Giant Cell ArteritisALERTNCT06894602
Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis
An observational study of Giant Cell Arteritis, run by University Hospital, Brest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Aug 2025to 1 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with giant cell arteritis at disease diagnosis
Who may be able to join
- Major patient
- Patients meeting ACR 2022 criteria for giant cell arteritis.
- No opposition expressed
Who cannot join
- Patients unable to understand the protocol, under guardianship or curatorship.
- Patients not affiliated to the French Social Security system.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Chu Brest
Brest, 29200
Sandrine Pr JOUSSE-JOULIN, 0298347267 ext. +33, sandrine.jousse-joulin@chu-brest.fr
Sandrine Pr JOUSSE-JOULIN
- Recruiting
Ch Quimper
Quimper, 29107
Guillaume Dr DERRIEN, 298526803 ext. +33, guillaume.derrien@ch-cornouaille.fr
Guillaume Dr DERRIEN
About this study
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.
Read the 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.
- Conditions
- Giant Cell Arteritis
- Keywords
- giant cell arteritis, Ultrasound, follow up, monitoring, OGUS score
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse according to EULAR 2018 criteria
Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
Measured: At 12 months
Secondary outcomes (22)
Relapse according to EULAR 2018 criteria
Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
Measured: 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)
Measured: At inclusion
Other prognostic marker : C-Reactive Protein
Pronostic markers are defined with C-Reactive Protein (in mg/L)
Measured: At inclusion, 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
Measured: 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
Measured: 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.
Measured: At 6 month, at 12 month
Clinical parameter : loss of vision
One Clinical parameter is defined with the sudden loss of vision (YES/NO)
Measured: 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)
Measured: At inclusion
Clinical parameter : temporal headaches
One Clinical parameter is defined with the temporal headaches (YES/NO)
Measured: At inclusion
Clinical parameter : scalp paresthesia
One Clinical parameter is defined with the scalp paresthesia (YES/NO)
Measured: 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)
Measured: 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)
Measured: At inclusion
Biological parameter : temporal artery biopsy
One biological parameter is defined with positive temporal artery biopsy (YES/NO)
Measured: At inclusion
Biological parameter : halo sign on ultrasound
One biological parameter is defined with halo sign on ultrasound (Present/Absent)
Measured: 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)
Measured: At inclusion
Biological parameter : aortitis
One biological parameter is defined with aortitis on PET scans of the thoracic or abdominal descending aorta (Present/Absent)
Measured: At inclusion
Biological parameter : Sedimentation rate
One biological parameter is defined with Sedimentation rate >= 50 mm/hour (YES/NO)
Measured: 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)
Measured: At inclusion
Other prognostic marker : hemoglobin
Pronostic markers are defined with hemoglobin (in g/dL)
Measured: At inclusion, At 6 month, At 12 month
Other prognostic marker : leukocytes
Pronostic markers are defined with leukocytes (in giga/L)
Measured: At inclusion, At 6 month, At 12 month
Other prognostic markers : platelets
Pronostic markers are defined with platelets (in giga/L)
Measured: At inclusion, At 6 month, At 12 month
Other prognostic marker : Sedimentation rate
Pronostic markers are defined with Sedimentation rate (in mm/hour)
Measured: At inclusion, At 6 month, At 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start5 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894602
- Sponsor's protocol ID
- 29BRC24.0371 - ALERT
- Acronym
- ALERT
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT06894602
- Acronym / sponsor ID
- ALERT / 29BRC24.0371 - ALERT
- Conditions
- Giant Cell Arteritis
- Keywords
- giant cell arteritis, Ultrasound, follow up, monitoring, OGUS score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with giant cell arteritis at disease diagnosis
Key inclusion criteria (3 listed)
- Major patient
- Patients meeting ACR 2022 criteria for giant cell arteritis.
- No opposition expressed
Key exclusion criteria (2 listed)
- Patients unable to understand the protocol, under guardianship or curatorship.
- Patients not affiliated to the French Social Security system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relapse according to EULAR 2018 criteria
Time frame: At 12 months
Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
22 secondary outcomes
Relapse according to EULAR 2018 criteria
Time frame: At 6 month; at 12 month
Clinical parameter : Age
Time frame: At inclusion
Other prognostic marker : C-Reactive Protein
Time frame: At inclusion, At 6 month, At 12 month
OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)
Time frame: At 6 month, at 12 month
C-Reactive Protein
Time frame: At 6 month, at 12 month
Erythrocyte Sedimentation Rate (ESR)
Time frame: At 6 month, at 12 month
Clinical parameter : loss of vision
Time frame: At inclusion
Clinical parameter : claudication of the jaw or tongue
Time frame: At inclusion
Clinical parameter : temporal headaches
Time frame: At inclusion
Clinical parameter : scalp paresthesia
Time frame: At inclusion
Clinical parameter : abnormal palpation of the temporal arteries
Time frame: At inclusion
Clinical parameter : morning stiffness of shoulders and/or neck
Time frame: At inclusion
Biological parameter : temporal artery biopsy
Time frame: At inclusion
Biological parameter : halo sign on ultrasound
Time frame: At inclusion
Biological parameter : bilateral axillary involvement
Time frame: At inclusion
Biological parameter : aortitis
Time frame: At inclusion
Biological parameter : Sedimentation rate
Time frame: At inclusion
Biological parameter : C-Reactive Protein
Time frame: At inclusion
Other prognostic marker : hemoglobin
Time frame: At inclusion, At 6 month, At 12 month
Other prognostic marker : leukocytes
Time frame: At inclusion, At 6 month, At 12 month
Other prognostic markers : platelets
Time frame: At inclusion, At 6 month, At 12 month
Other prognostic marker : Sedimentation rate
Time frame: At inclusion, At 6 month, At 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Pr JOUSSE-JOULIN (298347267 ext. +33, sandrine.jousse-joulin@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse according to EULAR 2018 criteria (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.