Assessing the safety of Kesimpta during pregnancy for women with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes real-world data to evaluate the safety of Kesimpta, a disease-modifying drug for multiple sclerosis, during pregnancy. It focuses on pregnant women diagnosed with MS, comparing outcomes for those exposed to Kesimpta against those exposed to other MS drugs and those not exposed at all. The study examines various pregnancy outcomes, including major congenital malformations and other adverse effects, using longitudinal data from Denmark, Sweden, and the US.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.