A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00424476
Last Updated: 2016-12-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
865 participants
INTERVENTIONAL
2007-05-31
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Belimumab 1 mg/kg
Belimumab 1 mg/kg
Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Interventions
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Placebo
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Belimumab 1 mg/kg
Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Belimumab 10 mg/kg
Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
Human Genome Sciences Inc.
Locations
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OMI, Organización Médica de Investigación
Buenos Aires, , Argentina
CIER, Centro de Investigaciones en Enfermedades Reumáticas
Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Buenos Aires, , Argentina
Hospital General de Agudos Carlos G. Durand
Buenos Aires, , Argentina
Centro Privado de Medicina Familiar
Buenos Aires, , Argentina
Hospital Sirio Libanes
Buenos Aires, , Argentina
Atencion Integral en Reumatologia
Buenos Aires, , Argentina
Instituto de Investigaciones Medicas
Buenos Aires, , Argentina
Hospital Interzonal General San Martín
La Plata, , Argentina
CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
Rosario, , Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, , Argentina
Repatriation Hospital
Daw Park, , Australia
Emeritus Research, Cabrini Hospital
Melbourne, , Australia
Monash Medical Centre
Melbourne, , Australia
Royal Perth Hospital
Shenton Park, , Australia
Hospital de Clínicas - UNICAMP
Campinas, , Brazil
Hospital das Clínicas - Universidade do Paraná
Curitiba, , Brazil
Hospital de Clínicas - Universidade Federal de Pernambuco
Fortaleza, , Brazil
Hospital Geral de Goiânia
Goiânia, , Brazil
Hospital Universitário - Universidade Federal de Juiz de Fora
Juiz de Fora, , Brazil
Hospital São Lucas da PUC-RS
Porto Alegre, , Brazil
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, , Brazil
Hospital Unversitario Clementino Fraga Filho UFRJ
Rio de Janeiro, , Brazil
Hospital Santa Izabel
Salvador, , Brazil
Hospital Abreu Sodré
São Paulo, , Brazil
Hospital do Servidor Público Estadual de São Paulo - Francisco Morato de Oliveira
São Paulo, , Brazil
Hospital Heliópolis
São Paulo, , Brazil
Hospital Dr. Sotero del Rio
Santiago, , Chile
Pontificia Universidad Católica de Chile
Santiago, , Chile
Clínica Dávila
Santiago, , Chile
Hospital Dr. Gustavo Fricke
Viña del Mar, , Chile
Office of Dr. Guzman
Bogota, Cundinamarca, Colombia
Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle
Bucaramanga, Santander Department, Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, , Colombia
Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)
Bogotá, , Colombia
Fundación Instituto de Reumatología Fernando Chalem
Bogotá, , Colombia
Riesgo de Fracturas
Bogotá, , Colombia
SERVIMED
Bucaramanga, , Colombia
Corporación para Investigaciones Biológicas (CIB)
Medellín, , Colombia
Office of Dr. Jose Molina
Medellín, , Colombia
Pamela Youde Nethersole Eastern Hospital
Chai Wan, , Hong Kong
Rheumatology Assessment and Treatment Center, Pok Oi Hospital
Shatin, , Hong Kong
Tuen Mun Hospital
Tuenmen, , Hong Kong
St. John's Medical College Hospital
Bangalore, , India
Krishna Institute of Medical Sciences
Hyderabaad, , India
Nizam's Institute of Medical Sciences
Hyderabaad, , India
Apollo Hospitals
Hyderabad, , India
Chhatrapati Shahuji Maharaj Medical University
Lucknow, , India
King Edward Memorial (K.E.M.) Hospital
Mumbai, , India
Kerala Institute of Medical Sciences
Trivandrum, , India
Hospital Nacional Alberto Sabogal Sologuren ESSALUD
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima, , Peru
Clinica Ricardo Palma Anexo 9 - Javier Prado Este
Lima, , Peru
Instituto de Ginecología y Reproducción
Lima, , Peru
Chong Hua Hospital
Cebu City, , Philippines
Davao Medical Center
Davao City, , Philippines
University of Perpetual Help -Rizal
Las Piñas, , Philippines
Philippine General Hospital
Manila, , Philippines
University of Santo Tomas Hospital
Manila, , Philippines
St. Luke's Medical Center
Quezon City, , Philippines
Spitalul Clinic Sf Maria
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota
Bucharest, , Romania
Spitalul Clinic Dr. Ion Cantacuzino
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, , Romania
State Institution Scientific Research Institute of Rheumatology
Moscow, , Russia
St. Petersburg City Hospital (Rheumatology Center)
Saint Petersburg, , Russia
Academy of Post-Graduated Education
Saint Petersburg, , Russia
St.-Petersburg Region Clinical Hospital
Saint Petersburg, , Russia
Soloviev's City Clinical Hospital,
Yaroslavl, , Russia
City Healthcare Institution Municipal Hospital NPZ,
Yaroslavl, , Russia
Kyungpook National Univesity Hospital
Daegu, , South Korea
Eulji University Hospital
Daejeon, , South Korea
Inha University Hospital
Inchon, , South Korea
Dong-A University Hospital 3-1 (Dept. Rhuematology)
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Hospital for Rheumatic Diseases, Hanyang University Hospital
Seoul, , South Korea
Catholic Universtigy of Korea, Kangnam St. Mary's Hospital
Seoul, , South Korea
Catholic University, Yoido St. Mary's Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Buddhist Tzu Chi General Hospital, Dalin
Chiayi City, , Taiwan
Buddhist Tzu Chi General Hospital - Hualien
Haulien, , Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital, Kaosiung
Kaosiung, , Taiwan
Chang Gung Memorial Hospital-Keelung
Keelung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linko
Tau-Yuan County, , Taiwan
Countries
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References
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Botto J, Cetrez N, Nikolopoulos D, Regardt M, Heintz E, Lindblom J, Parodis I. Predicting EQ-5D full health state in systemic lupus erythematosus using machine learning algorithms. Rheumatol Adv Pract. 2025 Apr 18;9(2):rkaf032. doi: 10.1093/rap/rkaf032. eCollection 2025.
Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.
Jesus D, Henriques C, Matos A, Doria A, Ines LS. Systemic Lupus Erythematosus Disease Activity Score Remission and Low Disease Activity States Discriminate Drug From Placebo and Better Health-Related Quality of Life. Arthritis Care Res (Hoboken). 2024 Jun;76(6):788-795. doi: 10.1002/acr.25305. Epub 2024 Feb 29.
Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.
Emamikia S, Oon S, Gomez A, Lindblom J, Borg A, Enman Y, Morand E, Grannas D, van Vollenhoven RF, Nikpour M, Parodis I. Impact of remission and low disease activity on health-related quality of life in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2022 Nov 28;61(12):4752-4762. doi: 10.1093/rheumatology/keac185.
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.
Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
Gomez A, Hani Butrus F, Johansson P, Akerstrom E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.
van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.
Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.
Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.
Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.
van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.
Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.
Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, Li EK, Thomas M, Kim HY, Leon MG, Tanasescu C, Nasonov E, Lan JL, Pineda L, Zhong ZJ, Freimuth W, Petri MA; BLISS-52 Study Group. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011 Feb 26;377(9767):721-31. doi: 10.1016/S0140-6736(10)61354-2. Epub 2011 Feb 4.
Study Documents
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Document Type: Informed Consent Form
View DocumentDocument Type: Clinical Study Report
View DocumentDocument Type: Study Protocol
View DocumentDocument Type: Annotated Case Report Form
View DocumentDocument Type: Dataset Specification
View DocumentDocument Type: Statistical Analysis Plan
View DocumentDocument Type: Individual Participant Data Set
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Other Identifiers
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BLISS-52
Identifier Type: OTHER
Identifier Source: secondary_id
110752
Identifier Type: OTHER
Identifier Source: secondary_id
HGS1006-C1057
Identifier Type: -
Identifier Source: org_study_id