A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: No intervention

• Registration Number: NCT06433765
• Lead Sponsor: TG Therapeutics, Inc.

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-30
• Study Start: 2024-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2035-03-31
• Study Completion: 2035-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 728

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRIUMVI® Unexposed Cohort	No intervention	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.
BRIUMVI® Exposed Cohort	No intervention	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 \[DOC\]).

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Major Congenital Malformations (MCMs)	Up to 52 weeks post-delivery

Trial Locations

Locations (1)

BRIUMVI® Pregnancy Registry Virtual Research Coordination Center; 🇺🇸 Wilmington, North Carolina, United States