Clinical Trial

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

Completed
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Summary
The aim of this retrospective observational study is to investigate and compare the real-world effectiveness and safety of upadacitinib when used as first-line exposure versus rescue exposure in patients with acute severe ulcerative colitis (ASUC). The key questions to be addressed are: In patients with ASUC, does upadacitinib administered as first-line induction exposure result in higher rates of colectomy-free survival, clinical remission, and endoscopic healing compared with its use as rescue exposure following failure of conventional or biologic therapies? What are the differences in the incidence, type, and severity of adverse events between these two real-world treatment exposure patterns? The researchers will conduct a retrospective analysis of medical records and electronic health data from patients diagnosed with ASUC who received upadacitinib either as part of routine first-line clinical care or routine rescue clinical care. All treatment decisions were made by treating clinicians per standard of care; the investigator did not assign or modify any therapeutic interventions. Data will be collected during a defined follow-up period to compare the real-world effectiveness and safety profiles of the two treatment exposure strategies.
Trial Details
NCT Number NCT07472309
Lead Sponsor Xijing Hospital of Digestive Diseases
Conditions Ulcerative Colitis (UC), Acute Severe Ulcerative Colitis, Upadacitinib
Enrollment 81 participants
Start Date 2023-06-06
Primary Completion 2026-03-03 (estimated)
Study Completion 2026-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-16