Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
NCT05658497
This study is recruiting at 2 US sites in 2 states, according to its ClinicalTrials.gov record last updated .
Summary
The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease…
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Multiple Sclerosis
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- Any age
- Sex
- Female
- Healthy volunteers
- Not accepted
- Sponsor
- Biogen
- Last updated on ClinicalTrials.gov
- August 11, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Colorado · 1
- University of Colorado Anschutz Medical Campus · Aurora, CO
North Carolina · 1
- IQVIA US Office · Durham, NC
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.