Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-09

Study Completion Date

2023-04-14

Brief Summary

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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 \[SAEs\].

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Detailed Description

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Conditions

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Relapsing Forms of MS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Diroximel Fumarate

Intervention Type DRUG

Administered as specified in the treatment arm.

Interventions

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Diroximel Fumarate

Administered as specified in the treatment arm.

Intervention Type DRUG

Other Intervention Names

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VUMERITY BIIB098

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No