NCT06156683Recruiting
Kesimpta Pregnancy and Infant Safety Study Using Real World Data
Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
Source: ClinicalTrials.gov · Last updated 1 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1500 (estimated)
- First submitted
- 27 Nov 2023
- Start date
- 30 Jun 2024
- Primary completion date
- 1 Feb 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Multiple sclerosis
- NCT number
- NCT06156683
What you commit to
- Study type: Observational
- Planned participants: 1500
- From 30 Jun 2024 to the primary completion date, 1 Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome
Lab values
- 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:
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.