An observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated with etanercept or other biologics using merged data from Sweden, Denmark and Finland

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25620
• EU PAS number:
  EUPAS20081
• Study ID:
  25620
• Official title and acronym:
  An observational cohort study to evaluate the risk of adverse pregnancy outcomes in patients treated with etanercept compared to those not treated with etanercept or other biologics using merged data from Sweden, Denmark and Finland
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Sweden
• Study description:
  This is a population-based study of data from the national health registers of Sweden, Denmark and Finland. The study will compare the rate of adverse outcomes, including birth defects, preterm birth, small for gestational age and infections in infancy among infats to women exposed to etanercept with infants to women not exposed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Department of Clinical Epidemiology Aarhus University, Aarhus, Denmark, National Institute for Health and Welfare Helsinki, Finland

Study timelines

Date when funding contract was signed

Planned: 01/07/2017

Actual: 01/07/2017

Study start date

Planned: 01/07/2006

Actual: 01/07/2006

Data analysis start date

Planned: 01/07/2017

Actual: 01/07/2017

Date of final study report

Planned: 31/12/2018

Actual: 02/07/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

Enbrel PASS protocol_B1801396_v 3

Regulatory

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