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Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering

Study acronym: CORTODOSE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Nov 2023 to May 3, 2028
    • Start date changed from estimate of Nov 5, 2020 to Mar 3, 2021
    • Study sites: 0 to 1
    • Study completion date: Jan 2027 to May 3, 2029
  2. Minor Study description revisedv3
  3. Notable Start date: Sep 2019 to Nov 5, 2020
    • Primary completion date: Dec 2023 to Nov 2023
    • Study description expanded, about 248 words
    • Study title shortened, about 14 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Corticosteroid therapy has always been the standard treatment for giant cell arteritis (GCA), with very good initial clinical efficacy but a high relapse rate when it declines. The target population of this condition, often elderly, is particularly exposed to the numerous undesirable effects of corticosteroid therapy, and this especially as its duration lengthens with the re-increases of doses according to relapses: metabolic complications, osteo-muscular , infectious or neuropsychiatric. Investigators propose to compare prospectively the results of a "conventional" corticosteroid regimen as recommended by European societies, to those of a "lighter and / or shorter" scheme, inspired by recent North American trials. , including the largest prospective global study in the field. Investigators hypothesize non-inferiority of the lightened regimen for relapse rate without relapse at S52, but with a decrease in treatment-related adverse events whose cumulative doses should be lower. Investigators therefore plan to include prospectively over 3 years 150 patients, 75 for each of the two arms, with a newly diagnosed ACG. A randomization of the treatment arm will be performed and a predefined pattern of cortisone adapted to body weight will be given to the patient. Relapse rates, maintenance of remission, cumulative doses of cortisone and adverse effects of treatment will be analyzed at the 52nd week of the introduction of corticosteroid therapy. An interim analysis is planned at S28.
Trial Details
NCT Number NCT04012905
Lead Sponsor University Hospital, Caen
Collaborators: University Hospital, Lille, Amiens University Hospital, University Hospital, Rouen, University Hospital, Limoges, Central Hospital Saint Quentin, Central Hospital, Valenciennes, Central Hospital, Lisieux
Conditions
(from sponsor)
Giant Cell Arteritis
Related terms Giant Cell Arteritis, Recurrence
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov