Study of Diroximel Fumarate in the Real-World Setting
Stopped early
Conditions studied: Relapsing Forms of MS
In brief
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 facts
- Study ID
- NCT04746976
- Run by
- Biogen
- People needed
- 75
- Starts
- 2021-03-01
- Expected to finish
- 2023-04-14
- Last updated by the study team
- 2023-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Jacobs School of Medicine and Biomedical Sciences — Buffalo, New York, United States
- Cone Health — Greensboro, North Carolina, United States
- Providence Brain and Spine Institute — Portland, Oregon, United States
- Geisinger Medical Center — Danville, Pennsylvania, United States
- Hope Neurology — Knoxville, Tennessee, United States
- UTHealth Neurosciences Texas Medical Center II — Houston, Texas, United States
- Riverside Neurology Specialists — Newport News, Virginia, United States
- Providence Medical Research Center — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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