A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of infliximab (Remicade) in patients with Ulcerative Colitis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Clinical Trial Description

This study is designed to investigate the safety and effectiveness of infliximab in adult patients with active ulcerative colitis. The purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication infliximab, and what dose is needed to do that safely.Patients will receive infusions of either 5 or 10 mg/kg or placebo at weeks 0, 2, 6, 14, and 22 up to week 164. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.

Patients will receive infusions (into the vein) of either 5 or 10 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks up to week 164. ;

Study Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT00096655
• Study type: Interventional
• Source: Centocor, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: May 2002
• Completion date: August 2007