- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156683
Kesimpta Pregnancy and Infant Safety Study Using Real World Data
Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Kesimpta-exposed
exposure to Kesimpta during the risk period
|
There is no treatment allocation.
Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.
|
MSDMD-exposed
exposure to at least one Multiple sclerosis disease modifying drug (MSDMD) (other than Kesimpta) during the risk period
|
There is no treatment allocation.
Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.
|
MSDMD-unexposed
no exposure to Kesimpta or any other Multiple sclerosis disease modifying drug (MSDMD) during the risk period
|
There is no treatment allocation.
Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of major congenital malformations (MCM) among live births
Time Frame: First year of life, up to 12 months
|
The primary outcome of interest concerns MCMs occurring in pregnancies ending in at least one live birth.
MCMs are defined as defects that have either cosmetic or functional significance to the child (e.g., a cleft lip)
|
First year of life, up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with spontaneous abortions
Time Frame: Up to 9 months
|
Also termed miscarriage, is defined as the unintended loss of an intrauterine pregnancy less than 20 weeks of gestation (<20 weeks).
|
Up to 9 months
|
Number of participants with elective termination of pregnancy
Time Frame: Up to 9 months
|
Defined as the intentional termination of pregnancy at any time in gestation for any reason.
When possible, reasons for elective termination are captured and classified as elective termination of pregnancy for fetal anomaly or for other reasons.
|
Up to 9 months
|
Number of participants with stillbirths
Time Frame: Up to 9 months
|
Defined as the unintended fetal death occurring at or after 20 weeks of gestation.
|
Up to 9 months
|
Number of participants with preterm births
Time Frame: Up to 9 months
|
Defined as live births less than 37 weeks of gestation (<37 weeks).
Elective caesarean deliveries or inductions prior to 37 completed weeks will be described separately.
|
Up to 9 months
|
Number of participants with preeclampsia
Time Frame: Up to 9 months
|
Preeclampsia is defined as the new-onset of hypertension with a systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg at or after 20 weeks of gestation with proteinuria and/or endorgan dysfunction (renal dysfunction, liver dysfunction, central nervous system disturbances, pulmonary edema, and thrombocytopenia).
|
Up to 9 months
|
Number of participants with eclampsia
Time Frame: Up to 9 months
|
Eclampsia is defined as the new onset of generalized tonic-clonic seizures in a woman with preeclampsia
|
Up to 9 months
|
Number of participants small for gestational age (SGA)
Time Frame: Up to 9 months
|
Defined as a birth weight lower than the 10th percentile for gestational age and sex using the national standards in each study country in a live birth
|
Up to 9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COMB157G2405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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