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

Inclusion criteria

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