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

Stopped early · Phase 3

Conditions studied: Lupus Erythematosus, Systemic

In brief

This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.

Key facts

Study ID

NCT00381810

Run by

Genentech, Inc.

People needed

31

Starts

2006-06-22

Expected to finish

2012-02-29

Last updated by the study team

2017-08-01

Who can join

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

You may qualify if…

• Subjects with systemic lupus erythematosus (SLE) who participated and satisfactorily completed their Week 52 evaluation in Study U2971g.
• For partial clinical response (PCR) or nonclinical response (NCR), active disease at screening as defined by one or more domains with a British Isles Lupus Assessment Group (BILAG) A score or 2 or more domains with a BILAG B score.

You may not qualify if…

• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.
• Any safety concern potentially attributed to rituximab that in the investigator's opinion would jeopardize subject safety.
• Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.
• Subjects, that in the investigator's opinion, have not demonstrated any clinical improvement by Week 52 in study U2971g and in whom the proposed therapy would represent risk without benefit.
• Unstable subjects 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.
• Pregnant women or nursing (breastfeeding) mothers.
• History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
• 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 within 8 weeks of screening or oral antibiotics within 2 weeks prior to screening.
• History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
• Major surgery within 4 weeks prior to screening.
• Intolerance or contraindication to oral or IV corticosteroids.
• Positive hepatitis B surface antigen (BsAg) or hepatitis C serology.
• Receipt of a live vaccine within 28 days prior to treatment.

Where it is running

• Arizona Arthritis & Rheumatology Research, Pllc — Paradise Valley, Arizona, United States
• Eden Medical Center San Leandro Hospital — San Leandro, California, United States
• Intermountain Research Center — Boise, Idaho, United States
• Coeur D'Alene Arthritis Clinic — Coeur d'Alene, Idaho, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology — Great Neck, New York, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Medical Univ of South Carolina — Charleston, South Carolina, United States
• Texas Research Center — Sugar Land, Texas, United States
• Seattle Rheumatology Assoc; Swedish Rheumatology Research — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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