RECRUITING

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

Conditions

Relapsing Multiple Sclerosis Multiple Sclerosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-03-26

Study Completion:2025-06-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06143514

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

PROVIDE Virtual Research Coordination Center

CONTACT

1-877-296-4411

briumvi_lactationstudy@ppd.com

Study Locations (Sites)

PROVIDE Virtual Research Coordination Center

Wilmington, North Carolina, 28401-3331

United States

Collaborators and Investigators

Sponsor: TG Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-26

Study Completion Date2025-06-28

Study Record Updates

Study Start Date2024-03-26

Study Completion Date2025-06-28

Terms related to this study

Keywords Provided by Researchers

Multiple Sclerosis

Additional Relevant MeSH Terms

Relapsing Multiple Sclerosis