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
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.
- 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