Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

Disease Activity Monitoring in Patients With Giant Cell Arteritis

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.

Inclusion Criteria:

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

2. 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.
   • Normal CRP level (< 10 mg/L) within 7 days before inclusion.

3. Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.

4. A continuous tapering of monotherapy or combination therapy is planned.

5. Age > 50 years.

6. Study participants must be able to speak and understand spoken and written Danish.

Exclusion Criteria:

1. Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.
2. Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.
3. Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.