Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

Inclusion: - Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints; - must also have DAS of 3.2 or greater at study entry, - normal laboratory parameters and ESR >20, - satisfactory response or intolerance to one or more prior DMARDs and - be willing and able to give informed consent. Exclusion: - Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia, - history of acute inflammatory joint disease other than RA, - prior treatment with cyclophosphamide or chlorambucil, - prior treatment with intravenous immunoglobulin within 70 days, - history of malignant lymphoma, - history of uncontrolled diabetes, - unstable ischemic heart disease, - active inflammatory bowel disease, - active peptic ulcer disease or stroke, - positive HIV status, - positive serology for Hepatitis B or C, - no previous history of tuberculosis or listeria infection, - no previous history of cancer other than successfully treated skin cancer; - women can not be pregnant or be breastfeeding