RecruitingNCT06143514

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

A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)


Sponsor

TG Therapeutics, Inc.

Enrollment

16 participants

Start Date

Mar 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The primary objective of the lactation study is to characterize the presence and concentration of BRIUMVI™ in breast milk among breastfeeding participants who receive BRIUMVI™ therapeutically for the treatment of relapsing forms of multiple sclerosis (RMS).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study measures how much of the multiple sclerosis drug ublituximab (brand name BRIUMVI) passes into breast milk, to help determine whether it is safe for breastfeeding mothers and their infants. **You may be eligible if...** - You have relapsing multiple sclerosis (including relapsing-remitting MS or active secondary progressive MS) - You have independently decided to take BRIUMVI before joining the study - You are currently breastfeeding or pumping breast milk - Your baby was born at 35 weeks gestation or later and is at a healthy weight **You may NOT be eligible if...** - You have an active infection that prevents breastfeeding - You have had breast surgery (implants, augmentation, reduction, or mastectomy) that significantly affects milk production - You have a breast infection or mastitis - You are using medications known to be harmful to infants through breast milk (such as tetracyclines or fluoroquinolones) - Your infant has a significant medical condition including heart, lung, or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

No intervention


Locations(5)

PROVIDE Virtual Research Coordination Center

San Francisco, California, United States

PROVIDE Virtual Research Coordination Center

Smyrna, Georgia, United States

TG Therapeutics Investigational Trial Site

Boston, Massachusetts, United States

PROVIDE Virtual Research Coordination Center

Wilmington, North Carolina, United States

PROVIDE Virtual Research Coordination Center

Nashville, Tennessee, United States

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NCT06143514


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