A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Rituximab; Methylprednisolone; Acetaminophen; Diphenhydramine
Intervention description: Rituximab will be supplied as a liquid for intravenous infusion.
Intervention MeSH terms: Acetaminophen; Diphenhydramine; Promethazine; Methylprednisolone; Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rituxan; SLE; Lupus

Summary:

      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.
    

Eligibility criteria:

        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          -  Subjects who were withdrawn from study U2971g because of protocol non-compliance or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          -  Subjects who were withdrawn from study U2971g and received rituximab rescue therapy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.