Evaluating the effects of BRIUMVI® on pregnancy outcomes in women with Multiple Sclerosis
BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
This study is trying to see if using BRIUMVI® during pregnancy affects the health of babies born to women with Multiple Sclerosis compared to those who didn’t use the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 728 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | Female |
| Sponsor | TG Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT06433765 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the prevalence of major congenital malformations in two groups of pregnant women with Multiple Sclerosis (MS): those who have been exposed to BRIUMVI® (Ublituximab) and those who have not. Participants must have a diagnosis of MS and be currently or recently pregnant. The study will collect data from a registry to assess the outcomes of pregnancies in these cohorts, focusing on the safety of BRIUMVI® during pregnancy.
Who should consider this trial
Good fit: Ideal candidates include pregnant women diagnosed with Multiple Sclerosis who have either been exposed to BRIUMVI® or have not been exposed during their pregnancy.
Not a fit: Patients who have been exposed to anti-CD20 monoclonal antibodies or known teratogens during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of BRIUMVI® during pregnancy, potentially guiding treatment decisions for pregnant women with MS.
How similar studies have performed: While studies on the effects of medications during pregnancy are common, this specific evaluation of BRIUMVI® in pregnant women with MS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wilmington, North Carolina
- BRIUMVI® Pregnancy Registry Virtual Research Coordination Center — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
- Email: briumvipregnancyregistry@ppd.com
- Phone: 1-877-411-4605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.