Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207766
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-09-13
Brief Title:
A Study of the Safety and Efficacy of Infliximab Remicade in Subjects With Fistulizing Crohns Disease
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
ACCENT II - A Randomized Double-blind Placebo-controlled Trial of Anti-TNF Chimeric Monoclonal Antibody Infliximab Remicade in the Long Term Treatment of Patients With Fistulizing CROHNS Disease
Status:
COMPLETED
Status Verified Date:
2009-01
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:
A study of infliximab in patients with Fistulizing Crohns Disease
Detailed Description:
This is a medical research study for patients with Crohns disease who have one or more draining enterocutaneous fistula fistula from the bowel to the skin Fistulas are a common complication of Crohns disease Fistulas rarely close spontaneously but they may get better with treatment of the underlying Crohns disease This study will investigate the safety and efficacy of maintenance dosing of an anti-TNF anti-tumor necrosis factor antibody a protein called infliximab compared to a placebo inactive substance in providing sustained reductions in the number of draining fistulas
Subjects will receive infliximab at weeks 0 2 and 6 followed by infusions of infliximab 5 mgkg or placebo at weeks 14 and every 8 weeks until week 46 Patients who lose response are eligible for increasing treatment by 5 mgkg of infliximab
Subjects will receive infliximab at weeks 0 2 and 6 followed by infusions of infliximab 5 mgkg or placebo at weeks 14 and every 8 weeks until week 46 Patients who lose response are eligible for increasing treatment by 5 mgkg of infliximab
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