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A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®

Who can join

Ages 15 to 50 · Women

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.

About the study

The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.

What is being tested

• No intervention (other)

Sponsor: TG Therapeutics, Inc. · Participants: 728 · Started: Jun 1, 2024

Contact the study team

• BRIUMVI® Pregnancy Registry Virtual Research Coordination Center · Phone: 1-877-411-4605
• TG Therapeutics Clinical Support Team · Phone: 1-877-555-8489

Official record on ClinicalTrials.gov — NCT06433765

Locations in the U.S.

Conditions

• Multiple Sclerosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.