A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078611
• Other study ID #: ELN100226-CD307
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2004
• Last updated: June 14, 2016
• Start date: March 2004
• Est. completion date: March 2005

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 trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.

Description:

Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn's disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn's disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn's disease. Individuals with Crohn's disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• Males and females 18 years of age or older

• Diagnosis of Crohn's disease for at least 6 months

• Females must not be pregnant or breastfeeding

• Must not have previously taken natalizumab

• Use of some other Crohn's disease medications is permitted, but will be closely supervised

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
Canada	University of Calgary	Calgary	Alberta
Canada	GI Research	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Queen Elizabeth II Science Center	Halifax	Nova Scotia
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	Montreal General Hospital	Montreal	Quebec
Canada	Chauq Hopital Du St. Sacrement	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook & Women's College Health Sciences Center	Toronto	Ontario
Canada	Liver and Intestinal Research Centre	Vancouver	British Columbia
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Health Sciences Center	Winnipeg	Manitoba
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Asheville Gastroenterology Associates	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Austin Gastroenterology, PA	Austin	Texas
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina - Digestive Disease Center	Charleston	South Carolina
United States	Charlotte Gastroenterology & Hepatology, PLLC.	Charlotte	North Carolina
United States	UVA Health System	Charlottesville	Virginia
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	University of Chicago Hospitals	Chicago	Illinois
United States	Consultants for Clinical Research, Inc.	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Internal Medicine Associates	Danville	Virginia
United States	Malcolm Randall VA Medical Center	Gainesville	Florida
United States	Rocky Mountain Gastroenterology	Golden	Colorado
United States	Long Island Clinical Research Associates, LLP	Great Neck	New York
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Atilla Ertan, MD, PA	Houston	Texas
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	Outpatient Clinical Research Facility	Indianapolis	Indiana
United States	Borland Groover Clinic	Jacksonville	Florida
United States	New York Center for Clinical Research	Lake Success	New York
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Arapahoe Gastroenterology	LIttleton	Colorado
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	David Geffen School of Medicine at UCLA, Division of Digestive Diseases	Los Angeles	California
United States	Digestive Diseases Foundation	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Center for Medical Research, LLC	Manchester	Connecticut
United States	Gastroenterology Center of the Midsouth, P.C.	Memphis	Tennessee
United States	Summit Research Solutions	Memphis	Tennessee
United States	Drug Research Service, Inc.	Metairie	Louisiana
United States	Miami Research Associates, Inc.	Miami	Florida
United States	Aurora Helath Care	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma Foundation for Digestive Research	Oklahoma City	Oklahoma
United States	Community Clinical Trials	Orange	California
United States	Harmony Clinical Research	Oro Valley	Arizona
United States	Allegheny Center for Digestive Health	Pittsburgh	Pennsylvania
United States	Minnesota Gastroenterology, P.A.	Plymouth	Minnesota
United States	Gastroenterology Associates	Providence	Rhode Island
United States	Wake Research Associates	Raleigh	North Carolina
United States	McGuire DVAMC GI (111N)	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Rochester Institute for Digestive Diseases and Sciences, Inc.	Rochester	New York
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Gastroenterology Clinic of San Antonio, P.A.	San Antonio	Texas
United States	UCSF / Mt. Zion IBD Center	San Francisco	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Tacoma Digestive Disease Research Center	Tacoma	Washington
United States	Shared Medical Research Foundation	Tarzana	California
United States	Advanced Clinical Therapeutics	Tucson	Arizona
United States	Oklahoma Gastroenterology Associates	Tulsa	Oklahoma
United States	Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo	Washington	District of Columbia
United States	Waterside Clinical Research Services, Inc.	West Palm Beach	Florida
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Center	Winterpark	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Biogen	Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,