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A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Belimumab 1 mg/kg
Belimumab 4 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 Arthritis, Rheumatoid focused on measuring RA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Primary Inclusion Criteria: Diagnosis of RA for at least 1 year Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab) Active RA disease of at least moderate disease activity Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days Primary Exclusion Criteria: Received a non-FDA approved investigational agent within the last 28 days Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra) Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide Steroid injection into any joint within the last 30 days History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days 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
  • Wallace Rheumatic Disease 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.
  • Radiant Research Boise
  • Institute of Arthritis and Research
  • Northwestern University Medical School
  • Rheumatology Associates
  • Rockford Clinic
  • Medical Specialists
  • Kentuckiana Center for Better Bone and Joint Health
  • Ochsner Clinic Foundation
  • Johns Hopkins Hospital
  • The Osteoporosis and Arthritis Clinical Trial Center
  • Center for Rhematology and Bone Research
  • Tufts - New England Medical Center
  • The University of Michigan Health System
  • Mayo Clinic
  • 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
  • University of North Carolina at Chapel Hill
  • Arthritis Clinic and Carolina Bone and Joint
  • Wake Forest University School of Medicine
  • Stat Research, Inc.
  • McBride Clinic
  • Oklahoma Medical Research Foundation
  • Oklahoma Center For Arthritis Therapy & Research
  • Thomas Jefferson University Hospital
  • University of Pittsburgh School of Medicine & ASPH
  • Rheumatic Disease Associates
  • Arthritis Centers of Texas
  • Research Associates of North Texas
  • UT Southwestern Medical Center at Dallas
  • Houston Institute for Clinical Research
  • Texas Research Center
  • Arthritis and Rheumatic Diseases Clinic
  • Arthritis Clinic of Northern Virginia, P.C.
  • Edmonds Rheumatology Associates
  • Evergreen Clinical Reserach
  • Arthritis Northwest Rheumatology
  • Rheumatology Northwest Clinical Trials
  • Rheumatic Disease Center
  • Gundersen Clinic, Ltd.
  • The Medical College of Wisconsin , Inc
  • Marshfield Medical Research Foundation

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 of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)
An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).

Secondary Outcome Measures

Percentage of Patients With an ACR50 Response at Week 24, Based on ESR
An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).
Percentage of Patients With an ACR70 Response at Week 24, Based on ESR
An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).
Time to First ACR20 Response, Based on ESR
The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.
Time to First ACR50 Response, Based on ESR
Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.
Time to First ACR70 Response, Based on ESR
Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.
Mean Change in Disease Activity Score 28 (DAS28) at Week 24
DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.
Time to First DAS28 Response
DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a "good" or a "moderate" improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1.
Mean Change in Modified Total Sharp Score at Week 24
The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.

Full Information

First Posted
October 31, 2003
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00071812
Brief Title
A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
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 Rheumatoid Arthritis (RA)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
December 2005 (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 rheumatoid arthritis (RA).
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 RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-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
Arthritis, Rheumatoid
Keywords
RA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
283 (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 RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 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 RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 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 RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 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 RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.
Primary Outcome Measure Information:
Title
Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)
Description
An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Patients With an ACR50 Response at Week 24, Based on ESR
Description
An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).
Time Frame
Baseline, 24 weeks
Title
Percentage of Patients With an ACR70 Response at Week 24, Based on ESR
Description
An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).
Time Frame
Baseline, 24 weeks
Title
Time to First ACR20 Response, Based on ESR
Description
The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.
Time Frame
0 to 24 weeks
Title
Time to First ACR50 Response, Based on ESR
Description
Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.
Time Frame
0 to 24 weeks
Title
Time to First ACR70 Response, Based on ESR
Description
Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.
Time Frame
0 to 24 weeks
Title
Mean Change in Disease Activity Score 28 (DAS28) at Week 24
Description
DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.
Time Frame
Baseline, 24 weeks
Title
Time to First DAS28 Response
Description
DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a "good" or a "moderate" improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1.
Time Frame
0 to 24 weeks
Title
Mean Change in Modified Total Sharp Score at Week 24
Description
The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.
Time Frame
Baseline, 24 weeks
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 48/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 (LBRA99/NCT00583557).
Time Frame
Up to 56 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: Diagnosis of RA for at least 1 year Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab) Active RA disease of at least moderate disease activity Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days Primary Exclusion Criteria: Received a non-FDA approved investigational agent within the last 28 days Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra) Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide Steroid injection into any joint within the last 30 days History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days 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
Wallace Rheumatic Disease 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
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
Rockford Clinic
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61103
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
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 Rhematology 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
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
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
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
McBride Clinic
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
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
Arthritis Centers of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
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
Houston Institute for Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
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 Diseases Clinic
City
Weber
State/Province
Utah
ZIP/Postal Code
84403
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
Evergreen Clinical Reserach
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
Rheumatology Northwest Clinical Trials
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
23547209
Citation
Stohl W, Merrill JT, McKay JD, Lisse JR, Zhong ZJ, Freimuth WW, Genovese MC. Efficacy and safety of belimumab in patients with rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled, dose-ranging Study. J Rheumatol. 2013 May;40(5):579-89. doi: 10.3899/jrheum.120886. Epub 2013 Apr 1.
Results Reference
derived

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A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

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