NCT04102930

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

76 active sites

Status
recruiting

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 Progress92%
Jun 2005Mar 2028

Study Start

First participant enrolled

June 10, 2005

Completed
14.1 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

22.8 years

First QC Date

July 30, 2019

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary outcome for genetic susceptibility studies:

    Diagnosis of GCA (or PMR), confirmed by a specialist (e.g. rheumatologist, ophthalmologist) with relevant expertise.

    At baseline

Secondary Outcomes (7)

  • Phenotype

    At baseline

  • Life impact questionnaires

    At baseline

  • Long term outcomes

    At baseline

  • Diagnosis of GCA/PMR

    Through study completion, an average of 1 year

  • Exploratory analyses

    At baseline

  • +2 more secondary outcomes

Study Arms (2)

Retrospective

A patient who has a diagnosis of GCA or PMR

Prospective

Patient with suspected GCA and PMR

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients predominantly recruited from secondary but can be identified and/or recruited in primary care.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient unwilling or unable to give fully informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (76)

Queen Elizabeth The Queen Mother Hospital

Canterbury, Kent, CT 1 3NG, United Kingdom

RECRUITING

Whiston Hospital

Prescot, Merseyside, L35 5DR, 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, LL57 2PW, 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

Arrowe Park Hospital, Wirral University Hospital NHS Foundation Trust

Metropolitan Borough of Wirral, United Kingdom

RECRUITING

Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust

Newcastle, United Kingdom

RECRUITING

North Tyneside General Hospital, Northumbria Healthcare NHS Foundation Trust

North Shields, United Kingdom

RECRUITING

Northampton General Hospital, Northampton General Hospital NHS Trust

Northampton, United Kingdom

RECRUITING

Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

COMPLETED

Queens Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

RECRUITING

Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Trust

Oxford, United Kingdom

NOT YET RECRUITING

Peterborough City Hospital, North West Anglia NHS Foundation Trust

Peterborough, United Kingdom

RECRUITING

Derriford Hospital, University Hospital Plymouth NHS Trust

Plymouth, United Kingdom

RECRUITING

Poole Hospital, University Hospitals Dorset NHS Foundation Trust

Poole, United Kingdom

RECRUITING

Minerva Health Centre, Lancashire and South Cumbria NHS Foundation Trust

Preston, United Kingdom

RECRUITING

Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

RECRUITING

Salford Royal Hospital, Salford Royal NHS Foundation Trust

Salford, United Kingdom

RECRUITING

Scarborough General Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust

Scarborough, United Kingdom

RECRUITING

Southend University Hospital, Southend University Hospital NHS Foundation Trust

Southend-on-Sea, United Kingdom

RECRUITING

Lister Hospital, East and North Hertfordshire NHS Trust

Stevenage, United Kingdom

RECRUITING

Haywood Hospital, Midlands Partnership NHS Foundation Trust

Stoke-on-Trent, United Kingdom

RECRUITING

Great Western Hospital, The Great Western Hospitals NHS Foundation Trust

Swindon, United Kingdom

RECRUITING

Torbay Hospital, Torbay and South Devon NHS Foundation Trust

Torquay, United Kingdom

COMPLETED

Royal Cornwall Hospital, Royal Cornwall Hospitals NHS Trust

Truro, United Kingdom

RECRUITING

Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

RECRUITING

Warrington Hospital, Warrington and Halton Hospitals NHS Foundation Trust

Warrington, United Kingdom

RECRUITING

Warwick Hospital, South Warwickshire NHS Foundation Trust

Warwick, United Kingdom

COMPLETED

Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

RECRUITING

University Hospital Wishaw, NHS Lanarkshire

Wishaw, United Kingdom

RECRUITING

York Hospital, York and Scarborough Teaching Hospitals NHS Foundation Trust

York, United Kingdom

COMPLETED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, cellular and subcellular fractions of blood, urine or arterial tissue, DNA, RNA, proteins and metabolites

MeSH Terms

Conditions

Giant Cell ArteritisPolymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue Diseases

Study Officials

  • Ann Morgan

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
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

July 30, 2019

First Posted

September 25, 2019

Study Start

June 10, 2005

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations