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 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT04973033
Eligibility Criteria:
Inclusion Criteria:
* Patients with active AAV met the criteria of 1990 ACR and 2012 Chapel Hill criteria
* Age 18 to 75 years
* Written informed consent obtained before taking part in the study
Exclusion Criteria:
* Severe AAV defined as potentially organ- or life-threatening disease (i.e. alveolar haemorrhage, heart failure caused by myocarditis or pericarditis, progressive neurological symptoms, deaf, blindness, et al.)
* Serum creatinine\>120umol/L or proteinuria\>1.0g/d
* Receipt of a JAKi therapy previously
* Co-existence of another systemic autoimmune disease
* Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs)
* Malignancy or history of malignancy
* Infection by HIV, HCV, HBV or tuberculosis-
* Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis
* Allergic to JAKi
* Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.5 x 109/L; Platelet count \<100 x 109/L; Alanine transaminase or aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; Estimated glomerular filtration rate\<60ml/min/1.73m2
* Incapacity or refusal to understand or sign the informed consent form.
* Pregnancy, breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04973033
Study Brief:
Protocol Section:
NCT04973033