Giant Cell Arteritis Clinical Trial
Official title:
Prospective Study for the Follow-up of Aortic Diameter in Patients With Arteritis Temporalis / Giant Cell Arteritis.
Giant cell arteritis (GCA) is the most frequent vasculitis in patients above 50 years of age. The disease has limited mortality, mostly due to the development of aortic aneurysms, leading to dissection and rupture. The probability to develop this complication is 17 x higher at the level of the thoracic aorta and 2,4 x at the level of the abdominal aorta in patients with GCA when compared with a control group. Therefore, follow-up of the aortic diameter in patients with GCA is part of good clinical practice. Previous retrospective research showed a link between FDG-uptake at the level of the thoracic aorta, on positron-emission-tomography (PET) at the time of diagnosis, and the increase of diameter and volume of the thoracic aorta during follow-up (on computed tomography (CT)). The purpose of this prospective study is to follow-up on the aortic diameter, and to correlate these measures with FDG-PET uptake at diagnosis. Ideally, this would allow us to define a group of patients at high risk to develop an aortic aneurysm, already at the time of diagnosis.
As standard care, all patients with a suspicion of GCA undergo a biopsy of the temporal artery and a PET scintigraphy to evaluate the presence of large vessel vasculitis. Patients with proven GCA on biopsy and/or scintigraphy undergo a computed tomography (CT) of the aorta without the administration of contrast, at diagnosis and yearly thereafter (every 12 +/- 3 months) for 10 years. Measurements include the diameter of the ascending aorta, aortic arch, descending aorta, suprarenal, juxtarenal and infrarenal aorta, and the volume of the thoracic and the abdominal aorta. These measurements are correlated with FDG-uptake at the level of the aorta on PET-scintigraphy at the time of diagnosis. All patients will be treated according to accepted guidelines and standard care in our center (methylprednisolone started at 32 mg/day, with slowly declining doses until stop after 1 to 1,5 years of treatment). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03812302 -
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
|
Phase 2 | |
Recruiting |
NCT02257866 -
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
|
||
Recruiting |
NCT04888221 -
Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement
|
Phase 3 | |
Recruiting |
NCT05380453 -
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
|
Phase 3 | |
Recruiting |
NCT02333708 -
Study of Circulating Microparticles in Giant Cell Arteritis
|
||
Completed |
NCT01450137 -
Tocilizumab for Patients With Giant Cell Arteritis
|
Phase 2 | |
Completed |
NCT03827018 -
KPL-301 for Subjects With Giant Cell Arteritis
|
Phase 2 | |
Active, not recruiting |
NCT04519580 -
Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
|
||
Recruiting |
NCT04239196 -
Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA
|
Phase 2 | |
Recruiting |
NCT06460142 -
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
|
||
Completed |
NCT03202368 -
An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)
|
Phase 3 | |
Not yet recruiting |
NCT02523625 -
Giant Cell Arteritis: Improving Use of Ultrasound Evaluation
|
N/A | |
Completed |
NCT03285945 -
FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment
|
N/A | |
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
Terminated |
NCT02531633 -
Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis
|
Phase 3 | |
Completed |
NCT03765424 -
Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
|
||
Completed |
NCT03409913 -
Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA
|
N/A | |
Completed |
NCT01910038 -
Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.
|
Phase 2 | |
Not yet recruiting |
NCT04012905 -
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
|
Phase 3 |