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)
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
Scroll for more (3 remaining)Cedars-Sinai IBD Center🇺🇸Los Angeles, California, United States