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

Phase 3 Completed 94 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 the treatment of patients with fistulizing Crohn's disease.

Timeline

Start: 1996-05
Primary completion: 1998-02
Completion: 1998-02

Outcome

Met primary endpoint

paper 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point PMID 10228190 ↗

paper achieved the primary end point, as compared with 26 percent of the patients in the placebo group (P=0.002 and P=0.02, respectively). PMID 10228190 ↗

Publications

Results Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405. doi: 10.1056/NEJM199905063401804.

Drugs

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