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

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.
ClinicalTrials.gov Identifier: NCT00032799
Recruitment Status : Completed
First Posted : April 4, 2002
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: natalizumab Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 905 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease
Study Start Date : December 2001
Primary Completion Date : September 2003
Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Natalizumab
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

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
Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderately to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during the study.
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): NCT00032799


Locations
United States, California
Elan Pharmaceuticals
San Diego, California, United States, 92121
Sponsors and Collaborators
Biogen
Elan Pharmaceuticals
More Information

Publications:
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00032799     History of Changes
Other Study ID Numbers: CD301
First Posted: April 4, 2002    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: March 2012

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