A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
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)
1 other identifier
interventional
283
1 country
63
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2003
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2003
CompletedFirst Posted
Study publicly available on registry
November 5, 2003
CompletedStudy Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
June 25, 2012
CompletedAugust 14, 2013
August 1, 2013
1.1 years
October 31, 2003
February 27, 2012
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 \[ESR\]).
Baseline, 24 weeks
Secondary Outcomes (8)
Percentage of Patients With an ACR50 Response at Week 24, Based on ESR
Baseline, 24 weeks
Percentage of Patients With an ACR70 Response at Week 24, Based on ESR
Baseline, 24 weeks
Time to First ACR20 Response, Based on ESR
0 to 24 weeks
Time to First ACR50 Response, Based on ESR
0 to 24 weeks
Time to First ACR70 Response, Based on ESR
0 to 24 weeks
- +3 more secondary outcomes
Other Outcomes (1)
Adverse Events (AE) Overview
Up to 56 weeks
Study Arms (4)
Placebo plus SOC
PLACEBO COMPARATORBelimumab 1 mg/kg plus SOC
EXPERIMENTALBelimumab 4 mg/kg plus SOC
EXPERIMENTALBelimumab 10 mg/kg plus SOC
EXPERIMENTALInterventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006, United States
Arizona Arthritis Research
Paradise Valley, Arizona, 85253, United States
University of Arizona
Tucson, Arizona, 85724, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Wallace Rheumatic Disease Center
Los Angeles, California, 90048, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
UCDMC
Sacramento, California, 95817-1418, United States
Arthritis Care Center, Inc.
San Jose, California, 95126-1650, United States
Arthritis Associates & Osteoporosis Center Of Colorado Springs
Colorado Springs, Colorado, 80910, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, 33180, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
Tampa Medical Group, P.A.
Tampa, Florida, 33614, United States
Radiant Research Boise
Boise, Idaho, 83704, United States
Institute of Arthritis and Research
Idaho Falls, Idaho, 83404, United States
Northwestern University Medical School
Chicago, Illinois, 60611, United States
Rheumatology Associates
Chicago, Illinois, 60612, United States
Rockford Clinic
Rockford, Illinois, 61103, United States
Medical Specialists
Munster, Indiana, 46321, United States
Kentuckiana Center for Better Bone and Joint Health
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
The Osteoporosis and Arthritis Clinical Trial Center
Cumberland, Maryland, 21502, United States
Center for Rhematology and Bone Research
Wheaton, Maryland, 20902, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
The University of Michigan Health System
Ann Arbor, Michigan, 48109-0358, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, 68506, United States
Arthritis and Osteoporosis Center
Concord, New Hampshire, 03301, United States
Strafford Medical Associates, P.A.
Dover, New Hampshire, 03820, United States
The Center For Rheumatology
Albany, New York, 12206, United States
SUNY-Downstate Medical Center
Brooklyn, New York, 11203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7280, United States
Arthritis Clinic and Carolina Bone and Joint
Charlotte, North Carolina, 28210, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157, United States
Stat Research, Inc.
Dayton, Ohio, 45402, United States
McBride Clinic
Oklahoma City, Oklahoma, 73101, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, 74114, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh School of Medicine & ASPH
Pittsburgh, Pennsylvania, 15261, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, United States
Arthritis Centers of Texas
Dallas, Texas, 75246, United States
Research Associates of North Texas
Dallas, Texas, 75246, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8884, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Texas Research Center
Sugar Land, Texas, 77479, United States
Arthritis and Rheumatic Diseases Clinic
Morgan, Utah, 84403, United States
Arthritis Clinic of Northern Virginia, P.C.
Arlington, Virginia, 22205, United States
Edmonds Rheumatology Associates
Edmonds, Washington, 98026-8047, United States
Evergreen Clinical Reserach
Edmonds, Washington, 98026-8047, United States
Arthritis Northwest Rheumatology
Spokane, Washington, 99204, United States
Rheumatology Northwest Clinical Trials
Yakima, Washington, 98902, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
Gundersen Clinic, Ltd.
La Crosse, Wisconsin, 54610, United States
The Medical College of Wisconsin , Inc
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Research Foundation
Wausau, Wisconsin, 54401, United States
Related Publications (1)
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.
PMID: 23547209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2003
First Posted
November 5, 2003
Study Start
December 1, 2003
Primary Completion
January 1, 2005
Study Completion
December 1, 2005
Last Updated
August 14, 2013
Results First Posted
June 25, 2012
Record last verified: 2013-08