A Study of the Safety and Efficacy of Infliximab (Remicade) in Subjects With Fistulizing Crohn's Disease

Crohn Disease Clinical Trial

Official title: ACCENT II - A Randomized, Double-blind, Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody (Infliximab, Remicade) in the Long Term Treatment of Patients With Fistulizing CROHN'S Disease

Status Completed

Clinical Trial Summary

A study of infliximab in patients with Fistulizing Crohn's Disease

Clinical Trial Description

This is a medical research study for patients with Crohn's disease who have one or more draining enterocutaneous fistula (fistula from the bowel to the skin). Fistulas are a common complication of Crohn's disease. Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohn's disease. This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF (anti-tumor necrosis factor) antibody (a protein), called infliximab, compared to a placebo (inactive substance) in providing sustained reductions in the number of draining fistulas.

Subjects will receive infliximab at weeks 0, 2 and 6 followed by infusions of infliximab 5 mg/kg or placebo at weeks 14 and every 8 weeks until week 46. Patients who lose response are eligible for increasing treatment by 5 mg/kg of infliximab. ;

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT00207766
• Study type: Interventional
• Source: Centocor, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: June 2000
• Completion date: August 2006