Crohn's Disease Clinical Trial
OBJECTIVES:
I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in
closure of enterocutaneous fistulae in patients with Crohn's disease.
Status | Completed |
Enrollment | 94 |
Est. completion date | July 1996 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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FDA Office of Orphan Products Development | Centocor, Inc. |
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