Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

Exclusion Criteria

• •Major surgery within 28 days prior to Day 0
• •Joint replacement surgery within 60 days prior to Day 0 or joint replacement surgery planned within 9 months following Day 0
• •Known HIV antibody, or hepatitis B surface antigen
• •History of malignancy within 5 years prior to Screening other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
• •Immunodeficiency
• •History or symptoms of a demyelinating disease
• •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 \< 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
• •History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON -TB test result is eligible.
• •Chronic obstructive pulmonary disease (COPD), asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily
• •Significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis)
• •Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function. If the diagnosis of liver disease was based on positive Hep C serology due to prior vaccination, the subject is eligible.
• •Pregnant or planning to become pregnant during the course of the study, or breast-feeding