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

This study has been completed.
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00055367
First received: February 26, 2003
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

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

Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 30
Study Start Date: April 2002
Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055367

Locations
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
Biogen Idec
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00055367     History of Changes
Other Study ID Numbers: CD305
Study First Received: February 26, 2003
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 23, 2013