Kesimpta Pregnancy and Infant Safety Study Using Real World Data

Multiple Sclerosis Clinical Trial

Official title:

Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06156683
• Other study ID #: COMB157G2405
• Status: Not yet recruiting
• Start date: June 3, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: May 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of major congenital malformations (MCM) among live births	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	Number of participants with spontaneous abortions	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
Secondary	Number of participants with elective termination of pregnancy	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
Secondary	Number of participants with stillbirths	Defined as the unintended fetal death occurring at or after 20 weeks of gestation.	Up to 9 months
Secondary	Number of participants with preterm births	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
Secondary	Number of participants with preeclampsia	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
Secondary	Number of participants with eclampsia	Eclampsia is defined as the new onset of generalized tonic-clonic seizures in a woman with preeclampsia	Up to 9 months
Secondary	Number of participants small for gestational age (SGA)	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