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

NCT ID: NCT00381810

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-22
• Study Completion Date: 2012-02-29

Brief Summary

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab 1000 mg

Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Rituximab will be supplied as a liquid for intravenous infusion.

Methylprednisolone

Intervention Type: DRUG

Acetaminophen

Intervention Type: DRUG

Diphenhydramine

Intervention Type: DRUG

Interventions

Rituximab

Rituximab will be supplied as a liquid for intravenous infusion.

Intervention Type: DRUG

Methylprednisolone

Intervention Type: DRUG

Acetaminophen

Intervention Type: DRUG

Diphenhydramine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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• Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Brunetta, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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

Countries

United States

Other Identifiers

U3389g

Identifier Type: -

Identifier Source: org_study_id