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

US-VUM-11760

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) and to explore the real-world safety profile of DRF (ie, gastrointestinal \[GI\] tolerability, lymphocyte dynamics, adverse events \[AEs\] leading to discontinuation, and serious adverse events \[SAEs\]).

2021-03-01

2023-04-14

2023-04-14

Terminated

75

Key Inclusion Criteria: * Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the USPI. * DRF prescribed and planned to be initiated within 60 days after enrollment. Key Exclusion Criteria: * History of gastric bypass or required use of feeding tubes. * Have received prior treatment with DRF. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 75, 'type': 'ACTUAL'}}

2023-05-26