Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00071487
Last Updated: 2013-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
449 participants
INTERVENTIONAL
2003-10-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo plus SOC
Placebo
Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Belimumab 1 mg/kg plus SOC
Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 4 mg/kg plus SOC
Belimumab 4 mg/kg
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 10 mg/kg plus SOC
Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
Interventions
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Placebo
Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 4 mg/kg
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* "Active" SLE disease
* On a stable SLE treatment regimen
* History of measurable autoantibodies
Exclusion Criteria
* Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
* Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 90 days
* Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
* History of renal transplant
* History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
* History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
* Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
18 Years
65 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Arthritis Research
Paradise Valley, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Scripps Clinic
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Boling Clinical Trials
Rancho Cucamonga, California, United States
UCDMC
Sacramento, California, United States
Arthritis Care Center, Inc.
San Jose, California, United States
Arthritis Associates & Osteoporosis Center Of Colorado Springs
Colorado Springs, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Tampa Medical Group, P.A.
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Radiant Research Boise
Boise, Idaho, United States
Institute of Arthritis and Research
Idaho Falls, Idaho, United States
Northwestern University Medical School
Chicago, Illinois, United States
Rheumatology Associates
Chicago, Illinois, United States
Medical Specialists
Munster, Indiana, United States
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Tufts--New England Medical Center
Boston, Massachusetts, United States
The University of Michigan Health System
Ann Arbor, Michigan, United States
Washington University in St. Louis
St Louis, Missouri, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, United States
Arthritis and Osteoporosis Center
Concord, New Hampshire, United States
Strafford Medical Associates, P.A.
Dover, New Hampshire, United States
The Center for Rheumatology
Albany, New York, United States
SUNY-Downstate Medical Center
Brooklyn, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Aair Research
Rochester, New York, United States
Jacobi Medical Center
The Bronx, New York, 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
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
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 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
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Texas Research Center
Sugar Land, Texas, United States
Arthritis and Rheumatic Disease Clinic
Ogden, Utah, United States
Physicians Research Options, LC
Sandy City, Utah, United States
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, United States
Edmonds Rheumatology Associates
Edmonds, Washington, United States
Arthritis Northwest Rheumatology
Spokane, Washington, United States
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
Toronto Western Hospital
Toronto, Ontario, Canada
McGill University Health Center
Montreal, Quebec, Canada
Countries
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References
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Wallace DJ, Stohl W, Furie RA, Lisse JR, McKay JD, Merrill JT, Petri MA, Ginzler EM, Chatham WW, McCune WJ, Fernandez V, Chevrier MR, Zhong ZJ, Freimuth WW. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum. 2009 Sep 15;61(9):1168-78. doi: 10.1002/art.24699.
Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, Chatham WW, Strand V, Weinstein A, Chevrier MR, Zhong ZJ, Freimuth WW. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009 Sep 15;61(9):1143-51. doi: 10.1002/art.24698.
Arends EJ, Zlei M, Tipton CM, Cotic J, Osmani Z, de Bie FJ, Kamerling SWA, van Maurik A, Dimelow R, Gregan YI, Fox NL, Rabelink TJ, Roth DA, Sanz I, van Dongen JJM, van Kooten C, Teng YKO. Disruption of memory B-cell trafficking by belimumab in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2024 Sep 1;63(9):2387-2398. doi: 10.1093/rheumatology/keae286.
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Ginzler EM, Wallace DJ, Merrill JT, Furie RA, Stohl W, Chatham WW, Weinstein A, McKay JD, McCune WJ, Zhong ZJ, Freimuth WW, Petri MA; LBSL02/99 Study Group. Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus. J Rheumatol. 2014 Feb;41(2):300-9. doi: 10.3899/jrheum.121368. Epub 2013 Nov 1.
Struemper H, Chen C, Cai W. Population pharmacokinetics of belimumab following intravenous administration in patients with systemic lupus erythematosus. J Clin Pharmacol. 2013 Jul;53(7):711-20. doi: 10.1002/jcph.104. Epub 2013 May 16.
Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.
Merrill JT, Ginzler EM, Wallace DJ, McKay JD, Lisse JR, Aranow C, Wellborne FR, Burnette M, Condemi J, Zhong ZJ, Pineda L, Klein J, Freimuth WW; LBSL02/99 Study Group. Long-term safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Oct;64(10):3364-73. doi: 10.1002/art.34564.
Jacobi AM, Huang W, Wang T, Freimuth W, Sanz I, Furie R, Mackay M, Aranow C, Diamond B, Davidson A. Effect of long-term belimumab treatment on B cells in systemic lupus erythematosus: extension of a phase II, double-blind, placebo-controlled, dose-ranging study. Arthritis Rheum. 2010 Jan;62(1):201-10. doi: 10.1002/art.27189.
Other Identifiers
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LBSL02
Identifier Type: -
Identifier Source: org_study_id