NCT05634967

Kesimpta (Ofatumumab) Pregnancy Registry

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
• Phase: —
• Study type: Observational
• Enrollment: 725 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Multiple Sclerosis
• Pregnancy

Interventions

Type	Name	Description
OTHER	Kesimpta	Prospective non-interventional study. There is no treatment allocation. Patients participating in from the two independent sub-studies, namely the Kesimpta-OTIS sub-study and Kesimpta-DMSKW sub-study, of identical design, conducted in parallel, enrolling pregnant women (MS and non-MS) residing in US or Canada and pregnant women (MS only) from Germany respectively are eligible for enrolling to this study.

Timeline

• Start date: 2023-01-05
• Primary completion: 2033-02-28
• Completion: 2033-02-28
• First posted: 2022-12-02
• Last updated: 2025-01-14

Locations

1 site across 1 country: United States