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Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

NCT07472309 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-06
Primary Completion
2026-03-03
Completion
2026-03-03

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 NCT07472309 on ClinicalTrials.gov