Study of BRIUMVI Ublituximab Levels in Breast Milk of Women Treating Relapsing Multiple Sclerosis

What this Trial Is About

This research aims to understand how much BRIUMVI ublituximab, a treatment used for relapsing multiple sclerosis RMS, is present in the breast milk of breastfeeding women who receive this therapy. The study focuses on women diagnosed with RMS, including forms like clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Researchers want to see how BRIUMVI passes into breast milk over time to better understand exposure to nursing infants. Participants who are already being treated with BRIUMVI will have their breast milk collected for up to 24 hours after receiving their dose. Milk samples will be taken at multiple time points from before treatment and up to 90 days after dosing to measure the concentration of BRIUMVI. The study does not involve giving the drug as part of the trial but observes those receiving it as part of their routine care. During the study, participants will provide breast milk samples at scheduled times, including on Day 1 before dosing and several days afterward up to Day 90. The research team will analyze these samples to measure BRIUMVI levels and calculate various pharmacokinetic measures like area under the curve and maximum concentration. Infant health will also be monitored for adverse events during the study and up to 3 months after the dose. The total study duration for each participant spans about three months following the dose.

A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk