Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Caen

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 50 years

a temporal artery biopsy compatible with a diagnosis of CAG or

an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET scanner or

Echo Doppler compatible with a diagnosis of CAG

Disqualifiers

Early treatment of CAG disease with a dose> 1 mg / kg whatever the duration

Corticosteroids already started over 14 days

Giant arteritis cell on relapse

dementia syndrome

Trial design

Treatments tested in this trial

  • Corticosteroids for Systemic Use

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Caen

Lead sponsor

University Hospital, Lille

Collaborator

Amiens University Hospital

Collaborator

University Hospital, Rouen

Collaborator

University Hospital, Limoges

Collaborator

Central Hospital Saint Quentin

Collaborator

Central Hospital, Valenciennes

Collaborator

Central Hospital, Lisieux

Collaborator