Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

Qualifiers

Clinical GCA diagnosis established/confirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis < 3 years.

Clinical remission at the time of inclusion, defined as

Having adhered for ≥ 8 weeks prior to inclusion to either (a) the planned tapering of glucocorticoid therapy, or (b) the planned glucocorticoid-sparing DMARD treatment (with or without glucocorticoids).

Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.

Disqualifiers

Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.

Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.

Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Aalborg University Hospital

Collaborator

Svendborg Hospital

Collaborator

Glostrup University Hospital, Copenhagen

Collaborator

Vejle Hospital

Collaborator

Horsens Hospital

Collaborator

Regionshospitalet Silkeborg

Collaborator