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

Crohn's Disease Clinical Trial

Official title:

A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055536
• Other study ID #: CD306
• Status: Completed
• Phase: Phase 2
• First received: March 4, 2003
• Last updated: June 14, 2016
• Start date: April 2002
• Est. completion date: July 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Male and female patients at least 18 years of age with at least a six-month history of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)

• 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	Asheville Gastroenterology	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Austin Gastroenterology	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Mercury Street Medical	Butte	Montana
United States	Columbia Gastroenterology Associates	Columbia	South Carolina
United States	Internal Medicine Associates	Danville	Virginia
United States	Digestive Disease Associates	Gainesville	Florida
United States	Long Island Clinical Research Associates, LLP	Great Neck	New York
United States	Borland Groover Clinic	Jacksonville	Florida
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Gastroenterology Center of the MidSouth	Memphis	Tennessee
United States	Memphis Gastroenterology Group	Memphis	Tennessee
United States	Wake Research Associates	Raleigh	North Carolina
United States	Boice-Willis Clinic	Rocky Mount	North Carolina
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Digestive Health Specialists	Tacoma	Washington
United States	Gastroenterology Consultants	Virginia Beach	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Country where clinical trial is conducted

United States,