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

Launched by ABBOTT · Nov 13, 2002

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Eligibility 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