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

• Status: Completed
• Trial end date: 2008-08-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Acetaminophen; Diphenhydramine; Prednisone; Promethazine; Rituximab

Criteria

Inclusion Criteria:

• Diagnosis of systemic lupus erythematosus (SLE).

• Active disease at screening.

• Stable use of one immunosuppressive drug.

• Use of an antimalarial drug.

• For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.

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.