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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00381810
Recruitment Status : Terminated (During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.)
First Posted : September 28, 2006
Results First Posted : December 18, 2009
Last Update Posted : August 1, 2017
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Rituximab Drug: Methylprednisolone Drug: Acetaminophen Drug: Diphenhydramine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g
Actual Study Start Date : June 22, 2006
Primary Completion Date : July 31, 2008
Study Completion Date : February 29, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Rituximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: Rituximab
Rituximab will be supplied as a liquid for intravenous infusion.
Drug: Methylprednisolone Drug: Acetaminophen Drug: Diphenhydramine

Primary Outcome Measures :
  1. Percentage of Participants With at Least 1 Serious Adverse Event [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]
    A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381810

United States, Arizona
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, United States, 85253
United States, California
Eden Medical Center San Leandro Hospital
San Leandro, California, United States, 94578
United States, Idaho
Intermountain Research Center
Boise, Idaho, United States, 83702
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
Great Neck, New York, United States, 11021
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Medical Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Research Center
Sugar Land, Texas, United States, 77479
United States, Washington
Seattle Rheumatology Assoc; Swedish Rheumatology Research
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Genentech, Inc.
Study Director: Paul Brunetta, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00381810     History of Changes
Other Study ID Numbers: U3389g
First Posted: September 28, 2006    Key Record Dates
Results First Posted: December 18, 2009
Last Update Posted: August 1, 2017
Last Verified: June 2017

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Autonomic Agents
Gastrointestinal Agents