Table 1.
Primary objective | |
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1 | To compare cumulative GC doses in patients with isolated c-GCA as compared to LV-GCA (with or without c-GCA). |
Key secondary objectives | |
1 | To compare cumulative GC doses in patients with pure PMR* compared to PMR patients with subclinical LV-GCA. |
2 | To compare the incidence of aortic dilatation 2 years after diagnosis in patients with c-GCA as compared to LV-GCA (with or without c-GCA). |
3 | In the subpopulation of patients in whom a diagnostic FDG PET/CT was performed at diagnosis, to evaluate the risk of aortic complications (aneurysms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement. |
Secondary objectives | |
1 | To compare treatment response, risk of relapse, need for GC-sparring add-on treatment, and disease duration in patients with c-GCA as compared to LV-GCA (with or without c-GCA). |
2 | To compare treatment response, risk of relapse, need for GC-sparring add-on treatment, and disease duration in patients with pure PMR compared to PMR patients with subclinical LV-GCA. |
3 | In the subpopulation of patients in whom a diagnostic FDG PET/CT was performed, to evaluate the association between aortic FDG uptake and aortic dilatation at year 2. |
Exploratory objectives | |
1 | To identify clinical features associated with the different disease subsets, c-GCA, LV-GCA, and PMR. |
2 | To assess and evaluate risk factors and biomarkers predicting GCA in patients with PMR. |
3 | To assess and evaluate incidence, prevalence, and predictors of ischemic events and vascular complications in GCA patients. |
4 | To assess and evaluate incidence, prevalence, and predictors of comorbidity in GCA and PMR patients. |
5 | To assess and evaluate diagnostic strategies and implementation of diagnostic imaging in GCA and PMR. |
6 | To evaluate adherence to clinical guidelines. |
7 | To evaluate and predict treatment efficacy, safety, and predictors of treatment success, treatment failure, and maintenance of remission after therapy withdrawal. |
8 | To assess and evaluate risk factors and biomarkers predicting vascular complications in GCA. |
*Pure PMR; PMR patient without cranial GCA symptoms, new-onset claudication, or GCA. c-GCA, cranial giant cell arteritis; LV-GCA, large-vessel GCA; PMR, polymyalgia rheumatica; GC, glucocorticoid; 18F-FDG PET/CT, fluorine-18-fluorodeoxyglucose positron emission tomography with computed tomography.