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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
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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Sixth Affiliated Hospital, South China University of Technology City: Foshan
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FoshanChinaRecruiting
The First People's Hospital of Foshan
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FoshanChinaRecruiting
Foshan Fosun Chancheng Hospital, Foshan
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FoshanChinaRecruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaRecruiting
The second Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaRecruiting
the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District)
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ShenzhenChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.