UCRecruiting
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
Observational · No treatment assigned · 6 sites · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 2 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2023-01-01.
- Main results expected around 2025-11-30 (estimate from the record).
- 6 study sites listed (6 marked recruiting) in China.
Main thing being measured
- Clinical remission rate at the 8th-week (8th-week)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 150 (estimated) |
| Start date | 2023-01-01 |
| Primary completion (est.) | 2025-11-30 |
| First posted | 2026-03-02 |
| Last updated | 2026-07-31 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07442045 |
Interventions
- Upadacitinib (Drug)
Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy. - Vedolizumab (Drug)
Vedolizumab 300mg intravenously on weeks 0, 2, 6.
Full eligibility criteria (from the record)
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.
Locations (6)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.