Actively Recruiting
BRIUMVI4 Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI4
Led by TG Therapeutics, Inc. · Updated on 2026-05-12
728
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of BRIUMVI4 (Ublituximab) on pregnancy and infant outcomes in people with Multiple Sclerosis (MS). The study aims to compare the rate of major congenital malformations (MCMs) in pregnant participants with MS who have been exposed to BRIUMVI4 versus those who have not. This observational study aims to provide important information about the safety of BRIUMVI4 during pregnancy. The study includes two groups: one group of pregnant participants who have been exposed to any dose of BRIUMVI4 at any time during pregnancy or within six months before conception, and another group of pregnant participants who have not been exposed to BRIUMVI4 or other anti-CD20 monoclonal antibodies during pregnancy but may have used other MS treatments. No interventions are administered as part of the study, as it is observational. Participants will be followed up to 52 weeks after delivery to monitor and record the occurrence of major congenital malformations. Data collection includes information authorized by the healthcare provider and involves monitoring pregnancy outcomes and infant health. The study is expected to continue until March 2035, providing long-term observational data on pregnancy and infant outcomes in participants with MS.
CONDITIONS
Brief 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...
- Participant exposed to at least 1 dose of BRIUMVI4 for the exposed cohort
- Participant not exposed to BRIUMVI4 at any time during pregnancy for the unexposed cohort
- Diagnosis of Multiple Sclerosis
- Currently pregnant or pregnant within 1 year of pregnancy outcome
- Authorization from healthcare provider to share data with the registry
You will not qualify if you...
- Exposure to anti-CD20 monoclonal antibodies during pregnancy prior to enrollment
- Pregnancy outcome occurred before first contact with the virtual research coordination center
- Exposure to known teratogens or investigational medications during pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 52 weeks post-delivery
Participants who are pregnant and either exposed or not exposed to BRIUMVI® are observed for pregnancy and infant outcomes.
Periodic data collection throughout pregnancy and up to 52 weeks after delivery
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
T
TG Therapeutics Clinical Support Team
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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