Back to resultsSafety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Primary Purpose
Lupus Erythematosus, Systemic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Belimumab 1 mg/kg
Belimumab 4 mg/kg
Belimumab 10 mg/kg
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring SLE
Eligibility Criteria
Primary Inclusion Criteria Clinical diagnosis of SLE "Active" SLE disease On a stable SLE treatment regimen History of measurable autoantibodies Primary Exclusion Criteria Received a non-FDA approved investigational agent within last 28 days Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days History of renal transplant History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Sites / Locations
- University of Alabama at Birmingham
- Arizona Arthritis Research
- University of Arizona
- Scripps Clinic
- University of Southern California
- Cedars-Sinai Medical Center
- Stanford University School of Medicine
- Boling Clinical Trials
- UCDMC
- Arthritis Care Center, Inc.
- Arthritis Associates & Osteoporosis Center Of Colorado Springs
- Washington Hospital Center
- Arthritis and Rheumatic Disease Specialties
- Rheumatology Associates of Central Florida
- Tampa Medical Group, P.A.
- Emory University
- Radiant Research Boise
- Institute of Arthritis and Research
- Northwestern University Medical School
- Rheumatology Associates
- Medical Specialists
- Kentuckiana Center for Better Bone and Joint Health
- Ochsner Clinic Foundation
- Ochsner Clinic Foundation
- University of Maryland
- Johns Hopkins Hospital
- The Osteoporosis and Arthritis Clinical Trial Center
- Center for Rheumatology and Bone Research
- Tufts--New England Medical Center
- The University of Michigan Health System
- Washington University in St. Louis
- Arthritis Center of Nebraska
- Arthritis and Osteoporosis Center
- Strafford Medical Associates, P.A.
- The Center for Rheumatology
- Jacobi Medical Center
- SUNY-Downstate Medical Center
- North Shore University Hospital
- Aair Research
- University of North Carolina at Chapel Hill
- Arthritis Clinic and Carolina Bone and Joint
- Wake Forest University School of Medicine
- Stat Research Inc.
- Bone and Joint Hospital
- Oklahoma Medical Research Foundation
- Oklahoma Center For Arthritis Therapy & Research
- Thomas Jefferson University Hospital
- University of Pittsburgh School of Medicine & ASPH
- Rheumatic Disease Associates
- Research Associates of North Texas
- UT Southwestern Medical Center at Dallas
- Texas Research Center
- Arthritis and Rheumatic Disease Clinic
- Physicians Research Options, LC
- Arthritis Clinic of Northern Virginia, P.C.
- Edmonds Rheumatology Associates
- Arthritis Northwest Rheumatology
- Gundersen Clinic, Ltd.
- The Medical College of Wisconsin , Inc
- Marshfield Medical Research Foundation
- Toronto Western Hospital
- McGill University Health Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo plus SOC
Belimumab 1 mg/kg plus SOC
Belimumab 4 mg/kg plus SOC
Belimumab 10 mg/kg plus SOC
Arm Description
Outcomes
Primary Outcome Measures
Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
Secondary Outcome Measures
Percentage Change From Baseline in SELENA SLEDAI Score at Week 52
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52
The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
Area Under the Curve (AUC) of BILAG Score at Week 52
The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks
SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
Percentage of Patients With a Reduction in Prednisone Dose
Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.
Full Information
NCT ID
NCT00071487
First Posted
October 24, 2003
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00071487
Brief Title
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
Official Title
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
SLE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
449 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo plus SOC
Arm Type
Placebo Comparator
Arm Title
Belimumab 1 mg/kg plus SOC
Arm Type
Experimental
Arm Title
Belimumab 4 mg/kg plus SOC
Arm Type
Experimental
Arm Title
Belimumab 10 mg/kg plus SOC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Belimumab 1 mg/kg
Other Intervention Name(s)
LymphoStat-B®, BENLYSTA®
Intervention Description
Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Belimumab 4 mg/kg
Other Intervention Name(s)
LymphoStat-B®, BENLYSTA®
Intervention Description
Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Belimumab 10 mg/kg
Other Intervention Name(s)
LymphoStat-B®, BENLYSTA®
Intervention Description
Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on belimumab 10 mg/kg for an additional 24 weeks.
Primary Outcome Measure Information:
Title
Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.
Description
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.
Time Frame
Baseline, 24 weeks
Title
Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)
Description
The SLE Flare Index categorized SLE flare as "mild or moderate" or "severe" based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe).
Time Frame
0 to 52 weeks
Secondary Outcome Measure Information:
Title
Percentage Change From Baseline in SELENA SLEDAI Score at Week 52
Description
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare
Time Frame
Baseline, 52 weeks
Title
Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52
Description
SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.
Time Frame
Baseline and every 4 to 8 weeks through Week 52
Title
Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52
Description
The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.
Time Frame
Baseline, 52 weeks
Title
Area Under the Curve (AUC) of BILAG Score at Week 52
Description
The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.
Time Frame
Baseline and every 4 to 8 weeks through Week 52
Title
Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks
Description
SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.
Time Frame
0 to 52 weeks
Title
Percentage of Patients With a Reduction in Prednisone Dose
Description
Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.
Time Frame
Baseline, weeks 40 to 52
Other Pre-specified Outcome Measures:
Title
Adverse Events (AE) Overview
Description
Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).
Time Frame
Up to 84 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria
Clinical diagnosis of SLE
"Active" SLE disease
On a stable SLE treatment regimen
History of measurable autoantibodies
Primary Exclusion Criteria
Received a non-FDA approved investigational agent within last 28 days
Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days
Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
History of renal transplant
History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0006
Country
United States
Facility Name
Arizona Arthritis Research
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Scripps Clinic
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Boling Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
UCDMC
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-1418
Country
United States
Facility Name
Arthritis Care Center, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95126-1650
Country
United States
Facility Name
Arthritis Associates & Osteoporosis Center 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
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
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
Radiant Research Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Institute of Arthritis and Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Northwestern University Medical School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rheumatology Associates
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Medical Specialists
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
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
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
The Osteoporosis and Arthritis Clinical Trial Center
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Tufts--New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
The University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0358
Country
United States
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Arthritis Center of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Arthritis and Osteoporosis Center
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Strafford Medical Associates, P.A.
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
The Center for Rheumatology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Jacobi 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 University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Aair Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7280
Country
United States
Facility Name
Arthritis Clinic and Carolina Bone and Joint
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Stat Research Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Facility Name
Bone and Joint Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Center For Arthritis Therapy & Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh School of Medicine & ASPH
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Rheumatic Disease Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Research Associates of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8884
Country
United States
Facility Name
Texas Research Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Arthritis and Rheumatic Disease Clinic
City
Ogden
State/Province
Utah
ZIP/Postal Code
84044
Country
United States
Facility Name
Physicians Research Options, LC
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
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
Edmonds Rheumatology Associates
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026-8047
Country
United States
Facility Name
Arthritis Northwest Rheumatology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Gundersen Clinic, Ltd.
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54610
Country
United States
Facility Name
The Medical College of Wisconsin , Inc
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Marshfield Medical Research Foundation
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
Citations:
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Results Reference
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Citation
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Citation
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Learn more about this trial
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)
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