A Study for Patients Previously Enrolled in Study U2971g to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (VOYAGER)

Inclusion Criteria:

• Subjects with SLE who participated and satisfactorily completed their Week 52 evaluation in Study U2971g
• For PCR or NCR, active disease at screening as defined by one or more domains with a BILAG A score or two or more domains with a BILAG B score

Exclusion Criteria:

• Subjects who were withdrawn from Study U2971g because of protocol noncompliance or for safety issues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• Subjects who were withdrawn from Study U2971g and received rituximab rescue therapy outside of the protocol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 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 surface antigen (BsAg) or hepatitis C serology
• Receipt of a live vaccine within 28 days prior to treatment