A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
NCT06433765 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 728
Last updated 2026-05-12
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®.
Conditions
Interventions
- OTHER
-
No intervention
No intervention
Sponsors & Collaborators
-
TG Therapeutics, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 15 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2035-03-31
- Completion
- 2035-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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