Study identification

PURI

https://redirect.ema.europa.eu/resource/35666

EU PAS number

EUPAS35547

Study ID

35666

Official title and acronym

Knowledge survey to assess the effectiveness of educational materials among healthcare professionals who prescribe Lemtrada® (alemtuzumab)

DARWIN EU® study

No

Study countries

Belgium
Denmark
Germany
Greece
Italy
Netherlands
Norway
Spain
United Kingdom

Study description

The overall objective of the survey is to assess descriptively the knowledge level of Healthcare Professionals (HCPs) with regard to educational messages and thus the effectiveness of the educational materials to support the safe use of LEMTRADA:Research questions:1. What is the HCP's understanding and awareness of the risks associated with use of LEMTRADA?2. What is the HCP's knowledge of the key safety messages in the content of the HCP guide and HCP checklist?3. What is the HCP's knowledge and understanding of the risk minimization activities to be undertaken in relation to LEMTRADA?

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:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

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

ALEMLC09614_2015-11-30 LEMTRADA_HCP_PROTOCOL 1 7-WAVE 1-final

English (523.19 KB - PDF)View document
Updated protocol

ALEMLC09614_2017-05-08 LEMTRADA_HCP_PROTOCOL 1.8 - WAVE2-2

English (113.22 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)