Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease

NCT ID: NCT06274996

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 81 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Upadacitinib

Upadacitinib, a selective Janus kinase (JAK) inhibitor taken orally, is being assessed for its unique capacity to attenuate inflammatory pathways in IBD at a cellular level by selectively inhibiting JAK1, a pathway integral to inflammatory cytokine production. This study focuses on its use as monotherapy for Chinese patients unresponsive to conventional IBD treatments, such as aminosalicylates and corticosteroids. By centering on a demographic typically underrepresented in research, the study aims to provide new insights into dosing, treatment frequency, and duration, thus enhancing the understanding of Upadacitinib\'s safety and efficacy. The retrospective analysis of patient data is anticipated to inform more personalized treatment approaches, potentially improving IBD management and patient quality of life.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who were hospitalized in our institution or its branches between January 2020 and September 2023.

Patients with a confirmed diagnosis of Crohn's Disease (CD) or Ulcerative Colitis (UC).

Patients aged 18 years or older. Patients who have received at least 8 weeks of Upadacitinib treatment prior to December 2023.

Exclusion Criteria

• Patients with an unclear diagnosis. Patients under the age of 18. Patients who have been treated with Upadacitinib for less than 8 weeks.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jiayin Yao

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2024ZSLYEC-063

Identifier Type: -

Identifier Source: org_study_id