Actively Recruiting
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Led by Biogen · Updated on 2025-08-01
908
Participants Needed
7
Research Sites
453 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).
CONDITIONS
Official Title
Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must have a diagnosis of MS
- Participant was exposed to DRF from 2 weeks after the first day of their last menstrual period through any time during pregnancy, with known or estimated trimester of exposure
- Participant was unexposed to any DMT during pregnancy, including never treated, discontinued DRF at least 1 day before 2 weeks after last menstrual period, or discontinued other MS DMT more than 5 times its half-life before 2 weeks after last menstrual period
- Participant has knowledge of the pregnancy outcome (e.g., pregnancy loss or live birth)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
2
IQVIA US Office
Durham, North Carolina, United States, 27703
Actively Recruiting
3
Austin Hospital
Heidelberg, Australia, 3084
Actively Recruiting
4
Katholisches Klinikum Bochum
Bochum, North Rhine-Westphalia, Germany, 44791
Actively Recruiting
5
St Vincent's University Hospital
Dublin, Ireland, DO4 T6F4
Actively Recruiting
6
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
7
Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
CONTACT
G
Global Biogen Clinical Trial Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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