Evaluating BRIUMVI™ in Breast Milk of Breastfeeding Mothers with Multiple Sclerosis

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

This study looks at how much of the medication BRIUMVI™ gets into the breast milk of mothers with relapsing multiple sclerosis who are breastfeeding.

Quick facts

• Study type: Observational
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: TG Therapeutics, Inc. (Industry-sponsored)
• Locations: 5 sites (San Francisco, California and 4 other locations)
• Trial ID: NCT06143514 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the presence and concentration of BRIUMVI™ (Ublituximab) in the breast milk of breastfeeding mothers who are receiving this medication for the treatment of relapsing forms of multiple sclerosis. Participants will be required to breastfeed or pump regularly during the study period to ensure adequate milk supply. The study focuses on mothers diagnosed with relapsing multiple sclerosis, including various subtypes, and aims to gather data on the medication's transfer into breast milk. No interventions will be administered as part of this study.

Who should consider this trial

Good fit: Ideal candidates are breastfeeding mothers diagnosed with relapsing multiple sclerosis who have chosen to receive BRIUMVI™ treatment.

Not a fit: Patients who are not breastfeeding or those with conditions preventing them from breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information regarding the safety of breastfeeding while on BRIUMVI™, helping mothers make informed decisions about their treatment.

How similar studies have performed: While studies on drug transfer into breast milk are common, this specific evaluation of BRIUMVI™ is novel and has not been extensively tested in this context.

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 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

Infant Criteria:

* Gestational age at delivery ≥35 weeks
* Birthweight \> 10th percentile
* Weight \> 10th percentile as reported by the mother at the time of enrollment

Exclusion Criteria:

Maternal Criteria:

* 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

Infant Criteria:

\- Any abnormality noted or clinically significant medical condition, including cardiac, pulmonary, and liver disease, glucose instability, or active infection at the time of screening that, in the opinion of the investigator, may make implementation of the protocol or interpretation of the trial difficult or would put the infant at risk by participating in the study

Where this trial is running

San Francisco, California and 4 other locations

• PROVIDE Virtual Research Coordination Center — San Francisco, California, United States (Recruiting)
• PROVIDE Virtual Research Coordination Center — Smyrna, Georgia, United States (Recruiting)
• TG Therapeutics Investigational Trial Site — Boston, Massachusetts, United States (Recruiting)
• PROVIDE Virtual Research Coordination Center — Wilmington, North Carolina, United States (Recruiting)
• PROVIDE Virtual Research Coordination Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: PROVIDE Virtual Research Coordination Center

Conditions Relapsing Multiple Sclerosis; Multiple Sclerosis