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

An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g

This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.

Inclusion Criteria:

• Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
• For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.

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• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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• Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.