CLINICAL TRIAL: RITUXIMAB ON THE PROGRESSION OF TYPE 1 DIABETES IN NEW ONSET SUB

临床试验：利妥昔单抗对新发亚型 1 型糖尿病进展的影响

• 批准号: 7717894
• 负责人: DARRELL M WILSON
• 金额: $ 0.67万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717894
• 关键词: Age-Months; Antibodies; Autoantibodies; B-Cell NonHodgkins Lymphoma; B-Lymphocytes; Beta Cell; Binding; C-Peptide; CD20 Antigens; Cell physiology; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Diabetes Mellitus; Disease; Dose; Funding; Goals; Grant; Immunologic Markers; Immunologics; Individual; Institution; Insulin; Insulin-Dependent Diabetes Mellitus; Masks; Mediating; Monoclonal Antibody CD20; Mus; Outcome; Participant; Placebo Control; Placebos; Prevention; Randomized; Research; Research Design; Research Personnel; Resolution; Resources; Safety; Source; Standards of Weights and Measures; Study Subject; Surface; Surrogate Markers; United States National Institutes of Health; Upper arm; Value Meaning; Week; follow-up; human monoclonal antibodies; inclusion criteria; rituximab; treatment effect

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: TrialNet is an NIH funded multi-center group created to study immuno-therapies in prevention, delay and treatment of Type 1 diabetes. The proposed study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. Both groups will receive standard intensive diabetes treatment with insulin and dietary management. Treatment Description: Rituximab (RITUXANR, Genentech and Biogen Idec) is a chimeric murine/human monoclonal antibody approved for the treatment of B cell non-Hodgkin's lymphoma. The antibody binds to the CD20 antigen on the surface of B cells and mediates B cell depletion. Participants randomly assigned to rituximab treatment will receive four doses of 375mg/m2 IV each a week apart. Study Duration: Total duration is approximately 4 years (2 years accrual and 2 years follow-up). Follow-up for up to 4 years will continue for those who have persistence of beta cell function at 2 years and/or detectable immunologic effects of treatment by descriptive analysis until the disappearance of detectable beta cell function or resolution of immunologic changes. Objective: 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. Primary Outcome: The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects on rituximab differs significantly from the mean value for placebo subjects assessed at one year of follow-up. Secondary Goals: The study will examine the effect of the proposed treatment on surrogate markers for immunologic effects, namely disease-specific outcomes and immunological outcomes. Major Inclusion Criteria: Type 1 diabetes within past 3 months; age 8-45 years; and at least one diabetes associated autoantibody.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 研究设计： TrialNet 是一个由 NIH 资助的多中心小组，旨在研究预防、延迟和治疗 1 型糖尿病的免疫疗法。拟议的研究是一项双臂、多中心、随机、双盲、安慰剂对照临床试验。 两组都将接受标准的强化糖尿病治疗，包括胰岛素和饮食管理。 治疗说明： Rituximab（RITUXANR、Genentech 和 Biogen Idec）是一种嵌合鼠/人单克隆抗体，被批准用于治疗 B 细胞非霍奇金淋巴瘤。 该抗体与 B 细胞表面的 CD20 抗原结合并介导 B 细胞耗竭。 随机分配接受利妥昔单抗治疗的参与者将每周接受四剂 375mg/m2 静脉注射。 学习时间： 总持续时间约为 4 年（累计 2 年，后续 2 年）。 对于那些在 2 年内β细胞功能持续存在和/或通过描述性分析可检测到治疗的免疫学效应的患者，将继续进行长达 4 年的随访，直到可检测到的 β 细胞功能消失或免疫学变化得到解决。 客观的： 评估利妥昔单抗（抗 CD20 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。 主要成果： 本研究要评估的主要统计假设是，使用利妥昔单抗的研究受试者的平均 C 肽值是否与一年随访时评估的安慰剂受试者的平均值存在显着差异。 次要目标： 该研究将检查拟议治疗对免疫效应替代标志物的影响，即疾病特异性结果和免疫学结果。 主要纳入标准： 过去3个月内患有1型糖尿病；年龄8-45岁；和至少一种糖尿病相关自身抗体。