drugset / Trial / NCT00055367

Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

NCT00055367

Phase 2 Completed 30 enrolled Biogen Elan Pharmaceuticals · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). 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. Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352.

Timeline

Start
2002-04
Primary completion
2004-05
Completion
2004-05

Drugs

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody Intravenous

Indications