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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 or older hospitalized in the internal medicine department with a new diagnosis of ACG

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Free and informed consent signed by the participant and the investigator

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood tests to measure CRP

    Diagnostic test

    Blood tests to measure CRP levels

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patient with de novo diagnosis of GCAExperimental treatment 1 intervention

Trial outcomes

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

Time frame
1 year

Secondary outcomes

1

Determining Corticosteroid Dosages and Estimating Their Half-Lives

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

Time frame
5 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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