Kesimpta Pregnancy and Infant Safety Study Using Real World Data
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.
| Condition(s) | Multiple Sclerosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | Inclusion Criteria: The following overall criteria for study inclusion are applied: * Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period * Age 18-49 years at index date * A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources * Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date In addition, the following outcome and objective specific inclusion criteria are applied: * For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth * For analyses of spontaneous a |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Novartis Pharmaceuticals |
| Locations | Basel, Switzerland |
| Start date | 2024-06-30 |
| NCT ID | NCT06156683 |
| Official listing | https://clinicaltrials.gov/study/NCT06156683 |