NCT01903291已完成不适用
A Multicenter, Open-Label, 12-Month Observational Study Evaluating the Clinical Effectiveness and Impact on Patient-Reported Outcomes of Oral Tecfidera™ (Dimethyl Fumarate) Delayed-Release Capsules in Patients With Relapsing Forms of Multiple Sclerosis After Suboptimal Response to Glatiramer Acetate
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Annualized Relapse Rate
研究概览
简要总结
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with relapsing forms of multiple sclerosis (MS) who are treated with dimethyl fumarate (DMF) after suboptimal response to glatiramer acetate (GA). The secondary objectives of this study in this study population are to assess the impact of DMF over a 12-month period on patient-reported outcomes (PROs) and health economic-related outcomes and to evaluate additional clinical outcomes at Month 12.
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
- •Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use Protected Health Information in accordance with national and local patient privacy regulations.
- •Have the ability to read and understand written English.
- •Have access to the internet and are able to complete online assessments on a computer
- •Have a relapsing form of Multiple Sclerosis and satisfy the approved therapeutic indication for dimethyl fumarate (DMF) per the United States Prescribing Information (USPI).
- •Are being treated for relapsing forms of multiple sclerosis (MS) with glatiramer acetate (GA) but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to GA or have stopped treatment with GA for relapsing forms of MS as a result of suboptimal response within 30 days of enrollment.
- •Have decided to initiate treatment with dimethyl fumarate (DMF) under routine clinical care. The decision to initiate treatment with DMF must precede enrollment.
- •Have a complete blood count (CBC) available within 6 months of initiation of treatment with dimethyl fumarate (DMF).
排除标准
- •Are unwilling or unable to comply with study requirements, or, are deemed unsuitable for study participation at the discretion of the Prescribing Physician.
- •Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
- •Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
- •Have a history of and/or current serious infections.
- •Are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
- •Are receiving concomitant disease modifying therapies other than glatiramer acetate (GA) or have initiated treatment with a new disease-modifying therapy since discontinuation of glatiramer acetate (GA).
- •Are currently enrolled in any other clinical studies, with the exception of the dimethyl fumarate (DMF) Pregnancy Registry.
- •Have received prior treatment with dimethyl fumarate (DMF).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
dimethyl fumarate
To be taken according to the United States Prescribing Information (USPI)
干预措施: dimethyl fumarate (Drug)
结局指标
主要结局
Annualized Relapse Rate
时间窗: 12 months
次要结局
- Change in Patient-reported Expanded Disability Status Scale (patient-reported EDSS) scores.(Baseline to 12 months)
- Proportion of patients with relapses associated with hospitalizations.(Baseline to 12 months)
- Change in Modified Fatigue Impact Scale (MFIS-5) scores.(Baseline to 12 months)
- Change in 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14) scores.(Baseline to 12 months)
- Change in Short-Form 36 (SF-36) scores.(Baseline to 12 months)
- Change in Beck Depression Inventory (BDI-7) scores.(Baseline to 12 months)
- Change in Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS) scores.(Baseline to 12 months)
- Change in Morisky 8-item Medication Adherence Scale (MMAS-8) scores.(Baseline to 12 months)
- Proportion of patients experiencing a relapse.(Baseline to 12 months)
- Proportion of patients with relapses associated with steroid use.(Baseline to 12 months)
研究者
研究点 (1)
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