(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

Exclusion Criteria

• •1. Functional Class IV as defined by ACR classification of functional status in RA
• •2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
• •3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
• •4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
• •5. History of recurrent clinically significant infections
• •6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
• •7. History of severe allergic or anaphylactic reactions to other biologic agents
• •8. History of allergies to murine protein
• •9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
• •10. History of tuberculosis or latent infection currently undergoing treatment
• •11. History of malaria
• •12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
• •13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization
• •14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
• •15. Abnormal laboratory value at Screening or Day -1 considered clinically significant
• •16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
• •17. Positive for human immunodeficiency virus (HIV) antibody
• •18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)