Knowledge survey to assess the effectiveness of educational materials among patients prescribed LEMTRADA® (alemtuzumab)

Study identification

• EU PAS number:
  EUPAS35552
• Study ID:
  35661
• Official title and acronym:
  Knowledge survey to assess the effectiveness of educational materials among patients prescribed LEMTRADA® (alemtuzumab)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Germany

  Greece

  Italy

  Netherlands

  Norway

  Spain

  United Kingdom
• Study description:
  The objective of the survey is to assess descriptively the knowledge of treated patients about the key educational messages concerning autoimmune conditions and serious infections, and adherence to monitoring, to ensure the safe use of LEMTRADA. Research questions:1. Has the patient received the patient guide (PG) and patient alert card (PAC)?2. What is the knowledge of patients about the PG and PC?3. What is the knowledge of patients about the risks associated with the use of LEMTRADA?4. What is the knowledge of patients about risk minimization activities to be undertaken?
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned:01/12/2015

Actual:05/01/2016

Study start date

Planned:01/12/2015

Actual:01/03/2016

Data analysis start date

Planned:02/02/2016

Actual:02/08/2016

Date of interim report, if expected

Planned:01/03/2016

Actual:01/11/2016

Date of final study report

Planned:07/11/2017

Actual:06/11/2018

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

ALEMLC09615