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).
Study Type
OBSERVATIONAL
Enrollment
16
No intervention
PROVIDE Virtual Research Coordination Center
San Francisco, California, United States
RECRUITINGPROVIDE Virtual Research Coordination Center
Smyrna, Georgia, United States
RECRUITINGTG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States
Area Under the Milk Concentration-time Curve from Time 0 to Infinity (AUC0-inf) of BRIUMVI™
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Area Under the Milk Concentration-time Curve from Time 0 to the Last Measurable Observed Concentration (AUC0-last) of BRIUMVI™
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Area Under the Milk Concentration-Time Curve from Time 0 to 24 Hours Post-Dose (AUC0-24) of BRIUMVI™
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Maximum Observed Milk Concentration of BRIUMVI™ (Cmax)
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Observed Milk Concentration of BRIUMVI™ at End of Dosing Interval (Ctrough) of BRIUMVI™
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90
Time of Cmax (Tmax) of BRIUMVI™ in Milk
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Amount Excreted (Ae) of BRIUMVI™ in Milk
Total amount of drug excreted in milk (mg) as: Σ(total drug concentration in each milk collection x milk volume in each milk collection)
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PROVIDE Virtual Research Coordination Center
Wilmington, North Carolina, United States
RECRUITINGPROVIDE Virtual Research Coordination Center
Nashville, Tennessee, United States
RECRUITINGFraction of Dose Excreted (Fe) in Milk of BRIUMVI™
Fraction of dose excreted in milk calculated as Ae/Administered dose
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Infant Dose (ID) of BRIUMVI™
Infant dose = Ʃ drug concentration in each milk collection multiplied by the expressed milk volume in each milk collection.
Time frame: Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and at exit Day 90
Relative Infant Dose (RID) of BRIUMVI™
Relative infant dose = infant dose milligrams/kilograms (mg/kg)/ \[Maternal Dose (mg)/Maternal Bodyweight (kg)\] multiplied by 100
Time frame: Predose Day 1 and at multiple timepoints Post-dose Day 1, Day 2, Day 3, Day 7, Day 10, Day 14, Day 28, Day 60 and Day 90
Number of Infants with Adverse Events
Time frame: From the signing the inform consent form up to approximately 3 months after the index infusion