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

PHASE3CompletedINTERVENTIONAL
Enrollment

865

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

May 31, 2009

Study Completion Date

March 31, 2010

Conditions
Systemic Lupus Erythematosus
Interventions
DRUG

Placebo

Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.

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.

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.

Trial Locations (92)

100

National Taiwan University Hospital, Taipei

204

Chang Gung Memorial Hospital-Keelung, Keelung

333

Chang Gung Memorial Hospital, Linko, Tau-Yuan County

402

Chung Shan Medical University Hospital, Taichung

404

China Medical University Hospital, Taichung

407

Taichung Veterans General Hospital, Taichung

622

Buddhist Tzu Chi General Hospital, Dalin, Chiayi City

807

Chung-Ho Memorial Hospital, Kaohsiung Medical University, Kaohsiung City

813

Kaohsiung Veterans General Hospital, Kaohsiung City

833

Chang Gung Memorial Hospital, Kaosiung, Kaosiung

970

Buddhist Tzu Chi General Hospital - Hualien, Haulien

1000

Philippine General Hospital, Manila

1008

University of Santo Tomas Hospital, Manila

1102

St. Luke's Medical Center, Quezon City

1740

University of Perpetual Help -Rizal, Las Piñas

3144

Emeritus Research, Cabrini Hospital, Melbourne

3168

Monash Medical Centre, Melbourne

5041

Repatriation Hospital, Daw Park

6000

Chong Hua Hospital, Cebu City

6008

Royal Perth Hospital, Shenton Park

8000

Davao Medical Center, Davao City

40006

Spitalul Clinic Judetean de Urgenta Cluj-Napoca, Cluj-Napoca

115522

State Institution Scientific Research Institute of Rheumatology, Moscow

150003

Soloviev's City Clinical Hospital,, Yaroslavl

190068

St. Petersburg City Hospital (Rheumatology Center), Saint Petersburg

City Healthcare Institution Municipal Hospital NPZ,, Yaroslavl

191015

Academy of Post-Graduated Education, Saint Petersburg

194291

St.-Petersburg Region Clinical Hospital, Saint Petersburg

226018

Chhatrapati Shahuji Maharaj Medical University, Lucknow

695029

Kerala Institute of Medical Sciences, Trivandrum

2570017

Hospital Dr. Gustavo Fricke, Viña del Mar

8207257

Hospital Dr. Sotero del Rio, Santiago

8330033

Pontificia Universidad Católica de Chile, Santiago

8431657

Clínica Dávila, Santiago

C1015ABO

OMI, Organización Médica de Investigación, Buenos Aires

C1055AAF

CIER, Centro de Investigaciones en Enfermedades Reumáticas, Buenos Aires

C1280AEB

Hospital Britanico de Buenos Aires, Buenos Aires

C1405DCS

Hospital General de Agudos Carlos G. Durand, Buenos Aires

C1417EYG

Centro Privado de Medicina Familiar, Buenos Aires

C1419AHN

Hospital Sirio Libanes, Buenos Aires

C1426AAL

Atencion Integral en Reumatologia, Buenos Aires

C1427ARO

Instituto de Investigaciones Medicas, Buenos Aires

B1904CFH

Hospital Interzonal General San Martín, La Plata

S2000PBJ

CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral, Rosario

T4000AXL

Centro Medico Privado de Reumatologia, San Miguel de Tucumán

13083-888

Hospital de Clínicas - UNICAMP, Campinas

80060-240

Hospital das Clínicas - Universidade do Paraná, Curitiba

50670-901

Hospital de Clínicas - Universidade Federal de Pernambuco, Fortaleza

74110-120

Hospital Geral de Goiânia, Goiânia

36010-570

Hospital Universitário - Universidade Federal de Juiz de Fora, Juiz de Fora

90610-000

Hospital São Lucas da PUC-RS, Porto Alegre

20551-030

Hospital Universitário Pedro Ernesto - UERJ, Rio de Janeiro

21941-913

Hospital Unversitario Clementino Fraga Filho UFRJ, Rio de Janeiro

40050-410

Hospital Santa Izabel, Salvador

04027-000

Hospital Abreu Sodré, São Paulo

04039-901

Hospital do Servidor Público Estadual de São Paulo - Francisco Morato de Oliveira, São Paulo

04266-010

Hospital Heliópolis, São Paulo

Unknown

Office of Dr. Guzman, Bogota

Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle, Bucaramanga

Centro de Reumatologia y Ortopedia, Barranquilla

Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH), Bogotá

Fundación Instituto de Reumatología Fernando Chalem, Bogotá

Riesgo de Fracturas, Bogotá

SERVIMED, Bucaramanga

Corporación para Investigaciones Biológicas (CIB), Medellín

Office of Dr. Jose Molina, Medellín

Pamela Youde Nethersole Eastern Hospital, Chai Wan

Rheumatology Assessment and Treatment Center, Pok Oi Hospital, Shatin

Tuen Mun Hospital, Tuenmen

560 034

St. John's Medical College Hospital, Bangalore

500 003

Krishna Institute of Medical Sciences, Hyderabaad

500 082

Nizam's Institute of Medical Sciences, Hyderabaad

500 033

Apollo Hospitals, Hyderabad

400 012

King Edward Memorial (K.E.M.) Hospital, Mumbai

Callao 2

Hospital Nacional Alberto Sabogal Sologuren ESSALUD, Lima

L 13

Hospital Nacional Guillermo Almenara Irigoyen ESSALUD, Lima

L 27

Clinica Ricardo Palma Anexo 9 - Javier Prado Este, Lima

L 33

Instituto de Ginecología y Reproducción, Lima

011170

Spitalul Clinic Sf Maria, Bucharest

020125

Spitalul Clinic Colentina, Bucharest

Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota, Bucharest

020475

Spitalul Clinic Dr. Ion Cantacuzino, Bucharest

700-721

Kyungpook National Univesity Hospital, Daegu

302-799

Eulji University Hospital, Daejeon

400-711

Inha University Hospital, Inchon

602-715

Dong-A University Hospital 3-1 (Dept. Rhuematology), Pusan

602-739

Pusan National University Hospital, Pusan

110-744

Seoul National University Hospital, Seoul

133-792

The Hospital for Rheumatic Diseases, Hanyang University Hospital, Seoul

137-701

Catholic Universtigy of Korea, Kangnam St. Mary's Hospital, Seoul

150-713

Catholic University, Yoido St. Mary's Hospital, Seoul

443-721

Ajou University Hospital, Suwon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Human Genome Sciences Inc.

INDUSTRY