Clinical trial NCT00410384: A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Antibodies
Autoimmune Diseases
Systemic Lupus Erythematosus
SLE
Belimumab
Lupus
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2006-12-12
Enrollment: 819
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: SLE Responder Index (SRI) Response Rate at Week 52
timeFrame: Baseline, 52 Weeks
Secondary outcomes:
measure: SRI Response Rate at Week 76
timeFrame: Baseline, 76 Weeks
measure: Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
timeFrame: Baseline, 52 Weeks
measure: Mean Change in Physician's Global Assessment (PGA) at Week 24.
timeFrame: Baseline, 24 Weeks
measure: 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
measure: 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
Other outcomes:
measure: Adverse Event (AE) Overview
timeFrame: Up to 80 Weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Paradise Valley
country: United States
facility: Arizona Arthritis and Rheumatology Research, PPLC
state: Arizona
city: Tucson
country: United States
facility: The University of Arizona Arthritis Center
state: Arizona
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Wallace Rheumatic Study Center
state: California
city: Los Angeles
country: United States
facility: UCLA Rheumatology
state: California
city: San Jose
country: United States
facility: Arthritis Care Center, Inc.
state: California
city: Upland
country: United States
facility: Inland Rheumatic Disease Specialties
state: California
city: Colorado Springs
country: United States
facility: Arthritis Associates of Colorado Springs
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Miami
country: United States
facility: University of Miami-Division of Rheumatology and Immunology
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
city: Tampa
country: United States
facility: Southwest Florida Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, P.A.
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boise
country: United States
facility: Selah Medical Clinical Research Unit
state: Idaho
city: Chicago
country: United States
facility: Rheumatology Associates, SC
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
city: Munster
country: United States
facility: Medical Specialists Clinical Research
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Louisville
country: United States
facility: Kentuckiana Center for Better Bone and Joint Health
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cumberland
country: United States
facility: Osteoporosis and Clinical Trials Center
state: Maryland
city: Hagerstown
country: United States
facility: Osteoporosis & Clinical Trials Center
state: Maryland
city: Boston
country: United States
facility: Tufts - New England Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center - Regents of University of Michigan
state: Michigan
city: Lansing
country: United States
facility: Fiechtner Research, Inc.
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Dover
country: United States
facility: Stafford Medical Associates, PA
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY-Downstate Medical Center
state: New York
city: Lake Success
country: United States
facility: North Shore-LIJ Health System/Rheumatology and Allergy Clinic
state: New York
city: Manhasset
country: United States
facility: Feinstein Institute
state: New York
city: New York
country: United States
facility: Hopital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Smithtown
country: United States
facility: Rheumatology Associates
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Services
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Center For Arthritis Therapy & Research
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates
state: Pennsylvania
city: Duncanville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA/Low Country Research Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Palmetto Clinical Trial at Piedmont Arthritis Clinic
state: South Carolina
city: Austin
country: United States
facility: Walter Chase
state: Texas
city: Dallas
country: United States
facility: University of Texas - Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: The Rheumatic Disease Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Arthritis Center of South Texas
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center
state: Texas
city: Salt Lake City
country: United States
facility: Rheumatology Clinic
state: Utah
city: Arlington
country: United States
facility: Arthritis Clinic of Northern Virginia, P.C.
state: Virginia
city: Seattle
country: United States
facility: The Seattle Arthritis Clinic
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Onalaska
country: United States
facility: Gundersen Clinic, Ltd.
state: Wisconsin
city: Graz
country: Austria
facility: Universitatsklinik fur innere Medizin
city: Vienna
country: Austria
facility: Rheumazentrum Favoriten
city: Brussels
country: Belgium
facility: Cliniques Universitaires
city: Leuven
country: Belgium
facility: University Hospital
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Toronto
country: Canada
facility: Centre for Prognosis Studies in Rheaumatic Diseases
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre, Montreal General Hospital
city: San Jose
country: Costa Rica
facility: Hospital Clinica Biblica
city: Brno
country: Czech Republic
facility: University Hospital Brno
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Prague
country: Czech Republic
facility: Institute of Rheumatology
city: Le Kremlin Bicetre
country: France
facility: CHU Hospital de Bicetre
city: Lille Cedex
country: France
facility: Hospital Huriez
city: Stasbourg
country: France
facility: Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
city: Suresnes Cedex
country: France
facility: Hospital FOCH
city: Toulouse
country: France
facility: Centre Hospitalier Universitarie (CHU) - PURPAA
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klink Bad Nauheim
city: Berlin
country: Germany
facility: Schlossparkklinik
city: Berlin
country: Germany
facility: Charite
city: Dusseldorf
country: Germany
facility: Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
city: Erlangen
country: Germany
facility: FA Universitat Erlangen Nurnberg
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Medizinische Universitatsklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Jena
country: Germany
facility: Friedrich Schiller Universitat
city: Kiel
country: Germany
facility: Universitatsklinik Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Mainz
country: Germany
facility: Universitatsklinik Mainz
city: Tubingen
country: Germany
facility: Universitatsklinikum Tubingen
city: Beer-Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: B'nai-Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Petach Tikva
country: Israel
facility: Beilinson Hospital, Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Saurasky Medical Center
city: Ferrara
country: Italy
facility: A. O. Ospedaliera-Universitaria Arcispedale
city: Milano
country: Italy
facility: A.O. Ospedale San Carlo Borromeo
city: Modena
country: Italy
facility: Policlinico di Modena
city: Padova
country: Italy
facility: Policlinico Universitario of Padova
city: Rome
country: Italy
facility: A.O. San Camillo
city: Rome
country: Italy
facility: Policlinico Umberto 1
city: Scafati
country: Italy
facility: U.O. di reumatologia Presidio Ospedaliero di Scafati
city: Udine
country: Italy
facility: Azienda Ospedaliero University-Santa Maria della Misericordia
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"
city: Jalisco
country: Mexico
facility: Instituto Jalisciense de Investigacion Clinica
city: Mexico City
country: Mexico
facility: Hospital General de México
city: Mexico City
country: Mexico
facility: Hospital Regional 1o de Octubre - ISSSTE
city: Mexico City
country: Mexico
facility: Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
city: San Luis Potosi
country: Mexico
facility: Hospital Central de S.L.P. "Iganico Morones Prieto"
city: Toluca
country: Mexico
facility: Instituto de Seguridad Social del Estado de Mexico y Municipios
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: University Medical Center Maastricht
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Ikazia Ziekenhuis
city: Bydgoszcz
country: Poland
facility: Szpital Uniwerytecki nr Zim. dr. Jana Biziela
city: Konskie
country: Poland
facility: Szpital Specjalistyczny Sw. Lukasza
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne
city: Lublin
country: Poland
facility: Gabinety Profesorow Osrodek Baden Klinicznych
city: Warszawa
country: Poland
facility: Klinika Reumatologii im Prof. Eleonory Reicher
city: Wroclaw
country: Poland
facility: Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine
city: Rio Piedras
country: Puerto Rico
facility: University of Puerto Rico Medical Center
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Sf Maria"
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Piestany
country: Slovakia
facility: Narodny Ustav Reumatickych Chorob
city: Barcelona
country: Spain
facility: Hospital La Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Barcelona
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de SAS - Carlos Haya
city: Mallorca
country: Spain
facility: Hospital Son Dureta
city: Goteborg
country: Sweden
facility: Sahlgrensja University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Human Genome Sciences Inc.
name: GSK Clinical Trials
role: STUDY_DIRECTOR
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