SURVEY TO EVALUATE THE KNOWLEDGE AND UNDERSTANDING OF THE KEY SAFETY MESSAGES IN THE HEALTHCARE PROFESSIONAL GUIDE AND THE PATIENT GUIDE FOR SULIQUA

Study identification

• EU PAS number:
  EUPAS23920
• Study ID:
  46147
• Official title and acronym:
  SURVEY TO EVALUATE THE KNOWLEDGE AND UNDERSTANDING OF THE KEY SAFETY MESSAGES IN THE HEALTHCARE PROFESSIONAL GUIDE AND THE PATIENT GUIDE FOR SULIQUA
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  Hungary

  Romania

  Slovenia

  United Kingdom
• Study description:
  The objective is to assess the knowledge and understanding of the key safety messages in the health care professionals (HCP) and patient guides among HCPs who prescribed or dispensed SULIQUA and patients treated with SULIQUA, respectively. The study will be a cross-sectional survey conducted in 3 distinct waves in selected European countries, in which SULIQUA® will be marketed. Each wave will correspond to the sequential inclusion of the targeted countries according to the timing of SULIQUA launch and implementation of risk minimization measures in these countries. Each wave will last for approximately 7 months from HCP/patient enrolment to the submission of a report
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned:31/05/2018

Actual:31/05/2018

Study start date

Planned:01/01/2019

Actual:01/09/2019

Date of final study report

Planned:30/06/2022

Actual:13/01/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

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)

Other study registration identification numbers and links

INSLIC08571 / OBS16114