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

Recruiting now

Conditions studied: Multiple Sclerosis

In brief

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®.

Key facts

Study ID

NCT06433765

Run by

TG Therapeutics, Inc.

People needed

728

Starts

2024-06-01

Expected to finish

2035-03-31

Last updated by the study team

2026-07-17

Who can join

Age: 15 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• BRIUMVI® Pregnancy Registry Virtual Research Coordination Center — Wilmington, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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