Status:
NOT_YET_RECRUITING
Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
University Hospital, Lille
Amiens University Hospital
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Treatment of giant cell arteritis (GCA) relies on the use of glucocorticoids (GC), with a very good clinical response at treatment initiation. However, relapses at GC tapering are frequent. GCA popula...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04012905
Start Date
November 5 2020
End Date
January 1 2027
Last Update
October 19 2020
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