This study will evaluate whether ofatumumab is excreted at quantifiable levels and at which concentrations in breast milk of lactating women with RMS). The study will include lactating mothers who plan to breastfeed and initiate/re-initiate ofatumumab 2-24 weeks post-partum.
This is a Phase IV study in which breastfeeding mothers treated with ofatumumab and their babies are taking part for up to 1 year. The study consists of a Core Part and a Safety Follow-up Part. The Core Part includes a Screening period and a Sampling period. During the Screening period (up to 4 weeks), the study doctor will assess if mothers can join the study. The Sampling period, during which milk samples and a blood sample will be collected, will last for up to 12 weeks. The Safety Follow-up Part will last for about 9 months, to follow up on health and safety of mothers and their babies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
No study-treatment is provided for this study. Study participants will be treated with commercially available ofatumumab according to the local label.
UCSF
San Francisco, California, United States
Concentration of ofatumumab in breast milk.
Quantification of ofatumumab concentration in breast milk of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum.
Time frame: (pre-dose) on the day of second (or subsequent) maintenance dose, then 7, 14, 21, 28 days after the second (or subsequent) maintenance dose"
Evaluate other PK parameters of ofatumumab in breast milk and plasma of lactating women with RMS who have initiated or re-initiated ofatumumab treatment post-partum
proportion of at least one sample with quantifiable concentration; Maximum concentration; exposure (Area under curve); milk/plasma ratio
Time frame: 28 days after second(or subsequent) maintenance dose.
Estimation of relative infant dose of ofatumumab
Estimated relative infant dose (RID, %) over 28 days after the lactating mother receives second or subsequent maintenance dose
Time frame: 28 days after second (or subsequent) maintenance dose.
Safety data collected in lactating women receiving ofatumumab and their breastfed infants
Rate and nature of adverse events in the mothers treated with ofatumumab to up to 12 months after ofatumumab treatment initiation/re-initiation Rate and nature of serious adverse events and any infection adverse events in the breastfed infants of mothers up to 12 months after ofatumumab treatment initiation/re-initiation
Time frame: Upto 12 months
Plasma Pharmacokinetics of OMB157(Cmax)
Maximum concentration (Cmax) of ofatumumab in breast milk over 28 days after the second (or any subsequent) maintenance dose.
Time frame: over 28 days after the second (or any subsequent) maintenance dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UC Health Neuroscience Ctr
Aurora, Colorado, United States
ACTIVE_NOT_RECRUITINGNorthwestern Medicine Northwestern University
Winfield, Illinois, United States
ACTIVE_NOT_RECRUITINGBrigham and Womens Hospital
Brookline, Massachusetts, United States
ACTIVE_NOT_RECRUITINGDuke Neurology
Durham, North Carolina, United States
RECRUITINGNovartis Investigative Site
Munich, Bavaria, Germany
RECRUITINGNovartis Investigative Site
Bochum, Germany
ACTIVE_NOT_RECRUITINGNovartis Investigative Site
Hamburg, Germany
ACTIVE_NOT_RECRUITINGNovartis Investigative Site
Tübingen, Germany
RECRUITINGNovartis Investigative Site
Foggia, FG, Italy
ACTIVE_NOT_RECRUITING...and 12 more locations
Plasma Pharmacokinetics of OMB157(AUC)
The exposure (area under the curve (AUC) of ofatumumab in milk over 28 days (from the second or any subsequent maintenance dose to the next maintenance dose after initiation or re-initiation of ofatumumab post-partum)
Time frame: over 28 days
Plasma Pharmacokinetics of OMB157 (M/P Ratio)
Milk/Plasma (M/P) ratio of ofatumumab at 28 days after the second or any subsequent maintenance dose.
Time frame: at 28 days after the second or any subsequent maintenance dose.