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Kesimpta Pregnancy and Infant Safety Study Using Real World Data

Multiple Sclerosis Clinical Trial

Official title:
Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data

Clinical Trial Summary

The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.

Clinical Trial Description

Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies. The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS. The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes. The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06156683
Study type Observational
Source Novartis
Contact Novartis Pharmaceuticals
Phone +41613241111
Email novartis.email@novartis.com
Status Not yet recruiting
Phase
Start date June 3, 2024
Completion date February 1, 2028
View Details
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