Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering

Launched by UNIVERSITY HOSPITAL, CAEN · Jul 8, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the best way to taper off corticosteroids for patients with Giant Cell Arteritis (GCA), a condition that causes inflammation of blood vessels and mainly affects older adults. The researchers want to compare two different approaches: a standard treatment plan that is commonly used in Europe and a lighter, shorter treatment plan inspired by recent studies in North America. The goal is to find out if the lighter regimen can reduce the risk of relapses (return of symptoms) while also minimizing side effects from the medication.

To participate in this trial, individuals must be at least 50 years old and have a confirmed diagnosis of GCA. They should have started corticosteroid treatment within the last two weeks at a specific dose. Participants will be randomly assigned to one of the two treatment plans and will be monitored over a year to see how well the treatments work and what side effects occur. This study aims to include 150 patients over three years. If you're considering participating, it’s important to know that there are specific criteria that could exclude you, such as having had prior treatment with higher doses of corticosteroids or certain health conditions.

Gender

ALL

Eligibility criteria

• 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