Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269185
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-09
Brief Title:
Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Comparison of Short and Long-term Efficacy Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - a Retrospective Observational Multicenter Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Anti-TNF tumor necrosing factor treatment with infliximab IFX and adalimumab ADA are established first-line biological therapies used in treatment of patients with ulcerative colitis UC There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission However several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations
The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab IFX and adalimumab ADA in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment
The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab IFX and adalimumab ADA in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None