Registry to assess pregnancy outcomes in women with multiple sclerosis exposed to Vumerity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.