At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 273 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 4,500
- Started
- 2005-06-10
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for giant cell arteritis
- • Clinical study - 4,500 participants
- • A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA)
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with giant cell arteritis
Where?
- • Canterbury - Queen Elizabeth The Queen Mother Hospital
- • Prescot - Whiston Hospital
- • Abergavenny - Nevill Hall Hospital, Aneurin Bevan University Health Board
- • Aylesbury - Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust
- • +72 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A multi-centre observational study recruiting prospective and retrospective cohorts of patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). The primary aim is to find genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. A subset of the retrospective cohort is also enrolled in a post-marketing surveillance registry of patients eligible for, or receiving tocilizumab, to treat their relapsing or refractory GCA.
More detail
Giant cell arteritis (GCA), also known as temporal arteritis, is the most common form of primary systemic vasculitis, with up to 75,000 cases a year identified in the EU and US. It occurs almost exclusively in people over the age of 50 years and is considered to be a medical emergency. If not treated with high-dose glucocorticoids immediately, the thickening of the inflamed blood vessel wall can cause irreversible visual loss or stroke. GCA can lead to significant morbidity across a variety of systems, due to both the disease, and complications of treatment. Diagnosis may be confirmed with a temporal artery biopsy, imaging (e.g. USS/CT/MRA/PET-CR) or based on clinical signs (e.g. erythrocyte sedimentation rate) and symptoms (e.g. a new headache, jaw claudication, visual disturbances, temporal artery abnormality such as tenderness or decreased pulsation) . Polymyalgia rheumatica (PMR) is characterised by inflammatory limb-girdle pain with early morning stiffness, and a systemic inflammatory response demonstrated by elevated inflammatory markers. The UK GCA Consortium is a multi-centre observational study, the main arms of which recruit prospective (participants with suspected GCA) and retrospective cohorts (participants with confirmed GCA diagnosis). Analysis of data collected on these cohorts will help achieve the primary aim of finding genetic determinants of GCA and PMR susceptibility, in order to yield novel insights into disease pathogenesis. Secondary aims, and their associated analyses, are as follows: * Phenotype: characterising GCA and PMR subtypes, based on clinical features; imaging; cells; subcellular fractions and molecules in the circulation and/or arterial tissue; genetic/epigenetic/transcriptomic/proteomic or metabolomics factors, including next generation sequencing (whole exome sequencing) of selected cases. * Life impact: determining what aspects of the disease and treatments affect patients' quality of life, as assessed by patient-reported outcomes. * Long-term outcomes: characterising prognosis of GCA and PMR - both effects of the disease and its treatment - by longitudinal follow-up through electronic linkage to health records. * Exploratory analyses: exploring the potential role of environmental factors and co-morbidities on phenotype and outcomes. * Diagnosis, prognosis: improving diagnosis of GCA and PMR, and identifying factors that predict diagnosis, such as diagnostic clinical features, and prognostic and diagnostic biomarkers. * Disease activity: monitoring participants who commence a synthetic or biological disease-modifying anti-rheumatic drug (s/bDMARD). Finding a biomarker for GCA and PMR disease activity, which might be clinically useful in helping to optimise steroid and s/bDMARD treatments for individual patients.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓Willing to self-identify an ethnic group, such as Caucasian, Asian, Afro-Caribbean.
- ✓Have a firm clinical diagnosis of GCA or PMR, or (for patients identified prospectively) GCA or PMR should be more...
- ✓Able and willing to give agreement to take part. Patients will be 50 years of age or over, unless both biopsy-proven and a...
Who cannot take part
- ✗Patient unwilling or unable to give fully agreement to take part.
See the full criteria
Where Is This Study? (76 UK sites)
Queen Elizabeth The Queen Mother Hospital
Canterbury CT 1 3NG, United Kingdom
Whiston Hospital
Prescot L35 5DR, United Kingdom
Nevill Hall Hospital, Aneurin Bevan University Health Board
Abergavenny, United Kingdom
Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust
Aylesbury, United Kingdom
Betsi Cadwaladr University Health Board
Bangor LL57 2PW, United Kingdom
Barnsley Hospital, Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom
Basildon University Hospital, Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, United Kingdom
Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom
Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom
Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Queen's Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
Burton-on-Trent, United Kingdom
West Suffolk Hospital, West Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
Chelsea, United Kingdom
West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
Chelsea, United Kingdom
Ashford and St Peter's Hospitals, Ashford & St Peter's Hospitals NHS Foundation Trust
Chertsey, United Kingdom
Countess of Chester Hospital, Countess of Chester NHS Foundation Trust
Chester, United Kingdom
Christchurch Hospital, University Hospitals Dorset NHS Foundation Trust
Christchurch, United Kingdom
Croydon University Hospital, Croydon Health Service NHS Trust
Croydon, United Kingdom
Non Portfolio - Michael Chang Portfolio - South West Cluster Office
ch-tr.research@nhs.net0208 401 3610Darlington Memorial Hospital, County Durham and Darlington NHS Foundation Trust
Darlington, United Kingdom
Research and Development Team cdda-tr.Research@nhs.net
nencadmin@nihr.ac.uk01325 743366Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom
Doncaster Royal Infirmary, Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster, United Kingdom
Dr Jane Fearnside - Head of Research
dbth.clinicalresearch@nhs.net01302 644069Ninewells Hospital and Medical School, NHS Tayside
Dundee, United Kingdom
Royal Devon and Exeter Hospital, Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
Frimley Park Hospital, Frimley Park Hospital NHS Foundation Trust
Frimley, United Kingdom
Gateshead Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust
Gateshead, United Kingdom
Research and Development Team ghnt.researchanddevelopment@nhs.net
ghnt.researchanddevelopment@nhs.net0191 4820000Inverclyde 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
James Paget Hospital, James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom
Royal Surrey County Hospital, Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Harrogate and District Hospital, Harrogate and District NHS Foundation Trust
Harrogate, United Kingdom
Hull Royal Infirmary, Hull and East Yorkshire NHS Trust
Hull, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Ipswich Hospital, East Suffolk and North Essex NHS Foundation Trust
Ipswich, United Kingdom
Airedale General Hospital, Airedale NHS Foundation Trust
Keighley, United Kingdom
Mechele Couch-Upite
anhsft.researchanddevelopment@nhs.net01535 292278 / 01535 294655Westmorland General Hospital, University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, United Kingdom
The Queen Elizabeth Hospital, The Queen Elizabeth Hospital Kings Lynn NHS Foundation Trust
Kings Lynn, United Kingdom
Royal Lancaster Infirmary, University Hospitals of Morecambe NHS Foundation Trust
Lancaster, 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
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Aintree University Hospital, Aintree University Hospitals NHS Trust
Liverpool, United Kingdom
Royal Glamorgan Hospital, Cwm Taf University Health Board
Llantrisant, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
King's College Hospital, King's College Hospital NHS Foundation Trust, London
London, United Kingdom
Royal Free Hospital, Royal Free NHS Foundation Trust
London, United Kingdom
St George's Hospital, St George's University Hospitals NHS Foundation Trust
London, United Kingdom
University College London Hospital, University College London NHS Foundation Trust
London, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Manchester Royal Infirmary, Manchester University NHS Foundation Trust
Manchester, United Kingdom
Arrowe Park Hospital, Wirral University Hospital NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom
Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust
North Shields, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087Northampton General Hospital, Northampton General Hospital NHS Trust
Northampton, United Kingdom
Michelle Spinks, Head of Research
ngh-tr.research.unit@nhs.net01604 545941Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals 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 Trust
Oxford, United Kingdom
Peterborough City Hospital, North West Anglia NHS Foundation Trust
Peterborough, United Kingdom
Derriford Hospital, University Hospital Plymouth NHS Trust
Plymouth, United Kingdom
Poole Hospital, University Hospitals Dorset NHS Foundation Trust
Poole, United Kingdom
Minerva Health Centre, Lancashire and South Cumbria NHS Foundation Trust
Preston, United Kingdom
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom
Salford Royal Hospital, Salford Royal NHS Foundation Trust
Salford, United Kingdom
Scarborough General Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust
Scarborough, United Kingdom
Southend University Hospital, Southend University Hospital NHS Foundation Trust
Southend-on-Sea, United Kingdom
Lister Hospital, East and North Hertfordshire NHS Trust
Stevenage, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069Haywood Hospital, Midlands Partnership NHS Foundation Trust
Stoke-on-Trent, United Kingdom
Ruth Lambley-Burke & Tilly Grocott
researchsupportservices@mpft.nhs.uk07813400821Great Western Hospital, The Great Western Hospitals NHS Foundation Trust
Swindon, United Kingdom
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom
Royal Cornwall Hospital, Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom
Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust
Wakefield, United Kingdom
Warrington Hospital, Warrington and Halton Hospitals NHS Foundation Trust
Warrington, United Kingdom
Warwick Hospital, South Warwickshire NHS Foundation Trust
Warwick, United Kingdom
Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust
Winchester, United Kingdom
University Hospital Wishaw, NHS Lanarkshire
Wishaw, United Kingdom
York Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust
York, United Kingdom
How to Get in Touch
Louise Sorensen
Sponsor contactCONTACT