CLINICAL TRIAL: A MULTI-CENTER, OPEN-LABEL, CONTINUATION TRIAL OF LYMPHOSTAT-B A

该子项目是利用 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来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 研究中心，而研究中心不一定是研究者所在的机构。 这是一项关于人免疫球蛋白单克隆抗体（IgnaphoStat-B抗体）的开放标签研究，该抗体已在系统性红斑狼疮患者中显示出活性。研究受试者将全部完成初始II期研究，其中他们接受相同的药物[因此耐受性和发生的任何不良事件将是已知的]。 本研究的目的是确定治疗剂的长期疗效和安全性。这项多中心、开放标签、继续试验针对在II期研究（LBSL 02）中获得满意缓解的受试者。

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 an open label study of a human immune globulin monoclonal antibody (LymphoStat-B Antibody)which has demonstrated activity in patients with systemic lupus erythematosus. The study subjects will all have completed an initial phase 2 study in which they received the same drug [thus the tolerability and any adverse events that have occurred will be known]. The purpose of the study is to determine long term efficacy and safety of the treatment agent. This multi-center, open-label, continuation trial is directed at subjects who achieved a satisfactory response in the Phase 2 study (LBSL02).