ClinicaliQ Trial Snapshot
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate) — Recruiting • Neurology • NCT05658497.
- What is being tested: The study evaluates the safety of diroximel fumarate (DRF/Vumerity) exposure during pregnancy by estimating the risk of major congenital malformations in infants born to women with multiple sclerosis who were exposed to this disease-modifying therapy at any point….
- Patient eligibility overview: The registry enrolls women with multiple sclerosis who were exposed to diroximel fumarate during pregnancy, capturing data from conception through 2 weeks post-conception and following exposed pregnancies to determine birth outcomes and infant congenital abnormalities.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
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…
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.