Clinical trial NCT00078611: A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease
Inflammatory Bowel Disease
IBD
Gastroenterology
Regional Enteritis
Colitis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2004-03-08
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.

Detailed 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.

Eligibility criteria: * 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

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