Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00055367
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
The Children's Hospital
๐บ๐ธBoston, Massachusetts, United States
Johns Hopkins University School of Medicine
๐บ๐ธBaltimore, Maryland, United States
Children's Hospital of Philadelphia
๐บ๐ธPhiladelphia, Pennsylvania, United States
University of Rochester
๐บ๐ธRochester, New York, United States
Cedars-Sinai IBD Center
๐บ๐ธLos Angeles, California, United States
Royal Free Medical School
๐ฌ๐งLondon, United Kingdom
Hershey Medical Center
๐บ๐ธHershey, Pennsylvania, United States
Royal Hospital for Sick Children
๐ฌ๐งEdinburgh, United Kingdom
Mass General Hospital for Children, Pediatric GI & Nutrition
๐บ๐ธBoston, Massachusetts, United States
Connecticut Children's Medical Center
๐บ๐ธHartford, Connecticut, United States
Miami Research Associates
๐บ๐ธMiami, Florida, United States
Carolina Digestive Health Associates
๐บ๐ธCharlotte, North Carolina, United States
Medical College of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States