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A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (BLISS-76)

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 Antibodies, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Belimumab, Lupus

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

  • University of Alabama at Birmingham
  • Arizona Arthritis and Rheumatology Research, PPLC
  • The University of Arizona Arthritis Center
  • Talbert Medical Group
  • Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
  • University of Southern California
  • Wallace Rheumatic Study Center
  • UCLA Rheumatology
  • Arthritis Care Center, Inc.
  • Inland Rheumatic Disease Specialties
  • Arthritis Associates of Colorado Springs
  • Washington Hospital Center
  • Arthritis and Rheumatic Disease Specialties
  • University of Miami-Division of Rheumatology and Immunology
  • Rheumatology Associates of Central Florida
  • Southwest Florida Clinical Research Center
  • Tampa Medical Group, P.A.
  • Emory University
  • Selah Medical Clinical Research Unit
  • Rheumatology Associates, SC
  • University of Chicago Hospitals
  • Medical Specialists Clinical Research
  • Kansas University Medical Center
  • Kentuckiana Center for Better Bone and Joint Health
  • Ochsner Clinic Foundation
  • Johns Hopkins University
  • Osteoporosis and Clinical Trials Center
  • Osteoporosis & Clinical Trials Center
  • Tufts - New England Medical Center
  • University of Michigan Medical Center - Regents of University of Michigan
  • Fiechtner Research, Inc.
  • Washington University School of Medicine
  • Stafford Medical Associates, PA
  • Montefiore Medical Center
  • SUNY-Downstate Medical Center
  • North Shore-LIJ Health System/Rheumatology and Allergy Clinic
  • Feinstein Institute
  • Hopital for Joint Diseases
  • Hospital for Special Surgery
  • AAIR Research Center
  • Rheumatology Associates
  • University of North Carolina at Chapel Hill
  • Physicians East, PA
  • Wake Forest University Health Services
  • Ohio State University
  • STAT Research, Inc.
  • Oklahoma Medical Research Center
  • Oklahoma Center For Arthritis Therapy & Research
  • East Penn Rheumatology Associates
  • Altoona Center for Clinical Research
  • University of Pittsburgh
  • Low Country Rheumatology, PA/Low Country Research Center
  • Medical University of South Carolina
  • Palmetto Clinical Trial at Piedmont Arthritis Clinic
  • Walter Chase
  • University of Texas - Southwestern Medical Center
  • Texas Tech University Health Sciences Center
  • The Rheumatic Disease Clinical Research Center
  • Accurate Clinical Research
  • Houston Institute for Clinical Research
  • Arthritis Center of South Texas
  • Texas Research Center
  • Rheumatology Clinic
  • Arthritis Clinic of Northern Virginia, P.C.
  • The Seattle Arthritis Clinic
  • Arthritis Northwest, PLLC
  • Gundersen Clinic, Ltd.
  • Universitatsklinik fur innere Medizin
  • Rheumazentrum Favoriten
  • Cliniques Universitaires
  • University Hospital
  • CHU Sart Tilman
  • Toronto Western Hospital
  • Centre for Prognosis Studies in Rheaumatic Diseases
  • McGill University Health Centre, Montreal General Hospital
  • Hospital Clinica Biblica
  • University Hospital Brno
  • University Hospital Hradec Kralove
  • University Hospital Olomouc
  • Institute of Rheumatology
  • CHU Hospital de Bicetre
  • Hospital Huriez
  • Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
  • Hospital FOCH
  • Centre Hospitalier Universitarie (CHU) - PURPAA
  • Kerckhoff-Klink Bad Nauheim
  • Schlossparkklinik
  • Charite
  • Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
  • FA Universitat Erlangen Nurnberg
  • Universitatsklinikum Frankfurt
  • Medizinische Universitatsklinik
  • Medizinische Hochschule Hannover
  • Friedrich Schiller Universitat
  • Universitatsklinik Schleswig-Holstein, Campus Kiel
  • Universitatsklinikum Leipzig
  • Universitatsklinik Mainz
  • Universitatsklinikum Tubingen
  • Soroka University Medical Center
  • B'nai-Zion Medical Center
  • Rambam Medical Center
  • Carmel Medical Center
  • Beilinson Hospital, Rabin Medical Center
  • Sheba Medical Center
  • Kaplan Medical Center
  • Tel-Aviv Saurasky Medical Center
  • A. O. Ospedaliera-Universitaria Arcispedale
  • A.O. Ospedale San Carlo Borromeo
  • Policlinico di Modena
  • Policlinico Universitario of Padova
  • A.O. San Camillo
  • Policlinico Umberto 1
  • U.O. di reumatologia Presidio Ospedaliero di Scafati
  • Azienda Ospedaliero University-Santa Maria della Misericordia
  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"
  • Instituto Jalisciense de Investigacion Clinica
  • Hospital General de México
  • Hospital Regional 1o de Octubre - ISSSTE
  • Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
  • Hospital Central de S.L.P. "Iganico Morones Prieto"
  • Instituto de Seguridad Social del Estado de Mexico y Municipios
  • Leiden University Medical Center
  • University Medical Center Maastricht
  • Erasmus Medical Center
  • Ikazia Ziekenhuis
  • Szpital Uniwerytecki nr Zim. dr. Jana Biziela
  • Szpital Specjalistyczny Sw. Lukasza
  • Malopolskie Centrum Medyczne
  • Gabinety Profesorow Osrodek Baden Klinicznych
  • Klinika Reumatologii im Prof. Eleonory Reicher
  • Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
  • Ponce School of Medicine
  • University of Puerto Rico Medical Center
  • Spitalul Clinic "Sf Maria"
  • Spitalul Clinic Colentina
  • Narodny Ustav Reumatickych Chorob
  • Hospital La Vall d'Hebron
  • Hospital Clinic i Provincial Barcelona
  • Hospital Universitario San Cecilio
  • Hospital Universitario La Paz
  • Hospital Regional Universitario de SAS - Carlos Haya
  • Hospital Son Dureta
  • Sahlgrensja University Hospital
  • Karolinska Universitetssjukhuset
  • St. Thomas Hospital
  • Freeman Hospital

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

SRI Response Rate at Week 76
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).
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Mean Change in Physician's Global Assessment (PGA) at Week 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 Week 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
December 8, 2006
Last Updated
December 2, 2016
Sponsor
Human Genome Sciences Inc.
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00410384
Brief Title
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
Acronym
BLISS-76
Official Title
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week 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
December 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 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
Antibodies, Autoimmune Diseases, Systemic Lupus Erythematosus, SLE, Belimumab, Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
819 (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 72 weeks.
Intervention Type
Drug
Intervention Name(s)
Belimumab 1 mg/kg
Other Intervention Name(s)
LymphoStat-B™, belimumab
Intervention Description
Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
Intervention Type
Drug
Intervention Name(s)
Belimumab 10 mg/kg
Other Intervention Name(s)
LymphoStat-B™, belimumab
Intervention Description
Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
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
SRI Response Rate at Week 76
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, 76 Weeks
Title
Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Time Frame
Baseline, 52 Weeks
Title
Mean Change in Physician's Global Assessment (PGA) at Week 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 Week 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 40-52
Other Pre-specified Outcome Measures:
Title
Adverse Event (AE) Overview
Description
SEE ALSO ADVERSE EVENT RESULTS SECTION
Time Frame
Up to 80 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
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Arizona Arthritis and Rheumatology Research, PPLC
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
The University of Arizona Arthritis Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Valerius Medical Group & Research Ctr of Greater Long Beach, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Rheumatology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Arthritis Care Center, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95126
Country
United States
Facility Name
Inland Rheumatic Disease Specialties
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Arthritis Associates of Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Arthritis and Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
University of Miami-Division of Rheumatology and Immunology
City
Miami
State/Province
Florida
ZIP/Postal Code
03136
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Southwest Florida Clinical Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Tampa Medical Group, P.A.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Selah Medical Clinical Research Unit
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Rheumatology Associates, SC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Medical Specialists Clinical Research
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Kentuckiana Center for Better Bone and Joint Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Osteoporosis and Clinical Trials Center
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Osteoporosis & Clinical Trials Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan Medical Center - Regents of University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0358
Country
United States
Facility Name
Fiechtner Research, Inc.
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Stafford Medical Associates, PA
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
SUNY-Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore-LIJ Health System/Rheumatology and Allergy Clinic
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Feinstein Institute
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Hopital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Rheumatology Associates
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Physicians East, PA
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest University Health Services
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Oklahoma Medical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oklahoma Center For Arthritis Therapy & Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
East Penn Rheumatology Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncanville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Low Country Rheumatology, PA/Low Country Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Palmetto Clinical Trial at Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Walter Chase
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Texas - Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8884
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
The Rheumatic Disease Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Houston Institute for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Arthritis Center of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Texas Research Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Rheumatology Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Arthritis Clinic of Northern Virginia, P.C.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
The Seattle Arthritis Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Gundersen Clinic, Ltd.
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54650
Country
United States
Facility Name
Universitatsklinik fur innere Medizin
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Rheumazentrum Favoriten
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Cliniques Universitaires
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Centre for Prognosis Studies in Rheaumatic Diseases
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Facility Name
McGill University Health Centre, Montreal General Hospital
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hospital Clinica Biblica
City
San Jose
Country
Costa Rica
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Institute of Rheumatology
City
Prague
ZIP/Postal Code
12850
Country
Czech Republic
Facility Name
CHU Hospital de Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Hospital Huriez
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Nouvel Hospital Civil - Medecine Interne et Immunologie Clinique
City
Stasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Hospital FOCH
City
Suresnes Cedex
ZIP/Postal Code
92151
Country
France
Facility Name
Centre Hospitalier Universitarie (CHU) - PURPAA
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Kerckhoff-Klink Bad Nauheim
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Schlossparkklinik
City
Berlin
ZIP/Postal Code
10589
Country
Germany
Facility Name
Charite
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Uniklinik Dusseldorf-Klinik for Endokrinologie, Diabetologie and Rheumatologie Klinik
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
FA Universitat Erlangen Nurnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Universitatsklinik
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Friedrich Schiller Universitat
City
Jena
ZIP/Postal Code
07740
Country
Germany
Facility Name
Universitatsklinik Schleswig-Holstein, Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitatsklinik Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
B'nai-Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Beilinson Hospital, Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Saurasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
A. O. Ospedaliera-Universitaria Arcispedale
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
A.O. Ospedale San Carlo Borromeo
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Policlinico Universitario of Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
A.O. San Camillo
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Umberto 1
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
U.O. di reumatologia Presidio Ospedaliero di Scafati
City
Scafati
ZIP/Postal Code
84018
Country
Italy
Facility Name
Azienda Ospedaliero University-Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Hospital Civil de Guadalajara "Fray Antonio Alcalde"
City
Guadalajara
ZIP/Postal Code
45235
Country
Mexico
Facility Name
Instituto Jalisciense de Investigacion Clinica
City
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Hospital General de México
City
Mexico City
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Hospital Regional 1o de Octubre - ISSSTE
City
Mexico City
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Insituto Nacional de Ciencias Medicas y Nutricion Salvador Zubirin
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Central de S.L.P. "Iganico Morones Prieto"
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Instituto de Seguridad Social del Estado de Mexico y Municipios
City
Toluca
ZIP/Postal Code
52170
Country
Mexico
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Facility Name
University Medical Center Maastricht
City
Maastricht
ZIP/Postal Code
6229HX
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083AN
Country
Netherlands
Facility Name
Szpital Uniwerytecki nr Zim. dr. Jana Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Szpital Specjalistyczny Sw. Lukasza
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Gabinety Profesorow Osrodek Baden Klinicznych
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
Facility Name
Klinika Reumatologii im Prof. Eleonory Reicher
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Akademicki Szpital Klinika Reumatologii Chorob Wewnetrznych
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Ponce School of Medicine
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
University of Puerto Rico Medical Center
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Spitalul Clinic "Sf Maria"
City
Bucuresti
ZIP/Postal Code
011170
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Narodny Ustav Reumatickych Chorob
City
Piestany
ZIP/Postal Code
92112
Country
Slovakia
Facility Name
Hospital La Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario San Cecilio
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de SAS - Carlos Haya
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Son Dureta
City
Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Sahlgrensja University Hospital
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
St. Thomas Hospital
City
London
ZIP/Postal Code
SE17EH
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE77DN
Country
United Kingdom

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
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
Results Reference
derived
PubMed Identifier
34628605
Citation
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Results Reference
derived
PubMed Identifier
34531304
Citation
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Results Reference
derived
PubMed Identifier
33830377
Citation
Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). J Patient Rep Outcomes. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x.
Results Reference
derived
PubMed Identifier
33568389
Citation
Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
Results Reference
derived
PubMed Identifier
32918459
Citation
Gomez A, Hani Butrus F, Johansson P, Akerstrom E, Soukka S, Emamikia S, Enman Y, Pettersson S, Parodis I. Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus. Rheumatology (Oxford). 2021 Mar 2;60(3):1260-1272. doi: 10.1093/rheumatology/keaa453.
Results Reference
derived
PubMed Identifier
31302695
Citation
van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Results Reference
derived
PubMed Identifier
29409143
Citation
Furie RA, Wallace DJ, Aranow C, Fettiplace J, Wilson B, Mistry P, Roth DA, Gordon D. Long-Term Safety and Efficacy of Belimumab in Patients With Systemic Lupus Erythematosus: A Continuation of a Seventy-Six-Week Phase III Parent Study in the United States. Arthritis Rheumatol. 2018 Jun;70(6):868-877. doi: 10.1002/art.40439. Epub 2018 Apr 25.
Results Reference
derived
PubMed Identifier
25396065
Citation
Furie R, Petri MA, Strand V, Gladman DD, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials. Lupus Sci Med. 2014 Jun 26;1(1):e000031. doi: 10.1136/lupus-2014-000031. eCollection 2014.
Results Reference
derived
PubMed Identifier
23754628
Citation
Petri MA, van Vollenhoven RF, Buyon J, Levy RA, Navarra SV, Cervera R, Zhong ZJ, Freimuth WW; BLISS-52 and BLISS-76 Study Groups. Baseline predictors of systemic lupus erythematosus flares: data from the combined placebo groups in the phase III belimumab trials. Arthritis Rheum. 2013 Aug;65(8):2143-53. doi: 10.1002/art.37995.
Results Reference
derived
PubMed Identifier
23524886
Citation
Strand V, Levy RA, Cervera R, Petri MA, Birch H, Freimuth WW, Zhong ZJ, Clarke AE; BLISS-52 and -76 Study Groups. Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials. Ann Rheum Dis. 2014 May;73(5):838-44. doi: 10.1136/annrheumdis-2012-202865. Epub 2013 Mar 22.
Results Reference
derived
PubMed Identifier
23213069
Citation
Wallace DJ, Navarra S, Petri MA, Gallacher A, Thomas M, Furie R, Levy RA, van Vollenhoven RF, Cooper S, Zhong ZJ, Freimuth W, Cervera R; BLISS-52 and -76, and LBSL02 Study Groups. Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus. Lupus. 2013 Feb;22(2):144-54. doi: 10.1177/0961203312469259. Epub 2012 Dec 4.
Results Reference
derived
PubMed Identifier
22707609
Citation
Chatham WW, Wallace DJ, Stohl W, Latinis KM, Manzi S, McCune WJ, Tegzova D, McKay JD, Avila-Armengol HE, Utset TO, Zhong ZJ, Hough DR, Freimuth WW, Migone TS; BLISS-76 Study Group. Effect of belimumab on vaccine antigen antibodies to influenza, pneumococcal, and tetanus vaccines in patients with systemic lupus erythematosus in the BLISS-76 trial. J Rheumatol. 2012 Aug;39(8):1632-40. doi: 10.3899/jrheum.111587. Epub 2012 Jun 15.
Results Reference
derived
PubMed Identifier
22337213
Citation
van Vollenhoven RF, Petri MA, Cervera R, Roth DA, Ji BN, Kleoudis CS, Zhong ZJ, Freimuth W. Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response. Ann Rheum Dis. 2012 Aug;71(8):1343-9. doi: 10.1136/annrheumdis-2011-200937. Epub 2012 Feb 15.
Results Reference
derived
PubMed Identifier
22275291
Citation
Stohl W, Hiepe F, Latinis KM, Thomas M, Scheinberg MA, Clarke A, Aranow C, Wellborne FR, Abud-Mendoza C, Hough DR, Pineda L, Migone TS, Zhong ZJ, Freimuth WW, Chatham WW; BLISS-52 Study Group; BLISS-76 Study Group. Belimumab reduces autoantibodies, normalizes low complement levels, and reduces select B cell populations in patients with systemic lupus erythematosus. Arthritis Rheum. 2012 Jul;64(7):2328-37. doi: 10.1002/art.34400.
Results Reference
derived
PubMed Identifier
22127708
Citation
Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzova D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. doi: 10.1002/art.30613.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HGS1006-C1056
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

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