Kesimpta (Ofatumumab) Pregnancy Registry

Multiple Sclerosis Clinical Trial

Official title: Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pregnancy
• Sclerosis

• NCT number: NCT05634967
• Study type: Observational
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: 1-888-669-6682
• Email: novartis.email@novartis.com
• Status: Recruiting
• Start date: January 5, 2023
• Completion date: February 28, 2033