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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06271018
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18 years
* Signed informed consent
* Affiliation with the French national social security system
* Adequate and effective contraceptive measures
* For women of childbearing age, a negative serum pregnancy test.
* Diagnosis of GCA according to 2022 ACR/EULAR criteria
* Active newly diagnosed or relapsing Aortitis related to GCA proved by imaging (Tep-scan, angio-CT or magnetic resonance imaging angiography)
* No neoplasia
* No contraindication to Tocilizumab
Exclusion Criteria:
* Pregnancy or breastfeeding ;
* History of severe immunosuppression, HIV or HBsAg positive
* Non response or intolerance to previous therapy with tocilizumab
* Positive QuantiFERON test result (QFT-TBGIn-Tube)
* Have received live vaccines within 3 months prior to the start of the trial
* History of malignancy in the last 5 years
* Severe renal impairment (creatinine clearance \<30mL/min/1.73m²)
* Liver dysfunction defined as aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 at the upper limit of normal
* Blood count abnormality:
* Platelet count \< 50 x 10.3/mm3
* Neutropenia \< 1000/mm3
* Hemoglobin \< 8 g/dl
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06271018
Study Brief:
Protocol Section:
NCT06271018