Assessing the safety of Kesimpta during pregnancy for women with multiple sclerosis
Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
This study looks at whether using the MS drug Kesimpta during pregnancy is safe for women with multiple sclerosis compared to other treatments and no treatment at all.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (Basel) |
| Trial ID | NCT06156683 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-49 with a diagnosis of multiple sclerosis who have been exposed to Kesimpta or other MS disease-modifying drugs.
Not a fit: Patients who are not pregnant or those without a diagnosis of multiple sclerosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of Kesimpta for pregnant women with MS, potentially guiding treatment decisions.
How similar studies have performed: While there have been studies on the safety of other MS treatments during pregnancy, this specific focus on Kesimpta using real-world data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel
- Novartis Investigative Site — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.