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

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.

Study Overview

• Status: Recruiting
• Conditions: Giant Cell Arteritis
• Intervention / Treatment: Other: clinical examination; Other: biological examination; Other: ultrasound examination

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sandrine Pr JOUSSE-JOULIN; Phone Number: +33 298347267; Email: sandrine.jousse-joulin@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • CHU Brest
    • Contact: Sandrine Pr JOUSSE-JOULIN; Phone Number: +33 0298347267; Email: sandrine.jousse-joulin@chu-brest.fr
    • Principal Investigator: Sandrine Pr JOUSSE-JOULIN
  • Quimper, France, 29107
    • Recruiting
    • CH Quimper
    • Contact: Guillaume Dr DERRIEN; Phone Number: +33 298526803; Email: guillaume.derrien@ch-cornouaille.fr
    • Principal Investigator: Guillaume Dr DERRIEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with giant cell arteritis at disease diagnosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with giant cell arteritis at diagnosis; patients routinely monitored for their disease, and who typically benefit from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these are "general population" patients with suspected giant cell arteritis.	Other: clinical examination; examination performed as part of routine care; Other: biological examination; examination performed as part of routine care; Other: ultrasound examination; examination performed as part of routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse according to EULAR 2018 criteria	Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse according to EULAR 2018 criteria	Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.	At 6 month; at 12 month
OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)	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	At 6 month, at 12 month
C-Reactive Protein	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	At 6 month, at 12 month
Erythrocyte Sedimentation Rate (ESR)	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.	At 6 month, at 12 month
Clinical parameter : Age	One Clinical parameter is defined with the dichotomised variable : age > 50 years (YES) and age <=50 years (NO)	At inclusion
Other prognostic marker : C-Reactive Protein	Pronostic markers are defined with C-Reactive Protein (in mg/L)	At inclusion, At 6 month, At 12 month
Clinical parameter : loss of vision	One Clinical parameter is defined with the sudden loss of vision (YES/NO)	At inclusion
Clinical parameter : claudication of the jaw or tongue	One Clinical parameter is defined with the claudication of the jaw or tongue (YES/NO)	At inclusion
Clinical parameter : temporal headaches	One Clinical parameter is defined with the temporal headaches (YES/NO)	At inclusion
Clinical parameter : scalp paresthesia	One Clinical parameter is defined with the scalp paresthesia (YES/NO)	At inclusion
Clinical parameter : abnormal palpation of the temporal arteries	One Clinical parameter is defined with the abnormal palpation of the temporal arteries (YES/NO)	At inclusion
Clinical parameter : morning stiffness of shoulders and/or neck	One Clinical parameter is defined with morning stiffness of shoulders and/or neck (YES/NO)	At inclusion
Biological parameter : temporal artery biopsy	One biological parameter is defined with positive temporal artery biopsy (YES/NO)	At inclusion
Biological parameter : halo sign on ultrasound	One biological parameter is defined with halo sign on ultrasound (Present/Absent)	At inclusion
Biological parameter : bilateral axillary involvement	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)	At inclusion
Biological parameter : aortitis	One biological parameter is defined with aortitis on PET scans of the thoracic or abdominal descending aorta (Present/Absent)	At inclusion
Biological parameter : Sedimentation rate	One biological parameter is defined with Sedimentation rate >= 50 mm/hour (YES/NO)	At inclusion
Biological parameter : C-Reactive Protein	One biological parameter is defined with C-Reactive Protein >= 10 mg/L at the first hour (YES/NO)	At inclusion
Other prognostic marker : hemoglobin	Pronostic markers are defined with hemoglobin (in g/dL)	At inclusion, At 6 month, At 12 month
Other prognostic marker : leukocytes	Pronostic markers are defined with leukocytes (in giga/L)	At inclusion, At 6 month, At 12 month
Other prognostic markers : platelets	Pronostic markers are defined with platelets (in giga/L)	At inclusion, At 6 month, At 12 month
Other prognostic marker : Sedimentation rate	Pronostic markers are defined with Sedimentation rate (in mm/hour)	At inclusion, At 6 month, At 12 month

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; follow up; monitoring; giant cell arteritis; OGUS score
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Vasculitis, Central Nervous System; Arteritis; Skin and Connective Tissue Diseases; Giant Cell Arteritis
• Other Study ID Numbers: 29BRC24.0371 - ALERT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No