An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices (20150136)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49944
• EU PAS number:
  EUPAS17848
• Study ID:
  49944
• Official title and acronym:
  An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices (20150136)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  Finland

  France

  Germany

  Greece

  Italy

  Netherlands

  Poland

  Portugal

  Sweden

  Switzerland

  United Kingdom
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 16/06/2016

Actual: 16/06/2016

Study start date

Planned: 14/03/2017

Actual: 22/03/2017

Data analysis start date

Planned: 03/05/2024

Actual: 02/05/2024

Date of interim report, if expected

Planned: 08/07/2018

Actual: 03/07/2018

Date of final study report

Planned: 20/02/2025

Actual: 20/02/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Updated protocol

Protocol-Published Amendment 9 blinatumomab 20150136.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 1 (imposed as condition of marketing authorisation)