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

NCT07720804 | Not Yet Recruiting

• 1 other identifier: 87RI25_0058 (GIDEON)
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Giant Cell Arteritis (GCA)

Outcome Measures

Primary Outcomes (1)

• CRP testing

  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 year

Secondary Outcomes (1)

• Determining Corticosteroid Dosages and Estimating Their Half-Lives

  5 days

Study Arms (1)

Patient with de novo diagnosis of GCA

EXPERIMENTAL

Blood samples for CRP determination

Diagnostic Test: Blood tests to measure CRP

Interventions

Blood tests to measure CRP DIAGNOSTIC_TEST

Blood tests to measure CRP levels

Patient with de novo diagnosis of GCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Kim LY, Professor

CONTACT

05 55 05 05 05; Kim.Ly@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 22, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): June 22, 2029
• Study Completion (Estimated): June 22, 2030
• Last Updated: July 22, 2026

Record last verified: 2026-06