Kesimpta Pregnancy and Infant Safety Study Using Real World Data
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiple sclerosis disease modifying drug.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
Overview
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.
Detailed description
Outcomes among Kesimpta exposed pregnancies are compared primarily to MSDMD-exposed pregnancies and secondarily to MSDMD-unexposed pregnancies.
The main research question is to determine whether the exposure during pregnancy to Kesimpta increases the risk of adverse pregnancy and infant outcomes in women with MS.
The risk period is defined as the 1st trimester of pregnancy for analyses of Major congenital malformations and the entire duration of pregnancy for all other outcomes.
The data for this study is retrieved from data sources from Denmark, Sweden, and the US, based on an assessment of feasibility.
Interventions
- Other Multiple sclerosis disease modifying drug
There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.
Primary outcome measures
- Number of major congenital malformations (MCM) among live births [Time frame: First year of life, up to 12 months]
Secondary outcome measures (7)
- Number of participants with spontaneous abortions [Time frame: Up to 9 months]
- Number of participants with elective termination of pregnancy [Time frame: Up to 9 months]
- Number of participants with stillbirths [Time frame: Up to 9 months]
- Number of participants with preterm births [Time frame: Up to 9 months]
- Number of participants with preeclampsia [Time frame: Up to 9 months]
- Number of participants with eclampsia [Time frame: Up to 9 months]
- Number of participants small for gestational age (SGA) [Time frame: Up to 9 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Novartis Investigative Site — Basel
Identifiers
NCT: NCT06156683 · COMB157G2405 · EUPAS106133