Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207662
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-09-13
Brief Title:
A Safety and Efficacy Study of Infliximab Remicade in Patients With Moderate to Severe Active Crohns Disease
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
ACCENT I - A Randomized Double-blind Placebo-controlled Trial of Anti-TNFa Chimeric Monoclonal Antibody Infliximab Remicade in the Long-term Treatment of Patients With Moderately to Severely Active Crohns Disease
Status:
COMPLETED
Status Verified Date:
2010-04
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:
This is a study of infliximab Remicade in subjects with Crohns disease
Detailed Description:
Crohns disease is a disease characterized by inflammation the changes that happen when tissues in the body are injured and ulceration formation of pus of the bowel The purpose of this study is to investigate the safety and therapeutic effect of two different doses of an anti-TNFα tumor necrosis factor antibody a protein given multiple times compared to a single dose followed by placebo inactive substance The name of the antibody is infliximab Remicade The goal of the study is to evaluate whether patients respond longer to a single dose of infliximab or to repeated doses of infliximab
Subjects will receive an infusion of infliximab at week 0 followed by infusions of infliximab or placebo at weeks 2 6 14 and every 8 weeks until week 54 Patients who lose response are eligible for additional infliximab treatment
Subjects will receive an infusion of infliximab at week 0 followed by infusions of infliximab or placebo at weeks 2 6 14 and every 8 weeks until week 54 Patients who lose response are eligible for additional infliximab treatment
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