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NCT Number: NCT07720804

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood tests to measure CRP

Diagnostic Test

Blood tests to measure CRP levels

Primary outcomes

  1. CRP testing

    Time frame: 1 year

    • 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

Secondary outcomes

  1. Determining Corticosteroid Dosages and Estimating Their Half-Lives

    Time frame: 5 days

    Corticosteroid Dosage: Take daily, just before your morning dose of corticosteroids

Study contacts

Contact information is provided by the study sponsor or research team.

Kim LY, Professor

CONTACT

[email protected]

05 55 05 05 05

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: GIDEON

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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