---
title: Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis
nct_id: NCT07472309
overall_status: COMPLETED
sponsor: Xijing Hospital of Digestive Diseases
study_type: OBSERVATIONAL
primary_condition: Ulcerative Colitis (UC)
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07472309.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07472309"
ct_last_update_post_date: 2026-03-16
last_seen_at: "2026-05-12T06:36:28.814Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis

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

**NCT ID:** [NCT07472309](https://clinicaltrials.gov/study/NCT07472309)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 81
- **Lead Sponsor:** Xijing Hospital of Digestive Diseases
- **Conditions:** Ulcerative Colitis (UC), Acute Severe Ulcerative Colitis, Upadacitinib
- **Start Date:** 2023-06-06
- **Completion Date:** 2026-03-03
- **CT.gov Last Update:** 2026-03-16

## Brief 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.

## Eligibility

- **Minimum age:** 16 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients diagnosed with ASUC according to the modified Truelove and Witts criteria;
2. Patients treated with upadacitinib at 11 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2025；
3. Patients with complete and available clinical, endoscopic, and follow-up data；
4. 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:

1. Patients with hemodynamic instability;
2. 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;
3. Patients allergic to upadacitinib or its excipients;
4. Patients whose primary disease was gastrointestinal malignancy;
5. Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
6. Female patients during pregnancy and breastfeeding (including patients with reproductive needs)；
7. Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.);
8. Patients with missing key data for outcome assessment;
9. Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
```

## Arms

- **ASUC Patients with First-Line Upadacitinib Exposure** — This retrospective observational cohort includes patients diagnosed with acute severe ulcerative colitis (ASUC) who received upadacitinib as first-line therapy in routine clinical practice. First-line upadacitinib was defined as administration in ASUC patients who had not previously received corticosteroids or biologics during this episode. All treatment decisions were made by treating clinicians per standard of care; the investigator did not assign or modify any therapeutic interventions, and only retrospectively collected and analyzed clinical outcomes from medical records.
- **ASUC Patients with Rescue Upadacitinib Exposure** — This retrospective observational cohort includes patients diagnosed with acute severe ulcerative colitis (ASUC) who received upadacitinib as part of routine rescue therapy (second- and third-line treatment). Second-line rescue therapy was defined as upadacitinib initiation after 3-5 days of intravenous methylprednisolone (40-60 mg/day) with inadequate response. Third-line rescue therapy was defined as upadacitinib use following failure of both intravenous methylprednisolone and infliximab during the same ASUC episode. All treatment decisions were made by treating clinicians in accordance with standard of care; the investigator did not assign, modify, or control any therapeutic interventions, and only retrospectively collected and analyzed clinical outcomes from medical records.

## Interventions

- **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

- **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.
- **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

- **Patient-Reported Outcomes-2 (PRO2) score at week 1** _(time frame: 1 week after upadacitinib initiation)_
- **Clinical response rate at weeks 8 and 12** _(time frame: 8 weeks and 12 weeks after upadacitinib initiation)_
- **Clinical remission rate at weeks 8 and 12** _(time frame: 8 weeks and 12 weeks after upadacitinib initiation)_
- **Corticosteroid-free clinical remission rate at weeks 8 and 12** _(time frame: 8 weeks and 12 weeks after upadacitinib initiation)_
- **Endoscopic response rate at week 12** _(time frame: 12 weeks after upadacitinib initiation)_
- **Endoscopic remission rate at week 12** _(time frame: 12 weeks after upadacitinib initiation)_
- **Adverse events (AEs) rate** _(time frame: From upadacitinib initiation to study completion)_

## Locations (1)

- Xijing Hospital,Fourth Military Medical University, Xi'an, Shaanxi, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xijing hospital,fourth military medical university|xi'an|shaanxi|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07472309.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07472309*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*