NCT06156683 Kesimpta Pregnancy and Infant Safety Study Using Real World Data
| NCT ID | NCT06156683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Multiple Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2024-06-30 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2024-06-30 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06156683 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06156683 currently recruiting?
Yes, NCT06156683 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06156683 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06156683 clinical trial?
NCT06156683 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 1,500 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.