A Study to Evaluate the Effectiveness of the Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs) in the European Economic Area (EEA) (ACE-536-MDS-005)

Study identification

• EU PAS number:
  EUPAS42016
• Study ID:
  49997
• Official title and acronym:
  A Study to Evaluate the Effectiveness of the Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs) in the European Economic Area (EEA) (ACE-536-MDS-005)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Germany

  Italy
• Study description:
  This is a non-interventional post-authorization safety study (PASS) employing a cross-sectional design to evaluate the effectiveness of the additional risk minimization measures (aRMMs) for REBLOZYL. A survey will be used to measure the knowledge and comprehension of the REBLOZYL aRMMs among European Economic Area (EEA) based healthcare professionals (HCPs). The PASS will be conducted among HCPs in a representative sample of EEA countries where REBLOZYL is commercially available, potentially including Austria, Germany, Italy, Norway, Sweden, the Netherlands, Poland, and Spain. Additional EEA countries may be included, as needed, based on commercial availability and reimbursement status.
• Study status:
  Finalised

Research institutions and networks

Institutions

Celgene International

Study timelines

Date when funding contract was signed

Planned: 18/01/2021

Actual: 18/01/2021

Study start date

Planned: 20/07/2021

Actual: 26/07/2021

Data analysis start date

Planned: 03/11/2022

Actual: 03/11/2022

Date of final study report

Planned: 30/09/2023

Actual: 28/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

CELGENE INTERNATIONAL II SARL, a BRISTOL MYERS SQUIBB COMPANY

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)