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

• Status: Completed
• Trial end date: 1996-07-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborator: Centocor, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins; Infliximab