Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
80 participants
OBSERVATIONAL
2019-05-13
2020-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Case
Cases are patients that are prescribed tocilizumab as escalation therapy for relapsing/refractory GCA
No interventions assigned to this group
Control
Controls are those that are prescribed an alternative escalation therapy (not tocilizumab) for relapsing/refractory GCA.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Willing and able to consent
* Have refractory or relapsing GCA as defined by the NHS England commissioning statement for tocilizumab.
* Require treatment escalation
50 Years
ALL
No
Sponsors
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University of Oxford
OTHER
Hoffmann-La Roche
INDUSTRY
University of Leeds
OTHER
Responsible Party
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Ann Morgan
Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist
Principal Investigators
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Ann Morgan
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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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
Countries
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Other Identifiers
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MM05/7307
Identifier Type: -
Identifier Source: org_study_id
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