BRIUMVI™ for Relapsing Multiple Sclerosis and Breastfeeding

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

Recruiting Observational Study
Relapsing Multiple Sclerosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
16 (estimated)
Sponsor
TG Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for breastfeeding women who are being treated with BRIUMVI™ for relapsing multiple sclerosis. Participants will provide breast milk for testing during the study.

Are You a Good Fit for This Trial?
Must not be taking AspirinTetracyclinesFluoroquinolones

You may be able to join if

  • I have relapsing multiple sclerosis.
  • I have chosen to be treated with BRIUMVI™.
  • I am willing to breastfeed or pump regularly during the study.
  • I plan to continue giving my baby breast milk throughout the study.
  • My baby was delivered at 35 weeks or later.
  • My baby weighs more than the 10th percentile.
  • I am not weaning my baby.

You may not be able to join if

  • I have an active infection that prevents breastfeeding.
  • I have had breast surgery that affects breastfeeding.
  • I have had a mastectomy.
  • I have signs of mastitis or another significant infection.
  • I am currently using drugs known to transfer to breast milk and may harm my baby.
  • My baby has a significant health condition or abnormality.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: Maternal Criteria: * Participant has independently decided to be treated with BRIUMVI™ prior to providing consent to participate in the study * Diagnosis of RMS, to include clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary p…
Contacts

PROVIDE Virtual Research Coordination Center

1-877-296-4411

briumvi_lactationstudy@ppd.com

CONTACT