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An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohn's Disease

Crohn Disease Clinical Trial

Official title:
A Placebo-Controlled, Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohn's Disease

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease.

Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with fistulizing Crohn's disease. The primary efficacy outcome of the study is the number of patients with at least a 50% reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits.

Patients will be treated with either anti-TNF chimeric monoclonal antibody (cA2) or matching placebo. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00269841
Study type Interventional
Source Centocor, Inc.
Contact
Status Completed
Phase Phase 3
Start date May 1996
Completion date February 1998
View Details
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