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

Study identification

• 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:
  Finalised

Research institutions and networks

Institutions

Parexel International

United States

Leibniz Institute for Prevention Research and Epidemiology - BIPS

Germany

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

Study timelines

Date when funding contract was signed

Planned: 19/10/2020

Actual: 19/10/2020

Study start date

Planned: 01/05/2021

Actual: 07/09/2021

Date of interim report, if expected

Planned: 31/12/2023

Actual: 19/12/2023

Date of final study report

Planned: 30/09/2024

Actual: 20/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-Genzyme

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