NCT07552636 Disease Activity Monitoring in Patients With Giant Cell Arteritis Study
| NCT ID | NCT07552636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Giant Cell Arteritis (GCA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 175 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 175 participants in total. It began in 2026-05-06 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07552636 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Giant Cell Arteritis (GCA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07552636 currently recruiting?
Yes, NCT07552636 is actively recruiting participants. Contact the research team at mothas@rm.dk for enrollment information.
Where is the NCT07552636 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Glostrup Municipality, Denmark, Horsens, Denmark and 3 additional locations.
Who is sponsoring the NCT07552636 clinical trial?
NCT07552636 is sponsored by University of Aarhus. The trial plans to enroll 175 participants.