Last updated: 11/04/2018 08:06:47
A Study of Belimumab in Subjects with Systemic Lupus ErythematosusBLISS-76
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
SLE Responder Index (SRI) Response Rate at Week 52
Timeframe: Baseline, 52 Weeks
Secondary outcomes:
SRI Response Rate at Week 76
Timeframe: Baseline, 76 Weeks
Percent of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score at Week 52.
Timeframe: Baseline, 52 Weeks
Mean change in Physician's Global Assessment (PGA) at Week 24.
Timeframe: Baseline, 24 Weeks
Mean change from baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) physical component summary score (PCS) at Week 24.
Timeframe: Baseline, 24 Weeks
Percent of subjects whose average prednisone dose has been reduced by ≥ 25% from baseline to ≤ 7.5 mg/day during Weeks 40 through 52
Timeframe: Baseline, Weeks 40-52
Interventions:
Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Enrollment:
819
Observational study model:
Not applicable
Primary completion date:
2009-30-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GSK
Study date(s)
December 2006 to March 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Clinical diagnosis of SLE by ACR criteria. -Active SLE disease. -Autoantibody-positive. -On stable SLE treatment regimen.
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.
Trial location(s)
Location
University of Puerto Rico Medical Center
Rio Piedras, Puerto Rico, 00935
Status
Study Complete
Location
SUNY-Downstate Medical Center
Brooklyn, NY, United States, 11203
Status
Study Complete
Location
Hospital for Special Surgery
New York, New York, United States, 10021
Status
Study Complete
Location
Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
Wroclaw, Poland, 50-556
Status
Study Complete
Location
Ochsner Clinic Foundation
Baton Rouge, LA, United States, 70809
Status
Study Complete
Location
Arthritis Clinic of Northern Virginia, P.C.
Arlington, VA, United States, 22205
Status
Study Complete
Location
Stafford Medical Associates, PA
Dover, NH, United States, 03820
Status
Study Complete
Location
Hospital Regional Universitario de SAS - Carlos Haya
Malaga, Spain, 29010
Status
Study Complete
Location
Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
Mexico City, Mexico, 14000
Status
Study Complete
Location
Talbert Medical Group
Huntington Beach, CA, United States, 92646
Status
Study Complete
Location
Tufts - New England Medical Center
Boston, MA, United States, 02111
Status
Study Complete
Location
Oklahoma Center For Arthritis Therapy & Research
Tulsa, OK, United States, 74104
Status
Study Complete
Location
Palmetto Clinical Trial at Piedmont Arthritis Clinic
Greenville, SC, United States, 29601
Status
Study Complete
Location
Texas Tech University Health Sciences Center
El Paso, TX, United States, 79905
Status
Study Complete
Location
North Shore-LIJ Health System/Rheumatology and Allergy Clinic
Lake Success, NY, United States, 11042
Status
Study Complete
Location
Arizona Arthritis and Rheumatology Research, PPLC
Paradise Valley, AZ, United States, 85253
Status
Study Complete
Location
A. O. Ospedaliera-Universitaria Arcispedale
Ferrara, Italy, 44100
Status
Study Complete
Location
University of Chicago Hospitals
Chicago, IL, United States, 60637
Status
Study Complete
Location
Washington Hospital Center
Washington, DC, United States, 20010
Status
Study Complete
Location
Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
Stasbourg, France, 67091
Status
Study Complete
Location
University of Michigan Medical Center - Regents of University of Michigan
Ann Arbor, MI, United States, 48109-0358
Status
Study Complete
Location
East Penn Rheumatology Associates
Bethlehem, PA, United States, 18015
Status
Study Complete
Location
Centre Hospitalier Universitarie (CHU) - PURPAA
Toulouse, France, 31059
Status
Study Complete
Location
Montefiore Medical Center
Bronx, New York, United States, 10461
Status
Study Complete
Location
Kansas University Medical Center
Kansas City, KS, United States, 66160
Status
Study Complete
Location
Altoona Center for Clinical Research
Duncanville, PA, United States, 16635
Status
Study Complete
Location
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
Guadalajara, Mexico, 45235
Status
Study Complete
Location
University of Alabama at Birmingham
Birmingham, AL, United States, 35249
Status
Study Complete
Location
Selah Medical Clinical Research Unit
Boise, ID, United States, 83704
Status
Study Complete
Location
Rheumatology Associates of Central Florida
Orlando, FL, United States, 32806
Status
Study Complete
Location
Inland Rheumatic Disease Specialties
Upland, CA, United States, 91786
Status
Study Complete
Location
Centre for Prognosis Studies in Rheaumatic Diseases
Toronto, Ontario, Canada, M5T2S8
Status
Study Complete
Location
The University of Arizona Arthritis Center
Tucson, AZ, United States, 85724
Status
Study Complete
Location
Washington University School of Medicine
St. Louis, MO, United States, 63110
Status
Study Complete
Location
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
Long Beach, CA, United States, 90806
Status
Study Complete
Location
Szpital Uniwerytecki nr Zim. dr. Jana Biziela
Bydgoszcz, Poland, 85-168
Status
Study Complete
Location
Kentuckiana Center for Better Bone and Joint Health
Louisville, KY, United States, 40202
Status
Study Complete
Location
Hospital Central de S.L.P. "Iganico Morones Prieto"
San Luis Potosi, Mexico, 78240
Status
Study Complete
Location
Osteoporosis & Clinical Trials Center
Hagerstown, MD, United States, 21740
Status
Study Complete
Location
University of North Carolina at Chapel Hill
Chapel Hill, NC, United States, 27599-7600
Status
Study Complete
Location
Arthritis Center of South Texas
San Antonio, TX, United States, 78232
Status
Study Complete
Location
Medical Specialists Clinical Research
Munster, IN, United States, 46321
Status
Study Complete
Location
Instituto de Seguridad Social del Estado de Mexico y Municipios
Toluca, Mexico, 52170
Status
Study Complete
Location
University of Texas - Southwestern Medical Center
Dallas, TX, United States, 75390-8884
Status
Study Complete
Location
University of Miami-Division of Rheumatology and Immunology
Miami, FL, United States, 03136
Status
Study Complete
Location
Hospital Regional 1o de Octubre - ISSSTE
Mexico City, Mexico, 07760
Status
Study Complete
Location
Klinika Reumatologii im Prof. Eleonory Reicher
Warszawa, Poland, 02-637
Status
Study Complete
Location
Southwest Florida Clinical Research Center
Tampa, FL, United States, 33609
Status
Study Complete
Location
Instituto Jalisciense de Investigacion Clinica
Jalisco, Mexico, 44100
Status
Study Complete
Location
McGill University Health Centre, Montreal General Hospital
Montreal, Canada, H3G 1A4
Status
Study Complete
Location
Wallace Rheumatic Study Center
Los Angeles, CA, United States, 90048
Status
Study Complete
Location
Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
Dusseldorf, Germany, 40225
Status
Study Complete
Location
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 50005
Status
Study Complete
Location
University Medical Center Maastricht
Maastricht, Netherlands, 6229HX
Status
Study Complete
Location
Arthritis and Rheumatic Disease Specialties
Aventura, FL, United States, 33180
Status
Study Complete
Location
Medical University of South Carolina
Charleston, SC, United States, 29425
Status
Study Complete
Location
Low Country Rheumatology, PA/Low Country Research Center
Charleston, SC, United States, 29406
Status
Study Complete
Location
University of Southern California
Los Angeles, CA, United States, 90033
Status
Study Complete
Location
Osteoporosis and Clinical Trials Center
Cumberland, MD, United States, 21502
Status
Study Complete
Location
Universitatsklinik Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Status
Study Complete
Location
Azienda Ospedaliero University-Santa Maria della Misericordia
Udine, Italy, 33100
Status
Study Complete
Location
Gabinety Profesorow Osrodek Baden Klinicznych
Lublin, Poland, 20-022
Status
Study Complete
Location
Houston Institute for Clinical Research
Houston, TX, United States, 77074
Status
Study Complete
Location
The Rheumatic Disease Clinical Research Center
Houston, TX, United States, 77004
Status
Study Complete
Location
Beilinson Hospital, Rabin Medical Center
Petach Tikva, Israel, 49100
Status
Study Complete
Location
Oklahoma Medical Research Center
Oklahoma City, OK, United States, 74104
Status
Study Complete
Location
Wake Forest University Health Services
Winston-Salem, NC, United States, 27157
Status
Study Complete
Location
U.O. di reumatologia Presidio Ospedaliero di Scafati
Scafati, Italy, 84018
Status
Study Complete
Location
Arthritis Associates of Colorado Springs
Colorado Springs, CO, United States, 80910
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-30-09
Actual study completion date
2010-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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