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

Exclusion Criteria

• •Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
• •Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
• •Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
• •Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
• •Unstable subjects 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.
• •Pregnant women or nursing (breastfeeding) mothers.
• •History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
• •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 within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening.
• •History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
• •Major surgery within 4 weeks prior to screening.
• •Intolerance or contraindication to oral or IV corticosteroids.
• •Positive hepatitis B surface antigen (BsAg) or hepatitis C serology.
• •Receipt of a live vaccine within 28 days prior to treatment.