Looks at pregnancy and infant safety of Kesimpta in women with multiple sclerosis
Reviews past health records of pregnant women with multiple sclerosis who took Kesimpta.
Plain-language title generated from the registry record
Registry title: Kesimpta Pregnancy and Infant Safety Study Using Real World Data
Key facts
- Where
- Basel, SwitzerlandSee the site
Where in Switzerland
- BaselBasel, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06156683
- Record updated
- 1 August 2024
- Original description
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.Read full original descriptionShow less
Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
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.
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: For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome; 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:; The following overall criteria for exclusion are applied:; 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.