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

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Belimumab 1 mg/kg
Belimumab 10 mg/kg
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Autoimmune Diseases, Lupus, SLE, Systemic Lupus Erythematosus, Belimumab, Antibodies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Britanico de Buenos Aires
  • Centro Privado de Medicina Familiar
  • Hospital Sirio Libanes
  • Atencion Integral en Reumatologia
  • Instituto de Investigaciones Medicas
  • OMI, Organización Médica de Investigación
  • CIER, Centro de Investigaciones en Enfermedades Reumáticas
  • Hospital General de Agudos Carlos G. Durand
  • Hospital Interzonal General San Martín
  • CAICI, Instituto Centralizado de Asistencia e Investigación Clínica Integral
  • Centro Medico Privado de Reumatologia
  • Repatriation Hospital
  • Emeritus Research, Cabrini Hospital
  • Monash Medical Centre
  • Royal Perth Hospital
  • Hospital de Clínicas - UNICAMP
  • Hospital das Clínicas - Universidade do Paraná
  • Hospital de Clínicas - Universidade Federal de Pernambuco
  • Hospital Geral de Goiânia
  • Hospital Universitário - Universidade Federal de Juiz de Fora
  • Hospital São Lucas da PUC-RS
  • Hospital Universitário Pedro Ernesto - UERJ
  • Hospital Unversitario Clementino Fraga Filho UFRJ
  • Hospital Santa Izabel
  • Hospital Abreu Sodré
  • Hospital do Servidor Público Estadual de São Paulo - Francisco Morato de Oliveira
  • Hospital Heliópolis
  • Hospital Dr. Sotero del Rio
  • Pontificia Universidad Católica de Chile
  • Clínica Dávila
  • Hospital Dr. Gustavo Fricke
  • Office of Dr. Guzman
  • Fundación Oftalmologica de Santander Clinica Carlos Ardila Lulle
  • Centro de Reumatologia y Ortopedia
  • Fundación Instituto de Reumatología Fernando Chalem
  • Centrode de Investigaciones en Reumatologia Especialidades Medicas (CIREEH)
  • Riesgo de Fracturas
  • SERVIMED
  • Corporación para Investigaciones Biológicas (CIB)
  • Office of Dr. Jose Molina
  • Pamela Youde Nethersole Eastern Hospital
  • Rheumatology Assessment and Treatment Center, Pok Oi Hospital
  • Tuen Mun Hospital
  • St. John's Medical College Hospital
  • Krishna Institute of Medical Sciences
  • Nizam's Institute of Medical Sciences
  • Apollo Hospitals
  • Chhatrapati Shahuji Maharaj Medical University
  • King Edward Memorial (K.E.M.) Hospital
  • Kerala Institute of Medical Sciences
  • Kyungpook National Univesity Hospital
  • Eulji University Hospital
  • Inha University Hospital
  • Dong-A University Hospital 3-1 (Dept. Rhuematology)
  • Pusan National University Hospital
  • Seoul National University Hospital
  • The Hospital for Rheumatic Diseases, Hanyang University Hospital
  • Catholic Universtigy of Korea, Kangnam St. Mary's Hospital
  • Catholic University, Yoido St. Mary's Hospital
  • Ajou University Hospital
  • Hospital Nacional Alberto Sabogal Sologuren ESSALUD
  • Hospital Nacional Guillermo Almenara Irigoyen ESSALUD
  • Clinica Ricardo Palma Anexo 9 - Javier Prado Este
  • Instituto de Ginecología y Reproducción
  • Chong Hua Hospital
  • Davao Medical Center
  • University of Perpetual Help -Rizal
  • Philippine General Hospital
  • University of Santo Tomas Hospital
  • St. Luke's Medical Center
  • Spitalul Clinic Sf Maria
  • Spitalul Clinic Colentina
  • Spitalul de Urgenta al Ministerului Administratiei si Internelor Prof. Dr. Dimitrie Gerota
  • Spitalul Clinic Dr. Ion Cantacuzino
  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • State Institution Scientific Research Institute of Rheumatology
  • St. Petersburg City Hospital (Rheumatology Center)
  • Academy of Post-Graduated Education
  • St.-Petersburg Region Clinical Hospital
  • Soloviev's City Clinical Hospital,
  • City Healthcare Institution Municipal Hospital NPZ,
  • Buddhist Tzu Chi General Hospital, Dalin
  • Buddhist Tzu Chi General Hospital - Hualien
  • Chung-Ho Memorial Hospital, Kaohsiung Medical University
  • Kaohsiung Veterans General Hospital
  • Chang Gung Memorial Hospital, Kaosiung
  • Chang Gung Memorial Hospital-Keelung
  • Chung Shan Medical University Hospital
  • China Medical University Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital, Linko

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Belimumab 1 mg/kg

Belimumab 10 mg/kg

Arm Description

Placebo

Belimumab 1 mg/kg

Belimumab 10 mg/kg

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.
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.
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.
Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52

Full Information

First Posted
January 17, 2007
Last Updated
October 28, 2016
Sponsor
Human Genome Sciences Inc.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00424476
Brief Title
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Autoimmune Diseases, Lupus, SLE, Systemic Lupus Erythematosus, Belimumab, Antibodies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
865 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Belimumab 1 mg/kg
Arm Type
Experimental
Arm Description
Belimumab 1 mg/kg
Arm Title
Belimumab 10 mg/kg
Arm Type
Experimental
Arm Description
Belimumab 10 mg/kg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Intervention Type
Drug
Intervention Name(s)
Belimumab 1 mg/kg
Other Intervention Name(s)
BENLYSTA™ (formerly LymphoStat-B™)
Intervention Description
Belimumab 1 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Intervention Type
Drug
Intervention Name(s)
Belimumab 10 mg/kg
Other Intervention Name(s)
BENLYSTA™ (formerly LymphoStat-B™)
Intervention Description
Belimumab 10 mg/kg IV plus standard therapy on Days 0, 14, 28, and every 28 days thereafter through Week 48.
Primary Outcome Measure Information:
Title
SLE Responder Index (SRI) Response Rate at Week 52
Description
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).
Time Frame
Baseline, 52 weeks
Secondary Outcome Measure Information:
Title
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52.
Time Frame
Baseline, 52 weeks
Title
Mean Change in Physician's Global Assessment (PGA) at Wk 24.
Description
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.
Time Frame
Baseline, 24 weeks
Title
Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24.
Description
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.
Time Frame
Baseline, 24 weeks
Title
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
Other Pre-specified Outcome Measures:
Title
Adverse Events (AE) Overview
Description
SEE ALSO ADVERSE EVENTS RESULTS SECTION
Time Frame
Up to 56 Weeks

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
34741731
Citation
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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

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