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NCT Number: NCT07472309

Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis (UC) Acute Severe Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Upadacitinib

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital,Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with ASUC according to the modified Truelove and Witts criteria;
  • Patients treated with upadacitinib at 11 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2025；
  • Patients with complete and available clinical, endoscopic, and follow-up data；
  • Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki.

Exclusion criteria

  • Patients with hemodynamic instability;
  • Patients with obvious liver and kidney function injury: bilirubin,aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR < 60ml/min or dialysis patients;
  • Patients allergic to upadacitinib or its excipients;
  • Patients whose primary disease was gastrointestinal malignancy;
  • Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
  • Female patients during pregnancy and breastfeeding (including patients with reproductive needs)；
  • Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.);
  • Patients with missing key data for outcome assessment;
  • Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

Treatment and study plan

Upadacitinib

Drug

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.

Primary outcomes

  1. Clinical-endoscopic remission rate at 12 weeks

    Time frame: 12 weeks after upadacitinib initiation

    Clinical remission is defined as a total Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0; endoscopic remission is defined as a Mayo endoscopic subscore ≤ 1 without mucosal friability.Clinical-endoscopic remission requires achievement of both clinical and endoscopic remission, assessed at 12weeks after upadacitinib initiation.

  2. Colectomy-free rate within 90 days

    Time frame: 90 days after upadacitinib initiation

    The proportion of ASUC patients who did not undergo colectomy within 90 days after the initiation of upadacitinib treatment

Secondary outcomes

  1. Patient-Reported Outcomes-2 (PRO2) score at week 1

    Time frame: 1 week after upadacitinib initiation

  2. Clinical response rate at weeks 8 and 12

    Time frame: 8 weeks and 12 weeks after upadacitinib initiation

  3. Clinical remission rate at weeks 8 and 12

    Time frame: 8 weeks and 12 weeks after upadacitinib initiation

  4. Corticosteroid-free clinical remission rate at weeks 8 and 12

    Time frame: 8 weeks and 12 weeks after upadacitinib initiation

  5. Endoscopic response rate at week 12

    Time frame: 12 weeks after upadacitinib initiation

  6. Endoscopic remission rate at week 12

    Time frame: 12 weeks after upadacitinib initiation

  7. Adverse events (AEs) rate

    Time frame: From upadacitinib initiation to study completion

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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