Study of Diroximel Fumarate in the Real-World Setting

Conditions

• Relapsing Forms of MS

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Diroximel Fumarate — DRUG
  As described in the arm.

Study Details

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 \[SAEs\]).

Key Dates

Start date

Mar 1, 2021

Status verified

May 2023

Primary completion

Apr 14, 2023

Completion

Apr 14, 2023

Study Design

Enrollment

75 participants (actual)

Arms

• Arm: Diroximel Fumarate
  Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled.

Primary Outcome Measure

Percentage of Participants on Treatment with DRF at 1 Year [ Time Frame: 1 year ]

Locations (18)

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