Clinical Trial

Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

Study acronym: DiAcMo
Recruiting
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Summary
Giant Cell Arteritis (GCA) is a vasculitis of medium- and large-sized arteries in older adults that may lead to serious vascular complications, including permanent vision loss and aortic aneurysm formation. Glucocorticoids are effective, but relapse during tapering is common and poses a major clinical challenge, potentially contributing to prolonged glucocorticoid exposure. Symptoms are often nonspecific and conventional inflammatory markers lack sufficient reliability, particularly in patients treated with drugs targeting the interleukin-6 pathway. Thus, this project aims to evaluate different tools assisting disease activity monitoring and/or predict future relapses and higher treatment requirements. Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up. Participants undergo vascular ultrasonography, including double-blinded assessment at suspected relapse, complete patient-reported outcome measures, and provide biobank blood samples.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-16
Trial Details
NCT Number NCT07552636
Lead Sponsor University of Aarhus
Collaborators: Aarhus University Hospital, Aalborg University Hospital, Svendborg Hospital, Glostrup University Hospital, Copenhagen, Vejle Hospital, Horsens Hospital, Regionshospitalet Silkeborg
Conditions Giant Cell Arteritis (GCA)
Enrollment 175 participants
Start Date 2026-05-06
Primary Completion 2028-03 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2026-05-29