EFFICACY & SAFETY OF RITUXIMAB FOR MOD TO SEVERE SYSTEMIC LUPUS ERYTHEMATOSUS

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。 这是一项为期52周的II/III期随机、双盲、安慰剂对照研究，目的是评估利妥昔单抗与安慰剂相比在中、重度系统性红斑狼疮患者中与单一稳定背景免疫抑制药物联合使用时的有效性和安全性。受试者将在52周的访问后13周和26周进行2次随访。受试者必须是接受稳定治疗方案的中度活动期系统性红斑狼疮的成年人。不会因为种族或性别而被排除在外。受试者的年龄从16岁到75岁不等。包括弱势群体的将是有生育潜力的妇女和调查员的病人。已经制定了减少风险的计划来保护这些人口。在这个研究项目中，受试者将接受病史、体检、生命体征测量、胸部X光检查和心电图检查。将抽取血液进行实验室研究，包括血细胞计数和血清化学、药物/酒精筛查、乙肝和丙型肝炎筛查以及妊娠测试。将收集尿液进行检测，包括药物和酒精筛查。在整个研究过程中，患者在注射研究药物或安慰剂之前，将接受4次甲基强的松龙注射，以预防可能的药物反应。受试者还将接受特定剂量的泼尼松治疗，并遵循方案逐渐减少的时间表，以达到赞助商的预定剂量。研究记录将由研究代码标识。它们将只能通过主主题日志与受试者链接，该日志将与研究记录分开保存在一个双锁的橱柜中。只有经过认证的研究人员才能访问主要主题日志。知情同意书将是全面的书面项目特定知情同意书。成年受试者和监护人/父母将获得同意，18岁以下受试者将获得同意文件。

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. This is a Phase II/III, randomized, double-blind, placebo-controlled 52 week study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe SLE. subjects will be followed with 2 follow-up visits at 13 and 26 weeks after their 52 week visit. Subjects must be adults with moderately active SLE on a stable treatment regimen. There will be no exclusions based on race or gender. The age of the subjects will be 16 to 75 years of age. Included vulnerable populations will be women of childbearing potential and patients of the investigator. Risk reduction plans have been developed to protect these populations. For this research project, subjects will undergo medical histories, physical exams, measurement of vital signs, chest x-rays, ECGs. Blood will be drawn for laboratory studies including blood count and serum chemistry, drug/alcohol screening, Hepatitis B and C screening, and pregnancy tests. Urine will be collected for testing to include drug and alcohol screening. Patients will receive 4 infusions of methylprednisolone as a prophylactic for possible drug reaction before their infusion of study drug or placebo throughout the study. Subjects will also be placed on a specified dose of prednisone and follow the protocols tapering schedule to sponsor's predetermined dose. Research records will be identified by study codes. They will be linkable to the subjects only through a master subject log, which will be kept separately from the research records in a double-locked cabinet. Only certified study personnel will have access to the master subject log. The informed consent will be comprehensive written project specific informed consent. There will be a consent for the adult subjects and guardians/parents and a assent document for subjects under the age of 18.'