Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Registration Number
- NCT00071487
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
- Detailed Description
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 449
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Belimumab 4 mg/kg plus SOC Belimumab 4 mg/kg - Belimumab 10 mg/kg plus SOC Belimumab 10 mg/kg - Placebo plus SOC Placebo - Belimumab 1 mg/kg plus SOC Belimumab 1 mg/kg -
- Primary Outcome Measures
Name Time Method Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. Baseline, 24 weeks SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare.
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) 0 to 52 weeks The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
- Secondary Outcome Measures
Name Time Method Percentage Change From Baseline in SELENA SLEDAI Score at Week 52 Baseline, 52 weeks SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52 Baseline and every 4 to 8 weeks through Week 52 SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52 Baseline, 52 weeks The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
Area Under the Curve (AUC) of BILAG Score at Week 52 Baseline and every 4 to 8 weeks through Week 52 The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks 0 to 52 weeks SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
Percentage of Patients With a Reduction in Prednisone Dose Baseline, weeks 40 to 52 Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.
Trial Locations
- Locations (61)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Northwestern University Medical School
🇺🇸Chicago, Illinois, United States
Rheumatology Associates
🇺🇸Chicago, Illinois, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Texas Research Center
🇺🇸Sugar Land, Texas, United States
Arthritis Associates & Osteoporosis Center Of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
Arizona Arthritis Research
🇺🇸Paradise Valley, Arizona, United States
Boling Clinical Trials
🇺🇸Rancho Cucamonga, California, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
Scripps Clinic
🇺🇸LaJolla, California, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
UCDMC
🇺🇸Sacramento, California, United States
Arthritis Care Center, Inc.
🇺🇸San Jose, California, United States
Strafford Medical Associates, P.A.
🇺🇸Dover, New Hampshire, United States
Oklahoma Medical Research Foundation
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Center For Arthritis Therapy & Research
🇺🇸Tulsa, Oklahoma, United States
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
Kentuckiana Center for Better Bone and Joint Health
🇺🇸Louisville, Kentucky, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Medical Specialists
🇺🇸Munster, Indiana, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
The Osteoporosis and Arthritis Clinical Trial Center
🇺🇸Cumberland, Maryland, United States
Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
SUNY-Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Arthritis Center of Nebraska
🇺🇸Lincoln, Nebraska, United States
Aair Research
🇺🇸Rochester, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
The Center for Rheumatology
🇺🇸Albany, New York, United States
Arthritis and Osteoporosis Center
🇺🇸Concord, New Hampshire, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Arthritis Clinic and Carolina Bone and Joint
🇺🇸Charlotte, North Carolina, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Stat Research Inc.
🇺🇸Dayton, Ohio, United States
Bone and Joint Hospital
🇺🇸Oklahoma City, Oklahoma, United States
University of Pittsburgh School of Medicine & ASPH
🇺🇸Pittsburgh, Pennsylvania, United States
Rheumatic Disease Associates
🇺🇸Willow Grove, Pennsylvania, United States
Research Associates of North Texas
🇺🇸Dallas, Texas, United States
Arthritis and Rheumatic Disease Clinic
🇺🇸Ogden, Utah, United States
Physicians Research Options, LC
🇺🇸Sandy, Utah, United States
Edmonds Rheumatology Associates
🇺🇸Edmonds, Washington, United States
Arthritis Clinic of Northern Virginia, P.C.
🇺🇸Arlington, Virginia, United States
Arthritis Northwest Rheumatology
🇺🇸Spokane, Washington, United States
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Gundersen Clinic, Ltd.
🇺🇸La Crosse, Wisconsin, United States
The Medical College of Wisconsin , Inc
🇺🇸Milwaukee, Wisconsin, United States
Marshfield Medical Research Foundation
🇺🇸Wausau, Wisconsin, United States
McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Tufts--New England Medical Center
🇺🇸Boston, Massachusetts, United States
The University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Institute of Arthritis and Research
🇺🇸Idaho Falls, Idaho, United States
Radiant Research Boise
🇺🇸Boise, Idaho, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States