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

Not Recruiting

Trial ID: NCT00137969

Purpose

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.

Official Title

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

Eligibility


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.

Intervention(s):

drug: placebo

drug: prednisone

drug: Rituximab

drug: Acetaminophen

drug: Diphenhydramine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Hillygus
6507237416