Human Study on Diroximel Fumarate and Dimethyl Fumarate in Multiple Sclerosis
An observational study with 10,500 participants is planned to investigate serious adverse events (SAEs) related to Diroximel Fumarate and Dimethyl Fumarate among other disease-modifying therapies (DMTs) over a follow-up of up to 10 years. No results or endpoints have been posted as this is still in the planning phase.
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- #MSResearch
- Most relevant to
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- Source
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- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
Understanding the safety of these therapies is crucial for managing multiple sclerosis, especially regarding serious adverse events that can impact patient health.
What this does not prove
No results are available yet, and only planned enrollment details are mentioned, indicating that findings from the actual study are still forthcoming.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Observational
- Participants / samples
- 10500 · estimated
- Randomised
- Not reported
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- All
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- Not reported
- Pathway
- Not reported
- Population
- Not reported
- Size of effect
- Not reported
- Secondary endpoints
- Not reported
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (12)
study phaseStudy type: Observational
study designStudy type: Observational
subjectsParticipants: people; ages from 18 Years; sex All
sample sizeEnrollment: 10500 participants (estimated)
sample size basisEnrollment: 10500 participants (estimated)
relevant ms typesConditions: Multiple Sclerosis
interventionInterventions: Diroximel Fumarate; Dimethyl Fumarate; Disease-Modifying Therapies (DMTs)
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
primary endpointPrimary endpoints: Number of Participants With Confirmed Serious Adverse Events (SAEs) in the Vumerity, Tecfidera, Other Selected DMTs (Teriflunomide, Beta-interferons, or Glatiramer Acetate), or Vumerity/Tecfidera Switch Cohorts
follow upFollow-up: Up to 10 years
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.