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Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study (GIDEON)

Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07720804
Acronym
GIDEON
Enrollment
40
Registered
2026-07-22
Start date
2026-06-22
Completion date
2030-06-22
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis (GCA)

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTBlood tests to measure CRP

Blood tests to measure CRP levels

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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 * Known poor treatment adherence * Dementia * Pregnant or breastfeeding women * Patients under legal guardianship

Design outcomes

Primary

MeasureTime frameDescription
CRP testing1 year1. 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

Secondary

MeasureTime frameDescription
Determining Corticosteroid Dosages and Estimating Their Half-Lives5 daysCorticosteroid Dosage: Take daily, just before your morning dose of corticosteroids

Contacts

CONTACTKim LY, Professor
Kim.Ly@chu-limoges.fr05 55 05 05 05

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026