Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04012905
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04012905
Study Brief:
Protocol Section:
NCT04012905