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

Phase 2/3 Completed 108 enrolled Centocor, Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 1995-06
Primary completion: 1996-10
Completion: 1996-10

Publications

Results Targan SR, Hanauer SB, van Deventer SJ, Mayer L, Present DH, Braakman T, DeWoody KL, Schaible TF, Rutgeerts PJ. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group. N Engl J Med. 1997 Oct 9;337(15):1029-35. doi: 10.1056/NEJM199710093371502.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous
Subject	Infliximab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Infliximab	Monoclonal antibody	20 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications