Phase III Randomized Study of Anti-Tumor Necrosis Factor Chimeric Monoclonal Antibody (cA2) for Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Inclusion criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Crohn's disease of at least 3 months duration confirmed by radiography or endoscopy Single or multiple draining enterocutaneous (including perianal) fistulae of at least 3 months duration All fistulae separate and distinctly identifiable No local complications of Crohn's disease such as strictures or abscesses --Prior/Concurrent Therapy-- Biologic therapy: * No prior chimeric monoclonal antibody (cA2) * At least 3 months since treatment with other therapeutic agent targeted at reducing tumor necrosis factor (e.g., pentoxifylline or thalidomide) * At least 4 weeks since cyclosporine Chemotherapy: * Concurrent methotrexate permitted if treatment began at least 3 months prior to enrollment, dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period * Otherwise, no methotrexate within 4 weeks prior to enrollment Concurrent 6-mercaptopurine or azathioprine permitted if treatment began at least 6 months prior to enrollment, dose has been stable for at least 8 weeks prior to enrollment, and remains stable throughout study period Otherwise, no 6-mercaptopurine or azathioprine within 4 weeks prior to enrollment Endocrine therapy: * Concurrent corticosteroids (e.g., oral prednisone) permitted if dose has been stable for at least 3 weeks prior to enrollment, does not exceed 40 mg/kg, and remains stable throughout study period (dosage may be tapered after 6 weeks for some patients) * Otherwise, no corticosteroids within 4 weeks prior to enrollment Other: * Concurrent antibiotics or aminosalicylates for Crohn's disease permitted if dose has been stable for at least 4 weeks prior to enrollment and remains stable throughout study period * Otherwise, no antibiotics or aminosalicylates within 4 weeks prior to enrollment * At least 3 months since investigational drugs --Patient Characteristics-- Hematopoietic: * WBC at least 3,500/mm3 * Neutrophil count at least 1,500/mm3 * Lymphocyte count at least 500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 8.5 g/dL * No severe, progressive, or uncontrolled hematologic disease Hepatic: * SGOT no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 3 times ULN * No severe, progressive, or uncontrolled hepatic disease Renal: * Creatinine no greater than 1.7 mg/dL * No severe, progressive, or uncontrolled renal disease Cardiovascular: No severe, progressive, or uncontrolled cardiac disease Pulmonary: No severe, progressive, or uncontrolled pulmonary disease Neurologic: No severe, progressive, or uncontrolled neurologic or cerebral disease Other: * Negative pregnancy test required and no planned pregnancy within 7.5 months following first infusion * Effective contraception required of fertile patients during and for 6 months after study * No severe, progressive, or uncontrolled endocrine disease * No serious infections (e.g., hepatitis, pneumonia, pyelonephritis) within prior 3 months * No history of opportunistic infections (e.g., herpes zoster) within 2 months * No allergy to murine proteins * No active cytomegalovirus, Pneumocystis carinii, or drug resistant atypical mycobacterial infections * No recent drug or alcohol abuse * No HIV infection, ARC (AIDS-related complex) or AIDS * Total parenteral nutrition or tube feeding not permitted * No prior or concurrent malignancy within 5 years