Study identification

PURI

https://redirect.ema.europa.eu/resource/35676

EU PAS number

EUPAS31013

Study ID

35676

Official title and acronym

Behavior and knowledge survey to assess the effectiveness of educational materials among healthcare professionals who prescribe AUBAGIO® (teriflunomide) (cross-sectional survey)

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Greece
Italy
Netherlands
Spain
United Kingdom

Study description

The overall objective of the survey is to assess descriptively the knowledge level and behavior of Healthcare Professional (HCPs) with regard to educational messages and thus the effectiveness of the educational materials to support the safe use of AUBAGIO.Research questions:1. What is the HCPs' knowledge about the HCP Education/Discussion Guide?2. What are the reasons for not using this guide, and are there suggestions for change of the guide? Wave 2 only3. What is the knowledge of HCPs about the key points of content:a. Hepatic effectsb. Pregnancy and lactationc. Hematologic effectsd. Infections4. What is the behavior of HCPs with regard to liver enzyme monitoring and discussion of risks with patients (including delivery of Patient Cards to patients)?

Study status

Finalised
Research institutions 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

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Study protocol
Initial protocol

TERIFC09616_Wave 1 - protocol hcp - Aubagio

English (158.31 KB - PDF)View document
Updated protocol

TERIFC09616_Wave 2 - protocol hcp - Aubagio

English (336.41 KB - 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)