Ulcerative Colitis (UC)NCT07472309
Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis
An observational study of Ulcerative Colitis (UC) and Acute Severe Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC), Acute Severe Ulcerative Colitis, Upadacitinib
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2023to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a multicenter, retrospective cohort study conducted at 11 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2025. A total of 81 patients diagnosed with ASUC according to the modified Truelove and Witts criteria were enrolled. All patients received upadacitinib as first-line or rescue therapy. The study population was categorized into two groups: the first-line therapy group (upadacitinib administered in ASUC patients who had not previously received corticosteroids or biologics during this episode) and the rescue therapy group (including second-line and third-line therapy, defined as upadacitinib initiation after failure of intravenous methylprednisolone or both intravenous methylprednisolone and infliximab).
Who may be able to join
- 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.
Who cannot join
- 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)；
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital,Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
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
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:
Read more
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.
Read the 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.
- Being tested
- Upadacitinib
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Upadacitinib | |
| 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. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical-endoscopic remission rate at 12 weeks
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.
Measured: 12 weeks after upadacitinib initiation
Colectomy-free rate within 90 days
The proportion of ASUC patients who did not undergo colectomy within 90 days after the initiation of upadacitinib treatment
Measured: 90 days after upadacitinib initiation
Secondary outcomes (7)
Patient-Reported Outcomes-2 (PRO2) score at week 1
Measured: 1 week after upadacitinib initiation
Clinical response rate at weeks 8 and 12
Measured: 8 weeks and 12 weeks after upadacitinib initiation
Clinical remission rate at weeks 8 and 12
Measured: 8 weeks and 12 weeks after upadacitinib initiation
Corticosteroid-free clinical remission rate at weeks 8 and 12
Measured: 8 weeks and 12 weeks after upadacitinib initiation
Endoscopic response rate at week 12
Measured: 12 weeks after upadacitinib initiation
Endoscopic remission rate at week 12
Measured: 12 weeks after upadacitinib initiation
Adverse events (AEs) rate
Measured: From upadacitinib initiation to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start6 Jun 2023
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472309
- Sponsor's protocol ID
- KY20252556-F-1
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gisbert JP, Chaparro M. Acute severe ulcerative colitis: State of the art treatment. Best Pract Res Clin Gastroenterol. 2018 Feb-Apr;32-33:59-69. doi: 10.1016/j.bpg.2018.05.007. Epub 2018 May 12.
PubMed 30060940Gisbert JP, Chaparro M. Janus kinase inhibitors in the management of acute severe ulcerative colitis: a comprehensive review. J Crohns Colitis. 2025 Feb 4;19(2):jjaf021. doi: 10.1093/ecco-jcc/jjaf021.
PubMed 39886994
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07472309
- Acronym / sponsor ID
- KY20252556-F-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASUC Patients with First-Line Upadacitinib Exposure | – | Drug: UpadacitinibThis 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 | – | Drug: UpadacitinibThis 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a multicenter, retrospective cohort study conducted at 11 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2025. A total of 81 patients diagnosed with ASUC according to the modified Truelove and Witts criteria were enrolled. All patients received upadacitinib as first-line or rescue therapy. The study population was categorized into two groups: the first-line therapy group (upadacitinib administered in ASUC patients who had not previously received corticosteroids or biologics during this episode) and the rescue therapy group (including second-line and third-line therapy, defined as upadacitinib initiation after failure of intravenous methylprednisolone or both intravenous methylprednisolone and infliximab).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibUpadacitinib 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. | Drug | ASUC Patients with First-Line Upadacitinib Exposure, ASUC Patients with Rescue Upadacitinib Exposure |
Primary outcome
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
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 30060940Gisbert JP, Chaparro M. Acute severe ulcerative colitis: State of the art treatment. Best Pract Res Clin Gastroenterol. 2018 Feb-Apr;32-33:59-69. doi: 10.1016/j.bpg.2018.05.007. Epub 2018 May 12.
- Background: PubMed 39886994Gisbert JP, Chaparro M. Janus kinase inhibitors in the management of acute severe ulcerative colitis: a comprehensive review. J Crohns Colitis. 2025 Feb 4;19(2):jjaf021. doi: 10.1093/ecco-jcc/jjaf021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and Acute Severe Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical-endoscopic remission rate at 12 weeks (time frame: 12 weeks after upadacitinib initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07472309, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.