Study identification

PURI

https://redirect.ema.europa.eu/resource/35661

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
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

ALEMLC09615_2015-11-30 LEMTRADA_Patients_PROTOCOL 1 7 -WAVE1-final

English (666.14 KB - PDF)View document
Updated protocol

ALEMLC09615_2017-05-08 LEMTRADA_Patients_PROTOCOL 1.8 - WAVE 2

English (101.32 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)