Back to resultsA Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (VOYAGER)
Primary Purpose
Lupus Erythematosus, Systemic
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Methylprednisolone
Acetaminophen
Diphenhydramine
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Rituxan, SLE, Lupus
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- Subjects who were withdrawn from study U2971g because of protocol non-compliance or for safety issues.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- Subjects who were withdrawn from study U2971g and received rituximab rescue therapy outside of the protocol.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.
Sites / Locations
- Arizona Arthritis & Rheumatology Research, Pllc
- Eden Medical Center San Leandro Hospital
- Intermountain Research Center
- Coeur D'Alene Arthritis Clinic
- University of Chicago
- University of Kansas Medical Center
- North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
- Oklahoma Medical Research Foundation
- Medical Univ of South Carolina
- Texas Research Center
- Seattle Rheumatology Assoc; Swedish Rheumatology Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab 1000 mg
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least 1 Serious Adverse Event
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00381810
Brief Title
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
Acronym
VOYAGER
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.
Study Start Date
June 22, 2006 (Actual)
Primary Completion Date
July 31, 2008 (Actual)
Study Completion Date
February 29, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Rituxan, SLE, Lupus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab 1000 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab will be supplied as a liquid for intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 1 Serious Adverse Event
Description
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.
Time Frame
Baseline to the end of the study (up to 52 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Brunetta, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arthritis & Rheumatology Research, Pllc
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Eden Medical Center San Leandro Hospital
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Intermountain Research Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Coeur D'Alene Arthritis Clinic
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Medical Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Research Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Seattle Rheumatology Assoc; Swedish Rheumatology Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
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