Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study (GIDEON)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood tests to measure CRP.
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis (GCA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Kinetics of C-Reactive Protein in Giant Cell Arteritis Following Glucocorticoid Initiation: A Pilot Study
Overview
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 test Blood tests to measure CRP
Blood tests to measure CRP levels
Primary outcome measures
- CRP testing [Time frame: 1 year]
Secondary outcome measures (1)
- Determining Corticosteroid Dosages and Estimating Their Half-Lives [Time frame: 5 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07720804 · 87RI25_0058 (GIDEON)