Actively Recruiting
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-03-02
150
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter retrospective cohort study evaluates the real-world effectiveness and safety of upadacitinib used alone or in combination with vedolizumab in adult patients with moderate-to-severe ulcerative colitis (UC). UC is a chronic inflammatory bowel disease that often requires long-term management, and monotherapy may reach a therapeutic ceiling in clinical practice. Combination therapy with upadacitinib, a rapid-acting oral JAK inhibitor, and vedolizumab, a gut-selective biologic, may provide complementary benefits. The study uses existing clinical and laboratory data from six Chinese IBD centers to compare short-term outcomes, including clinical remission, clinical response, endoscopic remission, normalization of C-reactive protein, and occurrence of adverse events during the 8-week induction period. This study reflects routine clinical practice and aims to provide real-world evidence to support treatment decisions in patients with moderate-to-severe UC.
CONDITIONS
Official Title
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at treatment start
- Diagnosis of ulcerative colitis for at least 3 months confirmed by clinical, endoscopic, and histological evidence
- Moderate to severe active disease with modified Mayo score 4 or higher and endoscopic subscore 2 or higher
- Starting treatment with upadacitinib alone or combined with vedolizumab at participating centers
- Availability of baseline and 8-week follow-up clinical data
You will not qualify if you...
- Diagnosis of Crohn's disease, indeterminate colitis, or other non-ulcerative colitis colitis
- Previous or planned colectomy at treatment start
- Participation in another clinical trial involving upadacitinib during the study
- Insufficient data to assess disease activity at baseline or week 8
- Use of other advanced biologic or small-molecule therapies started after treatment began, except vedolizumab in combination group
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 501655
Actively Recruiting
Research Team
J
Jiayin Yao
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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