A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Registration Number
- NCT00410384
- Lead Sponsor
- Human Genome Sciences Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 819
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
Key
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received IV cyclophosphamide within 180 days of Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Belimumab 1 mg/kg Belimumab 1 mg/kg Belimumab 1 mg/kg Belimumab 10 mg/kg Belimumab 10 mg/kg Belimumab 10 mg/kg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method SLE Responder Index (SRI) Response Rate at Week 52 Baseline, 52 Weeks Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).
- Secondary Outcome Measures
Name Time Method SRI Response Rate at Week 76 Baseline, 76 Weeks Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E).Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52. Baseline, 52 Weeks Mean Change in Physician's Global Assessment (PGA) at Week 24. Baseline, 24 Weeks The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity.
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24. Baseline, 24 Weeks The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 Baseline, Weeks 40-52
Trial Locations
- Locations (146)
Emory University
🇺🇸Atlanta, Georgia, United States
Centre for Prognosis Studies in Rheaumatic Diseases
🇨🇦Toronto, Ontario, Canada
Institute of Rheumatology
🇨🇿Prague, Czech Republic
Instituto Jalisciense de Investigacion Clinica
🇲🇽Jalisco, Mexico
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Rambam Medical Center
🇮🇱Haifa, Israel
Spitalul Clinic "Sf Maria"
🇷🇴Bucuresti, Romania
Ohio State University
🇺🇸Columbus, Ohio, United States
Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
The Rheumatic Disease Clinical Research Center
🇺🇸Houston, Texas, United States
Houston Institute for Clinical Research
🇺🇸Houston, Texas, United States
Talbert Medical Group
🇺🇸Huntington Beach, California, United States
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
🇺🇸Long Beach, California, United States
The University of Arizona Arthritis Center
🇺🇸Tucson, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States
Arthritis Care Center, Inc.
🇺🇸San Jose, California, United States
Inland Rheumatic Disease Specialties
🇺🇸Upland, California, United States
UCLA Rheumatology
🇺🇸Los Angeles, California, United States
Arthritis Associates of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
Arthritis and Rheumatic Disease Specialties
🇺🇸Aventura, Florida, United States
University of Miami-Division of Rheumatology and Immunology
🇺🇸Miami, Florida, United States
Rheumatology Associates, SC
🇺🇸Chicago, Illinois, United States
University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
Medical Specialists Clinical Research
🇺🇸Munster, Indiana, United States
Osteoporosis and Clinical Trials Center
🇺🇸Cumberland, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Osteoporosis & Clinical Trials Center
🇺🇸Hagerstown, Maryland, United States
Stafford Medical Associates, PA
🇺🇸Dover, New Hampshire, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
East Penn Rheumatology Associates
🇺🇸Bethlehem, Pennsylvania, United States
STAT Research, Inc.
🇺🇸Dayton, Ohio, United States
University of Texas - Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Arthritis Clinic of Northern Virginia, P.C.
🇺🇸Arlington, Virginia, United States
Texas Research Center
🇺🇸Sugar Land, Texas, United States
CHU Sart Tilman
🇧🇪Liege, Belgium
McGill University Health Centre, Montreal General Hospital
🇨🇦Montreal, Canada
Rheumazentrum Favoriten
🇦🇹Vienna, Austria
The Seattle Arthritis Clinic
🇺🇸Seattle, Washington, United States
University Hospital
🇧🇪Leuven, Belgium
University Hospital Brno
🇨🇿Brno, Czech Republic
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Hospital Clinica Biblica
🇨🇷San Jose, Costa Rica
Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
🇫🇷Stasbourg, France
Centre Hospitalier Universitarie (CHU) - PURPAA
🇫🇷Toulouse, France
CHU Hospital de Bicetre
🇫🇷Le Kremlin Bicetre, France
University Hospital Olomouc
🇨🇿Olomouc, Czech Republic
Hospital Huriez
🇫🇷Lille Cedex, France
Hospital FOCH
🇫🇷Suresnes Cedex, France
Kerckhoff-Klink Bad Nauheim
🇩🇪Bad Nauheim, Germany
Charite
🇩🇪Berlin, Germany
Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
🇩🇪Dusseldorf, Germany
Medizinische Universitatsklinik
🇩🇪Freiburg, Germany
B'nai-Zion Medical Center
🇮🇱Haifa, Israel
Universitatsklinikum Tubingen
🇩🇪Tubingen, Germany
Universitatsklinik Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Germany
Universitatsklinik Mainz
🇩🇪Mainz, Germany
Kaplan Medical Center
🇮🇱Rehovot, Israel
Beilinson Hospital, Rabin Medical Center
🇮🇱Petach Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
🇲🇽Guadalajara, Mexico
Policlinico di Modena
🇮🇹Modena, Italy
Hospital Regional 1o de Octubre - ISSSTE
🇲🇽Mexico City, Mexico
Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
🇲🇽Mexico City, Mexico
Ikazia Ziekenhuis
🇳🇱Rotterdam, Netherlands
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Gabinety Profesorow Osrodek Baden Klinicznych
🇵🇱Lublin, Poland
Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
🇵🇱Wroclaw, Poland
University of Puerto Rico Medical Center
🇵🇷Rio Piedras, Puerto Rico
Hospital Son Dureta
🇪🇸Mallorca, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Hospital Clinic i Provincial Barcelona
🇪🇸Barcelona, Spain
Klinika Reumatologii im Prof. Eleonory Reicher
🇵🇱Warszawa, Poland
Spitalul Clinic Colentina
🇷🇴Bucuresti, Romania
Narodny Ustav Reumatickych Chorob
🇸🇰Piestany, Slovakia
Hospital La Vall d'Hebron
🇪🇸Barcelona, Spain
Sahlgrensja University Hospital
🇸🇪Goteborg, Sweden
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
A. O. Ospedaliera-Universitaria Arcispedale
🇮🇹Ferrara, Italy
A.O. Ospedale San Carlo Borromeo
🇮🇹Milano, Italy
Policlinico Universitario of Padova
🇮🇹Padova, Italy
A.O. San Camillo
🇮🇹Rome, Italy
Policlinico Umberto 1
🇮🇹Rome, Italy
U.O. di reumatologia Presidio Ospedaliero di Scafati
🇮🇹Scafati, Italy
Azienda Ospedaliero University-Santa Maria della Misericordia
🇮🇹Udine, Italy
Schlossparkklinik
🇩🇪Berlin, Germany
Hospital Regional Universitario de SAS - Carlos Haya
🇪🇸Malaga, Spain
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
North Shore-LIJ Health System/Rheumatology and Allergy Clinic
🇺🇸Lake Success, New York, United States
Universitatsklinik fur innere Medizin
🇦🇹Graz, Austria
St. Thomas Hospital
🇬🇧London, United Kingdom
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Gundersen Clinic, Ltd.
🇺🇸Onalaska, Wisconsin, United States
Palmetto Clinical Trial at Piedmont Arthritis Clinic
🇺🇸Greenville, South Carolina, United States
Altoona Center for Clinical Research
🇺🇸Duncanville, Pennsylvania, United States
Oklahoma Center For Arthritis Therapy & Research
🇺🇸Tulsa, Oklahoma, United States
Cliniques Universitaires
🇧🇪Brussels, Belgium
University Hospital Hradec Kralove
🇨🇿Hradec Kralove, Czech Republic
Hopital for Joint Diseases
🇺🇸New York, New York, United States
Rheumatology Associates
🇺🇸Smithtown, New York, United States
Fiechtner Research, Inc.
🇺🇸Lansing, Michigan, United States
FA Universitat Erlangen Nurnberg
🇩🇪Erlangen, Germany
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Physicians East, PA
🇺🇸Greenville, North Carolina, United States
Friedrich Schiller Universitat
🇩🇪Jena, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Szpital Uniwerytecki nr Zim. dr. Jana Biziela
🇵🇱Bydgoszcz, Poland
Selah Medical Clinical Research Unit
🇺🇸Boise, Idaho, United States
SUNY-Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Feinstein Institute
🇺🇸Manhasset, New York, United States
Ochsner Clinic Foundation
🇺🇸Baton Rouge, Louisiana, United States
Arizona Arthritis and Rheumatology Research, PPLC
🇺🇸Paradise Valley, Arizona, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Carmel Medical Center
🇮🇱Haifa, Israel
Tel-Aviv Saurasky Medical Center
🇮🇱Tel-Aviv, Israel
Hospital General de México
🇲🇽Mexico City, Mexico
Hospital Central de S.L.P. "Iganico Morones Prieto"
🇲🇽San Luis Potosi, Mexico
University Medical Center Maastricht
🇳🇱Maastricht, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Szpital Specjalistyczny Sw. Lukasza
🇵🇱Konskie, Poland
Ponce School of Medicine
🇵🇷Ponce, Puerto Rico
Instituto de Seguridad Social del Estado de Mexico y Municipios
🇲🇽Toluca, Mexico
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Southwest Florida Clinical Research Center
🇺🇸Tampa, Florida, United States
Tampa Medical Group, P.A.
🇺🇸Tampa, Florida, United States
University of Michigan Medical Center - Regents of University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Services
🇺🇸Winston-Salem, North Carolina, United States
Oklahoma Medical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Walter Chase
🇺🇸Austin, Texas, United States
Arthritis Center of South Texas
🇺🇸San Antonio, Texas, United States
Rheumatology Clinic
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Kentuckiana Center for Better Bone and Joint Health
🇺🇸Louisville, Kentucky, United States
Low Country Rheumatology, PA/Low Country Research Center
🇺🇸Charleston, South Carolina, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States