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NCT00055367 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00055367
Other study ID # CD305
Secondary ID
Status Completed
Phase Phase 2
First received February 26, 2003
Last updated June 14, 2016
Start date April 2002
Est. completion date May 2004

Study information
Verified date March 2012
Source Biogen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date May 2004
Est. primary completion date May 2004
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• natalizumab

Locations
Country Name City State
United Kingdom Royal Hospital for Sick Children Edinburgh
United Kingdom Royal Free Medical School London
United States Johns Hopkins University School of Medicine Baltimore Maryland
United States Mass General Hospital for Children, Pediatric GI & Nutrition Boston Massachusetts
United States The Children's Hospital Boston Massachusetts
United States Carolina Digestive Health Associates Charlotte North Carolina
United States Connecticut Children's Medical Center Hartford Connecticut
United States Hershey Medical Center Hershey Pennsylvania
United States Cedars-Sinai IBD Center Los Angeles California
United States Miami Research Associates Miami Florida
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of Rochester Rochester New York

Sponsors (2)
Lead Sponsor Collaborator
Biogen Elan Pharmaceuticals

Countries where clinical trial is conducted

United States,  United Kingdom, 

See also
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Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3