Trials / Terminated
TerminatedNCT04746976
Study of Diroximel Fumarate in the Real-World Setting
A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-US Study)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 75 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 \[SAEs\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Diroximel Fumarate | As described in the arm. |
Timeline
- Start date
- 2021-03-01
- Primary completion
- 2023-04-14
- Completion
- 2023-04-14
- First posted
- 2021-02-10
- Last updated
- 2023-05-26
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04746976. Inclusion in this directory is not an endorsement.