The study is expected to enroll for approximately 7 years and follow the pregnant women and their infant(s) over a maximum of 21 months.~The study will be conducted as two sub-studies leveraging independent ongoing pregnancy registries:~The Organization of Teratology Information Specialists (OTIS) Research Group, University of California, San Diego, USA (referred to as OTIS) will serve as data source for the Kesimpta-OTIS sub-study;~The German MS and pregnancy registry - Deutschsprachigen Multiple Sklerose und Kinderwunsch Register (DMSKW) at Katholisches Klinikum Bochum gGmbH, St Josef Hospital, Bochum, Germany (referred to as DMSKW) will serve as data source for the Kesimpta- DMSKW sub-study.~Both registries will independently collect and assess data related to the pregnancy and infant outcomes of interest and provide aggregate data which will be further combined (metaanalyses) by Novartis (referred to as the Sponsor) or a designated contract research organization (CRO).
The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.