Study of Diroximel Fumarate in the Real-World Setting

Biogen

Status: Terminated

Conditions: Relapsing Forms of MS

Treatments: Drug: Diroximel Fumarate

Study type: Observational

Funder types: Industry

Identifiers

NCT04746976

US-VUM-11760

Details and patient eligibility

About

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]).

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

75 participants in 1 patient group

Diroximel Fumarate

Description:

Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled.

Treatment:

Drug: Diroximel Fumarate