NCT04948606

Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-CA+IL Study)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[SAEs\].

Conditions

• Relapsing Forms of MS

Interventions

Type	Name	Description
DRUG	Diroximel Fumarate	Administered as specified in the treatment arm.

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-04-14
• Completion: 2023-04-14
• First posted: 2021-07-02
• Last updated: 2023-05-10

Locations

6 sites across 1 country: Israel

Regulatory

• FDA-regulated drug study