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

NCT ID: NCT06894602

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Giant Cell Arteritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu Brest

Brest, , France

Site Status

Ch Quimper

Quimper, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sandrine Pr JOUSSE-JOULIN

Role: CONTACT

298347267 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sandrine Pr JOUSSE-JOULIN

Role: primary

0298347267 ext. +33

Guillaume Dr DERRIEN

Role: primary

298526803 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29BRC24.0371 - ALERT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Biomarkers in Giant Cells Arteritis
NCT02844023 TERMINATED NA
Ustekinumab for the Treatment of Giant Cell Arteritis
NCT02955147 TERMINATED PHASE1/PHASE2
Bosentan in the Treatment of Giant Cell Arteritis
NCT06957002 NOT_YET_RECRUITING PHASE2