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

This study is looking for women who are at least 18 years old and have a type of multiple sclerosis called relapsing forms of MS. You must have recently given birth (your baby should have been born at 37 weeks or more) and be planning to breastfeed your baby exclusively. You also need to be starting or restarting your ofatumumab treatment for MS between 2 and 24 weeks after your baby was born.

There are some reasons why you might not be able to join. For example, if you've recently taken other experimental drugs, are pregnant, or have certain health conditions like a weak immune system or a history of alcohol or drug abuse. If you've had breast implants or certain breast surgeries, you wouldn't be able to join either. The decision to take ofatumumab and to breastfeed must be made with your doctor, completely separate from your decision to join this study.

If you decide to take part, the study will last for up to a year. First, there's a screening period of up to 4 weeks, where the study doctor will check if you can join. If you're eligible, you'll then enter a 'sampling period' which lasts up to 12 weeks. During this time, you'll need to provide breast milk samples at certain times, and we'll also take a blood sample from you.

After the sampling period, there's a 'safety follow-up' part that lasts for about 9 months. During this time, the study team will keep in touch to check on your health and the health of your baby. There aren't any extra medications given as part of this study; you'll continue with your regular ofatumumab treatment as prescribed by your doctor. The study is mainly about collecting information from mothers already taking the medication and breastfeeding.