Clinical trial NCT06894602: Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis
Official title: Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Giant Cell Arteritis
Keywords: giant cell arteritis
Ultrasound
follow up
monitoring
OGUS score
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with giant cell arteritis at disease diagnosis

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relapse according to EULAR 2018 criteria
timeFrame: At 12 months
Secondary outcomes:
measure: Relapse according to EULAR 2018 criteria
timeFrame: At 6 month; at 12 month
measure: Clinical parameter : Age
timeFrame: At inclusion
measure: Other prognostic marker : C-Reactive Protein
timeFrame: At inclusion, At 6 month, At 12 month
measure: OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)
timeFrame: At 6 month, at 12 month
measure: C-Reactive Protein
timeFrame: At 6 month, at 12 month
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: At 6 month, at 12 month
measure: Clinical parameter : loss of vision
timeFrame: At inclusion
measure: Clinical parameter : claudication of the jaw or tongue
timeFrame: At inclusion
measure: Clinical parameter : temporal headaches
timeFrame: At inclusion
measure: Clinical parameter : scalp paresthesia
timeFrame: At inclusion
measure: Clinical parameter : abnormal palpation of the temporal arteries
timeFrame: At inclusion
measure: Clinical parameter : morning stiffness of shoulders and/or neck
timeFrame: At inclusion
measure: Biological parameter : temporal artery biopsy
timeFrame: At inclusion
measure: Biological parameter : halo sign on ultrasound
timeFrame: At inclusion
measure: Biological parameter : bilateral axillary involvement
timeFrame: At inclusion
measure: Biological parameter : aortitis
timeFrame: At inclusion
measure: Biological parameter : Sedimentation rate
timeFrame: At inclusion
measure: Biological parameter : C-Reactive Protein
timeFrame: At inclusion
measure: Other prognostic marker : hemoglobin
timeFrame: At inclusion, At 6 month, At 12 month
measure: Other prognostic marker : leukocytes
timeFrame: At inclusion, At 6 month, At 12 month
measure: Other prognostic markers : platelets
timeFrame: At inclusion, At 6 month, At 12 month
measure: Other prognostic marker : Sedimentation rate
timeFrame: At inclusion, At 6 month, At 12 month
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
city: Quimper
country: France
facility: Ch Quimper
Study officials:
References: