A Post-marketing Study Evaluating the Presence and Concentration of BRIUMVI™ in Breast Milk (PROVIDE)
TG Therapeutics, Inc.
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 d…
Interventions
- OtherNo intervention
No intervention
Locations (5)
- PROVIDE Virtual Research Coordination CenterSan Francisco, California
- PROVIDE Virtual Research Coordination CenterSmyrna, Georgia
- TG Therapeutics Investigational Trial SiteBoston, Massachusetts
- PROVIDE Virtual Research Coordination CenterWilmington, North Carolina
- PROVIDE Virtual Research Coordination CenterNashville, Tennessee