The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43504
• EU PAS number:
  EUPAS30280
• Study ID:
  43504
• Official title and acronym:
  The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Italy

  Netherlands

  Norway

  Sweden
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Southern Denmark (SDU)

Denmark

Department of Epidemiology of the Regional Health Service - Lazio

Italy

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Pharmacoepi center, University of Southern Denmark

Denmark

Department of Chronic Diseases, Pharmacoepidemiologic Research Group, Norwegian Institute of Public Health (NIPH)

Norway

Universita di Verona, Department of Diagnostics and Public Health, Section of Pharmacology

Study timelines

Date when funding contract was signed

Actual: 17/04/2018

Study start date

Planned: 01/01/2020

Actual: 01/01/2020

Data analysis start date

Actual: 01/03/2024

Date of interim report, if expected

Planned: 07/06/2024

Date of final study report

Planned: 30/09/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

LEO Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)