449
Participants
Start Date
October 31, 2003
Primary Completion Date
August 31, 2005
Study Completion Date
June 30, 2006
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.
Jacobi Medical Center, The Bronx
North Shore University Hospital, Manhasset
SUNY-Downstate Medical Center, Brooklyn
The Center for Rheumatology, Albany
Aair Research, Rochester
University of Pittsburgh School of Medicine & ASPH, Pittsburgh
Rheumatic Disease Associates, Willow Grove
Thomas Jefferson University Hospital, Philadelphia
Washington Hospital Center, Washington D.C.
Center for Rheumatology and Bone Research, Wheaton
University of Maryland, Baltimore
Johns Hopkins Hospital, Baltimore
The Osteoporosis and Arthritis Clinical Trial Center, Cumberland
Arthritis Clinic of Northern Virginia, P.C., Arlington
Wake Forest University School of Medicine, Winston-Salem
Arthritis Clinic and Carolina Bone and Joint, Charlotte
Emory University, Atlanta
Rheumatology Associates of Central Florida, Orlando
Arthritis and Rheumatic Disease Specialties, Aventura
Tampa Medical Group, P.A., Tampa
Kentuckiana Center for Better Bone and Joint Health, Louisville
Stat Research Inc., Dayton
Medical Specialists, Munster
The Medical College of Wisconsin , Inc, Milwaukee
Marshfield Medical Research Foundation, Wausau
Gundersen Clinic, Ltd., La Crosse
Northwestern University Medical School, Chicago
Rheumatology Associates, Chicago
Washington University in St. Louis, St Louis
Arthritis Center of Nebraska, Lincoln
Ochsner Clinic Foundation, New Orleans
Ochsner Clinic Foundation, Baton Rouge
Bone and Joint Hospital, Oklahoma City
Oklahoma Medical Research Foundation, Oklahoma City
Oklahoma Center For Arthritis Therapy & Research, Tulsa
Research Associates of North Texas, Dallas
Texas Research Center, Sugar Land
Arthritis Associates & Osteoporosis Center Of Colorado Springs, Colorado Springs
Institute of Arthritis and Research, Idaho Falls
Radiant Research Boise, Boise
Arthritis and Rheumatic Disease Clinic, Ogden
Physicians Research Options, LC, Sandy City
Arizona Arthritis Research, Paradise Valley
University of Arizona, Tucson
University of Southern California, Los Angeles
Cedars-Sinai Medical Center, Los Angeles
Boling Clinical Trials, Rancho Cucamonga
Scripps Clinic, La Jolla
Stanford University School of Medicine, Palo Alto
Arthritis Northwest Rheumatology, Spokane
University of Alabama at Birmingham, Birmingham
UCDMC, Sacramento
Arthritis Care Center, Inc., San Jose
Tufts--New England Medical Center, Boston
The University of Michigan Health System, Ann Arbor
Arthritis and Osteoporosis Center, Concord
Strafford Medical Associates, P.A., Dover
University of North Carolina at Chapel Hill, Chapel Hill
UT Southwestern Medical Center at Dallas, Dallas
Edmonds Rheumatology Associates, Edmonds
Toronto Western Hospital, Toronto
McGill University Health Center, Montreal
Lead Sponsor
Human Genome Sciences Inc.
INDUSTRY