A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Key facts
- Where
- Wilmington, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 15 and 50 years old?
Where in United States
- BRIUMVI® Pregnancy Registry Virtual Research Coordination CenterWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TG Therapeutics, Inc.
- Trial code
- NCT06433765
- Record updated
- 29 October 2026
- Original description
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®.Read full original descriptionShow less
BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
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®.
Inclusion: 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.
Exclusion: 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.