Giant Cell Arteritis (GCA)GIDEONNCT07720804
Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study (GIDEON)
A study testing Blood tests to measure CRP in people with Giant Cell Arteritis (GCA), run by University Hospital, Limoges.
Trial summary
We propose to analyze the kinetics of the main marker of inflammation in GCA in order to understand its links with initial clinical manifestations and the possible appearance of complications and/or relapses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- What is being tested?
- Blood tests to measure CRP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 22 Jun 2030
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients aged 18 or older hospitalized in the internal medicine department with a new diagnosis of ACG
- Personne affiliée ou bénéficiaire d'un régime de sécurité sociale
- Free and informed consent signed by the participant and the investigator
Who cannot join
- Patients scheduled to be placed on a sparing regimen during hospitalization
- Patients with renal insufficiency (eGFR ≤ 60 mL/min/1.73 m²)
- Patients with a history of corticosteroid-treated pseudopolyarthritis
- Patients with ACG and visual impairment (severity criterion)
- Patients on immunosuppressants or biologic therapy
- HIV infection or progressive malignancy
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- Known poor treatment adherence
- Dementia
- Pregnant or breastfeeding women
- Patients under legal guardianship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study
We propose to analyze the kinetics of the main marker of inflammation in GCA in order to understand its links with initial clinical manifestations and the possible appearance of complications and/or relapses.
Early assessment of the rate of CRP normalization would enable us to adapt the therapeutic strategy in order to avoid complications and/or relapses.
Read the detailed description
Giant cell arteritis (GCA) is a chronic systemic vasculitis of the large vessels characterized by a significant inflammatory syndrome, correlated with disease activity and various inflammatory biomarkers, including CRP, which more effectively reflects disease activity.
Relapses remain frequent, with rates of up to 45.7%. Recommended treatments involve long-term corticosteroid therapy and/or sparing therapies, which are associated with adverse events.
Identifying relapsing patients is therefore crucial, in order to best adapt initial treatment and patient follow-up.
We therefore propose to study CRP kinetics at diagnosis and at initiation of corticosteroid therapy, to determine the link with disease progression.
- Conditions
- Giant Cell Arteritis (GCA)
- Being tested
- Blood tests to measure CRP
- 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.
Blood tests to measure CRPDiagnostic test
Blood tests to measure CRP levels
| Study group | Role | What they receive |
|---|---|---|
| Patient with de novo diagnosis of GCA | Experimental | Blood samples for CRP determination Receives: Diagnostic Test: Blood tests to measure CRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP testing
- Immediately before starting corticosteroids
- Every day immediately before taking the morning dose of corticosteroids, for 5 days, and up to 7 days if levels do not return to normal
- Then once a week for up to 1 month after starting corticosteroids
- Then monthly for 8 months during follow-up visits
- Then every 2 months for up to 1 year
Measured: 1 year
Secondary outcomes (1)
Determining Corticosteroid Dosages and Estimating Their Half-Lives
Corticosteroid Dosage: Take daily, just before your morning dose of corticosteroids
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start22 Jun 2026 (estimated)
- Primary completion22 Jun 2029 (estimated)
- Study completion22 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720804
- Sponsor's protocol ID
- 87RI25_0058 (GIDEON)
- Acronym
- GIDEON
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study
- ClinicalTrials.gov ID
- NCT07720804
- Acronym / sponsor ID
- GIDEON / 87RI25_0058 (GIDEON)
- Conditions
- Giant Cell Arteritis (GCA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 22 Jun 2029 (estimated)
- Study completion
- 22 Jun 2030 (estimated)
- First posted
- 22 Jul 2026 (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.
We propose to analyze the kinetics of the main marker of inflammation in GCA in order to understand its links with initial clinical manifestations and the possible appearance of complications and/or relapses.
Early assessment of the rate of CRP normalization would enable us to adapt the therapeutic strategy in order to avoid complications and/or relapses.
Detailed description
Giant cell arteritis (GCA) is a chronic systemic vasculitis of the large vessels characterized by a significant inflammatory syndrome, correlated with disease activity and various inflammatory biomarkers, including CRP, which more effectively reflects disease activity.
Relapses remain frequent, with rates of up to 45.7%. Recommended treatments involve long-term corticosteroid therapy and/or sparing therapies, which are associated with adverse events.
Identifying relapsing patients is therefore crucial, in order to best adapt initial treatment and patient follow-up.
We therefore propose to study CRP kinetics at diagnosis and at initiation of corticosteroid therapy, to determine the link with disease progression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with de novo diagnosis of GCA | Experimental | Diagnostic Test: Blood tests to measure CRPBlood samples for CRP determination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 or older hospitalized in the internal medicine department with a new diagnosis of ACG
- Personne affiliée ou bénéficiaire d'un régime de sécurité sociale
- Free and informed consent signed by the participant and the investigator
Key exclusion criteria (10 listed)
- Patients scheduled to be placed on a sparing regimen during hospitalization
- Patients with renal insufficiency (eGFR ≤ 60 mL/min/1.73 m²)
- Patients with a history of corticosteroid-treated pseudopolyarthritis
- Patients with ACG and visual impairment (severity criterion)
- Patients on immunosuppressants or biologic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood tests to measure CRPBlood tests to measure CRP levels | Diagnostic test | Patient with de novo diagnosis of GCA |
Primary outcome
CRP testing
Time frame: 1 year
1. Immediately before starting corticosteroids 2. Every day immediately before taking the morning dose of corticosteroids, for 5 days, and up to 7 days if levels do not return to normal 3. Then once a week for up to 1 month after starting corticosteroids 4. Then monthly for 8 months during follow-up visits 5. Then every 2 months for up to 1 year
1 secondary outcome
Determining Corticosteroid Dosages and Estimating Their Half-Lives
Time frame: 5 days
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 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood tests to measure CRP in people with Giant Cell Arteritis (GCA), run by University Hospital, Limoges.
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 10 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kim LY, Professor (05 55 05 05 05, Kim.Ly@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP testing (time frame: 1 year). 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 22 Jul 2026.