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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00078611
First Posted: March 8, 2004
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen
  Purpose
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.

Condition Intervention Phase
Crohn's Disease Drug: natalizumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Estimated Enrollment: 462
Study Start Date: March 2004
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: natalizumab
    Other Name: Antegren
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078611


  Show 75 Study Locations
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00078611     History of Changes
Other Study ID Numbers: ELN100226-CD307
First Submitted: March 1, 2004
First Posted: March 8, 2004
Last Update Posted: June 16, 2016
Last Verified: March 2012

Keywords provided by Biogen:
Crohn's disease
Inflammatory Bowel Disease
IBD
Gastroenterology
Regional Enteritis
Colitis

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs