NCT07472309

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

A Comparative Retrospective Observational Study of the Effectiveness and Safety of Upadacitinib as First-Line and Rescue Therapy in Acute Severe Ulcerative Colitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a retrospective observational cohort study. All interventions described are part of routine clinical care for acute severe ulcerative colitis (ASUC). Treatment decisions were made by treating clinicians per standard of care; the investigator did not prospectively assign, modify, or control any therapeutic interventions. Participants did not receive any intervention specifically for the purpose of this study. The study only involves retrospective analysis of existing medical records to compare real-world outcomes between different treatment exposure patterns.

Conditions

• Ulcerative Colitis (UC)
• Acute Severe Ulcerative Colitis
• Upadacitinib

Interventions

Type	Name	Description
DRUG	Upadacitinib	Upadacitinib was administered orally as part of routine clinical care for acute severe ulcerative colitis (ASUC), in accordance with standard clinical guidelines. The induction dose was 45 mg once daily for up to 12 weeks (8 weeks for most patients, extended to 12 weeks for a subset with severe disease), followed by a maintenance dose of 30 mg once daily. All dosing decisions were made by treating clinicians; the investigator did not assign, modify, or control any dosing regimen for research purposes.

Timeline

• Start date: 2023-06-06
• Primary completion: 2026-03-03
• Completion: 2026-03-03
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China