NCT07442045Recruiting
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
Real-World Comparative Effectiveness and Safety of Upadacitinib Plus Vedolizumab Versus Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis: A Multicenter Retrospective Cohort Study
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
This multicenter retrospective comparative cohort study evaluated the real-world effectiveness and safety of upadacitinib plus vedolizumab compared with upadacitinib monotherapy during 8-week induction in adults with moderate-to-severe ulcerative colitis. Consecutive eligible patients who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, between January 2023 and September 2025 at six tertiary inflammatory bowel disease referral centers in China were included. The primary outcome was modified Mayo clinical remission at week 8. Secondary outcomes were modified Mayo clinical response, C-reactive protein normalization among patients with an elevated baseline C-reactive protein concentration, and endoscopic remission. Safety outcomes were assessed from the index date through the week-8 assessment.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 20 Feb 2026
- Start date
- 1 Jan 2023
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Ulcerative colitis
- NCT number
- NCT07442045
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Jan 2023 to the primary completion date, 30 Nov 2025
- 6 sites 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.
Prior treatment
- Previous colectomy or colectomy planned at the index date.
- Previous exposure to upadacitinib or vedolizumab.
- Initiation of another biologic or small-molecule advanced therapy during the 8-week induction period, except for vedolizumab in the combination-therapy group.
Other illness
- Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.
Who the study is looking for
- Age 18 years or older at the index date.
- Established diagnosis of ulcerative colitis for at least 3 months, supported by compatible clinical, endoscopic, and histologic findings.
- Moderately to severely active ulcerative colitis at baseline, defined as a modified Mayo score of 4 to 9 and a Mayo endoscopic subscore of at least 2.
- Initiation of upadacitinib induction therapy during the predefined study period.
- For the combination-therapy group, initiation of vedolizumab concomitantly with upadacitinib at the index date.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital, South China University of Technology City: Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| Foshan Fosun Chancheng Hospital, Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District) Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.