Study of BRIUMVI Ublituximab Effects on Pregnancy and Baby Outcomes in Women with Multiple Sclerosis

What this Trial Is About

This research aims to compare the rate of major congenital malformations MCM in pregnant participants with multiple sclerosis MS who have been exposed to BRIUMVI4 Ublituximab versus those who have not. The study focuses on participants who are currently or recently pregnant and evaluates pregnancy and infant outcomes related to exposure to this medication. The study is observational and collects data prospectively. Participants are divided into two groups one cohort includes pregnant individuals with MS who have received any dose of BRIUMVI4 during pregnancy or within six months before conception. The other cohort includes pregnant participants with MS who have not been exposed to BRIUMVI4 or other anti-CD20 monoclonal antibodies during pregnancy but may have used other MS treatments. There is no intervention administered as part of the study. During the study, researchers collect data up to 52 weeks after delivery to assess the percentage of participants with major congenital malformations. Participants provide authorization to share their medical data with the registry. The study monitors pregnancy outcomes and infant health, focusing on safety and developmental measures. The overall participation period extends from pregnancy through one year after delivery.

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