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®
1 other identifier
observational
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1 country
1
Brief Summary
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2035
February 27, 2026
February 1, 2026
10.8 years
May 23, 2024
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Major Congenital Malformations (MCMs)
Up to 52 weeks post-delivery
Study Arms (2)
BRIUMVI® Exposed Cohort
Pregnant participants with MS who are exposed to any dose of BRIUMVI® at any time during pregnancy (from conception to pregnancy outcome) or before pregnancy (within 6 months of the date of conception \[DOC\]).
BRIUMVI® Unexposed Cohort
Pregnant participants with MS who are not exposed to any dose of BRIUMVI® or other anti-CD20 monoclonal antibodies at any time during pregnancy but may be exposed to other products for the treatment of MS.
Interventions
Eligibility Criteria
The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
Wilmington, North Carolina, 28401-3331, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2024
First Posted
May 30, 2024
Study Start
June 1, 2024
Primary Completion (Estimated)
March 31, 2035
Study Completion (Estimated)
March 31, 2035
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share