Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269841
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2005-12-22
Brief Title:
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Fistulizing Crohns Disease
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Placebo-Controlled Repeated-Dose Study of Anti-TNF Chimeric Monoclonal Antibody cA2 in the Treatment of Patients With Enterocutaneous Fistulae as a Complication of Crohns Disease
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody cA2 compared to placebo in the treatment of patients with fistulizing Crohns disease
Detailed Description:
This is a randomized placebo-controlled double-blind repeated-dose study to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody cA2 compared to placebo in the treatment of patients with fistulizing Crohns disease The primary efficacy outcome of the study is the number of patients with at least a 50 reduction from baseline in the number of open fistulae observed for at least two consecutive evaluation visits
Patients will be treated with either anti-TNF chimeric monoclonal antibody cA2 or matching placebo
Patients will be treated with either anti-TNF chimeric monoclonal antibody cA2 or matching placebo
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