Giant Cell Arteritis - Ways to Precision Medicine

Not yet recruiting

• Conditions: Giant Cell Arteritis; Polymyalgia Rheumatic (PMR)

• Registration Number: NCT07084480
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

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).

Detailed Description

In this non-interventional cohort study the following aspects should be addressed:

* Can regular imaging procedures help to better assess the risk of aortic aneurysms and dissections over a period of 5-10 years after initial diagnosis of GCA?

* Which prognostic factors correlate with aortic events?

* What conclusions can be drawn about glucocorticoid-associated side effects over the longer (5-year) course?

* Can modern imaging in correlation with standardized clinical examination, serological markers and immunophenotypic testing define patient clusters within the clinically heterogeneous disease spectrum of GCA and PMR with the aim of individualizing therapy?

* What is the value of orbital MRI together with an ophthalmologic examination including fudoscopy and optical coherence tomography (OCT) in the detection of ischemic manifestations of GCA?

* Can a contrast agent-saving MRI technique (with 25 % less contrast agent) be used in GCA without impairing signal quality?

* Can rare lymphocyte populations be found by immunophenotyping, which provide information on the probability of recurrence or allow therapy control?

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-16
• Study First Posted: 2025-07-24
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-29
• Study Start: 2025-08-01
• Primary Completion: 2030-07-31
• Study Completion: 2033-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Age greater or similar to 18 years
• Primary diagnosis of GCA or PMR

Exclusion Criteria

• Age under 18 years
• lack of capacity to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of aortic adverse events	Within 5 years	Aortic adverse events include new foramation or progress of aortic aneurysms, and aortic dissection

Secondary Outcome Measures

Name	Time	Method
Incidence of glucocorticoid-related adverse events	within 5 years	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)
Detection of ischemic complications in the eyes	within 5 years	Is orbital MRI together with optic coherence tomography suitable to detect ischemic manifestations of GCA in the eye?
Performance of gadopiclenol in detecting vessel wall inflammation	within 5 years	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.