A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Exclusion Criteria

• •Unstable patients with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
• •Active moderate to severe glomerulonephritis.
• •Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
• •Lack of peripheral venous access.
• •Pregnant women or nursing (breast feeding) mothers.
• •History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
• •Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
• •Concomitant conditions that require oral or systemic corticosteroid use.
• •Known human immunodeficiency virus (HIV) infection.
• •Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
• •History of deep space infection.
• •History of serious recurrent or chronic infection.
• •History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
• •Active alcohol or drug abuse, or history of alcohol or drug abuse.
• •Major surgery.
• •Previous treatment with CAMPATH-1H antibody.
• •Previous treatment with any B cell-targeted therapy.
• •Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
• •Receipt of a live vaccine within 28 days prior to screening.
• •Intolerance or contraindication to oral or IV corticosteroids.
• •Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
• •Prednisone dose of ≥ 1 mg/kg/day prior to screening.
• •Treatment with cyclophosphamide or a calcineurin inhibitor.
• •Treatment with a second immunosuppressive or immunomodulatory drug.
• •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x the upper limit of normal.