Last reviewed · How we verify
NCT04746976
Study of Diroximel Fumarate in the Real-World Setting
trial testing Diroximel Fumarate in Relapsing Forms of MS in 75 participants. Terminated before completion.
14 April 2023
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 75 |
| Start date | 1 March 2021 |
| Primary completion | 14 April 2023 |
| Estimated completion | 14 April 2023 |
| Sites | 18 locations across United States |
Drugs / interventions tested
- Diroximel Fumarate (DIROXIMEL FUMARATE) — full drug profile →
Conditions studied
- Relapsing Forms of MS — all drugs for Relapsing Forms of MS →
Sponsor
Biogen — full company profile →
Who can join
18 and older, any sex, with Relapsing Forms of MS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 \[SAEs\]).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Efficacy and Safety of Multiple Sclerosis Drugs Approved Since 2018 and Future Developments.
Faissner S, Gold R. · · 2022 · cited 21× · PMID 35869335 · DOI 10.1007/s40263-022-00939-9
Verify or expand the search:
- PubMed search for NCT04746976
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Diroximel Fumarate
Trials testing the same drug.
- NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
- NCT05767736 — A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS) · active not recruiting
- NCT05658497 — Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate) · recruiting
- NCT04948606 — Exploring Diroximel Fumarate Real-world Experience in Canada and Israel · terminated
- NCT05688436 — A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy An · recruiting
Other Biogen trials
Trials by the same sponsor.
- NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
- NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
- NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
- NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
- NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04746976 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Biogen
- Last refreshed: 26 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04746976.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing