Concentration of Ofatumumab in the Breast Milk of Lactating Women With Relapsing Forms of Multiple Sclerosis

Description

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.