NCT06433765Recruiting
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®
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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®.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 728 (estimated)
- First submitted
- 23 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 31 Mar 2035
- Lead sponsor
- TG Therapeutics, Inc.
- Diseases
- Multiple sclerosis
- NCT number
- NCT06433765
What you commit to
- Study type: Observational
- Planned participants: 728
- From 1 Jun 2024 to the primary completion date, 31 Mar 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 15 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BRIUMVI® Pregnancy Registry Virtual Research Coordination Center Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.