Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06274996 |
Other study ID # |
2024ZSLYEC-063 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2021 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
February 2024 |
Source |
Sixth Affiliated Hospital, Sun Yat-sen University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
This study focuses on evaluating Upadacitinib, a new oral medication that inhibits specific
enzymes involved in inflammation, for treating inflammatory bowel disease (IBD), which
includes conditions such as Crohn's Disease and Ulcerative Colitis. The goal is to
determine how effective and safe this drug is for patients in China, where data is currently
lacking.IBD significantly affects individuals' quality of life and imposes a high burden
on society and healthcare systems. Current treatments don't work for everyone, and some
patients may need surgery. Upadacitinib has shown promise in other countries for treating IBD
and related conditions and has been approved by the US FDA for such use.
Our study is retrospective and multicenter, meaning it will look back at patient records from
multiple hospitals to analyze the outcomes of those who have received Upadacitinib.
Investigators aim to enroll patients treated between January 2020 and December 2023, focusing
on adults who have taken Upadacitinib for at least 8 weeks.For patients, families, and
healthcare providers, this research could mean a potential new treatment option for IBD.
Understanding Upadacitinib's efficacy and safety could lead to better management of the
disease, possibly reducing the need for surgery and improving the quality of life for those
affected by IBD. The ultimate goal is to provide more personalized and effective treatment
strategies for IBD patients in China.
Description:
This retrospective, multicenter study is designed to evaluate the efficacy and safety of
Upadacitinib, an oral selective enzyme inhibitor, in the treatment of inflammatory bowel
disease (IBD) within the Chinese patient population. IBD, encompassing conditions such as
Crohn's Disease and Ulcerative Colitis, 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, they 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 IBD management,
there is a scarcity of data on its effectiveness and safety among Chinese patients.Our
research aims to fill this knowledge gap by retrospectively analyzing patient records from
multiple hospitals across China. The study targets the adult patient demographic that has
undergone Upadacitinib treatment for a minimum duration of eight weeks between January 2020
and December 2023. By assessing the outcomes of these patients, our objective is to ascertain
the potential of Upadacitinib as a viable treatment alternative, which may revolutionize the
current IBD treatment paradigm in China.
The implications of this study are significant for patients, their families, and healthcare
providers, as it could herald a new therapeutic avenue for IBD management. A clearer
understanding of Upadacitinib's role in disease control could enhance patient care by
decreasing the necessity for surgical procedures and ameliorating life quality for IBD
sufferers. The overarching ambition of this research is to pave the way for more
individualized and efficacious treatment methodologies for the IBD patient populace in China.