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 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT01598857
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older (male or female).
2. Granulomatosis with polyangiitis (GPA, or Wegener's granulomatosis) or microscopic polyangiitis (MPA) according to the definitions of the American College of Rheumatology and Chapel Hill Consensus Conference.
3. Active GPA or MPA disease at screening.
4. Positive for either PR3-ANCA or MPO-ANCA at screening.
5. Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline.
6. Clinical intention to prescribe MTX therapy for treatment of GPA or MPA.
Exclusion Criteria:
1. Diagnosed with Churg Strauss syndrome.
2. Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide.
3. Nursing or pregnant.
4. Active systemic infection or deep-space infection.
5. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
6. Liver disease.
7. History of documented anti-glomerular basement membrane (GBM) disease.
8. Malignancy within the past 5 years.
9. History of active tuberculosis (TB) or history of TB infection.
10. Anemia, neutropenia, or thrombocytopenia.
11. Serum creatinine level greater than 2.5 mg/dL.
12. Prior administration of a B-cell modulating therapy other than rituximab.
13. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study.
14. History of congenital immunodeficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01598857
Study Brief:
Protocol Section:
NCT01598857