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โ† Trials
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Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering

RecruitingPhase 3Ages 50 Years - anyAllUniversity Hospital, Caen
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In plain words

What the trial is, and whether it could suit you

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, bu

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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
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What it tests

  • Corticosteroids for Systemic Use
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Where

1 site
CHU de Caen Normandie
Caen, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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