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

Description

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).

Conditions

Relapsing Multiple Sclerosis

Study Overview

Study Details

Study overview

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).

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

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

Condition
Relapsing Multiple Sclerosis
Intervention / Treatment

-

Contacts and Locations

Wilmington

PROVIDE Virtual Research Coordination Center, Wilmington, North Carolina, United States, 28401-3331

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 progressive multiple sclerosis (SPMS)
  • * Willing to breastfeed or pump regularly during the study period to maintain milk supply and exclusively pump breast milk for the 24-hour period of breast milk collection Day 1 post IV dose
  • * Plans to continue feeding infant breast milk at least throughout the duration of the study and is not weaning
  • * Gestational age at delivery ≥35 weeks
  • * Birthweight \> 10th percentile
  • * Weight \> 10th percentile as reported by the mother at the time of enrollment
  • * Any active infection or other condition that would prevent the individual from breastfeeding
  • * History of breast implants, breast augmentation, or breast reduction surgery that significantly impacts breastfeeding or collection of milk from 1 or both breasts
  • * History of mastectomy
  • * Evidence of mastitis or any other significant active infection at Day 1 (pre-dose) that would prevent collection of milk from one or both breasts
  • * Current use of drugs known to transfer to the breast milk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye's syndrome), tetracyclines or fluoroquinolones

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

TG Therapeutics, Inc.,

Study Record Dates

2025-06-28