NCT06156683

Kesimpta Pregnancy and Infant Safety Study Using Real World Data

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Multiple sclerosis disease modifying drug	There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.

Timeline

• Start date: 2024-06-30
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2023-12-05
• Last updated: 2024-08-01

Locations

1 site across 1 country: Switzerland