NCT00269841

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Infliximab 10 mg/kg	Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 10 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2 and 6.
DRUG	Infliximab 5 mg/kg	Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 5 mg/kg will be administered as infusion at Week 0, 2 and 6.
DRUG	Placebo	Matching placebo will be adminstered at Week 0, 2 and 6.

Timeline

• Start date: 1996-05-01
• Primary completion: 1998-02-01
• Completion: 1998-02-01
• First posted: 2005-12-26
• Last updated: 2014-11-04