Behavior and knowledge survey to assess the effectiveness of educational materials in patients treated with AUBAGIO® (teriflunomide) (cross-sectional survey)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35671
• EU PAS number:
  EUPAS31883
• Study ID:
  35671
• Official title and acronym:
  Behavior and knowledge survey to assess the effectiveness of educational materials in patients treated with AUBAGIO® (teriflunomide) (cross-sectional survey)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Greece

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  The objective of the survey is to assess descriptively knowledgeand behavior of treated patients about the educational materialsand thus the effectiveness of these materials and tools to ensurethe safe use of Aubagio®.Research questions:1. Has the patient received the Patient Card?2. What is the knowledge of patients about the Patient Card (PC)?3. What is the knowledge of patients about the risks associated with the use of Aubagio®?4. Does patients’ self-report indicate that they are undertaking risk minimization behavior (contraception, compliance with blood monitoring)?
• Study status:
  Finalised

Research institution and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Actual: 05/01/2016

Study start date

Actual: 01/03/2016

Date of final study report

Actual: 21/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

TERIFC09617_Wave 1 - protocol patient - Aubagio

Updated protocol

TERIFC09617_Wave 2 - protocol patient - Aubagio

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

TERIFC09617