drugset / Trial / NCT00055536

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

NCT00055536

Phase 2 Completed 60 enrolled Biogen Elan Pharmaceuticals · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. 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 ELN100226-351.

Timeline

Start
2002-04
Primary completion
2003-07
Completion
2003-07

Drugs

EvaluationDrugModalityDoseRoute
Subject natalizumab Monoclonal antibody Intravenous

Indications