A non-interventional post-authorisation safety study to investigate the risk of mortality in multiple sclerosis patients treated with alemtuzumab (LEMTRADA®) relative to comparable multiple sclerosis patients using other disease modifying therapies: a cohort study

First published 26/08/2021

Last updated 06/05/2025

EU PAS number:

EUPAS42543

Study

Finalised

Documents

Study protocol

Initial protocol

alemtuzumab-lemtrada-pass-mort-protocol-may-2021_Redacted

English (2.09 MB - PDF)View document

Updated protocol

Redacted_ lem-mortality[csa002]-protocol-amendment-v4.0.pdf

First published: 25/02/2025

English (2.02 MB - PDF)View document

Study results

alemtuzumab_mort_csa0002_abstract_upload_emahma_22april2025.pdf

English (198.38 KB - PDF)View document

Study report

Other information

Study, other information

lem_pass_mort_protocol_may192021

English (1.37 MB - PDF)View document

ENCePP Seal

ENCePP Seal documents

Secondary tabs