Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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]).

Official Title

A Prospective, Observational Study Evaluating Persistence on Treatment, Safety, Tolerability, and Effectiveness of Diroximel Fumarate in the Real-World Setting (EXPERIENCE-US Study)

Keywords

Relapsing Forms of MS, Clinically isolated syndrome, Relapsing-remitting disease, Active secondary progressive disease, Diroximel Fumarate

Eligibility

You can join if…

Open to people ages 18 years and up

  • Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the USPI.
  • DRF prescribed and planned to be initiated within 60 days after enrollment.

You CAN'T join if...

  • History of gastric bypass or required use of feeding tubes.
  • Have received prior treatment with DRF.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of Calfornia San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Regina Berkovich MD Phd Inc not yet accepting patients
    West Hollywood California 90048 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Biogen
ID
NCT04746976
Study Type
Observational
Participants
Expecting 200 study participants
Last Updated