Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering

NCT04012905 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Caen

Phase

Phase 3

Started

2021-03-03

Last updated

2026-06-26

Condition(s) studied

Giant Cell Arteritis

Investigational drug(s) / intervention(s)

Corticosteroids for Systemic Use

Corticosteroids for Systemic Use: Corticosteroids tapering over 28 weeks: J0 = 0,7 mg/kg S2 = 0,6 mg/kg S4 = 0,5 mg/kg S6 = 0,4 mg/kg S8 = 0,3 mg/kg S10 = 0,25 mg/kg S12 = 0,2 mg/kg S14 = 0,15 mg/kg S16 = 0,15 mg/kg S20 = 0,1 mg/kg S24 = 0,05 mg/kg S28 = 0 mg/kg Corticosteroids tapering over 52 weeks: J0 = 0,7 mg/kg S2 = 0,6 mg/kg S4 = 0,6 mg/kg S6 = 0,5 mg/kg S8 = 0,4 mg/kg S10 = 0,3 mg/kg S12 = 0,25 mg/kg S14 = 0,2 mg/kg S16 = 0,175 mg/kg S20 = 0,15 mg/kg S24 = 0,125 mg/kg S28 = 0,01 mg/kg S32 to S52: - 1mg per month

Study summary

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

Sex

ALL

Min age

50 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 50 years * Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American College of Rheumatology (ACR) that given : * 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 * Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal to 1 mg / Kg * Patient wo has given its written consent Patient affiliated with a social security Exclusion Criteria: Subjects checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include: * 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 * No compliant patient * Patients who live more than 150 km from the investigation center * Person under judicial protection, guardianship * Hypersensitivity to prednisone or any of its excipients * Infection requiring an systemic treatment * Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus) * Immunization with live vaccines / mitigated during the 8 weeks preceding inclusion * Pregnancy, breastfeeding women or women of childbearing potential not using contraception

Primary outcome measure(s)

Patient in complete remission over a follow up of 52 weeks, without relapse — Baseline up to 52 weeks

Trial sites (1)

Facility	City	Region	Status
CHU de Caen Normandie	Caen	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04012905 on ClinicalTrials.gov ↗ ← All trials in France