Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting now
Conditions studied: Multiple Sclerosis
In brief
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).
Key facts
- Study ID
- NCT05658497
- Run by
- Biogen
- People needed
- 908
- Starts
- 2023-10-27
- Expected to finish
- 2032-07-06
- Last updated by the study team
- 2025-08-01
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- IQVIA US Office — Durham, North Carolina, United States (enrolling)
- Austin Hospital — Heidelberg, Australia (enrolling)
- Katholisches Klinikum Bochum — Bochum, North Rhine-Westphalia, Germany (enrolling)
- St Vincent's University Hospital — Dublin, Ireland (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Inselspital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.