A non-interventional post-authorisation safety study to investigate drug utilisation and safety monitoring patterns for Lemtrada (alemtuzumab)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50553
• EU PAS number:
  EUPAS42540
• Study ID:
  50553
• Official title and acronym:
  A non-interventional post-authorisation safety study to investigate drug utilisation and safety monitoring patterns for Lemtrada (alemtuzumab)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Czechia

  Germany

  United Kingdom
• Study status:
  Ongoing

Research institutions and networks

Institutions

Parexel International

United States

Czech MS Registry Czech Republic, AIM-IMA Belgium, MS Center Dresden, Center of Clinical Neuroscience Germany, University Hospital of Wales UK, Cambridge University Hospitals UK, Derriford Hospital/ Plymouth University UK

Study timelines

Date when funding contract was signed

Planned: 19/10/2020

Actual: 19/10/2020

Study start date

Planned: 01/04/2021

Actual: 15/11/2021

Date of final study report

Planned: 30/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Genzyme

Study protocol

Initial protocol

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

Updated protocol

lemtrada-dus-pass-amended-protocol-V3.1-Final_clean version_12-Dec-2023_redacted.pdf

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)