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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Giant Cell Arteritis (GCA)
• Intervention / Treatment: Diagnostic test: Blood tests to measure CRP

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim LY, Professor; Phone Number: 05 55 05 05 05; Email: Kim.Ly@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with de novo diagnosis of GCA; Blood samples for CRP determination	Diagnostic test: Blood tests to measure CRP; Blood tests to measure CRP levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining Corticosteroid Dosages and Estimating Their Half-Lives	Corticosteroid Dosage: Take daily, just before your morning dose of corticosteroids	5 days

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): June 22, 2029
• Study Completion (Estimated): June 22, 2030

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Skin Diseases; Skin Diseases, Vascular; Vasculitis; Vasculitis, Central Nervous System; Arteritis; Skin and Connective Tissue Diseases; Giant Cell Arteritis
• Other Study ID Numbers: 87RI25_0058 (GIDEON)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No