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:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT06244069
Eligibility Criteria:
Inclusion Criteria:
* Patients with suspected active GCA entering into a fast-track work-up and healthy matched controls.
* Capability of providing valid consent to study enrollment.
* Possibility of performing temporal artery biopsy within three hours from enrollment.
Exclusion Criteria:
* Active concurrent viral, fungal or bacterial infections (including active/latent tuberculosis treated for less than 4 weeks, HIV and Hepatitis B/C virus (HBV/HCV) infections.
* Concurrent systemic inflammation not attributable to GCA (inflammatory diseases in treatment-free remission are accepted).
* Use of other immunosuppressive agents in the last 3 months.
* Use of systemic steroids (any dose in the last week, \> 15 mg/die of prednisone equivalent in the last month).
* Solid or hematologic malignancies (active or with less than 6 months free of disease or antiblastic chemotherapy (hormone therapy is allowed).
* Previous solid or hematopoietic stem cell transplantation (corneal transplants are allowed).
* Any systemic immunosuppressive or steroidal therapy.
* Chronic renal failure with Glomerular Filtration Rate (GFR) \< 45 ml/min \*1.73 m2.
* Moderate-severe liver failure (Child-Pugh B or C), hepatitis in stages of activity.
* Diabetes mellitus.
* Heart failure with New York Heart Association score (NYHA) \>=2.
* Severe hypoproteinemia/malnutrition.
* Chronic respiratory failure requiring O2 therapy or ventilation therapy at home.
* Any other condition judged by the local investigator as a contra-indication to eligibility.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06244069
Study Brief:
Protocol Section:
NCT06244069