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

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT07442045
Status
Recruiting
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Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy.
  • Vedolizumab — DRUG
    Vedolizumab 300mg intravenously on weeks 1, 2, 6.

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Feb 2026
Primary completion
Sep 30, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Combination treatment group
    A combination treatment of Upadacitinib and Vedolizumab for 8 weeks in the induction therapy.
  • Arm: Single treatment group
    Single treatment of Upadacitinib in the induction therapy

Primary Outcome Measure

Clinical remission rate at the 8th-week [ Time Frame: 8th-week ]

Central Contacts

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