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

Systemic Lupus Erythematosus Clinical Trial

— BLISS-52  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424476
• Other study ID #: HGS1006-C1057
• Secondary ID: BLISS-52110752
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2007
• Last updated: February 13, 2014
• Start date: May 2007
• Est. completion date: March 2010

Study information

• Verified date: February 2014
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public HealthBrazil: National Health Surveillance AgencyUnited States: Food and Drug AdministrationKorea: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosChile: Instituto de Salud Pública de ChileTaiwan: Department of HealthIndia: Drugs Controller General of IndiaPhilippines: Bureau of Food and DrugsArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaHong Kong: Department of HealthRussia: Ministry of Health of the Russian FederationPeru: General Directorate of Pharmaceuticals, Devices, and DrugsAustralia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 865
• Est. completion date: March 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Argentina	Atencion Integral en Reumatologia	Buenos Aires
Argentina	Centro Privado de Medicina Familiar	Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Buenos Aires
Argentina	Hospital Sirio Libanes	Buenos Aires
Argentina	Instituto de Investigaciones Medicas	Buenos Aires
Argentina	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	OMI, Organización Médica de Investigación	Ciudad Autonoma de 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 Tucuman
Australia	Repatriation Hospital	Daw Park
Australia	Emeritus Research, Cabrini Hospital	Melbourne
Australia	Monash Medical Centre	Melbourne
Australia	Royal Perth Hospital	Shenton Park
Brazil	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
Chile	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
Colombia	Centro de Reumatologia y Ortopedia	Barranquilla
Colombia	Fundación Instituto de Reumatología Fernando Chalem	Bogota
Colombia	Office of Dr. Guzman	Bogota	Cundinamarca
Colombia	Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)	Bogotá
Colombia	Riesgo de Fracturas	Bogotá
Colombia	Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle	Bucaramanga	Santander
Colombia	SERVIMED	Bucaramanga
Colombia	Corporación para Investigaciones Biológicas (CIB)	Medellín
Colombia	Office of Dr. Jose Molina	Medellín
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
India	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
Korea, Republic of	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	Catholic University, Yoido St. Mary's Hospital	Seoul
Korea, Republic of	Catholic Universtigy of Korea, Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Hospital for Rheumatic Diseases, Hanyang University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Peru	Clinica Ricardo Palma Anexo 9 - Javier Prado Este	Lima
Peru	Hospital Nacional Alberto Sabogal Sologuren ESSALUD	Lima
Peru	Hospital Nacional Guillermo Almenara Irigoyen ESSALUD	Lima
Peru	Instituto de Ginecología y Reproducción	Lima
Philippines	Chong Hua Hospital	Cebu City
Philippines	Davao Medical Center	Davao City
Philippines	University of Perpetual Help -Rizal	Las Pinas City
Philippines	Philippine General Hospital	Manila City
Philippines	University of Santo Tomas Hospital	Manila City
Philippines	St. Luke's Medical Center	Quezon City
Romania	Spitalul Clinic Colentina	Bucharest
Romania	Spitalul Clinic Dr. Ion Cantacuzino	Bucharest
Romania	Spitalul Clinic Sf Maria	Bucharest
Romania	Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota	Bucharest
Romania	Spitalul Clinic Judetean de Urgenta Cluj-Napoca	Cluj Napoca
Russian Federation	State Institution Scientific Research Institute of Rheumatology	Moscow
Russian Federation	St. Petersburg City Hospital (Rheumatology Center)	St. Petersburg
Russian Federation	Academy of Post-Graduated Education	St.-Petersburg
Russian Federation	St.-Petersburg Region Clinical Hospital	St.-Petersburg
Russian Federation	City Healthcare Institution Municipal Hospital NPZ,	Yaroslavl
Russian Federation	Soloviev's City Clinical Hospital,	Yaroslavl
Taiwan	Buddhist Tzu Chi General Hospital, Dalin	Chia-Yi
Taiwan	Buddhist Tzu Chi General Hospital - Hualien	Haulien
Taiwan	Chung-Ho Memorial Hospital, Kaohsiung Medical University	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Chang Gung Memorial Hospital, Kaosiung	Kaosiung
Taiwan	Chang Gung Memorial Hospital-Keelung	Keelung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan 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

Sponsors (2)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.	GlaxoSmithKline

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Chile,  Colombia,  Hong Kong,  India,  Korea, Republic of,  Peru,  Philippines,  Romania,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events (AE) Overview	SEE ALSO ADVERSE EVENTS RESULTS SECTION	Up to 56 Weeks	Yes
Primary	SLE Responder Index (SRI) Response Rate at Week 52	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).	Baseline, 52 weeks	No
Secondary	Percent of Subjects With a = 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.		Baseline, 52 weeks	No
Secondary	Mean Change in Physician's Global Assessment (PGA) at Wk 24.	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.	Baseline, 24 weeks	No
Secondary	Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.	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.	Baseline, 24 weeks	No
Secondary	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	No