A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-CA+IL Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Biogen
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Percentage of Participants on Treatment with DRF
研究概览
简要总结
The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs); to assess the impact of DRF on disability; to assess treatment satisfaction with DRF; to explore the real-world safety profile of DRF (i.e., gastrointestinal [GI] tolerability, lymphocyte dynamics, adverse events [AEs] leading to discontinuation, and serious adverse events [SAEs].
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 a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the prescribing information.
- •DRF prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose.
排除标准
- •History of gastric bypass or required use of feeding tubes.
- •Current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (PI) and Biogen
- •Have received prior treatment with DRF (more than 7 days before enrollment).
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Diroximel Fumarate (DRF)
Participants with a confirmed diagnosis of MS who are newly prescribed DRF in routine clinical practice and who satisfy the approved therapeutic indication for DRF will be enrolled.
干预措施: Diroximel Fumarate (Drug)
结局指标
主要结局
Percentage of Participants on Treatment with DRF
时间窗: Year 1
次要结局
- Percentage of Participants on Treatment with DRF(Year 2)
- Annualized Relapse Rate (ARR) with DRF(Year 1 and 2)
- Percentage of Participants Relapsed(Year 1 and 2)
- Number of Participants with Gastrointestinal (GI) Adverse Events (AEs)(Up to Month 32)
- Number of Participants with AEs Leading to Treatment Discontinuation(Up to Month 32)
- Change in Cognitive Processing Speed Test (CPST) Score(Baseline, Year 1 and 2)
- Change in Score for Each Domain of Quality of Life in Neurological Disorders (Neuro- QoL™) Questionnaire(Baseline, Year 1 and 2)
- Change in Disability, as Measured by Expanded Disability Status Scale (EDSS)(Baseline, Year 1 and 2)
- Mean Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Score(Baseline, Year 1 and 2)
- Number of Participants with Serious Adverse Events (SAEs)(Up to Month 32)
- Number of Participants with Relevant Concomitant Medication Use(Up to Month 32)
- Number of Participants Categorized by the Types of Actions Taken Due to GI AEs(Up to Month 32)
- Median Absolute Lymphocyte Count (ALC) Over Time(Baseline, Month 6, Year 1 and 2)
- Percent Change from Baseline in Median ALC(Baseline, Month 6, Year 1 and 2)
- Number of Participants with Lymphopenia According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) Severity Grading(Up to Month 32)