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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT00315393
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA and MPA.
* For diagnosis of GPA, meets at least 2 of the following 5 modified American College of Rheumatology (ACR) criteria:
1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
3. Urinary sediment with microhematuria or red cell casts
4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy
5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA
* For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:
1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)
2. Necrotizing arteritis involving small- and medium-sized arteries may be present
3. Necrotizing glomerulonephritis is very common
4. Pulmonary capillaritis often occurs
* Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria:
* Simultaneous diagnoses of both GPA and MPA
* Granulomatosis with polyangiitis (Churg-Strauss)
* Takayasu's arteritis
* Giant cell arteritis
* Polyarteritis nodosa
* Cogan's syndrome
* Behcet's disease
* Sarcoidosis
* Kawasaki disease
* Tuberculosis or any atypical mycobacterial infections
* Deep fungal infections
* Lymphoma, lymphomatoid granulomatosis, or any other type of cancer that mimics anti-neutrophil cytoplasmic antibody-associated vasculitis (AAVs)
* Cryoglobulinemic vasculitis
* Systemic lupus erythematosus
* Rheumatoid arthritis
* Mixed connective tissue disease or any overlapping autoimmune syndrome
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00315393
Study Brief:
Protocol Section:
NCT00315393