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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00032786
Collaborator
Elan Pharmaceuticals (Industry)
24
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate 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
Phase 3

Study Design

Study Type:
Interventional
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 Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease
Study Start Date :
Mar 1, 2002
Actual Primary Completion Date :
Mar 1, 2004
Actual Study Completion Date :
Mar 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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 moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Biogen
    • Elan Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT00032786
    Other Study ID Numbers:
    • CD303
    First Posted:
    Apr 4, 2002
    Last Update Posted:
    Jun 16, 2016
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Crohn Disease
    Natalizumab

    Study Results

    No Results Posted as of Jun 16, 2016