Proposal for establishment of a UK post-marketing surveillance registry to study the effectiveness, safety and prescribing habits of tocilizumab for the treatment of giant cell arteritis in the UK National Health Service, nested within the existing structure of the UK GCA Consortium and UKIVAS studies (TARGET)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44323
• EU PAS number:
  EUPAS31845
• Study ID:
  44323
• Official title and acronym:
  Proposal for establishment of a UK post-marketing surveillance registry to study the effectiveness, safety and prescribing habits of tocilizumab for the treatment of giant cell arteritis in the UK National Health Service, nested within the existing structure of the UK GCA Consortium and UKIVAS studies (TARGET)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study was terminated due to insufficient enrollment and no formal CSR will be available. This study aims to assess the effectiveness and safety of tocilizumab in controlling refractory or relapsing giant cell arteritis (GCA) in patients who require escalation of therapy to reach sustained remission defined by the absence of active disease features.
• Study status:
  Finalised

Research institutions and networks

Institutions

Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust Birmingham, United Kingdom, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust Cambridge, United Kingdom, Royal Derby Hospital, University Hospital of Derby and Burton NHS Foundation Trust Derby, United Kingdom, Ninewells Hospital and Medical School, NHS Tayside Dundee, United Kingdom, NHS Lothian, Edinburgh Edinburgh, United Kingdom, Inverclyde Royal Hospital, NHS Greater Glasgow and Clyde Glasgow, United Kingdom, Royal Alexandra Hospital, NHS Greater Glasgow and Clyde Glasgow, United Kingdom, Vale of Leven Hospital, NHS Greater Glasgow and Clyde Glasgow, United Kingdom, Harrogate and District NHS Foundation Trust Harrogate, United Kingdom, Airedale General Hospital, Airedale NHS Foundation Trust Keighley, United Kingdom

Networks

UKIVAS (UK and Ireland Vasculitis Rare Disease Group)

Study timelines

Date when funding contract was signed

Actual: 20/12/2018

Study start date

Actual: 13/06/2019

Data analysis start date

Planned: 31/03/2022

Date of final study report

Planned: 11/12/2021

Actual: 09/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Hoffmann-La Roche

Study protocol

Initial protocol

Affiliate Protocol (initial submission) WA40984 (TARGET GCAT registry) tocilizumab, United Kingdom of Great Britain and Northern Ireland_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable