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

NCT06894602 | Recruiting

• 1 other identifier: 29BRC24.0371 - ALERT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Giant Cell Arteritis

Keywords

giant cell arteritis; Ultrasound; follow up; monitoring; OGUS score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Relapse according to EULAR 2018 criteria

  At 6 month; at 12 month

• Clinical parameter : Age

  At inclusion

• Other prognostic marker : C-Reactive Protein

  At inclusion, At 6 month, At 12 month

• OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)

  At 6 month, at 12 month

• C-Reactive Protein

  At 6 month, at 12 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with giant cell arteritis at disease diagnosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Chu Brest

Brest, 29200, France

RECRUITING

Ch Quimper

Quimper, 29107, France

RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Sandrine Pr JOUSSE-JOULIN

CONTACT

298347267; sandrine.jousse-joulin@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• 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.

Locations

FR (2)