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

Crohn's Disease Clinical Trial

Official title:

A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032799
• Other study ID #: CD301
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2002
• Last updated: June 14, 2016
• Start date: December 2001
• Est. completion date: September 2003

Study information

• Verified date: March 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 905
• Est. completion date: September 2003
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 moderately to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• natalizumab

Locations

Country	Name	City	State
United States	Elan Pharmaceuticals	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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) T — View Citation