Clinical trial NCT06922331: Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis
Official title: Age-Stratified Efficacy of Upadacitinib in Refractory Inflammatory Bowel Disease Among Asian Populations: Pediatric Crohn's Disease Versus Elderly Ulcerative Colitis Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn&#39;s Disease (CD)
Ulcerative Colitis (UC)
Refractory Crohn&#39;s Disease
Refractory Ulcerative Colitis
Inflammatory Bowel Disease (IBD)
Pediatric Crohn&#39;s Disease
Geriatric Ulcerative Colitis
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 21
Sex: ALL
Minimum age (years): 9
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian pediatric patients (ages 9-17) with refractory Crohn's disease and elderly patients (60 years and older) with refractory ulcerative colitis.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IBD according to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2023)"; Failure of at least two prior biological therapies (anti-TNF/anti-integrin/IL-12/23 inhibitors); Complete baseline and follow-up data (at least 12 weeks))

Exclusion Criteria:

* Active infection, malignancy, severe cardiovascular disease, or hepatic/renal insufficiency; Pregnancy or breastfeeding; Use of other JAK inhibitors within 30 days prior to baseline)

Primary outcomes:
measure: Clinical Remission Rate at Week 12
timeFrame: Week 12
measure: Endoscopic Response Rate at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Clinical Response Rate at Week 12
timeFrame: Week 12
measure: Change in CRP from Baseline to Week 12
timeFrame: Baseline to Week 12
Other outcomes:
measure: Incidence of Adverse Events
timeFrame: Week 0 to Week 12
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: