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

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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 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.'