CLINICAL TRIAL: EFFECTS OF RITUXIMAB ON THE PROGRESSION OF TYPE 1 DIABETES IN NE

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。子项目及 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。 1型糖尿病T1 D仍然与巨大的发病率和过早死亡率相关。患者需要在一生中每天多次注射胰岛素，并密切监测其饮食和血糖水平，以防止并发症。不幸的是，目前还没有永久治愈糖尿病的方法。 整个胰腺或胰岛细胞移植仅适用于非常有限数量的患者，并且需要潜在的终身免疫抑制治疗。Rituximab RITUXAN、Genentech和Biogen Idec是一种嵌合鼠/人单克隆抗体，批准用于治疗B细胞非霍奇金淋巴瘤。该抗体与B细胞表面的CD 20抗原结合并介导B细胞耗竭。本研究是一项在新发1型糖尿病患者中进行的利妥昔单抗双组、多中心、随机、双问、安慰剂对照临床试验。两组都将接受胰岛素和饮食管理的标准强化糖尿病治疗。本研究的目的是评估利妥昔单抗（抗CD 20单克隆抗体）治疗新发1型糖尿病患者的安全性、有效性和作用方式。

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. Type 1 diabetes T1D is still associated with tremendous morbidity and premature mortality. Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. Unfortunately, there is presently no permanent cure for diabetes. Whole pancreas or islet cell transplantation is available only to a very limited number of patients and necessitates potential lifelong immunosuppressive therapy. Rituximab RITUXAN, Genentech and Biogen Idec is a chimeric murine/human monoclonal antibody approved for the treatment of B cell non-Hodgkins lymphoma. The antibody binds to the CD20 antigen on the surface of B cells and mediates B cell depletion. This study is a two-arm, multicenter, randomized, doublemasked, placebo-controlled clinical trial of Rituximab in patients with new onset Type 1 diabetes. Both groups will receive standard intensive diabetes treatment with insulin and dietary management. The objective of this study is to assess the safety, efficacy, and mode of action of rituximab, anti-CD20 monoclonal antibody, for the treatment of individuals with new onset type 1 diabetes.