Actively Recruiting
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Led by TG Therapeutics, Inc. · Updated on 2026-05-12
728
Participants Needed
1
Research Sites
565 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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®.
CONDITIONS
Official Title
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI4.
- For unexposed cohort: Participants not exposed to BRIUMVI4 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina, United States, 28401-3331
Actively Recruiting
Research Team
B
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
CONTACT
T
TG Therapeutics Clinical Support Team
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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