Eligibility Criteria - RAVE - Rituximab for ANCA-Associated Vasculitis

Eligibility Criteria

Inclusion Criteria:

Weight of at least 88 lbs (40 kg)
Diagnosis of Wegener’s granulomatosis (WG) or microscopic polyangiitis (MPA) according to the definitions of the Chapel Hill Consensus Conference
Newly diagnosed patient of WG or MPA OR must be experiencing a disease flare characterized by: (a) active disease with a BVAS/WG of 3 or greater that would normally require treatment with CYC; OR (b) disease severe enough to require treatment with CYC; OR (c) must be positive for either PR3-ANCA or MPO-ANCA at the screening
Willing to use acceptable forms of contraception for the duration of the study and for up to 1 year after stopping study medications
Willing to report pregnancies (female participants or male participants’ partners) occurring at any time during the study and for up to 1 year after stopping study medications

Exclusion Criteria:

Diagnosis of Churg Strauss syndrome as defined by the Chapel Hill Consensus Conference
Have limited disease that would not normally be treated with CYC
Requires mechanical ventilation because of alveolar hemorrhage
History of severe allergic reactions to human or chimeric monoclonal antibodies
Active systemic infection
Have a deep-space infection, such as osteomyelitis, septic arthritis, or pneumonia, complicated by pleural cavity or lung abscess, within 6 months prior to study entry
History of or current hepatitis B or C infection
HIV infected
Acute or chronic liver disease that, in the opinion of the investigator, may interfere with the study
History of or active cancer diagnosed within the last 5 years. Individuals with squamous cell or basal cell carcinomas of the skin and individuals with cervical carcinoma in situ who have received curative surgical treatment may be eligible for this study.
History of anti-glomerular basement membrane (anti-GBM) disease
Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
Pregnancy or breastfeeding

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