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

June 14, 2016 updated by: Biogen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

462

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1S 4L8
        • Chauq Hopital Du St. Sacrement
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
      • Edmonton, Alberta, Canada, T5H 4B9
        • GI Research
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Liver and Intestinal Research Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Center
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Science Center
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook & Women's College Health Sciences Center
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
  • United States
    • Arizona
      • Oro Valley, Arizona, United States, 85739
        • Harmony Clinical Research
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90067
        • Digestive Diseases Foundation
      • Los Angeles, California, United States, 90092-7019
        • David Geffen School of Medicine at UCLA, Division of Digestive Diseases
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • San Francisco, California, United States, 94115
        • UCSF / Mt. Zion IBD Center
      • Tarzana, California, United States, 91356
        • Shared Medical Research Foundation
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Lynn Institute Of The Rockies
      • Golden, Colorado, United States, 80215
        • Rocky Mountain Gastroenterology
      • LIttleton, Colorado, United States, 80120
        • Arapahoe Gastroenterology
    • Connecticut
      • Manchester, Connecticut, United States, 06040
        • Center for Medical Research, LLC
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo
    • Florida
      • Gainesville, Florida, United States, 32608
        • Malcolm Randall VA Medical Center
      • Jacksonville, Florida, United States, 32256
        • Borland Groover Clinic
      • Miami, Florida, United States, 33173
        • Miami Research Associates, Inc.
      • West Palm Beach, Florida, United States, 33407
        • Waterside Clinical Research Services, Inc.
      • Winterpark, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5250
        • Outpatient Clinical Research Facility
      • Indianapolis, Indiana, United States, 46227
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • Metairie, Louisiana, United States, 70001
        • Drug Research Service, Inc.
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P.A.
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • Lake Success, New York, United States, 11042
        • New York Center for Clinical Research
      • New York, New York, United States, 10028
        • Mount Sinai School of Medicine
      • Rochester, New York, United States, 14607
        • Rochester Institute for Digestive Diseases and Sciences, Inc.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC.
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Winston-Salem, North Carolina, United States, 27012
        • Wake Forest University School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants For Clinical Research, Inc.
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Gastroenterology Associates
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Center for Digestive Health
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Gastroenterology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina - Digestive Disease Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Southeastern Clinical Research
      • Memphis, Tennessee, United States, 38120
        • Gastroenterology Center of the Midsouth, P.C.
      • Memphis, Tennessee, United States, 38120
        • Summit Research Solutions
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Austin, Texas, United States, 78745
        • Austin Gastroenterology, PA
      • Houston, Texas, United States, 77030
        • Atilla Ertan, MD, PA
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Clinic of San Antonio, P.A.
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA Health System
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Danville, Virginia, United States, 24541
        • Internal Medicine Associates
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC GI (111N)
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • Tacoma Digestive Disease Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Helath Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

March 1, 2004

First Submitted That Met QC Criteria

March 5, 2004

First Posted (ESTIMATE)

March 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELN100226-CD307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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