Last updated: 11/04/2018 08:08:07
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)BLISS-52
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, 52-Wk 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:
Percent of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score at Wk 52.
Timeframe: Baseline, 52 weeks
Mean change in Physician's Global Assessment (PGA) at Wk 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 Wk 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 through 52
Interventions:
Drug: Placebo
Drug: Belimumab 1 mg/kg
Drug: Belimumab 10 mg/kg
Enrollment:
865
Observational study model:
Not applicable
Primary completion date:
2009-31-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
GlaxoSmithKline, GSK
Study date(s)
May 2007 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
Hospital das Clínicas - Universidade do Paraná
Curitiba, Brazil, 80060-240
Status
Study Complete
Location
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj Napoca, Romania, 40006
Status
Study Complete
Location
Hospital Unversitario Clementino Fraga Filho UFRJ
Rio de Janeiro, Brazil, 21941-913
Status
Study Complete
Location
Hospital Interzonal General San Martín
La Plata, Argentina, B1904CFH
Status
Study Complete
Location
Fundación Instituto de Reumatología Fernando Chalem
Bogota, Colombia
Status
Study Complete
Location
Buddhist Tzu Chi General Hospital - Hualien
Haulien, Taiwan, 970
Status
Study Complete
Location
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Brazil, 20551-030
Status
Study Complete
Location
Hospital Nacional Alberto Sabogal Sologuren ESSALUD
Lima, Peru, Callao 2
Status
Study Complete
Location
Academy of Post-Graduated Education
St.-Petersburg, Russia, 191015
Status
Study Complete
Location
CIER, Centro de Investigaciones en Enfermedades Reumáticas
Ciudad Autonoma de Buenos Aires, Argentina, C1055AAF
Status
Study Complete
Location
Corporación para Investigaciones Biológicas (CIB)
Medellín, Colombia
Status
Study Complete
Location
Clinica Ricardo Palma Anexo 9 - Javier Prado Este
Lima, Peru, L 27
Status
Study Complete
Location
Hospital de Clínicas - Universidade Federal de Pernambuco
Fortaleza, Brazil, 50670-901
Status
Study Complete
Location
The Hospital for Rheumatic Diseases, Hanyang University Hospital
Seoul, South Korea, 133-792
Status
Study Complete
Location
Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle
Bucaramanga, Santander, Colombia
Status
Study Complete
Location
St. Petersburg City Hospital (Rheumatology Center)
St. Petersburg, Russia, 190068
Status
Study Complete
Location
Krishna Institute of Medical Sciences
Hyderabaad, India, 500 003
Status
Study Complete
Location
Chang Gung Memorial Hospital, Linko
Tau-Yuan County, Taiwan, 333
Status
Study Complete
Location
CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
Rosario, Argentina, S2000PBJ
Status
Study Complete
Location
Centro Privado de Medicina Familiar
Buenos Aires, Argentina, C1417EYG
Status
Study Complete
Location
Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota
Bucharest, Romania, 020125
Status
Study Complete
Location
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima, Peru, L 13
Status
Study Complete
Location
Kyungpook National Univesity Hospital
Daegu, South Korea, 700-721
Status
Study Complete
Location
Chhatrapati Shahuji Maharaj Medical University
Lucknow, India, 226018
Status
Study Complete
Location
Hospital do Servidor Público Estadual de São Paulo - Francisco Morato de Oliveira
São Paulo, Brazil, 04039-901
Status
Study Complete
Location
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Argentina, T4000AXL
Status
Study Complete
Location
Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)
Bogotá, Colombia
Status
Study Complete
Location
Dong-A University Hospital 3-1 (Dept. Rhuematology)
Pusan, South Korea, 602-715
Status
Study Complete
Location
Rheumatology Assessment and Treatment Center, Pok Oi Hospital
Shatin, Hong Kong
Status
Study Complete
Location
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina, C1280AEB
Status
Study Complete
Location
University of Santo Tomas Hospital
Manila City, Philippines, 1008
Status
Study Complete
Location
Instituto de Investigaciones Medicas
Buenos Aires, Argentina, C1427ARO
Status
Study Complete
Location
Pontificia Universidad Católica de Chile
Santiago, Chile, 8330033
Status
Study Complete
Location
City Healthcare Institution Municipal Hospital NPZ,
Yaroslavl, Russia, 190068
Status
Study Complete
Location
Catholic Universtigy of Korea, Kangnam St. Mary's Hospital
Seoul, South Korea, 137-701
Status
Study Complete
Location
St.-Petersburg Region Clinical Hospital
St.-Petersburg, Russia, 194291
Status
Study Complete
Location
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung, Taiwan, 807
Status
Study Complete
Location
State Institution Scientific Research Institute of Rheumatology
Moscow, Russia, 115522
Status
Study Complete
Location
University of Perpetual Help -Rizal
Las Pinas City, Philippines, 1740
Status
Study Complete
Location
Atencion Integral en Reumatologia
Buenos Aires, Argentina, C1426AAL
Status
Study Complete
Location
OMI, Organización Médica de Investigación
Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO
Status
Study Complete
Location
Hospital Universitário - Universidade Federal de Juiz de Fora
Juiz de Fora, Brazil, 36010-570
Status
Study Complete
Location
Nizam's Institute of Medical Sciences
Hyderabaad, India, 500 082
Status
Study Complete
Location
Catholic University, Yoido St. Mary's Hospital
Seoul, South Korea, 150-713
Status
Study Complete
Location
Hospital General de Agudos Carlos G. Durand
Ciudad Autonoma de Buenos Aires, Argentina, C1405DCS
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
2009-31-05
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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