Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055367
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2003-02-26
Brief Title:
Safety Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohns Disease
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
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 Crohns Disease
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns 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 Crohns disease
Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352
Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-352
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None