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