RITUXIMAB THERAPY FOR REMISSION AND TOLERANCE IN ANCA ASSOCIATED VASCULITIS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Study Design: Phase II/II, randomized, multicenter, double-masked, placebo-controlled study Study Objectives: The purpose to this study is to learn about how safe and effective rituximab will be for people diagnosed with ANCA-associated vasculitis (AAV) Study Medication: Rituximab (Rituxan) Number of Subjects: 200 Number of Centers: 9 (US and Europe) AAV is a severe autoimmune disorder that leads to inflammation within the blood vessels. The cause of AAV is unknown. Patients with AAV have problems with their immune system. Rituximab works by decreasing the immune cells in the body that may have a role in AAV. Once those cells are removed, the body will make new cells. This study will also help to learn if the new immune cells will not cause the disease to come back. Participants will be randomized 1:1 to either the control or the experimental arm. Participants will remain in the study until the last participant enrolled completes all required study visits, which will take at least 18 months.