Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis

Not yet recruiting

• Conditions: Giant Cell Arteritis

• Registration Number: NCT06894602
• Lead Sponsor: University Hospital, Brest

Brief Summary

Ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (GCA), a disease primarily affecting medium- and large-caliber vessels. Structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. There is currently a follow-up score (the OGUS score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.

Detailed Description

Prospective bicentric longitudinal study evaluating the association between ultrasound lesions and clinico-biological relapse in patients with giant cell arteritis.

This is a non-interventional study with patients routinely followed for their pathology and classically benefiting from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these will be "general population" patients with suspected giant cell arteritis.

The center will enroll 100 patients. The study will take place over 3 visits, including a clinical, biological and ultrasound examination. Ultrasound will not be blinded to the clinic, so we will only need one examiner in the center.

This is a study in routine care, with no additional costs and no expected constraints. The ultrasound examination will be performed as part of their routine follow-up.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Study Start: 2025-05-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Major patient
• Patients meeting ACR 2022 criteria for giant cell arteritis.
• No opposition expressed

Exclusion Criteria

• Patients unable to understand the protocol, under guardianship or curatorship.
• Patients not affiliated to the French Social Security system.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse according to EULAR 2018 criteria	At 12 months	Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.

Secondary Outcome Measures

Name	Time	Method
OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)	At 6 month, at 12 month	It is a score for ultrasound monitoring of temporal arteries by measuring the intima media complex of 8 vascular sites (common temporal trunk, frontal and parietal branches, axillary arteries). If OGUS score is \>= 1, the criteria is YES, if OGUS score \< 1, the criteria is NO
C-Reactive Protein	At 6 month, at 12 month	It is a biological marker expressed in mg/L. If CRP \>=10 mg/L, the criteria is YES. If CRF \< 10 mg/L, the criteria is NO
Erythrocyte Sedimentation Rate (ESR)	At 6 month, at 12 month	It is a blood test that can show the inflammation in the body, in mm/hour. If ESR \>= 15 mm/h, the criteria is YES. If ESR \< 15 mm/h, the criteria is NO.
Clinical parameter : loss of vision	At inclusion	One Clinical parameter is defined with the sudden loss of vision (YES/NO)
Clinical parameter : claudication of the jaw or tongue	At inclusion	One Clinical parameter is defined with the claudication of the jaw or tongue (YES/NO)
Clinical parameter : temporal headaches	At inclusion	One Clinical parameter is defined with the temporal headaches (YES/NO)
Biological parameter : bilateral axillary involvement	At inclusion	One biological parameter is defined with bilateral axillary involvement (occlusion or stenosis visualized on ultrasound or CT angio or PET scan or MRI)(Present/Absent)
Biological parameter : aortitis	At inclusion	One biological parameter is defined with aortitis on PET scans of the thoracic or abdominal descending aorta (Present/Absent)
Relapse according to EULAR 2018 criteria	At 6 month; at 12 month	Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
Clinical parameter : Age	At inclusion	One Clinical parameter is defined with the dichotomised variable : age \> 50 years (YES) and age \<=50 years (NO)
Other prognostic marker : C-Reactive Protein	At inclusion, At 6 month, At 12 month	Pronostic markers are defined with C-Reactive Protein (in mg/L)
Clinical parameter : scalp paresthesia	At inclusion	One Clinical parameter is defined with the scalp paresthesia (YES/NO)
Clinical parameter : abnormal palpation of the temporal arteries	At inclusion	One Clinical parameter is defined with the abnormal palpation of the temporal arteries (YES/NO)
Clinical parameter : morning stiffness of shoulders and/or neck	At inclusion	One Clinical parameter is defined with morning stiffness of shoulders and/or neck (YES/NO)
Biological parameter : temporal artery biopsy	At inclusion	One biological parameter is defined with positive temporal artery biopsy (YES/NO)
Biological parameter : halo sign on ultrasound	At inclusion	One biological parameter is defined with halo sign on ultrasound (Present/Absent)
Biological parameter : Sedimentation rate	At inclusion	One biological parameter is defined with Sedimentation rate \>= 50 mm/hour (YES/NO)
Biological parameter : C-Reactive Protein	At inclusion	One biological parameter is defined with C-Reactive Protein \>= 10 mg/L at the first hour (YES/NO)
Other prognostic marker : hemoglobin	At inclusion, At 6 month, At 12 month	Pronostic markers are defined with hemoglobin (in g/dL)
Other prognostic marker : leukocytes	At inclusion, At 6 month, At 12 month	Pronostic markers are defined with leukocytes (in giga/L)
Other prognostic markers : platelets	At inclusion, At 6 month, At 12 month	Pronostic markers are defined with platelets (in giga/L)
Other prognostic marker : Sedimentation rate	At inclusion, At 6 month, At 12 month	Pronostic markers are defined with Sedimentation rate (in mm/hour)

Trial Locations

Locations (2)

Chu Brest; 🇫🇷 Brest, France

Ch Quimper; 🇫🇷 Quimper, France