Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02771457
Status:
WITHDRAWN
Last Update Posted:
2016-06-30
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Managing Infliximab Reinduction After Temporary Discontinuation of Drug
Status:
WITHDRAWN
Status Verified Date:
2016-06
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 primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: