Safety and Efficacy of Cpn10 in Rheumatoid Arthritis

INTERVENTION: Cpn10 7.5mg twice a week or Cpn10 10mg twice per week given as intravenous injections for 12 weeks CONDITION: Rheumatoid Arthritis PRIMARY OUTCOME: Reduction in disease activity score (DAS28) anytime during the 12 week treatment period. SECONDARY OUTCOME: 1. Change in Tender Joint Count, Swollen Joint Count, Health Assessment Questionnaire (HAQ) and morning stiffness. 2. Change in DAS28 score 3. Change in Physician global assessment, patient global assessment, patient pain VAS, Patient fatigue VAS and SF‐36. 4. Change in CRP and ESR. 5. Cytokine production by PBMC stimulated in vitro. INCLUSION CRITERIA: 1. Fulfils the 1987 American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis2. Onset of RA after 18 years of age3. Disease duration of at least 6 months4. Stable dose of DMARD, including hydroxychloroquine, sulphasalazine or methotrexate for at least 3 months prior to screening. Patients taking more than one DMARD are allowed entry into the trial but these patients cannot be taking more than one immunosuppressive drug. Patients using leflunomide and another immunosuppressive may be considered for trial inclusion, however, leflunomide must be washed out with cholestyramine for 11 days. These patients may only be enrolled at least 30 days after the last dose of cholestyramine.5. Active RA defined as 8 tender joints of the 68 examined and 8 swollen joints of 66 examined, ESR greater than or equal to 28 mm/hour, OR CRP greater than or equal tp 10 mg/L, OR morning stiffness greater than or equal to 45minutes.6. ACR functional class I‐III7. Male or fema