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

Crohn Disease Clinical Trial

Official title: A Placebo-Controlled, Dose-Ranging Study Followed by a Placebo-Controlled, Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody (cA2) in the Treatment of Patients With Active Crohn's Disease

Status Completed

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 patients with active Crohn's disease.

Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, dose-ranging study followed by a placebo-controlled, double-blind, repeated-dose extension to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in the treatment of patients with active Crohn's disease. The primary efficacy outcome of the study is a comparison of the proportion of patients achieving a clinical response at the 4-week evaluation. Clinical response is defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 70 points. Additional measurements of effectiveness include the clinical response over time, the time to loss of response, clinical remission over time, and changes in the Crohn's Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Disease Endoscopic Index of Severity (CDEIS) scores and C-reactive protein values.

Anti-TNF Chimeric Monoclonal Antibody (cA2) or 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

• Crohn Disease

• NCT number: NCT00269854
• Study type: Interventional
• Source: Centocor, Inc.
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 1995
• Completion date: October 1996