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Clinical Trials in Switzerland / NCT06156683
Recruiting Observational

Kesimpta Pregnancy and Infant Safety Study Using Real World Data

NCT06156683 · tracked via the Priya Life Science Switzerland tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2024-06-30
Last updated
2024-08-01

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Multiple sclerosis disease modifying drug

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of major congenital malformations (MCM) among live births — First year of life, up to 12 months
    The primary outcome of interest concerns MCMs occurring in pregnancies ending in at least one live birth. MCMs are defined as defects that have either cosmetic or functional significance to the child (e.g., a cleft lip)

Trial sites (1)

FacilityCityRegionStatus
Novartis Investigative Site Basel Switzerland Recruiting

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Other trials for the same condition

Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS? Recruiting
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting
Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis (Switzerland) Recruiting
A Real-World Study of Ofatumumab in Multiple Sclerosis Patients in Germany and Japan Active, not recruiting
Swiss Pediatric Inflammatory Brain Disease Registry (Swiss-Ped-IBrainD) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06156683 on ClinicalTrials.gov ↗ ← All trials in Switzerland