Kesimpta (ofatumumab) pregnancy and infant safety study using real world data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106134
• EU PAS number:
  EUPAS106133
• Study ID:
  106134
• Official title and acronym:
  Kesimpta (ofatumumab) pregnancy and infant safety study using real world data
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Sweden

  United States
• Study description:
  The study is an observational retrospective cohort study using longitudinal secondary data. The objective of the study is to compare the risk of adverse pregnancy and infant outcomes in female MS patients exposed to Kesimpta versus female MS patients unexposed to Kesimpta. The primary objective concerns the risk of major congenital malformations among live births (MCM). The secondary objectives concern the risk of spontaneous abortion, elective termination, stillbirth, preterm birth, preeclampsia, eclampsia, and having an infant that is small for gestation age (SGA).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 22/04/2021

Actual: 22/04/2021

Study start date

Planned: 30/06/2024

Actual: 30/06/2024

Data analysis start date

Planned: 01/02/2028

Date of final study report

Planned: 03/12/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis

Study protocol

Initial protocol

OMB157G2405 - V1.0 --protocol_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

COMB157G2405

Link to ClinicalTrials.gov registration