NCT07472309Completed
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
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 81 (actual)
- First submitted
- 4 Mar 2026
- Start date
- 6 Jun 2023
- Primary completion date
- 3 Mar 2026
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Ulcerative colitis
- NCT number
- NCT07472309
What you commit to
- Study type: Observational
- Participants enrolled: 81
- From 6 Jun 2023 to the primary completion date, 3 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.;
- Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.);
Lab values
- 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;
Other
- Patients with hemodynamic instability;
- Female patients during pregnancy and breastfeeding (including patients with reproductive needs)；
- 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.
Who the study is looking for
- 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.
Age in the registry: 16 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hospital, Fourth Military Medical University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.