) at the discretion of the Investigator.
- •Have previously received or are receiving treatment with MS therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for RRMS.
- •Are hypersensitive to the active ingredient in the DMF drug product (i.e., DMF) or to any of the excipients listed in the local DMF product information.
- •Current enrollment in any clinical trial except for the Biogen Idec DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local registries).
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
DMF
Experimental
120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
干预措施: dimethyl fumarate (Drug)
结局指标
主要结局
Annualized Relapse Rate (ARR)
时间窗: 12 Months
次要结局
- Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score(12 Months)
- Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score(12 Months)
- Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index(12 Months)
- Change from Baseline in participants-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score(12 Months)
- Change from Baseline in Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score(12 Months)
- Change from Baseline in Beck Depression Inventory-Fast Screen (BDI-Fast Screen) score(12 Months)
- Proportion of participants with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression(12 Months)
- Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6(Baseline, 6 Months)
- Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score(12 Months)
- The proportion of participants relapsed(12 Months)
- Number of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS(12 Months)
- Proportion of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS(12 Months)
- Proportion of participants who report taking the prescribed DMF dose(12 Months)
- Percentage of participants who report taking the prescribed DMF dose(12 Months)
- Reasons reported by participants for not taking prescribed DMF dose(12 Months)
- Change from baseline in EQ Visual Analog Scale (EQVAS) score(12 Months)
研究者
研究点 (1)
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