CLINICAL TRIAL: PILOT TRIAL OF RITUXIMAB IN REFRACTORY MYASTHENIA GRAVIS

临床试验：利妥昔单抗治疗难治性重症肌无力的试点试验

• 批准号: 7952100
• 负责人: RUP TANDAN
• 金额: $ 1.4万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952100
• 关键词: Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Feasibility Studies; Funding; Grant; Institution; Literature; Myasthenia Gravis; Patients; Phase; Refractory; Refractory Disease; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; Widespread Disease; open label; pilot trial; 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. There is preliminary evidence in the literature that treatment of MG patients with rituximab is likely to be of benefit. This will be an open-label, Phase I-II, four-center 36-week feasibility study of rituximab in 10 consecutive MG patients with active symptomatic and refractory generalized disease. The primary objective is to examine the effects of rituximab on disease activity in MG patients with refractory disease. The secondary objective is to determine the safety and tolerability of rituximab in these patients.

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。 文献中有初步证据表明，利妥昔单抗治疗重症肌无力患者可能是有益的。这将是一项开放标签、I-II期、为期4个中心、为期36周的利妥昔单抗可行性研究，研究对象为连续10名患有活动期症状和难治性全身性疾病的MG患者。 主要目的是检测利妥昔单抗对患有难治性疾病的重症肌无力患者疾病活动性的影响。第二个目标是确定利妥昔单抗在这些患者中的安全性和耐受性。