RecruitingNCT06433765

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®


Sponsor

TG Therapeutics, Inc.

Enrollment

728 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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®.


Eligibility

Sex: FEMALEMin Age: 15 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This pregnancy registry study is tracking outcomes for women with multiple sclerosis (MS) who became pregnant while taking or after taking BRIUMVI (ublituximab), to understand how the drug affects pregnancy and newborn health. **You may be eligible if...** - You have a diagnosis of multiple sclerosis - You are currently pregnant or have recently been pregnant (within the past year) - Either you were exposed to at least one dose of BRIUMVI at any point (exposed group), OR you have never taken BRIUMVI during pregnancy (comparison group) - Your healthcare provider has authorized sharing your data with the registry **You may NOT be eligible if...** - You were exposed to anti-CD20 antibody drugs (a class of MS medications including BRIUMVI) at any point during the current pregnancy before joining — if enrolling in the unexposed group - Your pregnancy already ended before you first contacted the study team (retrospective enrollment) - You were exposed to medications known to harm the fetus or other experimental drugs during pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERNo intervention

No intervention


Locations(1)

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center

Wilmington, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06433765


Related Trials