RITUXIMAB THERAPY FOR REMISSION AND TOLERANCE IN ANCA ASSOCIATED VASCULITIS

利妥昔单抗治疗 ANCA 相关性血管炎的缓解和耐受

• 批准号: 7606255
• 负责人: Peter A Merkel
• 金额: $ 6.68万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-03 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606255
• 关键词: Autoimmune Diseases; Back; Blood Vessels; Cells; Computer Retrieval of Information on Scientific Projects Database; Diagnosis; Disease; Disease remission; Enrollment; Europe; Funding; Grant; Immune; Immune system; Inflammation; Institution; Learning; Masks; Numbers; Participant; Patients; Pharmaceutical Preparations; Phase; Purpose; Randomized; Research; Research Design; Research Personnel; Resources; Roche brand of rituximab; Role; Source; United States National Institutes of Health; Upper arm; Vasculitis; Visit; Work; placebo controlled study; rituximab

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 研究设计：II/II期、随机、多中心、双盲、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 研究药物：利妥昔单抗（Rituxan） 受试者人数：200人 中心数量：9家（美国和欧洲） AAV是一种严重的自身免疫性疾病，导致血管内的炎症。AAV的病因尚不清楚。AAV患者的免疫系统有问题。利妥昔单抗通过减少体内可能在AAV中起作用的免疫细胞来起作用。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不会导致疾病复发。受试者将以1：1的比例随机分配至对照组或实验组。受试者将留在研究中，直到最后一名入组的受试者完成所有要求的研究访视，这将需要至少18个月。