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A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-US Study)
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 \[SAEs\]).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Regina Berkovich MD Phd Inc
West Hollywood, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Glendale Neurological Associates, PC
Farmington, Michigan, United States
Memorial Healthcare
Owosso, Michigan, United States
St. Luke's Neurology
Kansas City, Missouri, United States
CentraState Healthcare System - Linda Cardinale MS Center
Freehold, New Jersey, United States
MS Center at St Barnabas
Livingston, New Jersey, United States
Multiple Sclerosis Center JSUMC
Neptune City, New Jersey, United States
Start Date
March 1, 2021
Primary Completion Date
April 14, 2023
Completion Date
April 14, 2023
Last Updated
May 26, 2023
75
ACTUAL participants
Diroximel Fumarate
DRUG
Lead Sponsor
Biogen
Data Source & Attribution
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