Multiple Sclerosis Clinical Trial

Study of Diroximel Fumarate in the Real-World Setting

Summary

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]).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

75

Study ID:

NCT04746976

Recruitment Status:

Terminated

Sponsor:

Biogen

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There are 18 Locations for this study

See Locations Near You

Regina Berkovich MD Phd Inc
West Hollywood California, 90048, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Norton Neuroscience Institute
Louisville Kentucky, 40207, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Glendale Neurological Associates, PC
Farmington Michigan, 48071, United States
Memorial Healthcare
Owosso Michigan, 48867, United States
St. Luke's Neurology
Kansas City Missouri, 64111, United States
CentraState Healthcare System - Linda Cardinale MS Center
Freehold New Jersey, 07728, United States
MS Center at St Barnabas
Livingston New Jersey, 07039, United States
Multiple Sclerosis Center JSUMC
Neptune New Jersey, 07753, United States
Jacobs School of Medicine and Biomedical Sciences
Buffalo New York, 14202, United States
Cone Health
Greensboro North Carolina, 27405, United States
Providence Brain and Spine Institute
Portland Oregon, 97225, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Hope Neurology
Knoxville Tennessee, 37922, United States
UTHealth Neurosciences Texas Medical Center II
Houston Texas, 77030, United States
Riverside Neurology Specialists
Newport News Virginia, 23601, United States
Providence Medical Research Center
Spokane Washington, 99204, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

75

Study ID:

NCT04746976

Recruitment Status:

Terminated

Sponsor:


Biogen

How clear is this clinincal trial information?

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