Education and Training
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: placebo
- drug: prednisone
- drug: Rituximab
- drug: Acetaminophen
- drug: Diphenhydramine
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.
Ages Eligible for Study
16 Years - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jennifer Hillygus
6507237416
Not Recruiting