A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00410384
First received: December 8, 2006
Last updated: February 13, 2014
Last verified: February 2014
  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, autoantibody-positive systemic lupus erythematosus (SLE) disease.


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


Further study details as provided by Human Genome Sciences Inc.:

Primary Outcome Measures:
  • SLE Responder Index (SRI) Response Rate at Week 52 [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]

    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:
  • SRI Response Rate at Week 76 [ Time Frame: Baseline, 76 Weeks ] [ Designated as safety issue: No ]

    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. [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
  • Mean Change in Physician's Global Assessment (PGA) at Week 24. [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline, 24 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Weeks 40-52 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse Event (AE) Overview [ Time Frame: Up to 80 Weeks ] [ Designated as safety issue: Yes ]
    SEE ALSO ADVERSE EVENT RESULTS SECTION


Enrollment: 819
Study Start Date: December 2006
Study Completion Date: March 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Other Name: Placebo
Experimental: Belimumab 1 mg/kg
Belimumab 1 mg/kg
Drug: Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Other Names:
  • LymphoStat-B™
  • belimumab
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg
Drug: Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Other Names:
  • LymphoStat-B™
  • belimumab

  Eligibility

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

Key Inclusion Criteria:

  • Clinical diagnosis of SLE by ACR criteria.
  • Active SLE disease.
  • Autoantibody-positive.
  • On stable SLE treatment regimen.

Key Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Arizona Arthritis and Rheumatology Research, PPLC
Paradise Valley, Arizona, United States, 85253
The University of Arizona Arthritis Center
Tucson, Arizona, United States, 85724
United States, California
Talbert Medical Group
Huntington Beach, California, United States, 92646
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
Long Beach, California, United States, 90806
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
University of Southern California
Los Angeles, California, United States, 90033
UCLA Rheumatology
Los Angeles, California, United States, 90095
Arthritis Care Center, Inc.
San Jose, California, United States, 95126
Inland Rheumatic Disease Specialties
Upland, California, United States, 91786
United States, Colorado
Arthritis Associates of Colorado Springs
Colorado Springs, Colorado, United States, 80910
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
University of Miami-Division of Rheumatology and Immunology
Miami, Florida, United States, 03136
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
Tampa Medical Group, P.A.
Tampa, Florida, United States, 33614
Southwest Florida Clinical Research Center
Tampa, Florida, United States, 33609
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Idaho
Selah Medical Clinical Research Unit
Boise, Idaho, United States, 83704
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
Rheumatology Associates, SC
Chicago, Illinois, United States, 60612
United States, Indiana
Medical Specialists Clinical Research
Munster, Indiana, United States, 46321
United States, Kansas
Kansas University 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 and Clinical Trials Center
Cumberland, Maryland, United States, 21502
Osteoporosis & Clinical Trials Center
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan Medical Center - Regents of University of Michigan
Ann Arbor, Michigan, United States, 48109-0358
Fiechtner Research, Inc.
Lansing, Michigan, United States, 48910
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Hampshire
Stafford Medical Associates, PA
Dover, New Hampshire, United States, 03820
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
SUNY-Downstate Medical Center
Brooklyn, New York, United States, 11203
North Shore-LIJ Health System/Rheumatology and Allergy Clinic
Lake Success, New York, United States, 11042
Feinstein Institute
Manhasset, New York, United States, 11030
Hopital for Joint Diseases
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
AAIR Research Center
Rochester, New York, United States, 14618
Rheumatology Associates
Smithtown, New York, United States, 11787
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
Physicians East, PA
Greenville, North Carolina, United States, 27834
Wake Forest University Health Services
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
STAT Research, Inc.
Dayton, Ohio, United States, 45408
United States, Oklahoma
Oklahoma Medical Research Center
Oklahoma City, Oklahoma, United States, 74104
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
East Penn Rheumatology Associates
Bethlehem, Pennsylvania, United States, 18015
Altoona Center for Clinical Research
Duncanville, Pennsylvania, United States, 16635
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Low Country Rheumatology, PA/Low Country Research Center
Charleston, South Carolina, United States, 29406
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Palmetto Clinical Trial at Piedmont Arthritis Clinic
Greenville, South Carolina, United States, 29601
United States, Texas
Walter Chase
Austin, Texas, United States, 78705
University of Texas - Southwestern Medical Center
Dallas, Texas, United States, 75390-8884
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
The Rheumatic Disease Clinical Research Center
Houston, Texas, United States, 77004
Accurate Clinical Research
Houston, Texas, United States, 77034
Houston Institute for Clinical Research
Houston, Texas, United States, 77074
Arthritis Center of South Texas
San Antonio, Texas, United States, 78232
Texas Research Center
Sugar Land, Texas, United States, 77479
United States, Utah
Rheumatology Clinic
Salt Lake City, Utah, United States, 84124
United States, Virginia
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, United States, 22205
United States, Washington
The Seattle Arthritis Clinic
Seattle, Washington, United States, 98133
Arthritis Northwest, PLLC
Spokane, Washington, United States, 99204
United States, Wisconsin
Gundersen Clinic, Ltd.
Onalaska, Wisconsin, United States, 54650
Austria
Universitatsklinik fur innere Medizin
Graz, Austria, 8036
Rheumazentrum Favoriten
Vienna, Austria, 1100
Belgium
Cliniques Universitaires
Brussels, Belgium, 1200
University Hospital
Leuven, Belgium, 3000
CHU Sart Tilman
Liege, Belgium, 4000
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Centre for Prognosis Studies in Rheaumatic Diseases
Toronto, Ontario, Canada, M5T2S8
Canada
McGill University Health Centre, Montreal General Hospital
Montreal, Canada, H3G 1A4
Costa Rica
Hospital Clinica Biblica
San Jose, Costa Rica
Czech Republic
University Hospital Brno
Brno, Czech Republic, 62500
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 50005
University Hospital Olomouc
Olomouc, Czech Republic, 77520
Institute of Rheumatology
Prague, Czech Republic, 12850
France
CHU Hospital de Bicetre
Le Kremlin Bicetre, France, 94270
Hospital Huriez
Lille Cedex, France, 59037
Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
Stasbourg, France, 67091
Hospital FOCH
Suresnes Cedex, France, 92151
Centre Hospitalier Universitarie (CHU) - PURPAA
Toulouse, France, 31059
Germany
Kerckhoff-Klink Bad Nauheim
Bad Nauheim, Germany, 61231
Schlossparkklinik
Berlin, Germany, 10589
Charite
Berlin, Germany, 13353
Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
Dusseldorf, Germany, 40225
FA Universitat Erlangen Nurnberg
Erlangen, Germany, 91054
Universitatsklinikum Frankfurt
Frankfurt, Germany, 60590
Medizinische Universitatsklinik
Freiburg, Germany, 79106
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Friedrich Schiller Universitat
Jena, Germany, 07740
Universitatsklinik Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Universitatsklinikum Leipzig
Leipzig, Germany, 04103
Universitatsklinik Mainz
Mainz, Germany, 55131
Universitatsklinikum Tubingen
Tubingen, Germany, 72076
Israel
Soroka University Medical Center
Beer-Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 31096
B'nai-Zion Medical Center
Haifa, Israel, 31048
Carmel Medical Center
Haifa, Israel, 34362
Beilinson Hospital, Rabin Medical Center
Petach Tikva, Israel, 49100
Sheba Medical Center
Ramat Gan, Israel, 52621
Kaplan Medical Center
Rehovot, Israel, 76100
Tel-Aviv Saurasky Medical Center
Tel-Aviv, Israel, 64239
Italy
A. O. Ospedaliera-Universitaria Arcispedale
Ferrara, Italy, 44100
A.O. Ospedale San Carlo Borromeo
Milano, Italy, 20153
Policlinico di Modena
Modena, Italy, 41100
Policlinico Universitario of Padova
Padova, Italy, 35128
A.O. San Camillo
Rome, Italy, 00152
Policlinico Umberto 1
Rome, Italy, 00161
U.O. di reumatologia Presidio Ospedaliero di Scafati
Scafati, Italy, 84018
Azienda Ospedaliero University-Santa Maria della Misericordia
Udine, Italy, 33100
Mexico
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Mexico, 45235
Instituto Jalisciense de Investigacion Clinica
Jalisco, Mexico, 44100
Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
Mexico City, Mexico, 14000
Hospital Regional 1o de Octubre - ISSSTE
Mexico City, Mexico, 07760
Hospital General de México
Mexico City, Mexico, 06726
Hospital Central de S.L.P. "Iganico Morones Prieto"
San Luis Potosi, Mexico, 78240
Instituto de Seguridad Social del Estado de Mexico y Municipios
Toluca, Mexico, 52170
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333ZA
University Medical Center Maastricht
Maastricht, Netherlands, 6229HX
Erasmus Medical Center
Rotterdam, Netherlands, 3015CE
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083AN
Poland
Szpital Uniwerytecki nr Zim. dr. Jana Biziela
Bydgoszcz, Poland, 85-168
Szpital Specjalistyczny Sw. Lukasza
Konskie, Poland, 26-200
Malopolskie Centrum Medyczne
Krakow, Poland, 30-510
Gabinety Profesorow Osrodek Baden Klinicznych
Lublin, Poland, 20-022
Klinika Reumatologii im Prof. Eleonory Reicher
Warszawa, Poland, 02-637
Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
Wroclaw, Poland, 50-556
Puerto Rico
Ponce School of Medicine
Ponce, Puerto Rico, 00716
University of Puerto Rico Medical Center
Rio Piedras, Puerto Rico, 00935
Romania
Spitalul Clinic Colentina
Bucuresti, Romania, 020125
Spitalul Clinic "Sf Maria"
Bucuresti, Romania, 011170
Slovakia
Narodny Ustav Reumatickych Chorob
Piestany, Slovakia, 92112
Spain
Hospital Clinic i Provincial Barcelona
Barcelona, Spain, 08036
Hospital La Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario San Cecilio
Granada, Spain, 18012
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Regional Universitario de SAS - Carlos Haya
Malaga, Spain, 29010
Hospital Son Dureta
Mallorca, Spain, 07014
Sweden
Sahlgrensja University Hospital
Goteborg, Sweden, 41345
Karolinska Universitetssjukhuset
Stockholm, Sweden, 17176
United Kingdom
St. Thomas Hospital
London, United Kingdom, SE17EH
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE77DN
Sponsors and Collaborators
Human Genome Sciences Inc.
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials Human Genome Sciences Inc.
  More Information

No publications provided by Human Genome Sciences Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT00410384     History of Changes
Other Study ID Numbers: HGS1006-C1056, BLISS-76, 110751
Study First Received: December 8, 2006
Results First Received: April 7, 2011
Last Updated: February 13, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Romania: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Austria: Agency for Health and Food Safety
France: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: Ministry of Health
Poland: Ministry of Health
Canada: Health Canada
Mexico: Ministry of Health
Israel: Ministry of Health
Sweden: Medical Products Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Czech Republic: State Institute for Drug Control

Keywords provided by Human Genome Sciences Inc.:
Antibodies
Autoimmune Diseases
Systemic Lupus Erythematosus
SLE
Belimumab
Lupus

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014