Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055536
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2003-03-04
Brief Title:
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohns Disease
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase II Multi-Center Double-Blind Placebo-Controlled Study of the Safety Tolerability and Efficacy of Intravenous Antegren Natalizumab in Crohns Disease Subjects Concurrently Receiving Remicade Infliximab and Not in Remission
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 tolerability and efficacy of natalizumab in individuals diagnosed with active Crohns Disease that are not in remission CDAI greater thanequal to 150 and are currently taking Remicade 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 ELN100226-351
Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351
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