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 0, 2, 6.

Study Details

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.

Key Dates

First listed
Mar 2, 2026
Start date
Jan 1, 2023
Status verified
Jul 2026
Primary completion
Nov 30, 2025
Completion
Sep 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Upadacitinib Plus Vedolizumab
    Patients received oral upadacitinib 45 mg once daily for 8 weeks and intravenous vedolizumab 300 mg at weeks 0, 2, and 6 during induction.
  • Arm: Upadacitinib Monotherapy
    Patients received oral upadacitinib 45 mg once daily for 8 weeks without concomitant vedolizumab or another advanced therapy.

Primary Outcome Measure

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

Central Contacts

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