Study identification

PURI

https://redirect.ema.europa.eu/resource/46147

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 institution and networks

Institutions

Sanofi
First published:
01/02/2024
Institution

Contact details

Trial Transparency Team Trial Transparency Team

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Study protocol
Initial protocol

rdct-INSLIC08571-protocol-PDFA

English (2.73 MB - PDF)View document
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)