Upadacitinib with or without vedolizumab for induction in moderate-to-severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter retrospective cohort using electronic medical records and pharmacy data from six tertiary IBD centers in China to compare upadacitinib monotherapy versus upadacitinib combined with vedolizumab. Adult patients with moderately to severely active ulcerative colitis who started upadacitinib between January 2023 and December 2025 and had baseline and 8-week follow-up data are included. Short-term outcomes include clinical remission and response, endoscopic remission, CRP normalization, and adverse events during the 8-week induction period. The analysis reflects routine clinical practice and aims to provide real-world comparative safety and effectiveness information.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older at the index date.
2. Established diagnosis of ulcerative colitis for at least 3 months, supported by compatible clinical, endoscopic, and histologic findings.
3. 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.
4. Initiation of upadacitinib induction therapy during the predefined study period.
5. For the combination-therapy group, initiation of vedolizumab concomitantly with upadacitinib at the index date.

Exclusion Criteria:

1. Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.
2. Previous colectomy or colectomy planned at the index date.
3. Previous exposure to upadacitinib or vedolizumab.
4. Initiation of another biologic or small-molecule advanced therapy during the 8-week induction period, except for vedolizumab in the combination-therapy group.

Where it's running

• The First People's Hospital of Foshan
  Foshan, Guangdong, China Recruiting
• Foshan Fosun Chancheng Hospital, Foshan
  Foshan, Guangdong, China Recruiting
• The Sixth Affiliated Hospital, South China University of Technology City: Foshan
  Foshan, Guangdong, China Recruiting
• the Sixth Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District)
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Jiayin Yao
• Email: yjyin@mail2.sysu.edu.cn
• Phone: 13826462890

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.