Status:
COMPLETED
FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment
Lead Sponsor:
University of Aarhus
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Brief Summary
Giant cell arteritis (GCA) affects large and medium sized vessels. Large vessel-GCA (LV-GCA) affecting aorta and/or its main branches is seen a) together with temporal arteritis (AT-GCA), b) as isolat...
Detailed Description
As standard of care, patients suspected of GCA undergo clinical examination, laboratory screening, temporal artery biopsy, vascular ultrasound examination and FDG PET/CT. All patients with a diagnosi...
Eligibility Criteria
Inclusion
- Clinical suspicion of GCA; Cranial symptoms, new-onset extremity claudication or protracted constitutional symptoms (weight loss \> 5 kilograms or fever \>38C for \> 3 weeks).
- C reactive protein \>15 mg/l or erythrocyte sedimentation rate \>40 mm/h
- FDG PET/CT verified LV-GCA (steroid-naive) defined by FDG uptake in the aortic wall and/or supra-aortic branches with FDG uptake score ≥3.
Exclusion
- oral glucocorticoid treatment within the past month
- subcutaneously, intramuscularly, intraarticularly or intravenously administered glucocorticoid within the past 2 months
- treatment with DMARDs or other immunosuppressive therapy ongoing or within the past 3 months
- ongoing treatment with interleukin2
- any disease mimicking GCA, including
- a) autoimmune diseases with possible aortitis; rheumatoid arthritis, Cogans syndrome, relapsing polychondritis, ankylosing spondylitis, systemic lupus erythematosus, Buerger's disease, Bechet's disease, inflammatory bowel disease
- b) infections with possible aortitis: syphilis, known active current or history of recurrent tuberculosis, hepatitis or HIV
- c) other large-vessel disease: sarcoidosis, neurofibromatosis, congenital coarctation, Marfans syndrome, Ehlers-Danlos syndrome, retroperitoneal fibrosis
- body weight of \>150 kg.
- Previously diagnosed and treated for PMR or GCA
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03285945
Start Date
October 1 2014
End Date
September 1 2016
Last Update
September 18 2017
Active Locations (1)
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1
Department of Rheumatology
Aarhus, Denmark, 8000