Actively Recruiting
Disease Activity Monitoring in Patients With Giant Cell Arteritis
Led by University of Aarhus · Updated on 2026-05-29
175
Participants Needed
7
Research Sites
48 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Giant Cell Arteritis (GCA) is a disease affecting medium- and large-sized arteries in older adults, which can lead to serious complications like permanent vision loss and aortic aneurysm. Researchers are studying tools to monitor disease activity and predict relapses in patients with GCA who are currently in remission. This project aims to improve how relapses and treatment needs are identified, especially since symptoms can be unclear and usual inflammation tests may not work well in patients treated with certain drugs. Participants will undergo vascular ultrasonography scans including a double-blinded review if relapse is suspected. They will also complete patient-reported outcome questionnaires and provide blood samples for biobank storage. The study will enroll up to 175 patients with GCA in remission and follow them for one year to assess disease activity using these methods. During the study, participants will be monitored through regular ultrasound scans and symptom questionnaires. Researchers will measure how well changes in ultrasound and patient-reported scores detect relapses and predict future disease activity. Blood samples will be collected to support these assessments. The main outcome will be the accuracy of ultrasound changes from the start of the study to suspected relapse within 10 months. The total study duration includes follow-up for 12 months to observe relapse timing and related outcomes.
CONDITIONS
Brief Title
Disease Activity Monitoring in Patients With Giant Cell Arteritis Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Giant Cell Arteritis confirmed by a rheumatologist with positive imaging or biopsy within the past 3 years
- Currently in clinical remission with no worsening symptoms for at least 8 weeks
- Normal C-reactive protein level (less than 10 mg/L) within 7 days before inclusion
- On planned tapering of glucocorticoid therapy or glucocorticoid-sparing DMARD treatment for at least 8 weeks prior
- Current prednisolone dose of 5 mg or more if on glucocorticoid monotherapy
- Age over 50 years
- Able to speak and understand Danish and complete online questionnaires
You will not qualify if you...
- Received intra-articular, intravenous, or intramuscular glucocorticoids within 7 weeks before inclusion
- Unable to complete online questionnaires and therefore not eligible for the patient-reported outcome component
- Presence of cognitive impairment, including significant dementia, that affects informed consent or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants are monitored to assess disease activity and detect possible relapses of Giant Cell Arteritis using vascular ultrasonography and patient-reported outcomes.
Regular assessments including imaging and questionnaires during the 12 months
Trial Site Locations
Total: 7 locations
1
Aalborg University Hospital, Department of Rheumatology
Aalborg, Denmark, 9000
Not Yet Recruiting
2
Aarhus University Hospital, Department of Rheumatology
Aarhus, Denmark, 8200
Not Yet Recruiting
3
Rigshospitalet Glostrup, Center for Rheumatology and Spine Diseases Rigshospitalet
Glostrup Municipality, Denmark, 2600
Not Yet Recruiting
4
Regional Hospital Horsens, Department of Medicine
Horsens, Denmark, 8700
Actively Recruiting
5
Hospitalsenhed Midt, Medicinsk Diagnostisk Center
Silkeborg, Denmark, 8600
Not Yet Recruiting
6
Svendborg Hospital, Department of Medicine
Svendborg, Denmark, 5700
Not Yet Recruiting
7
Vejle Hospital, Department of Medicine
Vejle, Denmark, 7100
Not Yet Recruiting
Research Team
M
Morten Hansen, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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