RITUXIMAB THERAPY FOR REMISSION AND TOLERANCE IN ANCA ASSOCIATED VASCULITIS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 研究设计：II/II期随机、多中心、双掩蔽、安慰剂对照研究 研究目的：本研究的目的是了解利妥昔单抗对诊断为ANCA相关性血管炎(Aav)的患者的安全性和有效性。 研究用药：利妥昔单抗(Rituxan) 受试人数：200人 中心数量：9个(美国和欧洲) AAV是一种严重的自身免疫性疾病，会导致血管内炎症。AAV的原因尚不清楚。甲型肝炎病毒患者的免疫系统存在问题。利妥昔单抗通过减少体内可能在AAV中发挥作用的免疫细胞来发挥作用。一旦这些细胞被移除，身体就会产生新的细胞。这项研究还将有助于了解新的免疫细胞是否会导致疾病复发。参与者将被1：1随机分配到对照组或试验组。参与者将留在研究中，直到最后一名注册的参与者完成所有必需的研究访问，这将需要至少18个月的时间。

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.