Understanding genetic factors in Giant Cell Arteritis and Polymyalgia Rheumatica
UK GCA Consortium: Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)
This study is trying to find out if certain genes make people more likely to get Giant Cell Arteritis or Polymyalgia Rheumatica, focusing on patients aged 50 and older who have these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Drugs / interventions | tocilizumab |
| Locations | 76 sites (Canterbury, Kent and 75 other locations) |
| Trial ID | NCT04102930 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the clinical and immunogenetic aspects of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR) by recruiting both prospective and retrospective patient cohorts. The primary goal is to identify genetic determinants that contribute to the susceptibility of these conditions, which could provide insights into their underlying mechanisms. Additionally, a subset of patients will be monitored in a post-marketing surveillance registry for those receiving tocilizumab for relapsing or refractory GCA. The study involves multiple centers and focuses on patients aged 50 and above, with a firm diagnosis of GCA or PMR.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 50 and over with a confirmed diagnosis of GCA or PMR.
Not a fit: Patients who are unwilling or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of GCA and PMR, potentially reducing complications and enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in identifying genetic factors related to autoimmune conditions, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 likely than any alternative explanation for the patient's symptoms. * Able and willing to give informed consent. Patients will be 50 years of age or over, unless both biopsy-proven and a clinically classical case of GCA. Exclusion Criteria: • Patient unwilling or unable to give fully informed consent.
Where this trial is running
Canterbury, Kent and 75 other locations
- Queen Elizabeth The Queen Mother Hospital — Canterbury, Kent, United Kingdom (Recruiting)
- Whiston Hospital — Prescot, Merseyside, United Kingdom (Recruiting)
- Nevill Hall Hospital, Aneurin Bevan University Health Board — Abergavenny, United Kingdom (Recruiting)
- Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust — Aylesbury, United Kingdom (Recruiting)
- Betsi Cadwaladr University Health Board — Bangor, United Kingdom (Recruiting)
- Barnsley Hospital, Barnsley Hospital NHS Foundation Trust — Barnsley, United Kingdom (Completed)
- Basildon University Hospital, Basildon and Thurrock University Hospitals NHS Foundation Trust — Basildon, United Kingdom (Recruiting)
- Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust — Basingstoke, United Kingdom (Recruiting)
- Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Foundation Trust — Bath, United Kingdom (Recruiting)
- Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
- Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)
- Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom (Recruiting)
- Queen's Hospital, University Hospitals of Derby and Burton NHS Foundation Trust — Burton-on-Trent, United Kingdom (Recruiting)
- West Suffolk Hospital, West Suffolk NHS Foundation Trust — Bury St Edmunds, United Kingdom (Recruiting)
- Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust — Chelsea, United Kingdom (Recruiting)
- West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust — Chelsea, United Kingdom (Recruiting)
- Ashford and St Peter's Hospitals, Ashford & St Peter's Hospitals NHS Foundation Trust — Chertsey, United Kingdom (Recruiting)
- Countess of Chester Hospital, Countess of Chester NHS Foundation Trust — Chester, United Kingdom (Recruiting)
- Christchurch Hospital, University Hospitals Dorset NHS Foundation Trust — Christchurch, United Kingdom (Recruiting)
- Croydon University Hospital, Croydon Health Service NHS Trust — Croydon, United Kingdom (Recruiting)
- Darlington Memorial Hospital, County Durham and Darlington NHS Foundation Trust — Darlington, United Kingdom (Recruiting)
- Royal Derby Hospital, University Hospitals of Derby and Burton NHS Foundation Trust — Derby, United Kingdom (Recruiting)
- Doncaster Royal Infirmary, Doncaster and Bassetlaw Hospitals NHS Foundation Trust — Doncaster, United Kingdom (Recruiting)
- Ninewells Hospital and Medical School, NHS Tayside — Dundee, United Kingdom (Completed)
- Royal Devon and Exeter Hospital, Royal Devon and Exeter NHS Foundation Trust — Exeter, United Kingdom (Recruiting)
- Frimley Park Hospital, Frimley Park Hospital NHS Foundation Trust — Frimley, United Kingdom (Completed)
- Gateshead Queen Elizabeth Hospital, Gateshead Health NHS Foundation Trust — Gateshead, United Kingdom (Recruiting)
- Inverclyde Royal Hospital, NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Completed)
- Royal Alexandra Hospital, NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Completed)
- Vale of Leven Hospital, NHS Greater Glasgow and Clyde — Glasgow, United Kingdom (Completed)
- James Paget Hospital, James Paget University Hospitals NHS Foundation Trust — Great Yarmouth, United Kingdom (Completed)
- Royal Surrey County Hospital, Royal Surrey County Hospital NHS Foundation Trust — Guildford, United Kingdom (Completed)
- Harrogate and District Hospital, Harrogate and District NHS Foundation Trust — Harrogate, United Kingdom (Recruiting)
- Hull Royal Infirmary, Hull and East Yorkshire NHS Trust — Hull, United Kingdom (Recruiting)
- Ipswich Hospital, East Suffolk and North Essex NHS Foundation Trust — Ipswich, United Kingdom (Completed)
- Airedale General Hospital, Airedale NHS Foundation Trust — Keighley, United Kingdom (Recruiting)
- Westmorland General Hospital, University Hospitals of Morecambe Bay NHS Foundation Trust — Kendal, United Kingdom (Recruiting)
- The Queen Elizabeth Hospital, The Queen Elizabeth Hospital Kings Lynn NHS Foundation Trust — Kings Lynn, United Kingdom (Completed)
- Royal Lancaster Infirmary, University Hospitals of Morecambe NHS Foundation Trust — Lancaster, United Kingdom (Recruiting)
- Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust — Leeds, United Kingdom (Recruiting)
- Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust — Leicester, United Kingdom (Recruiting)
- Aintree University Hospital, Aintree University Hospitals NHS Trust — Liverpool, United Kingdom (Recruiting)
- Royal Glamorgan Hospital, Cwm Taf University Health Board — Llantrisant, United Kingdom (Recruiting)
- Hammersmith Hospital, Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- King's College Hospital, King's College Hospital NHS Foundation Trust, London — London, United Kingdom (Recruiting)
- Royal Free Hospital, Royal Free NHS Foundation Trust — London, United Kingdom (Recruiting)
- St George's Hospital, St George's University Hospitals NHS Foundation Trust — London, United Kingdom (Recruiting)
- University College London Hospital, University College London NHS Foundation Trust — London, United Kingdom (Recruiting)
- Manchester Royal Infirmary, Manchester University NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
+26 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Ann Morgan — University of Leeds
- Study coordinator: Louise Sorensen
- Email: MRCTarget@leeds.ac.uk
- Phone: 0113 343 7764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.