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Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00055367
Collaborator
Elan Pharmaceuticals (Industry)
30
Enrollment
13
Locations
25
Duration (Months)
2.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn's disease (CD). 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.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
May 1, 2004
Actual Study Completion Date :
May 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Male and female patients, 12-17 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. Females must not be breastfeeding or pregnant, and must not become pregnant during the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai IBD Center Los Angeles California United States 90048
    2 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    3 Miami Research Associates Miami Florida United States 33173
    4 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287-2631
    5 Mass General Hospital for Children, Pediatric GI & Nutrition Boston Massachusetts United States 02114
    6 The Children's Hospital Boston Massachusetts United States 02115
    7 University of Rochester Rochester New York United States 14642
    8 Carolina Digestive Health Associates Charlotte North Carolina United States 28211
    9 Hershey Medical Center Hershey Pennsylvania United States 17033
    10 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104-4399
    11 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    12 Royal Hospital for Sick Children Edinburgh United Kingdom EH9 1LF
    13 Royal Free Medical School London United Kingdom NWS 2QG

    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:
    NCT00055367
    Other Study ID Numbers:
    • CD305
    First Posted:
    Feb 28, 2003
    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