Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

Phase 3 Completed Biogen Elan Pharmaceuticals · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Timeline

Start: 2002-03
Primary completion: 2004-03
Completion: 2004-03

Outcome

Missed primary endpoint

paper In the first trial, the natalizumab and placebo groups had similar rates of response (56 percent and 49 percent, respectively; P=0.05) PMID 16267322 ↗

paper Induction therapy with natalizumab for Crohn's disease resulted in small, nonsignificant improvements in response and remission rates. PMID 16267322 ↗

Publications

Results Sandborn WJ, Colombel JF, Enns R, Feagan BG, Hanauer SB, Lawrance IC, Panaccione R, Sanders M, Schreiber S, Targan S, van Deventer S, Goldblum R, Despain D, Hogge GS, Rutgeerts P; International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005 Nov 3;353(18):1912-25. doi: 10.1056/NEJMoa043335.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	natalizumab	Monoclonal antibody	300 mg	Intravenous