Non-Interventional Post-Authorisation Safety Study (PASS) survey to evaluate the effectiveness of the Isatuximab Educational Materials, to minimise the Risk of Interference for blood typing (minor antigen) (positive indirect Coombs’ test).

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48387
• EU PAS number:
  EUPAS46988
• Study ID:
  48387
• Official title and acronym:
  Non-Interventional Post-Authorisation Safety Study (PASS) survey to evaluate the effectiveness of the Isatuximab Educational Materials, to minimise the Risk of Interference for blood typing (minor antigen) (positive indirect Coombs’ test).
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Netherlands

  Poland

  Sweden

  Switzerland

  United Kingdom
• Study description:
  The study aims to assess the effectiveness of the isatuximab Educational Materials in terms of process indicator, meaning implementation, knowledge and behaviour with respect to the safety messages conveyed in these materials.
• Study status:
  Finalised

Research institution and networks

Institutions

Evidera

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 24/09/2020

Study start date

Planned: 02/05/2022

Actual: 09/05/2022

Data analysis start date

Planned: 31/03/2023

Actual: 20/04/2023

Date of final study report

Planned: 01/02/2024

Actual: 22/08/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-Aventis Groupe

Study protocol

Initial protocol

Sanofi Isatuximab PASS survey protocol_PRAC_V1.4_21Oct2021_clean_EUPAS46988 for publication.pdf

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)