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

This study has been completed.
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Identifier:
First received: February 26, 2003
Last updated: June 14, 2016
Last verified: March 2012

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 Intervention Phase
Crohn's Disease
Drug: natalizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Biogen:

Estimated Enrollment: 30
Study Start Date: April 2002
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   12 Years to 17 Years   (Child)
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
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Please refer to this study by its identifier: NCT00055367

United States, California
Cedars-Sinai IBD Center
Los Angeles, California, United States, 90048
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287-2631
United States, Massachusetts
Mass General Hospital for Children, Pediatric GI & Nutrition
Boston, Massachusetts, United States, 02114
The Children's Hospital
Boston, Massachusetts, United States, 02115
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28211
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4399
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
United Kingdom
Royal Hospital for Sick Children
Edinburgh, United Kingdom, EH9 1LF
Royal Free Medical School
London, United Kingdom, NWS 2QG
Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

Responsible Party: Biogen Identifier: NCT00055367     History of Changes
Other Study ID Numbers: CD305
Study First Received: February 26, 2003
Last Updated: June 14, 2016

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 24, 2017