Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering (NCT04012905) | Clinical Trial Compass
RecruitingPhase 3
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
France150 participantsStarted 2021-03-03
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient in complete remission over a follow up of 52 weeks, without relapse