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Study identifier: NCT07442045 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Ulcerative Colitis (UC)  ·  Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

PhaseN/A
Planned participants150
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jiayin Yao  ·  13826462890  ·  yjyin@mail3.sysu.edu.cn

Always discuss trial participation with your own doctor first.

Locations (1)

the Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, Guangdong, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07442045