Upadacitinib with or without vedolizumab for moderate-to-severe ulcerative colitis
Compares upadacitinib alone versus with vedolizumab in adults with moderate-to-severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
Key facts
- Where
- Foshan, Guangzhou, and Shenzhen, ChinaSee the 6 sites
Where in China
- Foshan Fosun Chancheng Hospital, FoshanFoshan, ChinaTaking people
- The First People's Hospital of FoshanFoshan, ChinaTaking people
- The Sixth Affiliated Hospital, South China University of Technology City: FoshanFoshan, ChinaTaking people
- The second Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaTaking people
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District)Shenzhen, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sixth Affiliated Hospital, Sun Yat-sen University
- Trial code
- NCT07442045
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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; Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.