A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Registration Number
- NCT00424476
- Lead Sponsor
- Human Genome Sciences Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 865
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Belimumab 10 mg/kg Belimumab 10 mg/kg Belimumab 10 mg/kg Placebo Placebo Placebo Belimumab 1 mg/kg Belimumab 1 mg/kg Belimumab 1 mg/kg
- Primary Outcome Measures
Name Time Method SLE Responder Index (SRI) Response Rate at Week 52 Baseline, 52 weeks 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
Name Time Method Mean Change in Physician's Global Assessment (PGA) at Wk 24. Baseline, 24 weeks 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.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 Baseline, Weeks 40 through 52 Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. Baseline, 52 weeks Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24. Baseline, 24 weeks 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.
Trial Locations
- Locations (92)
CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
🇦🇷Rosario, Argentina
Fundación Instituto de Reumatología Fernando Chalem
🇨🇴Bogota, Colombia
Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)
🇨🇴Bogotá, Colombia
Davao Medical Center
🇵🇭Davao City, Philippines
University of Santo Tomas Hospital
🇵🇭Manila City, Philippines
University of Perpetual Help -Rizal
🇵🇭Las Pinas City, Philippines
St. Petersburg City Hospital (Rheumatology Center)
🇷🇺St. Petersburg, Russian Federation
Buddhist Tzu Chi General Hospital, Dalin
🇨🇳Chia-Yi, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital, Linko
🇨🇳Tau-Yuan County, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
St.-Petersburg Region Clinical Hospital
🇷🇺St.-Petersburg, Russian Federation
City Healthcare Institution Municipal Hospital NPZ,
🇷🇺Yaroslavl, Russian Federation
Buddhist Tzu Chi General Hospital - Hualien
🇨🇳Haulien, Taiwan
Hospital Interzonal General San Martín
🇦🇷La Plata, Argentina
Spitalul Clinic Dr. Ion Cantacuzino
🇷🇴Bucharest, Romania
Chang Gung Memorial Hospital, Kaosiung
🇨🇳Kaosiung, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Spitalul Clinic Colentina
🇷🇴Bucharest, Romania
State Institution Scientific Research Institute of Rheumatology
🇷🇺Moscow, Russian Federation
Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota
🇷🇴Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
🇷🇴Cluj Napoca, Romania
Academy of Post-Graduated Education
🇷🇺St.-Petersburg, Russian Federation
Soloviev's City Clinical Hospital,
🇷🇺Yaroslavl, Russian Federation
Chung-Ho Memorial Hospital, Kaohsiung Medical University
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Chang Gung Memorial Hospital-Keelung
🇨🇳Keelung, Taiwan
Hospital Sirio Libanes
🇦🇷Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Centro Privado de Medicina Familiar
🇦🇷Buenos Aires, Argentina
Atencion Integral en Reumatologia
🇦🇷Buenos Aires, Argentina
Instituto de Investigaciones Medicas
🇦🇷Buenos Aires, Argentina
OMI, Organización Médica de Investigación
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Repatriation Hospital
🇦🇺Daw Park, Australia
CIER, Centro de Investigaciones en Enfermedades Reumáticas
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Hospital General de Agudos Carlos G. Durand
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Centro Medico Privado de Reumatologia
🇦🇷San Miguel de Tucuman, Argentina
Emeritus Research, Cabrini Hospital
🇦🇺Melbourne, Australia
Monash Medical Centre
🇦🇺Melbourne, Australia
Hospital de Clínicas - UNICAMP
🇧🇷Campinas, Brazil
Royal Perth Hospital
🇦🇺Shenton Park, Australia
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 Pedro Ernesto - UERJ
🇧🇷Rio de Janeiro, Brazil
Hospital Unversitario Clementino Fraga Filho UFRJ
🇧🇷Rio de Janeiro, Brazil
Hospital São Lucas da PUC-RS
🇧🇷Porto Alegre, 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
Clínica Dávila
🇨🇱Santiago, Chile
Hospital Dr. Sotero del Rio
🇨🇱Santiago, Chile
Pontificia Universidad Católica de Chile
🇨🇱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, Colombia
Centro de Reumatologia y Ortopedia
🇨🇴Barranquilla, Colombia
Riesgo de Fracturas
🇨🇴Bogotá, Colombia
SERVIMED
🇨🇴Bucaramanga, Colombia
Office of Dr. Jose Molina
🇨🇴Medellín, Colombia
Corporación para Investigaciones Biológicas (CIB)
🇨🇴Medellín, Colombia
St. John's Medical College Hospital
🇮🇳Bangalore, India
Krishna Institute of Medical Sciences
🇮🇳Hyderabaad, India
Apollo Hospitals
🇮🇳Hyderabad, India
Nizam's Institute of Medical Sciences
🇮🇳Hyderabaad, India
Chhatrapati Shahuji Maharaj Medical University
🇮🇳Lucknow, India
King Edward Memorial (K.E.M.) Hospital
🇮🇳Mumbai, India
Kerala Institute of Medical Sciences
🇮🇳Trivandrum, India
Kyungpook National Univesity Hospital
🇰🇷Daegu, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
Dong-A University Hospital 3-1 (Dept. Rhuematology)
🇰🇷Pusan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Hospital for Rheumatic Diseases, Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University, Yoido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Hospital Nacional Alberto Sabogal Sologuren ESSALUD
🇵🇪Lima, Peru
Clinica Ricardo Palma Anexo 9 - Javier Prado Este
🇵🇪Lima, Peru
Chong Hua Hospital
🇵🇭Cebu City, Philippines
Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
🇵🇪Lima, Peru
Instituto de Ginecología y Reproducción
🇵🇪Lima, Peru
Philippine General Hospital
🇵🇭Manila City, Philippines
St. Luke's Medical Center
🇵🇭Quezon City, Philippines
Spitalul Clinic Sf Maria
🇷🇴Bucharest, Romania
Hospital Universitário - Universidade Federal de Juiz de Fora
🇧🇷Juiz de Fora, Brazil
Hospital Santa Izabel
🇧🇷Salvador, Brazil
Catholic Universtigy of Korea, Kangnam St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Tuen Mun Hospital
🇭🇰Tuen Mun, Hong Kong
Pamela Youde Nethersole Eastern Hospital
🇭🇰Chai Wan, Hong Kong
Rheumatology Assessment and Treatment Center, Pok Oi Hospital
🇭🇰Shatin, Hong Kong