A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis

Exclusion Criteria

• •Significant involvement of secondary RA (eg, Felty's syndrome, pulmonary fibrosis, Sjogren's syndrome, vasculitis (keratoconjunctivitis sicca is not exclusionary)
• •Received a live vaccine within 30 days of receiving fontolizumab
• •Received an investigational agent within 30 days or five half-lives of the agent, whichever is longer, of receiving fontolizumab
• •Received a corticosteroid injection into any joint, or has been treated with \> 10 mg/day of a corticosteroid within 30 days of receiving fontolizumab
• •Received etanercept or anakinra within 30 days of receiving fontolizumab
• •Received gold salts, infliximab, or adalimumab within 60 days of receiving fontolizumab
• •Received IV gamma-globulin or Prosorba column therapy within 90 days of receiving fontolizumab
• •Received rituximab or cyclophosphamide within 6 months of receiving fontolizumab
• •Failed B cell recovery after exposure to rituximab
• •History of hypersensitivity to glycine, histidine, or Polysorbate 80
• •Pregnant women or nursing mothers
• •Malignancy within 5 years (excluding basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ)
• •Known chronic viral infections with HIV, hepatitis B, or hepatitis C
• •Clinical, PPD, or clear radiographic evidence of prior TB
• •Infection requiring hospitalization or parenteral medication, such as an antibiotic, antiviral, antifungal, or antiparasitic agent, within 90 days of receiving fontolizumab
• •History of inflammatory joint disease (eg, gout, Lyme disease, psoriatic arthritis, reactive arthritis, seronegative spondyloarthropathy) or chronic inflammatory diseases (eg, inflammatory bowel disease, inflammatory myopathy, multiple sclerosis, overlap syndrome, scleroderma, systemic lupus erythematosus) other than RA
• •Clinically significant unstable or poorly controlled acute or chronic diseases, such as myocardial infarction within 6 months, unstable angina, poorly controlled diabetes or hypertension
• •ALT \> 1.5 × the upper limit of normal; AST \> 1.5 × the upper limit of normal; creatinine 1.5 × the upper limit of normal; absolute neutrophil count (ANC) \< 1000/mm3; platelet count \< 50,000/mm3
• •History of any other medical disease, laboratory abnormalities, or psychological conditions that would make the subject (based upon the principal investigator's judgment) unsuitable for study enrollment
• •Current abuse of alcohol or drugs (based upon investigator's assessment)
• •Major surgery within 3 months prior to or planned elective surgery during or within 3 months after last dose of study drug