Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078611
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2004-03-01
Brief Title:
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohns Disease
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase III Multicenter Double-Blind Placebo-Controlled Study of the Safety and Efficacy of Intravenous AntegrenTM Natalizumab in Subjects With Moderately to Severely Active Crohns Disease With Elevated C-Reactive Protein
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 trial is to evaluate natalizumab in individuals with moderately to severely active Crohns Disease
Detailed Description:
Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohns disease It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue These cells are thought to cause damage to the bowel leading to the symptoms of Crohns disease Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohns disease Individuals with Crohns disease will be randomly assigned to receive either placebo an inactive solution or natalizumab by intravenous infusion this means putting it directly into a vein in the arm There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab For those patients who do not enroll into the extension study the total participation in this study will last for approximately 22 weeks
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