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Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

NCT07552636 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Giant Cell Arteritis (GCA)

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Svendborg Hospital

    collaborator OTHER

  • Glostrup University Hospital, Copenhagen

    collaborator OTHER

  • Vejle Hospital

    collaborator OTHER

  • Horsens Hospital

    collaborator OTHER

  • Regionshospitalet Silkeborg

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2028-03-31
Completion
2029-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552636 on ClinicalTrials.gov