A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-52)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Human Genome Sciences Inc.
ClinicalTrials.gov Identifier:
NCT00424476
First received: January 17, 2007
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, 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)

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:
  • Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Mean Change in Physician's Global Assessment (PGA) at Wk 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 Wk 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 through 52 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse Events (AE) Overview [ Time Frame: Up to 56 Weeks ] [ Designated as safety issue: Yes ]
    SEE ALSO ADVERSE EVENTS RESULTS SECTION


Enrollment: 865
Study Start Date: May 2007
Study Completion Date: March 2010
Primary Completion Date: May 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 Week 48.
Experimental: Belimumab 1 mg/kg
Belimumab 1 mg/kg
Drug: 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.
Other Name: BENLYSTA™ (formerly LymphoStat-B™)
Experimental: Belimumab 10 mg/kg
Belimumab 10 mg/kg
Drug: 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 Name: BENLYSTA™ (formerly LymphoStat-B™)

  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: NCT00424476

  Hide Study Locations
Locations
Argentina
Centro Privado de Medicina Familiar
Buenos Aires, Argentina, C1417EYG
Hospital Sirio Libanes
Buenos Aires, Argentina, C1419AHN
Instituto de Investigaciones Medicas
Buenos Aires, Argentina, C1427ARO
Atencion Integral en Reumatologia
Buenos Aires, Argentina, C1426AAL
Hospital Britanico de Buenos Aires
Buenos Aires, Argentina, C1280AEB
OMI, Organización Médica de Investigación
Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO
Hospital General de Agudos Carlos G. Durand
Ciudad Autonoma de Buenos Aires, Argentina, C1405DCS
CIER, Centro de Investigaciones en Enfermedades Reumáticas
Ciudad Autonoma de Buenos Aires, Argentina, C1055AAF
Hospital Interzonal General San Martín
La Plata, Argentina, B1904CFH
CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
Rosario, Argentina, S2000PBJ
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Argentina, T4000AXL
Australia
Repatriation Hospital
Daw Park, Australia, 5041
Emeritus Research, Cabrini Hospital
Melbourne, Australia, 3144
Monash Medical Centre
Melbourne, Australia, 3168
Royal Perth Hospital
Shenton Park, Australia, 6008
Brazil
Hospital de Clínicas - UNICAMP
Campinas, Brazil, 13083-888
Hospital das Clínicas - Universidade do Paraná
Curitiba, Brazil, 80060-240
Hospital de Clínicas - Universidade Federal de Pernambuco
Fortaleza, Brazil, 50670-901
Hospital Geral de Goiânia
Goiânia, Brazil, 74110-120
Hospital Universitário - Universidade Federal de Juiz de Fora
Juiz de Fora, Brazil, 36010-570
Hospital São Lucas da PUC-RS
Porto Alegre, Brazil, 90610-000
Hospital Unversitario Clementino Fraga Filho UFRJ
Rio de Janeiro, Brazil, 21941-913
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Brazil, 20551-030
Hospital Santa Izabel
Salvador, Brazil, 40050-410
Hospital Heliópolis
São Paulo, Brazil, 04266-010
Hospital Abreu Sodré
São Paulo, Brazil, 04027-000
Hospital do Servidor Público Estadual de São Paulo - Francisco Morato de Oliveira
São Paulo, Brazil, 04039-901
Chile
Clínica Dávila
Santiago, Chile, 8431657
Hospital Dr. Sotero del Rio
Santiago, Chile, 8207257
Pontificia Universidad Católica de Chile
Santiago, Chile, 8330033
Hospital Dr. Gustavo Fricke
Viña del Mar, Chile, 2570017
Colombia
Office of Dr. Guzman
Bogota, Cundinamarca, Colombia
Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle
Bucaramanga, Santander, Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, Colombia
Fundación Instituto de Reumatología Fernando Chalem
Bogota, Colombia
Riesgo de Fracturas
Bogotá, Colombia
Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)
Bogotá, Colombia
SERVIMED
Bucaramanga, Colombia
Office of Dr. Jose Molina
Medellín, Colombia
Corporación para Investigaciones Biológicas (CIB)
Medellín, Colombia
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Rheumatology Assessment and Treatment Center, Pok Oi Hospital
Shatin, Hong Kong
Tuen Mun Hospital
Tuen Mun, Hong Kong
India
St. John's Medical College Hospital
Bangalore, India, 560 034
Nizam's Institute of Medical Sciences
Hyderabaad, India, 500 082
Krishna Institute of Medical Sciences
Hyderabaad, India, 500 003
Apollo Hospitals
Hyderabad, India, 500 033
Chhatrapati Shahuji Maharaj Medical University
Lucknow, India, 226018
King Edward Memorial (K.E.M.) Hospital
Mumbai, India, 400 012
Kerala Institute of Medical Sciences
Trivandrum, India, 695029
Korea, Republic of
Kyungpook National Univesity Hospital
Daegu, Korea, Republic of, 700-721
Eulji University Hospital
Daejeon, Korea, Republic of, 302-799
Inha University Hospital
Inchon, Korea, Republic of, 400-711
Pusan National University Hospital
Pusan, Korea, Republic of, 602-739
Dong-A University Hospital 3-1 (Dept. Rhuematology)
Pusan, Korea, Republic of, 602-715
Catholic Universtigy of Korea, Kangnam St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Catholic University, Yoido St. Mary's Hospital
Seoul, Korea, Republic of, 150-713
The Hospital for Rheumatic Diseases, Hanyang University Hospital
Seoul, Korea, Republic of, 133-792
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Ajou University Hospital
Suwon, Korea, Republic of, 443-721
Peru
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
Lima, Peru, L 13
Hospital Nacional Alberto Sabogal Sologuren ESSALUD
Lima, Peru, Callao 2
Instituto de Ginecología y Reproducción
Lima, Peru, L 33
Clinica Ricardo Palma Anexo 9 - Javier Prado Este
Lima, Peru, L 27
Philippines
Chong Hua Hospital
Cebu City, Philippines, 6000
Davao Medical Center
Davao City, Philippines, 8000
University of Perpetual Help -Rizal
Las Pinas City, Philippines, 1740
Philippine General Hospital
Manila City, Philippines, 1000
University of Santo Tomas Hospital
Manila City, Philippines, 1008
St. Luke's Medical Center
Quezon City, Philippines, 1102
Romania
Spitalul Clinic Colentina
Bucharest, Romania, 020125
Spitalul Clinic Dr. Ion Cantacuzino
Bucharest, Romania, 020475
Spitalul Clinic Sf Maria
Bucharest, Romania, 011170
Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota
Bucharest, Romania, 020125
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj Napoca, Romania, 40006
Russian Federation
State Institution Scientific Research Institute of Rheumatology
Moscow, Russian Federation, 115522
St. Petersburg City Hospital (Rheumatology Center)
St. Petersburg, Russian Federation, 190068
Academy of Post-Graduated Education
St.-Petersburg, Russian Federation, 191015
St.-Petersburg Region Clinical Hospital
St.-Petersburg, Russian Federation, 194291
Soloviev's City Clinical Hospital,
Yaroslavl, Russian Federation, 150003
City Healthcare Institution Municipal Hospital NPZ,
Yaroslavl, Russian Federation, 190068
Taiwan
Buddhist Tzu Chi General Hospital, Dalin
Chia-Yi, Taiwan, 622
Buddhist Tzu Chi General Hospital - Hualien
Haulien, Taiwan, 970
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Chang Gung Memorial Hospital, Kaosiung
Kaosiung, Taiwan, 833
Chang Gung Memorial Hospital-Keelung
Keelung, Taiwan, 204
Taichung Veterans General Hospital
Taichung, Taiwan, 407
China Medical University Hospital
Taichung, Taiwan, 404
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
National Taiwan University Hospital
Taipei, Taiwan, 100
Chang Gung Memorial Hospital, Linko
Tau-Yuan County, Taiwan, 333
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: NCT00424476     History of Changes
Other Study ID Numbers: HGS1006-C1057, BLISS-52, 110752
Study First Received: January 17, 2007
Results First Received: April 7, 2011
Last Updated: February 13, 2014
Health Authority: Romania: Ministry of Public Health
Brazil: National Health Surveillance Agency
United States: Food and Drug Administration
Korea: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Chile: Instituto de Salud Pública de Chile
Taiwan: Department of Health
India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Hong Kong: Department of Health
Russia: Ministry of Health of the Russian Federation
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Australia: Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Belimumab
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014