Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE)
Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
About this trial
This is an interventional treatment trial for Vasculitis focused on measuring ANCA, Vasculitis, Wegener's Granulomatosis, microscopic polyangiitis, ANCA-positive, ANCA-associated, ANCA-associated vasculitis, MPA
Eligibility Criteria
Inclusion Criteria: Weight of at least 88 pounds(40 kilograms) Diagnosis of Wegener's granulomatosis or microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference Newly diagnosed patient of Wegener's granulomatosis or microscopic polyangiitis OR must be experiencing a disease flare characterized by: (a) active disease with a Birmingham Vasculitis Activity Score for Wegener's granulomatosis (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 (ANCA directed against proteinase 3) or MPO-ANCA (ANCA directed against myeloperoxidase)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 Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria: Diagnosis of Churg-Strauss Syndrome according to the definitions of 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 (human immunodeficiency virus) 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
Sites / Locations
- University of Alabama
- Johns Hopkins University
- Boston University
- Mayo Clinic Foundation
- Hospital for Special Surgery
- Duke University
- The Cleveland Clinic
- University Hospital Groningen
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rituximab
Control Group