RecruitingNCT07442045

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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

150 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis (UC)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining real-world patients with moderate-to-severe ulcerative colitis (UC) who are being treated with upadacitinib — a targeted oral medication — either alone or in combination with another drug called vedolizumab. The goal is to understand whether combining these two treatments improves outcomes compared to upadacitinib alone, particularly in the first 8 weeks. **You may be eligible if...** - You are 18 or older - You have had confirmed ulcerative colitis for at least 3 months - Your disease is moderately to severely active based on endoscopy (colonoscopy) results - You have started upadacitinib (with or without vedolizumab) as part of your regular medical care - Your doctor has recorded your disease activity before starting treatment and at 8 weeks **You may NOT be eligible if...** - You have Crohn's disease, indeterminate colitis, or another form of colitis - You have already had your colon removed, or removal is planned - You participated in a upadacitinib clinical trial - Your medical data from baseline or 8 weeks is incomplete - You started other advanced therapies after beginning upadacitinib (except vedolizumab if you're in the combination group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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