Sponsor decision - not related to safety

This is a continuation trial of LymphoStat-B™ to evaluate the long-term safety in subjects with Rheumatoid Arthritis that completed study LBRA01 and benefitted from treatment.

This is a multi-center, open label, continuation trial of LymphoStat-B™ in Rheumatoid Arthritis (RA) subjects who achieved at least an ACR20 response in the Phase 2 study LBRA01 (NCT00071812).

Primary Inclusion Criteria:

1. Have completed the LBRA01 trial.
2. Have achieved at least an ACR20 response at the end of LBRA01.

Primary Exclusion Criteria:

1. Have switched NSAIDs due to worsening RA disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of LBRA01.

2. Required a new DMARD (not otherwise excluded in protocol LBRA01) to replace an ineffective one, or an additional DMARD (not to exceed 2 DMARDs in total) within the last 60 days of LBRA01.

3. Used prohibited medications during their participation in LBRA01. These medications include the following:

   • Other investigational agents.
   • Biologic response modifiers
   • Cyclophosphamide.
   • Corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months).
   • 2 new DMARDs.
   • 1 new DMARD plus high dose prednisone >10 mg/day.