An observational study in Giant Cell Arteritis and Polymyalgia Rheumatic (PMR), sponsored by Wuerzburg University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Wuerzburg University Hospital · Observational
Long-term follow-up of aortal adverse events, as well as glucocortioid-associated adverse events in patients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA).
In this non-interventional cohort study the following aspects should be addressed:
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's planned enrollment of 400 is above the median of 128 across 78 observational studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
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GCA and PMR patients will be recruited in the department of rheumatology of the university hospital of Würzburg
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Exclusion Criteria:
Patients, who are already known and had regular visits in the outpatient rheumatology department of the Würzburg university hospital. These patients already receive immunosuppressive therapy.
Patients who have not yet been treated by the outpatient rheumatology department of the Würzburg university hospital, preferably but not limited to immunosuppressive therapy-naive patients.
Incidence of aortic adverse events
Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection
Time frame: Within 5 years
Incidence of glucocorticoid-related adverse events
Assessment of the glucocorticoid toxicity index (GTI; excluding regular bone density measurements) to detect glucocorticoid-related adverse events. The GIT includes 1) a cumulative worsening score, which includes the cumulative glucocorticoid toxicity over time (minimum value of 0 and a maximum value of 439, a decrease is not possible) and 2) an aggregate improvement score, which allows for decreases and increases of toxicity (range from -346 to 439, with negative values indicating improvement and positive values indicating worsening of glucocorticoid toxicity)
Time frame: within 5 years
Detection of ischemic complications in the eyes
Is orbital MRI together with optic coherence tomography suitable to detect ischemic manifestations of GCA in the eye?
Time frame: within 5 years
Performance of gadopiclenol in detecting vessel wall inflammation
The contrast agent gadopiclenol should be evaluated for its use in MR angiography, i.e. if it depicts (peri) vessel wall inflammation equally to older contrast agents. In a sub-cohort of 20 % of the patients , MR angiographies will be performed with 25% reduced gadoplicenol.
Time frame: within 5 years
Plan to share: No — single center study
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Wuerzburg University Hospital