Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
Completed · Phase 2
Conditions studied: Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT00055367
- Run by
- Biogen
- People needed
- 30
- Starts
- 2002-04-01
- Expected to finish
- 2004-05-01
- Last updated by the study team
- 2016-06-16
Who can join
Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Cedars-Sinai IBD Center — Los Angeles, California, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Miami Research Associates — Miami, Florida, 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
- University of Rochester — Rochester, New York, United States
- Carolina Digestive Health Associates — Charlotte, North Carolina, United States
- Hershey Medical Center — Hershey, Pennsylvania, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Royal Hospital for Sick Children — Edinburgh, United Kingdom
- Royal Free Medical School — London, United Kingdom
Full record on ClinicalTrials.gov
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