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Efficacy and Safety Analysis of Upadacitinib in Inflammatory Bowel Disease

NCT06274996 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2024-02-23

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

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.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274996 on ClinicalTrials.gov