Kesimpta Pregnancy and Infant Safety Study Using Real World Data

NCT06156683 | Recruiting

• 2 other identifiers: COMB157G2405EUPAS106133
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Kesimpta; ofatumumab; real world data

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of participants with spontaneous abortions

  Up to 9 months

• Number of participants with elective termination of pregnancy

  Up to 9 months

• Number of participants with stillbirths

  Up to 9 months

• Number of participants with preterm births

  Up to 9 months

• Number of participants with preeclampsia

  Up to 9 months

Study Arms (3)

Kesimpta-exposed

exposure to Kesimpta during the risk period

Other: Multiple sclerosis disease modifying drug

MSDMD-exposed

exposure to at least one Multiple sclerosis disease modifying drug (MSDMD) (other than Kesimpta) during the risk period

Other: Multiple sclerosis disease modifying drug

MSDMD-unexposed

no exposure to Kesimpta or any other Multiple sclerosis disease modifying drug (MSDMD) during the risk period

Other: Multiple sclerosis disease modifying drug

Interventions

Multiple sclerosis disease modifying drug OTHER

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

Kesimpta-exposed; MSDMD-exposed; MSDMD-unexposed

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The overall study population consists of women with MS with a recorded pregnancy outcome during the inclusion period. Pregnancies exposed to MSDMDs with a known teratogenic effect or non-MSDMDs with a known moderate to high teratogenic effect are excluded.

You may qualify if:

• Age 18-49 years at index date
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: June 30, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)