Kesimpta Pregnancy and Infant Safety Study Using Real World Data

NCT ID: NCT06156683

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2028-02-01

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.

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Kesimpta-exposed

exposure to Kesimpta during the risk period

Multiple sclerosis disease modifying drug

Intervention Type: OTHER

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

Multiple sclerosis disease modifying drug

Intervention Type: OTHER

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

Multiple sclerosis disease modifying drug

Intervention Type: OTHER

There is no treatment allocation. Women with multiple sclerosis with a recorded pregnancy outcome during the inclusion period will be recruited.

Interventions

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.

Intervention Type: OTHER

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Novartis Pharmaceuticals

Role: CONTACT

novartis.email@novartis.com

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

EUPAS106133

Identifier Type: OTHER

Identifier Source: secondary_id

COMB157G2405

Identifier Type: -

Identifier Source: org_study_id