Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03812302
Eligibility Criteria:
Inclusion Criteria:
Participants must:
1. Meet the revised GCA diagnosis criteria (modified from ref 1)
2. Have either newly-diagnosed or relapsing disease
3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)
4. Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
5. Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.
GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).
1. Age ≥ 50 years
2. And at least 1 of a. or b. :
1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication
2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
3. And at least 1 of a. or b.:
1. Temporal artery biopsy revealing features of GCA
2. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)
Exclusion Criteria:
* Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03812302
Study Brief:
Protocol Section:
NCT03812302