Study of Diroximel Fumarate in the Real-World Setting

NCT ID: NCT04746976

Last Updated: 2023-05-26

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

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

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) 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 \[SAEs\]).

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

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

Diroximel Fumarate

Intervention Type DRUG

As described in the arm.

Interventions

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Diroximel Fumarate

As described in the 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 USPI.
* DRF prescribed and planned to be initiated within 60 days after enrollment.

Exclusion Criteria

* History of gastric bypass or required use of feeding tubes.
* Have received prior treatment with DRF.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Regina Berkovich MD Phd Inc

West Hollywood, California, United States

Site Status

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status

Norton Neuroscience Institute

Louisville, Kentucky, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Glendale Neurological Associates, PC

Farmington, Michigan, United States

Site Status

Memorial Healthcare

Owosso, Michigan, United States

Site Status

St. Luke's Neurology

Kansas City, Missouri, United States

Site Status

CentraState Healthcare System - Linda Cardinale MS Center

Freehold, New Jersey, United States

Site Status

MS Center at St Barnabas

Livingston, New Jersey, United States

Site Status

Multiple Sclerosis Center JSUMC

Neptune City, New Jersey, United States

Site Status

Jacobs School of Medicine and Biomedical Sciences

Buffalo, New York, United States

Site Status

Cone Health

Greensboro, North Carolina, United States

Site Status

Providence Brain and Spine Institute

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Hope Neurology

Knoxville, Tennessee, United States

Site Status

UTHealth Neurosciences Texas Medical Center II

Houston, Texas, United States

Site Status

Riverside Neurology Specialists

Newport News, Virginia, United States

Site Status

Providence Medical Research Center

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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US-VUM-11760

Identifier Type: -

Identifier Source: org_study_id

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