Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269854
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 Crohns Disease
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Placebo-Controlled Dose-Ranging Study Followed by a Placebo-Controlled Repeated-Dose Extension of Anti-TNF Chimeric Monoclonal Antibody cA2 in the Treatment of Patients With Active 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 patients with active Crohns disease
Detailed Description:
This is a randomized placebo-controlled double-blind dose-ranging study followed by a placebo-controlled double-blind repeated-dose extension to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody cA2 compared to placebo in the treatment of patients with active Crohns disease The primary efficacy outcome of the study is a comparison of the proportion of patients achieving a clinical response at the 4-week evaluation Clinical response is defined as a reduction from baseline in the Crohns Disease Activity Index CDAI score of at least 70 points Additional measurements of effectiveness include the clinical response over time the time to loss of response clinical remission over time and changes in the Crohns Disease Activity Index CDAI Inflammatory Bowel Disease Questionnaire IBDQ Crohns Disease Endoscopic Index of Severity CDEIS scores and C-reactive protein values
Anti-TNF Chimeric Monoclonal Antibody cA2 or placebo
Anti-TNF Chimeric Monoclonal Antibody cA2 or 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