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)

Date de début de l'étude : 1 décembre 2003

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