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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | A patient who has a diagnosis of GCA or PMR | ||
| Prospective | Patient with suspected GCA and PMR |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome for genetic susceptibility studies: | Diagnosis of GCA (or PMR), confirmed by a specialist (e.g. rheumatologist, ophthalmologist) with relevant expertise. | At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Phenotype | Clinical phenotype or subtype of GCA/PMR based on disease features and imaging undertaken as part of routine clinical practice, and on research tests, such as imaging performed for research purposes, cells, subcellular fractions and molecules in the circulation and/or arterial tissue and genetic/ epigenetic/ transcriptomic/ proteomic or metabolomic factors, including next generation sequencing (whole exome sequencing) of selected cases. |
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Inclusion Criteria:
Exclusion Criteria:
• Patient unwilling or unable to give fully informed consent.
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Patients predominantly recruited from secondary but can be identified and/or recruited in primary care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louise Sorensen | Contact | 0113 343 7764 | MRCTarget@leeds.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Ann Morgan | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth The Queen Mother Hospital | Recruiting | Canterbury | Kent | CT 1 3NG | United Kingdom |
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Serum, plasma, cellular and subcellular fractions of blood, urine or arterial tissue, DNA, RNA, proteins and metabolites
| At baseline |
| Life impact questionnaires | Assessment of the impact the disease and treatment has on the patients' lives as reported by the patient | At baseline |
| Long term outcomes | Longitudinal follow-up of patients (as far as is possible from medical and electronic records and without requiring additional study visits) to define prognosis/disease outcomes, such as ischaemic manifestations, aneurysm formation, duration of steroid therapy, disease flares, complications related to steroid therapy. | At baseline |
| Diagnosis of GCA/PMR | Diagnosis in patients presenting with suspected GCA/PMR (prospective study). | Through study completion, an average of 1 year |
| Exploratory analyses | To investigate role of genetics, environmental factors (e.g. diet and sunlight) and co-morbidities (e.g. periodontal disease) on disease phenotype and outcome as assessed by the patient-administered questionnaires. | At baseline |
| Disease activity defined as an increase in clinical and patient reported activity of disease | Participants commencing a synthetic or biological disease modifying anti-rheumatic drug with or without additional steroid therapy will have their disease activity assessed. | At baseline |
| Proteomic and genomic analyses on serum, plasma and urine samples. | A variety of 'omic technologies will be applied to cell populations isolated from the blood and/or routine diagnostic arterial biopsies, including, but not limited to, RNASeq and a variety of proteomic approaches. | At baseline |
| Whiston Hospital | Recruiting | Prescot | Merseyside | L35 5DR | United Kingdom |
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| Nevill Hall Hospital, Aneurin Bevan University Health Board | Recruiting | Abergavenny | United Kingdom |
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| Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust | Recruiting | Aylesbury | United Kingdom |
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| Betsi Cadwaladr University Health Board | Recruiting | Bangor | LL57 2PW | United Kingdom |
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| Barnsley Hospital, Barnsley Hospital NHS Foundation Trust | Completed | Barnsley | United Kingdom |
| Basildon University Hospital, Basildon and Thurrock University Hospitals NHS Foundation Trust | Recruiting | Basildon | United Kingdom |
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| Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust | Recruiting | Basingstoke | United Kingdom |
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| Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Foundation Trust | Recruiting | Bath | United Kingdom |
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| Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust | Recruiting | Birmingham | United Kingdom |
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| Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust | Recruiting | Birmingham | United Kingdom |
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| Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust | Recruiting | Bristol | United Kingdom |
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| Queen's Hospital, University Hospitals of Derby and Burton NHS Foundation Trust | Recruiting | Burton-on-Trent | United Kingdom |
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| West Suffolk Hospital, West Suffolk NHS Foundation Trust | Recruiting | Bury St Edmunds | United Kingdom |
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| Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust | Recruiting | Cambridge | United Kingdom |
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| Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust | Recruiting | Chelsea | United Kingdom |
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| West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust | Recruiting | Chelsea | United Kingdom |
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| Ashford and St Peter's Hospitals, Ashford & St Peter's Hospitals NHS Foundation Trust | Recruiting | Chertsey | United Kingdom |
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| Countess of Chester Hospital, Countess of Chester NHS Foundation Trust | Recruiting | Chester | United Kingdom |
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| Christchurch Hospital, University Hospitals Dorset NHS Foundation Trust | Recruiting | Christchurch | United Kingdom |
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| Croydon University Hospital, Croydon Health Service NHS Trust | Recruiting | Croydon | United Kingdom |
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| Darlington Memorial Hospital, County Durham and Darlington NHS Foundation Trust | Recruiting | Darlington | United Kingdom |
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| Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust | Recruiting | Derby | United Kingdom |
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| Doncaster Royal Infirmary, Doncaster and Bassetlaw Hospitals NHS Foundation Trust | Recruiting | Doncaster | United Kingdom |
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| Ninewells Hospital and Medical School, NHS Tayside | Completed | Dundee | United Kingdom |
| Royal Devon and Exeter Hospital, Royal Devon and Exeter NHS Foundation Trust | Recruiting | Exeter | United Kingdom |
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| Frimley Park Hospital, Frimley Park Hospital NHS Foundation Trust | Completed | Frimley | United Kingdom |
| Gateshead Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust | Recruiting | Gateshead | United Kingdom |
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| Inverclyde Royal Hospital, NHS Greater Glasgow and Clyde | Completed | Glasgow | United Kingdom |
| Royal Alexandra Hospital, NHS Greater Glasgow and Clyde | Completed | Glasgow | United Kingdom |
| Vale of Leven Hospital, NHS Greater Glasgow and Clyde | Completed | Glasgow | United Kingdom |
| James Paget Hospital, James Paget University Hospitals NHS Foundation Trust | Completed | Great Yarmouth | United Kingdom |
| Royal Surrey County Hospital, Royal Surrey County Hospital NHS Foundation Trust | Completed | Guildford | United Kingdom |
| Harrogate and District Hospital, Harrogate and District NHS Foundation Trust | Recruiting | Harrogate | United Kingdom |
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| Hull Royal Infirmary, Hull and East Yorkshire NHS Trust | Recruiting | Hull | United Kingdom |
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| Ipswich Hospital, East Suffolk and North Essex NHS Foundation Trust | Completed | Ipswich | United Kingdom |
| Airedale General Hospital, Airedale NHS Foundation Trust | Recruiting | Keighley | United Kingdom |
|
| Westmorland General Hospital, University Hospitals of Morecambe Bay NHS Foundation Trust | Recruiting | Kendal | United Kingdom |
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| The Queen Elizabeth Hospital, The Queen Elizabeth Hospital Kings Lynn NHS Foundation Trust | Completed | Kings Lynn | United Kingdom |
| Royal Lancaster Infirmary, University Hospitals of Morecambe NHS Foundation Trust | Recruiting | Lancaster | United Kingdom |
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| Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust | Recruiting | Leeds | United Kingdom |
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| Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust | Recruiting | Leicester | United Kingdom |
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| Aintree University Hospital, Aintree University Hospitals NHS Trust | Recruiting | Liverpool | United Kingdom |
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| Royal Glamorgan Hospital, Cwm Taf University Health Board | Recruiting | Llantrisant | United Kingdom |
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| Hammersmith Hospital, Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
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| King's College Hospital, King's College Hospital NHS Foundation Trust, London | Recruiting | London | United Kingdom |
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| Royal Free Hospital, Royal Free NHS Foundation Trust | Recruiting | London | United Kingdom |
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| St George's Hospital, St George's University Hospitals NHS Foundation Trust | Recruiting | London | United Kingdom |
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| University College London Hospital, University College London NHS Foundation Trust | Recruiting | London | United Kingdom |
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| Manchester Royal Infirmary, Manchester University NHS Foundation Trust | Recruiting | Manchester | United Kingdom |
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| Arrowe Park Hospital, Wirral University Hospital NHS Foundation Trust | Recruiting | Metropolitan Borough of Wirral | United Kingdom |
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| Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust | Recruiting | Newcastle | United Kingdom |
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| North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust | Recruiting | North Shields | United Kingdom |
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| Northampton General Hospital, Northampton General Hospital NHS Trust | Recruiting | Northampton | United Kingdom |
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| Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust | Completed | Norwich | United Kingdom |
| Queens Medical Centre, Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | United Kingdom |
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| Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust | Not yet recruiting | Oxford | United Kingdom |
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| Peterborough City Hospital, North West Anglia NHS Foundation Trust | Recruiting | Peterborough | United Kingdom |
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| Derriford Hospital, University Hospital Plymouth NHS Trust | Recruiting | Plymouth | United Kingdom |
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| Poole Hospital, University Hospitals Dorset NHS Foundation Trust | Recruiting | Poole | United Kingdom |
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| Minerva Health Centre, Lancashire and South Cumbria NHS Foundation Trust | Recruiting | Preston | United Kingdom |
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| Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust | Recruiting | Preston | United Kingdom |
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| Salford Royal Hospital, Salford Royal NHS Foundation Trust | Recruiting | Salford | United Kingdom |
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| Scarborough General Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust | Recruiting | Scarborough | United Kingdom |
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| Southend University Hospital, Southend University Hospital NHS Foundation Trust | Recruiting | Southend-on-Sea | United Kingdom |
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| Lister Hospital, East and North Hertfordshire NHS Trust | Recruiting | Stevenage | United Kingdom |
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| Haywood Hospital, Midlands Partnership NHS Foundation Trust | Recruiting | Stoke-on-Trent | United Kingdom |
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| Great Western Hospital, The Great Western Hospitals NHS Foundation Trust | Recruiting | Swindon | United Kingdom |
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| Torbay Hospital, Torbay and South Devon NHS Foundation Trust | Completed | Torquay | United Kingdom |
| Royal Cornwall Hospital, Royal Cornwall Hospitals NHS Trust | Recruiting | Truro | United Kingdom |
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| Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust | Recruiting | Wakefield | United Kingdom |
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| Warrington Hospital, Warrington and Halton Hospitals NHS Foundation Trust | Recruiting | Warrington | United Kingdom |
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| Warwick Hospital, South Warwickshire NHS Foundation Trust | Completed | Warwick | United Kingdom |
| Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust | Recruiting | Winchester | United Kingdom |
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| University Hospital Wishaw, NHS Lanarkshire | Recruiting | Wishaw | United Kingdom |
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| York Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust | Completed | York | United Kingdom |
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| D011111 | Polymyalgia Rheumatica |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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