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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT02257866
Eligibility Criteria:
* INCLUSION CRITERIA:
SUBJECTS WITH VASCULITIS
* Subjects who fulfill modified versions of the 1990 American College of Rheumatology (ACR) Classification Criteria for GPA31 and PAN
* Subjects who fulfill the 1990 ACR Classification Criteria for EGPA, GCA, and TAK
* Subjects who fulfill the 2012 Chapel Hill Nomenclature definition for MPA
* Subjects with other suspected systemic or single-organ vasculitides
HEALTHY VOLUNTEERS
-Volunteers able to provide consent, or in the case of minors, assent
EXCLUSION CRITERIA:
SUBJECTS WITH VASCULITIS:
* Subjects less than 3 years of age
* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion
* Inability to provide consent, or in the case of minors, assent
* Subjects with bleeding diathesis or on anticoagulant medications (e.g. coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participation in nasal brushing or biopsy studies
HEALTHY VOLUNTEERS
* Volunteers less than 3 years of age
* Diagnosis of vasculitis or other autoimmune/autoinflamamtory disease, including systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, mixed connective tissue disease or any overlap autoimmune syndrome
* Active malignancy, infection, or any medical condition that in the opinion of the investigator would warrant exclusion
* Pregnant (by history of last menstrual period) or breast feeding subjects
* Subjects with bleeding diathesis or taking anticoagulant medications (eg coumadin, heparin, clopidogrel but not including aspirin or NSAIDs) are excluded from participating in nasal brushing studies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT02257866
Study Brief:
Protocol Section:
NCT02257866