Table 2: Major Inclusion and Exclusion Criteria for Enrollment in RAVE

Inclusion Exclusion
  1. At least 15 years old.
  2. At least 40 kg in weight.
  3. Diagnosis of either GPA or MPA1.
  4. Active disease, minimum BVAS/WG2.
  5. Severe disease, with one or more BVAS/WG items, requiring CYC3 for usual standard of care.
  6. ANCA4 positive (either PR3- or MPO-ANCA).
  7. Willing to practice contraception and refrain from breastfeeding.
  8. Willing to comply with study procedures.
  9. Competence and willingness to provide informed consent.
  1. Limited disease (not treated with CYC under standard of care).
  2. On mechanical ventilation at time of eligibility.
  3. History of severe allergic reactions to human or chimeric monoclonal antibodies or murine protein, or history of human antichimeric antibodies (HACA).
  4. Active systemic infection.
  5. Deep space infection within 6 months.
  6. Known active hepatitis B or C or documented history of hepatitis B, C, or HIV.
  7. Significant acute or chronic liver disease
  8. Antiglomerular basement membrane disease.
  9. Active or history of malignancy in the last 5 years5.
  10. Drug or alcohol abuse.
  11. Cytopenias: white blood cell count < 4,000/mm3, platelet count < 120,000/mm3.
  12. Liver function tests: Serum AST6 or ALT concentration greater than 2.5 times the upper limit of normal that is not related to AAV.
  13. Creatinine: Serum creatinine > 4.0 mg/dL that is attributed to renal failure from a current flare.
  14. Pregnancy.
  15. Specific immunosuppressive or biologic agents (Proscribed Medications).
    • Glucocorticoids for Longer than 14 days prior to enrollment unless they were on a stable maintenance dose of prednisone at the time of the flare.
    • Daily oral CYC for more than 7 days prior to enrollment.
    • Completed a remission induction course of oral or intravenous CYC within 4 months of enrollment
    • Previous therapy with rituximab
    • Previous therapy with alemtuzumab
    • Anti-TNF therapy within 5 half-lifes of the specific agent
    • Plasma exchange within 3 month of enrollment
  16. Vaccines: They have had a live vaccine fewer than four weeks before randomization.