Status:
COMPLETED
A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 place...
Eligibility Criteria
Inclusion
- Primary
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00071812
Start Date
December 1 2003
End Date
December 1 2005
Last Update
August 14 2013
Active Locations (63)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Arizona Arthritis Research
Paradise Valley, Arizona, United States, 85253
3
University of Arizona
Tucson, Arizona, United States, 85724
4
Scripps Clinic
La Jolla, California, United States, 92037