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

Last updated: June 14, 2016
Sponsor: Biogen
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Crohn's Disease

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT00032786
CD303
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

Study Design

Study Start date:
March 01, 2002
Estimated Completion Date:
March 31, 2004