Study identification

PURI

https://redirect.ema.europa.eu/resource/50544

EU PAS number

EUPAS42543

Study ID

50544

Official title and acronym

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

DARWIN EU® study

No

Study countries

Belgium
Czechia
Denmark
Germany
Sweden
United Kingdom

Study status

Ongoing
Research institution and networks

Institutions

Parexel International
Sweden
First published:
26/04/2024
Institution
Non-Pharmaceutical companyENCePP partner
The Danish Multiple Sclerosis Registry Denmark, AIM-IMA (L'Agence Intermutualiste - Het InterMutualistisch Agentschap) Belgium, The Swedish Multiple Sclerosis Registry Sweden, The Czech Multiple Sclerosis Registry (ReMuS) Czechia, University Hospital of Wales Wales, Cambridge University Hospitals England, Derriford Hospital/ Plymouth University England

Contact details

Katja M Hakkarainen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi-Genzyme
Study protocol
Initial protocol

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

English (2.09 MB - PDF)View document
Updated protocol

lem_pass_mort_protocol_june242022_CLEAN_Redacted

English (1.17 MB - 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 1 (imposed as condition of marketing authorisation)

Regulatory procedure number

EMEA/H/C/003718