Status:
RECRUITING
Kesimpta Pregnancy and Infant Safety Study Using Real World Data
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
FEMALE
18+ years
Brief 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) an...
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 ...
Eligibility Criteria
Inclusion
- 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 abortion, elective termination of pregnancy, stillbirth, preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least one live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy
- For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in at least one live birth
- For analyses of MCMs among live births, spontaneous abortions, stillbirths, and elective terminations (exploratory objective): pregnancy ending in at least one live birth, spontaneous abortion, still birth, or elective termination
- For analyses of neonatal infection: live newborn
- For analyses of SII: newborn alive at 29 days after birth
Exclusion
- The following overall criteria for exclusion are applied:
- Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance
- The following outcome specific exclusion criteria are applied:
- For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome
- For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies involving multiples
- For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome specific risk period
Key Trial Info
Start Date :
June 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06156683
Start Date
June 30 2024
End Date
February 1 2028
Last Update
August 1 2024
Active Locations (1)
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1
Novartis Investigative Site
Basel, Switzerland