What is this study trying to find out about ulcerative colitis?

This study is evaluating the real-world effectiveness and safety of upadacitinib alone or combined with vedolizumab in adults with moderate-to-severe ulcerative colitis. Researchers want to understand which treatment approach better supports remission and disease control during an 8-week induction period. The study is led by Sixth Affiliated Hospital, Sun Yat-sen University and uses data from routine clinical practice.

Who may be eligible for this ulcerative colitis clinical trial?

Adults aged 18 years or older with a diagnosis of moderate-to-severe ulcerative colitis for at least 3 months may be eligible. Both men and women can participate if they have started upadacitinib treatment alone or combined with vedolizumab. Certain conditions like Crohn's disease or participation in other upadacitinib trials may exclude you. Please review eligibility criteria for more details.

Is there any cost to participate in this ulcerative colitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Age: 18Years +

All Genders

ID07442045

Real-World Comparative Effectiveness and Safety of Upadacitinib Plus Vedolizumab Versus 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

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the real-world effectiveness and safety of upadacitinib alone or combined with vedolizumab in adults with moderate-to-severe ulcerative colitis UC. UC is a chronic inflammatory bowel disease often requiring long-term management, and single treatments may have limited success. This multicenter retrospective cohort study uses data from six Chinese centers to compare these treatment strategies during an 8-week induction period to provide evidence for treatment decisions. Participants receive either upadacitinib alone or upadacitinib combined with vedolizumab. Upadacitinib is given orally at 45 mg per day for 8 weeks. Vedolizumab is given intravenously at 300 mg on weeks 1, 2, and 6. These two groups are compared for outcomes such as remission and response rates, with data collected from routine clinical practice between January 2023 and December 2025. During the study, researchers review clinical and laboratory data including modified Mayo scores, endoscopic findings, and markers like C-reactive protein at baseline and after 8 weeks. Outcomes measured include clinical remission, clinical response, endoscopic remission, normalization of inflammatory markers, and adverse events. The study aims to reflect routine care and inform treatment decisions based on real-world evidence from adult patients with moderate-to-severe UC.

CONDITIONS

Brief Title

Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at treatment start
Established diagnosis of ulcerative colitis for at least 3 months confirmed by clinical, endoscopic, and histopathological evidence
Moderate-to-severe active disease at baseline, defined by modified Mayo score 4 or higher and endoscopic subscore 2 or higher
Started treatment with upadacitinib alone or combined with vedolizumab in routine practice at participating centers
Available baseline clinical assessment and follow-up data at 8 weeks after treatment start

You will not qualify if you...

Diagnosis of Crohn's disease, indeterminate colitis, or other non-UC colitis
Prior or planned colectomy at time of treatment start
Participation in any interventional clinical trial involving upadacitinib during the study period
Insufficient clinical data to assess baseline disease activity or 8-week outcomes
Use of other advanced therapies started after treatment initiation, except vedolizumab in the combination group

Research Team

Jiayin Yao

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