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

NCT00004941 | Completed Phase 3

• 3 other identifiers: 199/13447CENTOCOR-C0168T20CENTOCOR-FDR001276
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

OBJECTIVES: I. Evaluate the efficacy of chimeric monoclonal antibody (cA2) compared with placebo in closure of enterocutaneous fistulae in patients with Crohn's disease.

Conditions

Crohn's Disease

Keywords

Crohn's disease; gastrointestinal disorders; rare disease

Interventions

monoclonal antibody cA2 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead
• Centocor, Inc.: collaborator

MeSH Terms

Conditions

Crohn Disease; Gastrointestinal Diseases; Rare Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Richard Vensel McCloskey

  Centocor, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: July 1, 1996
• Study Completion: July 1, 1996
• Last Updated: March 25, 2015

Record last verified: 2000-04