Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
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
1 other identifier
interventional
30
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2002
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 26, 2003
CompletedFirst Posted
Study publicly available on registry
February 28, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2004
CompletedJune 16, 2016
March 1, 2012
2.1 years
February 26, 2003
June 14, 2016
Conditions
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Biogenlead
- Elan Pharmaceuticalscollaborator
Study Sites (13)
Cedars-Sinai IBD Center
Los Angeles, California, 90048, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Miami Research Associates
Miami, Florida, 33173, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-2631, United States
Mass General Hospital for Children, Pediatric GI & Nutrition
Boston, Massachusetts, 02114, United States
The Children's Hospital
Boston, Massachusetts, 02115, United States
University of Rochester
Rochester, New York, 14642, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211, United States
Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Royal Hospital for Sick Children
Edinburgh, EH9 1LF, United Kingdom
Royal Free Medical School
London, NWS 2QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2003
First Posted
February 28, 2003
Study Start
April 1, 2002
Primary Completion
May 1, 2004
Study Completion
May 1, 2004
Last Updated
June 16, 2016
Record last verified: 2012-03