Evaluating the effects of BRIUMVI® on pregnancy outcomes in women with Multiple Sclerosis

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 compare the prevalence of major congenital malformations in two groups of pregnant women with Multiple Sclerosis (MS): those who have been exposed to BRIUMVI® (Ublituximab) and those who have not. Participants must have a diagnosis of MS and be currently or recently pregnant. The study will collect data from a registry to assess the outcomes of pregnancies in these cohorts, focusing on the safety of BRIUMVI® during pregnancy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
3. Diagnosis of MS.
4. Currently or recently (within 1 year of pregnancy outcome) pregnant.
5. Authorization from healthcare provider to provide data to registry.

Exclusion Criteria:

1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
3. Exposure to known teratogens and/or investigational medications during pregnancy.

Where it's running

• BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
  Wilmington, North Carolina, United States Recruiting

Study contacts

• Study coordinator: BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
• Email: CRGBriumviPregnancyRegistry@thermofisher.com
• Phone: 1-877-411-4605

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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.