A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Trial ID or NCT#
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.
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus
- - 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.
- - 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.
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