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RECRUITING

NCT06156683

Kesimpta Pregnancy and Infant Safety Study Using Real World Data

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2024-06-30

Completion Date

2028-02-01

Last Updated

2024-08-01

Healthy Volunteers

Conditions

Multiple Sclerosis

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.

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 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 Criteria: 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

Locations (1)

Novartis Investigative Site

Basel, Switzerland