Registry to assess pregnancy outcomes in women with multiple sclerosis exposed to Vumerity
Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry
This study is trying to see if taking a medication called Vumerity during early pregnancy affects the health of babies born to women with multiple sclerosis compared to those who didn't take it or took other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 908 (estimated) |
| Sex | Female |
| Sponsor | Biogen Industry-sponsored |
| Locations | 7 sites (Aurora, Colorado and 6 other locations) |
| Trial ID | NCT05658497 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the risk of major congenital malformations in infants born to women with multiple sclerosis who were exposed to diroximel fumarate during early pregnancy. It will compare pregnancy outcomes between women exposed to diroximel fumarate and those who were either unexposed to disease modifying therapies or exposed to other therapies like Avonex and Tysabri. The study will gather data on pregnancy outcomes from women with MS to better understand the effects of this medication during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include women diagnosed with multiple sclerosis who were exposed to diroximel fumarate during early pregnancy or who have not received any disease modifying therapies.
Not a fit: Patients who are not pregnant or those who have not been diagnosed with multiple sclerosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of diroximel fumarate during pregnancy for women with multiple sclerosis.
How similar studies have performed: Other studies have successfully evaluated pregnancy outcomes in women with multiple sclerosis and their exposure to various disease modifying therapies, indicating that this approach has been tested before.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participant must have a diagnosis of MS * Documentation that the participant was one of the following: 1. exposed to DRF at any time from 2 weeks after the first day of their LMP (i.e., conception date) up through any time during pregnancy. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure). 2. unexposed to any DMT during pregnancy, defined as having never received DMT therapy; discontinued treatment with DRF at least 1 day before 2 weeks after the first day of their LMP (i.e., conception date); or discontinued a non Registry-specified MS DMT more than 5 times its half-life prior to 2 weeks after the first day of their LMP (i.e., conception date) * Participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth) Key Exclusion Criteria: \- None NOTE: Other protocol defined Inclusion criteria may apply
Where this trial is running
Aurora, Colorado and 6 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- IQVIA US Office — Durham, North Carolina, United States (Recruiting)
- Austin Hospital — Heidelberg, Australia (Recruiting)
- Katholisches Klinikum Bochum — Bochum, North Rhine-Westphalia, Germany (Recruiting)
- St Vincent's University Hospital — Dublin, Ireland (Recruiting)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (Recruiting)
- Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.