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

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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).