A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-CA+IL Study)
Overview
- Phase
- Not Applicable
- Intervention
- Diroximel Fumarate
- Conditions
- Relapsing Forms of MS
- Sponsor
- Biogen
- Enrollment
- 64
- Locations
- 6
- Primary Endpoint
- Percentage of Participants on Treatment with DRF
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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].
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Diroximel Fumarate
Outcomes
Primary Outcomes
Percentage of Participants on Treatment with DRF
Time Frame: Year 1
Secondary Outcomes
- 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)