The purpose of this study is to evaluate the safety and efficacy of 3 different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with RA.

The purpose of this study is to evaluate the safety and efficacy of three different doses of LymphoStat-B, administered in addition to standard therapy, in subjects with RA.

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 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 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
• HIV, Hepatitis-B, Hepatitis-C