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Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Recruitingn/aAges any - anyFemaleBiogen
NCT05658497 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 p

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📋 Eligibility rules (as published)
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
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What it tests

  • Diroximel Fumarate
  • Avonex
  • Tysabri
  • Dimethyl Fumarate
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Where

8 sites
University of Colorado Anschutz Medical Campus
Aurora, United States
IQVIA US Office
Durham, United States
Austin Hospital
Heidelberg, Australia
Katholisches Klinikum Bochum
Bochum, Germany
St Vincent's University Hospital
Dublin, Ireland
Hospital Universitario Ramon y Cajal
Madrid, Spain
Inselspital
Bern, Switzerland
Salford Care Organization
Salford, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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