Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446219
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2024-06-01
Brief Title:
Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohns Disease
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
A Retrospective Analysis of the Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohns Disease
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This study focuses on Upadacitinib a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation The goal is to determine efficacy and safety of Upadacitinib for Crohns Disease patients in China compared with Vedolizumab which is used to inhibit recruitment of inflammatory cells Crohns Disease significantly affects individuals quality of life and imposes a high burden on society and healthcare systems Current treatments dont work for everyone and some patients may need surgery Upadacitinib has shown promise in other countries for treating Crohns Disease and related conditions and has been approved by the US FDA for such use
The investigators retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab Investigators aim to enroll patients treated between January 2020 and March 2024 who received follow-up for more than 12 weeks For patients families and healthcare providers this research could provide a potential new treatment option for Crohns Disease Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease possibly reducing the need for surgery and improving the quality of life The ultimate goal is to provide more personalized and effective treatment strategies for Crohns Disease patients in China
The investigators retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab Investigators aim to enroll patients treated between January 2020 and March 2024 who received follow-up for more than 12 weeks For patients families and healthcare providers this research could provide a potential new treatment option for Crohns Disease Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease possibly reducing the need for surgery and improving the quality of life The ultimate goal is to provide more personalized and effective treatment strategies for Crohns Disease patients in China
Detailed Description:
This retrospective multicenter study is designed to compare the efficacy and safety of Upadacitinib and Vedolizumab in second-line treatment for Crohns Disease the former is an oral selective enzyme inhibitor and the latter is a monoclonal antibody targeting integrin α4β7 Crohns Disease poses a significant impact on the quality of life for individuals and presents a considerable challenge to healthcare systems due to the societal burdens it incurs While current therapeutic interventions offer relief these interventions fail to suffice for all patients with some requiring surgical intervention Despite the approval of Upadacitinib by the US FDA and its promising application in other nations for Crohns Disease management there is a scarcity of data on its effectiveness and safety among Chinese patients The investigators research aims to fill this knowledge gap by retrospectively analyzing patient records from multiple hospitals across China The study targets the adult patients that has received follow-up for more than 12 weeks between January 2020 and March 2024 By assessing the outcomes of these patients the investigators objective is to ascertain the potential of Upadacitinib as a viable treatment alternative which may revolutionize the current Crohns Disease treatment paradigm in ChinaThe implications of this study are significant for patients their families and healthcare providers as it could herald a new therapeutic avenue for Crohns Disease management A clearer understanding of Upadacitinibs role in disease control could enhance patient care by decreasing the necessity for surgical procedures and ameliorating life quality for Crohns Disease sufferers The overarching ambition of this research is to pave the way for more individualized and efficacious treatment methodologies for the Crohns Disease patient populace in China
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None