Clinical and Immunogenetic Characterization of Giant Cell Arteritis (GCA) and Polymyalgia Rheumatica (PMR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Leeds
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients predominantly recruited from secondary but can be identified and/or recruited in primary care.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
4,500 Participants
are grouped into 2 trial groupsGroup A: Retrospective
Group B: Prospective
Trial outcomes
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.
Time frame
At baselineSecondary outcomes
1
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.
Time frame
At baseline2
Life impact questionnaires
Assessment of the impact the disease and treatment has on the patients' lives as reported by the patient
Time frame
At baseline3
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.
Time frame
At baseline4
Diagnosis of GCA/PMR
Diagnosis in patients presenting with suspected GCA/PMR (prospective study).
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leeds
Lead sponsor
University of Oxford
Collaborator
Source ClinicalTrials.gov