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

Launched by TG THERAPEUTICS, INC. · May 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how the medication BRIUMVI® (Ublituximab) affects pregnancy and the health of babies born to mothers with Multiple Sclerosis (MS). Specifically, the study will compare the rates of major birth defects in two groups of pregnant women: those who have taken BRIUMVI® during their pregnancy and those who have not taken the medication at all.

To participate in this study, women need to be diagnosed with MS and currently or recently pregnant. One group must have received at least one dose of BRIUMVI®, while the other group must not have taken it at any time during their pregnancy. The trial is currently recruiting participants, and it's important for interested women to consult with their healthcare provider for permission to share their health information. Participants will help researchers understand how this medication may influence pregnancy outcomes, which could be valuable for future mothers with MS.

Gender

FEMALE

Eligibility criteria

• 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.