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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT00137969

Run by

Genentech, Inc.

People needed

262

Starts

2005-05-10

Expected to finish

2008-08-25

Last updated by the study team

2019-08-20

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rheumatology Assoc of North AL — Huntsville, Alabama, United States
• Arizona Arthritis & Rheumatology Research, Pllc — Paradise Valley, Arizona, United States
• Univ of California, San Diego — La Jolla, California, United States
• Univ of Calif., Los Angeles; Rheumatology — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University Med Ctr;Div of Immunology/Rheumatology — Palo Alto, California, United States
• Univ of Calif, San Francisco; Rheumatology — San Francisco, California, United States
• Eden Medical Center San Leandro Hospital — San Leandro, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Arthritis & Rheumatism; Disease Specialities — Aventura, Florida, United States
• Family Arthritis Center — Jupiter, Florida, United States
• Emory Uni ; Division of Rheumatology — Atlanta, Georgia, United States
• Intermountain Research Center — Boise, Idaho, United States
• Coeur D'Alene Arthritis Clinic — Coeur d'Alene, Idaho, United States
• Northwestern University — Chicago, Illinois, United States
• Rheumatology Associates — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Tri-State Arth & Rheum Center — Evansville, Indiana, United States
• Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum — Kansas City, Kansas, United States
• Kentuckiana Cancer Institute — Louisville, Kentucky, United States
• LA State Univ; Medicine — Shreveport, Louisiana, United States
• Johns Hopkins Uni — Baltimore, Maryland, United States
• Center For Rheumatology & Bone Research — Wheaton, Maryland, United States
• Tufts - New England Medical Center — Boston, Massachusetts, United States
• Univ of Alabama School of Med; Clinical Immun Rheumatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.