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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Major patient

Patients meeting ACR 2022 criteria for giant cell arteritis.

No opposition expressed

Disqualifiers

Patients unable to understand the protocol, under guardianship or curatorship.

Patients not affiliated to the French Social Security system.

Trial population

All patients with giant cell arteritis at disease diagnosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: patients with giant cell arteritis at diagnosis

Trial outcomes

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.

Time frame
At 12 months

Secondary outcomes

1

Relapse according to EULAR 2018 criteria

Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.

Time frame
At 6 month; at 12 month
2

Clinical parameter : Age

One Clinical parameter is defined with the dichotomised variable : age \> 50 years (YES) and age \<=50 years (NO)

Time frame
At inclusion
3

Other prognostic marker : C-Reactive Protein

Pronostic markers are defined with C-Reactive Protein (in mg/L)

Time frame
At inclusion, At 6 month, At 12 month
4

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

Time frame
At 6 month, at 12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.