Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
300
Trial Sponsor
Clinical Trial Start Date
2002
0Primary Completion Date
2004
0Study Completion Date
2004
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 20
Participating Facility
Official Name
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 Disease0
Last Updated
June 16, 2016
0Allocation Type
Non-Randomized0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.
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