A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
Arthritis, Rheumatoid
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring RA
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
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
Placebo Comparator
Experimental
Experimental
Experimental
Placebo plus SOC
Belimumab 1 mg/kg plus SOC
Belimumab 4 mg/kg plus SOC
Belimumab 10 mg/kg plus SOC