Study Stopped
Covid-19
TARGET GCAT Registry
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
1 other identifier
observational
80
1 country
34
Brief Summary
A longitudinal post-marketing surveillance registry nested within the UK GCA Consortium that assesses the effectiveness and safety of tocilizumab in controlling refractory or relapsing forms of GCA in patients who require escalation of therapy to reach sustained remission. Half the patients recruited will have been prescribed tocilizumab (cases) and the other half will be prescribed alternative therapies (controls). There are four study visits over 18 months: baseline, 6 months, 12 months and 18 months. At each visit data is collected on demographics; diagnosis and investigations; previous and concomitant medications; medical history; co-morbidities, vital signs; smoking and alcohol; disease activity and damage; routine laboratory tests; reason for starting escalation therapy. Safety data is collected on an ongoing basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2019
CompletedFirst Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 12, 2021
May 1, 2021
1.1 years
August 5, 2019
May 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab
Data on disease features and lab tests collected at 6 month, compared with that collected at baseline
6 months
Secondary Outcomes (11)
To determine the proportion of eligible patients who achieve a sustained complete remission 6 months after the start of tocilizumab
6 months
To assess the safety (event reporting) and effectiveness (in terms of prevention of relapse) of tocilizumab compared to other strategies for refractory/relapsing disease in patients with GCA who require escalation therapy.
18 months
To compare characteristics (demographics, disease severity, risk factors for steroid toxicity, contraindications to tocilizumab, concomitant medications) of real-world patients prescribed tocilizumab to clinical trial populations.
0-18 months
To describe relapse rates in patients with GCA treated with tocilizumab at treatment completion (usually 12 months in the UK) and 6 months following discontinuation of tocilizumab
0-18 months
To describe disease activity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
0-12 months
- +6 more secondary outcomes
Study Arms (2)
Case
Cases are patients that are prescribed tocilizumab as escalation therapy for relapsing/refractory GCA
Control
Controls are those that are prescribed an alternative escalation therapy (not tocilizumab) for relapsing/refractory GCA.
Eligibility Criteria
500 patients prescribed tocilizumab for GCA within the NHS and 500 age-, sex- and centre-matched controls.
You may qualify if:
- Patient must have a diagnosis of GCA and be eligible for the UK GCA Consortium study
- Willing and able to consent
- Have refractory or relapsing GCA as defined by the NHS England commissioning statement for tocilizumab.
- Require treatment escalation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leedslead
- University of Oxfordcollaborator
- Hoffmann-La Rochecollaborator
Study Sites (34)
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 & Clyde
Glasgow, United Kingdom
Royal Alexandra Hospital, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Vale of Leven Hospital, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Harrogate and District NHS Foundation Trust
Harrogate, United Kingdom
Airedale General Hospital, Airedale NHS Foundation Trust
Keighley, United Kingdom
Royal Lancaster & Westmorland General, University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, United Kingdom
Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust
Leeds, United Kingdom
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Aintree University Hospital, Aintree University Hospital NHS Foundation Trust
Liverpool, United Kingdom
Royal Glamorgan Hospital, Cwm Taf University Health Board
Llantrisant, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom
Royal Free Hospital, Royal Free London NHS Foundation Trust
London, United Kingdom
University College London NHS Foundation Trust
London, United Kingdom
Luton and Dunstable Hospital, The Luton and Dunstable Hospitals NHS Foundation Trust
Luton, United Kingdom
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
The Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom
Queens Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Southend University Hospital NHS Foundation Trust
Southend-on-Sea, United Kingdom
Lister Hospital, East and North Hertfordshire NHS Trust
Stevenage, United Kingdom
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom
Royal Cornwall Hospitals NHS Foundation Trust
Truro, United Kingdom
Dewsbury & District Hospital, Mid Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
University Hospital Wishaw, NHS Lanarkshire
Wishaw, United Kingdom
York Teaching Hospital NHS Foundation Trust
York, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ann Morgan
University of Leeds
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist
Study Record Dates
First Submitted
August 5, 2019
First Posted
August 7, 2019
Study Start
May 13, 2019
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
May 12, 2021
Record last verified: 2021-05