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
monoclonal antibody cA2
Digestive System Diseases+7
+ Gastroenteritis
+ Intestinal Diseases
Treatment Study
Summary
Study start date: July 1, 1996
Actual date on which the first participant was enrolled.PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to investigational site and number of fistulae (single vs multiple). Patients are randomized to one of three treatment arms: Arm I: Patients receive an infusion of chimeric monoclonal antibody (cA2) on weeks 0, 2, and 6. Arm II: Patients receive an infusion of cA2 on weeks 0 and 2, and an infusion of placebo on week 6. Arm III: Patients receive an infusion of placebo on day 1 of weeks 0, 2, and 6. Patients are followed every month for 3 months, then every 6-12 months for up to 2 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.94 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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