Quantitative Testing of Healthcare Provider Knowledge about YESCARTA® (axicabtagene ciloleucel) Risk Minimisation Measures

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43134
• EU PAS number:
  EUPAS28523
• Study ID:
  43134
• Official title and acronym:
  Quantitative Testing of Healthcare Provider Knowledge about YESCARTA® (axicabtagene ciloleucel) Risk Minimisation Measures
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  France

  Germany

  Italy

  Netherlands

  Poland

  Spain

  Sweden

  United Kingdom
• Study description:
  KT-EU-471-0116: The study was a non-interventional, cross-sectional survey of Health Care Providers (HCPs) based in Europe. It was conducted using an online platform. The primary study objective was to assess HCPs’ awareness and knowledge of the routine and additional Risk Minimisation Measures (RMMs) addressing the key important identified risks associated with the use of Yescarta and their understanding of the handling and administration of Yescarta.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres

Study timelines

Date when funding contract was signed

Planned: 22/02/2019

Actual: 22/02/2019

Study start date

Planned: 01/07/2020

Actual: 23/07/2020

Date of final study report

Planned: 30/06/2021

Actual: 01/06/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

KT-EU-471-0116-appendix-16.1.1-protocol_f-redact

Updated protocol

KT-EU-471-0116-appendix-16.1.1-protocol amendment 2_f-redact

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)