Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Launched by BIOGEN · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called diroximel fumarate (DRF) on pregnancy outcomes in women with multiple sclerosis (MS). Specifically, the trial aims to find out if babies born to mothers who took DRF during the early stages of pregnancy have a higher risk of major birth defects compared to babies born to mothers who did not take any disease-modifying treatments or who took other similar medications. The trial will look at various groups of pregnant women, including those who have been treated with other MS medications, to see how their pregnancy outcomes compare.

To be eligible for this study, participants must be women diagnosed with MS. They should have either taken DRF during their pregnancy or not taken any disease-modifying therapies at all. Participants need to know the outcome of their pregnancy, whether it ended in a live birth or loss. Women who join the study can expect to provide information about their medication use and pregnancy outcomes, which will help researchers understand the safety of DRF for mothers and their babies. This trial is currently recruiting participants and aims to gather important data to guide future treatment options for pregnant women with MS.

Gender

FEMALE

Eligibility 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

Trial Officials