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

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。 这是一项对人类免疫球蛋白单抗(LymphStat-B抗体)的开放标记研究，该抗体已证明在系统性红斑狼疮患者中具有活性。所有研究对象都将完成最初的第二阶段研究，在该研究中，他们接受了相同的药物[因此，耐受性和发生的任何不良事件都将被知道]。这项研究的目的是确定该治疗剂的长期疗效和安全性。这项多中心、开放标签、继续试验的对象是在第二阶段研究(LBSL02)中取得满意反应的受试者。

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).