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Clinical trial

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

NCT05634967 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Novartis Pharmaceuticals
Phase
Observational
Overall status
Recruiting
Start date
January 5, 2023
Completion date
February 28, 2033
Enrollment
725 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

multiple sclerosis, pregnancy