课题基金 / 基金详情

CLINICAL TRIAL: PILOT TRIAL OF RITUXIMAB IN REFRACTORY MYASTHENIA GRAVIS

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
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-03-01 至 2010-02-28

项目摘要

项目成果

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中文摘要
翻译
这个子项目是许多利用 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。 文献中有初步证据表明利妥昔单抗治疗MG患者可能有益。 这将是一项开放标签、I-II期、四中心、为期36周的利妥昔单抗在10例连续MG患者中的可行性研究,这些患者患有活动性症状和难治性全身性疾病。 主要目的是研究利妥昔单抗对难治性MG患者疾病活动的影响。 次要目的是确定利妥昔单抗在这些患者中的安全性和耐受性。
英文摘要
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.
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