Kesimpta Pregnancy and Infant Safety Study Using Real World Data
NCT06156683 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500
Last updated 2024-08-01
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-30
- Primary Completion
- 2028-02-01
- Completion
- 2028-02-01
Countries
- Switzerland
Study Locations
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