ANCA-associated vasculitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Fulfil the classification criteria of either Wegener's granulomatosis or microscopic polyangiitis based on the Ministry of Health, Labor and Welfare of Japan, and satisfy one of the following criteria; A, failed to induce remission after 6 months of cyclophosphamide therapy. B, relapsed within 1 year of remission induction therapy with cyclophosphamide. C, difficult to repeat cyclophosphamide because of adverse reaction.
Exclusion criteria
Exclusion criteria: 1. severe infection (including tuberculosis, HCV, HBV and HIV). 2. history of hypersensitivity to mouse-derived protein 3. congestive heart failure with NYHA III or IV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, BVAS/WG, VDI | — |
Countries
Japan