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Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis

NCT06922331 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2025-04-10

No results posted yet for this study

Summary

This single-center, retrospective study aims to evaluate the effectiveness and safety of upadacitinib (UPA) in Asian pediatric patients with refractory Crohn's disease (CD) and elderly patients with refractory ulcerative colitis (UC). The study will analyze data from 21 patients (11 children aged 9-17 with CD and 10 adults aged 60 and older with UC) treated at the Sixth Affiliated Hospital of Sun Yat-sen University between January 2023 and December 2024. The primary objective is to assess the clinical remission rate and endoscopic response rate in both groups. Secondary objectives include comparing treatment outcomes between the two age groups, exploring the impact of immunosenescence on UPA efficacy in elderly UC patients, and analyzing the correlation between laboratory markers (CRP, albumin) and clinical outcomes. This study is the first in Asia to investigate the age-stratified efficacy of upadacitinib in pediatric CD and elderly UC patients. The findings will provide crucial real-world evidence to inform individualized treatment strategies for these specific populations. Patients included in this study will have previously failed at least two biological therapies. Data collected will include demographics, disease characteristics, prior treatment history, UPA dosage and duration, clinical and endoscopic scores (PCDAI/Mayo, SES-CD/UCEIS), imaging results, laboratory values, and adverse events. The study is registered on ClinicalTrials.gov (NCT06274996). Ethical considerations will be addressed through data anonymization and a waiver of informed consent due to the retrospective nature of the study.

Conditions

  • Crohn's Disease (CD)
  • Ulcerative Colitis (UC)
  • Refractory Crohn's Disease
  • Refractory Ulcerative Colitis
  • Inflammatory Bowel Disease (IBD)
  • Pediatric Crohn's Disease
  • Geriatric Ulcerative Colitis

Interventions

DRUG

Upadacitinib

A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Eligibility

Min Age
9 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2025-03-01
FDA Drug
Yes

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 NCT06922331 on ClinicalTrials.gov