A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) - Full Text View

Sponsor:	Human Genome Sciences
Collaborator:	GlaxoSmithKline
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00410384

Purpose

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 SLE disease.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: belimumab Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Belimumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

At Wk 52 the % of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score & no worsening in PGA & no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline at the time of assessment. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

At Wk 76, % of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score & no worsening in (PGA) and no new BILAG organ domain score or 2 new BILAG organ domain scores compared with baseline at the time of assessment. [ Time Frame: 76 Weeks ] [ Designated as safety issue: No ]
Percent of subjects with great than or equal to 4 point reduction from baseline in SELENA SLEDAI score at Wk 52. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]
Mean change in PGA at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Mean change in SF-36 Health Survey physical component summary score (PCS) at Wk 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Percent of subjects whose average prednisone dose has been reduced by greater than or equal to 25% from baseline to less than or equal to 7.5 mg/day during Weeks 40 through 52 [ Time Frame: Weeks 40-52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	810
Study Start Date:	December 2006
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1mg/kg	Drug: belimumab 1mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76
2: Experimental 10mg/kg	Drug: belimumab 10mg/kg, IV (in the vein) on Days 0, 14, 28, and every 28 days through 72 weeks with a final evaluation at Week 76
3: Placebo Comparator Placebo	Drug: Placebo Days 0, 14, 28, and every 28 days through 72 weeks

Detailed Description:

The purpose of this SLE trial 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 Systemic Lupus Erythematosus (SLE) disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410384

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Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 33614
United States, Arizona
Arizona Arthritis Research
Paradise Valley, Arizona, United States, 85253
The University of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Talbert Medical Group
Huntington Beach, California, United States, 92646
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
Long Beach, California, United States, 90802
UCLA Rheumatology
Los Angeles, California, United States, 90095
Wallace Rheumatic Disease Center
Los Angeles, California, United States, 90048
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Tampa Medical Group, P.A.
Tampa, Florida, United States, 33614
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Idaho
Covance - CRU - Boise
Boise, Idaho, United States, 83704
United States, Illinois
Rheumatology Associates, SC
Chicago, Illinois, United States, 60612
University of Chicago Rheumatology Section
Chicago, Illinois, United States, 60637
United States, Indiana
Medical Specialists Clinical Research
Munster, Indiana, United States, 46321
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States, 21740
United States, Michigan
The University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0358
Fiechtner Research, Inc.
Lansing, Michigan, United States, 48910
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63108
United States, New York
Feinstein Institute
Manhasset, New York, United States, 11030
Allergy Asthma Immunology of Rochester, P.C.
Rochester, New York, United States, 14618
Rheumatology Associates
Smithtown, New York, United States, 11787
SUNY-Downstate Medical Center
Brooklyn, New York, United States, 11203
Hopital for Joint Diseases
New York, New York, United States, 10003
NS-LIJ Faculty Practice Center
Lake Success, New York, United States, 11042
Montefiore Medical Center
Bronx, New York, United States, 10605
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
Wake Forest University Health Services
Winston-Salem, North Carolina, United States, 27157
Jeff Alloway
Greenville, North Carolina, United States, 27834
United States, Ohio
Stat Research, Inc.
Dayton, Ohio, United States, 45402
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States, 74104
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 74104
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States, 18015
Altoona Center for Clinical Research
Duncanville, Pennsylvania, United States, 16635
United States, South Carolina
Palmetto Clinical Trial Service, LLC
Simpsonville, South Carolina, United States, 29681
Low Country Rheumatology
Charleston, South Carolina, United States, 29406
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Research Center
Sugar Land, Texas, United States, 77479
University of Texas
Dallas, Texas, United States, 75390-8884
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Walter Chase
Austin, Texas, United States, 78705
Arthritis Center of South Texas
San Antonio, Texas, United States, 21740
Accurate Clinical Research
Houston, Texas, United States, 77034
United States, Utah
Rheumatology Clinic
Ogden, Utah, United States, 84403
United States, Virginia
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, United States, 22205
United States, Washington
Arthritis Northwest, PLLC
Spokane, Washington, United States, 99204
The Seattle Arthritis Clinic
Seattle, Washington, United States, 98133
United States, Wisconsin
Gundersen Clinic, Ltd.
Onalaska, Wisconsin, United States, 54650
Austria
Rheumazentrum Favoriten
Vienna, Austria, 1100
Universitatsklinik fur innere Medizin
Graz, Austria, 8036
Belgium
University Hospital
Leuven, Belgium, 3000
Cliniques Universitaires
Brussels, Belgium, 1200
CHU Sart Tilman
Liege, Belgium, 4000
Canada
McGill University Health Centre, Montreal General Hospital
Montreal, Canada, H3G 1A4
Canada, Ontario
Centre for Prognosis Studies in Rheaumatic Diseases
Toronto, Ontario, Canada, M5T2S8
Costa Rica
Hospital Clinica Catolica/Bio Trials S.A.
San Jose, Costa Rica
Czech Republic
University Hospital Olomouc
Olomouc, Czech Republic, 77520
Institute of Rheumatology
Prague, Czech Republic, 12850
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 50005
University Hospital Brno
Brno, Czech Republic, 62500
France
CHU Hospital de Bicetre
Le Kremlin Bicetre, France, 94270
Hospital Huriez
Lile Cedex, France, 59035
Hospital Civil
Stasbourg, France, 67091
Hospital FOCH
Suresnes Cedex, France, 92151
Hopital Purpan
Toulouse, France, 31059
Germany
Schlossparkklinik
Berlin, Germany, 14059
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60590
Charite
Berlin, Germany, 13353
Medizinische Universitatsklinik Stadtischen
Kiel, Germany, 24116
Medizinische Universitatsklinik
Freiburg, Germany, 79106
Uniklinik Dusseldorf
Dusseldorf, Germany, 40225
FA Universitat Erlangen Nurnberg
Nurnberg, Germany, 91054
Universitatsklinik Mainz
Mainz, Germany, 55131
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Medizinische Klinik II, Leipzig
Leipzig, Germany, 04103
Friedrich Schiller Universitat - Klinik fur Innere Medizin III
Jena, Germany, 07740
Israel
Shaari-Zedek Medical Center
Jerusalem, Israel, POB3235
Rabin Medical Center
Petach Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 76100
Soroka Medical
Beer-Sheva, Israel, 84101
Saurasky Medical Center
Tel-Aviv, Israel, 64239
Carmel Medical Center
Haifa, Israel, 31048
Rambam Medical Center
Haifa, Israel, 31048
B'nai-Zion Medical Center
Haifa, Israel, 31048
Sheba Medical Center
Ramat Gan, Israel, 52621
Italy
Policlinico Universitario of Padova
Padova, Italy, 35128
A.O. San Camillo
Rome, Italy, 151
A.O. Ospedale San Carlo Borromeo
Milano, Italy, 20153
Azienda Ospedaliero University-Santa Maria della Misericordia
Udine, Italy, 33100
U.O. di reumatologia Presidio Ospedaliero di Scafati
Scafati, Italy, 84018
Mexico
Hospital Civil de Guadalajara
Jalisco, Mexico, 44340
Hospital Civil Fray
Jalisco, Mexico, 44280
Hospital General de México
Mexico City, Mexico, 06726
INCMNSZ
Mexico City, Mexico, 14000
Hospital Central de S.L.P.
San Luis Potosi, Mexico, 78240
Rheumatology Hospital Regional
Mexico City, Mexico, 07760
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083
University Medical Center Maastricht
Maastricht, Netherlands, 6229
Erasmus Medical Center
Rotterdam, Netherlands, 3015CE
Poland
Klinika Chorob Tkanki Lacznej Instytut Reumatologii
Warszawa, Poland, 02-637
Malopolskie Centrum Medyczne
Krakow, Poland, 31-510
Akademii Medycznej
Wroclaw, Poland, 53-137
Osrodek Badan
Lublin, Poland, 20-022
Klinika Reumatologii Instytut Reumatologii
Warszawa, Poland, 02-637
Szpital Specjalistyczny Sw. Lukasza
Konskie, Poland, 26-200
SPOZ Wojewodzki Szpital dr J Biziela
Bydgoszcz, Poland, 85-168
Puerto Rico
University of Puerto Rico Medical Center
San Juan, Puerto Rico, 936
Ponce School of Medicine, CA Medical Center
Ponce, Puerto Rico, 00716
Romania
Spitalul Clinic "Sf Maria"
Bucuresti, Romania, 011170
Spitalul Clinic Colentina
Bucuresti, Romania, 020125
Slovakia
Narodny Ustav Reumatickych Chorob
Piestany, Slovakia, 92112
Spain
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Hospital La Vall d Hebron
Barcelona, Spain, 119-129
Hospital Universitario Carlos Haya
Malaga, Spain, 29010
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Son Dureta
Mallorca, Spain, 07014
Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden, 17176
Sahlgrensja University Hospital
Goteborg, Sweden, 41346
United Kingdom
St. Thomas Hospital
London, United Kingdom, SE17EH
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE77DN

Sponsors and Collaborators

Human Genome Sciences

GlaxoSmithKline

Investigators

Study Director:

William Freimuth, MD, PhD

Human Genome Sciences, Inc.

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Human Genome Sciences, Inc. ( William Freimuth, MD, PhD/Vice President of Clinical Research, Immunology, Rheumatology and Infectious Diseases )
Study ID Numbers:	HGS1006-C1056, BLISS-76
Study First Received:	December 8, 2006
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00410384 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Mexico: Ministry of Health; Germany: Paul-Ehrlich-Institut; Belgium: Ministry of Social Affairs, Public Health and the Environment; Netherlands: Independent Ethics Committee; Czech Republic: State Institute for Drug Control; Slovakia: State Institute for Drug Control; United Kingdom: Department of Health; France: Ministry of Health; Spain: Ministry of Health; Poland: Ministry of Health; Italy: Ministry of Health; Austria: Agency for Health and Food Safety; Israel: Ministry of Health; Sweden: Medical Products Agency; Romania: Ministry of Public Health