Ulcerative Colitis (UC)NCT07442045
Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis
An observational study of Ulcerative Colitis (UC), run by Sixth Affiliated Hospital, Sun Yat-sen University at 6 sites in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Upadacitinib and Vedolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 150 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2023to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of consecutive adults aged 18 years or older with an established diagnosis of moderate-to-severe ulcerative colitis who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, at six tertiary inflammatory bowel disease referral centers in China between January 2023 and September 2025. The index date was defined as the date of upadacitinib initiation. Treatment was selected by the treating physician as part of routine clinical care.
Who may be able to join
- 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.
Who cannot join
- Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The First People's Hospital of Foshan
Foshan, Guangdong, 510260
Peizhu Su, MD, supeizhu1986@163.com
- Recruiting
Foshan Fosun Chancheng Hospital, Foshan
Foshan, Guangdong, 528000
Ji Wu, MD, 13929190198@139.com
- Recruiting
The Sixth Affiliated Hospital, South China University of Technology City: Foshan
Foshan, Guangdong, 528200
Huangwei Chen, MD, chw1364@163.com
- Recruiting
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 501655
Jiayin Yao, MD, yjyin@mail2.sysu.edu.cn
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Tingting Xie, MD, jianning.22@163.com
- Recruiting
the Second Affiliated Hospital of Shenzhen University (People's Hospital of Shenzhen Bao'an District)
Shenzhen, Guangdong, 518000
Xiaoyu Liu, MD, LXY-631@126.com
About this study
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
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.
Read the detailed description
This multicenter retrospective comparative cohort study was conducted at six tertiary inflammatory bowel disease referral centers in China. Consecutive adults with moderate-to-severe ulcerative colitis who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, between January 2023 and September 2025 were screened for eligibility.
The index date was defined as the date of upadacitinib initiation. Treatment exposure was classified according to the regimen initiated at the index date: upadacitinib monotherapy or upadacitinib plus vedolizumab. The same eligibility criteria, treatment exposure definitions, assessment windows, outcome definitions, and statistical procedures were applied to both treatment groups.
Patients in the combination-therapy group received oral upadacitinib 45 mg once daily for 8 weeks and intravenous vedolizumab 300 mg at weeks 0, 2, and 6. Patients in the monotherapy group received oral upadacitinib 45 mg once daily for 8 weeks without concomitant vedolizumab or another advanced therapy.
Baseline clinical and biochemical assessments were defined as the most recent eligible assessments obtained before or on the index date. Week-8 clinical, biochemical, and endoscopic assessments were defined as the eligible assessments closest to day 56 after upadacitinib initiation. Endoscopic recordings were centrally reviewed by blinded gastroenterologists, and disagreements were resolved by a third blinded adjudicator.
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 was assessed from the index date through the week-8 assessment.
The primary analysis used propensity score-based stabilized inverse probability of treatment weighting, targeting the average treatment effect in the study population. Adjusted risk differences were estimated using survey-weighted linear probability models, and adjusted risk ratios were estimated using survey-weighted quasi-Poisson regression models with robust design-based standard errors. Sensitivity analyses included stabilized weights truncated at the 1st and 99th percentiles, overlap weighting, and conventional multivariable logistic regression without propensity-score weighting.
The protocol was reviewed and approved by the Research Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University (approval number 2026ZSLYEC-079). The requirement for informed consent was waived because the study involved retrospective analysis of de-identified clinical data.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Upadacitinib, Vedolizumab
- Keywords
- Ulcerative Colitis, Upadacitinib, Vedolizumab, Combination Therapy, Real-World Study
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Oral Upadacitinib 45mg/d for 8 weeks in the induction therapy.
VedolizumabDrug
Vedolizumab 300mg intravenously on weeks 0, 2, 6.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Upadacitinib; Drug: Vedolizumab | |
| Upadacitinib Monotherapy | Patients received oral upadacitinib 45 mg once daily for 8 weeks without concomitant vedolizumab or another advanced therapy. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate at the 8th-week
Clinical remission is defined as a total Mayo score ≤2, with no individual subscore >1 and a rectal bleeding subscore of 0.
Measured: 8th-week
Secondary outcomes (3)
Clincial response rate at the 8th week
Clinical response was defined as a decrease from baseline in the modified Mayo score of at least 2 points and at least 30%, accompanied by either a decrease in the rectal-bleeding subscore of at least 1 point or an absolute rectal-bleeding subscore of 1 or less.
Measured: 8th-week
C-Reactive Protein normalization rate at the 8th week
C-reactive protein normalization was evaluated only among patients with a baseline C-reactive protein concentration greater than 5 mg/L. Normalization was defined as a week-8 serum C-reactive protein concentration of 5 mg/L or less. Patients with a baseline C-reactive protein concentration of 5 mg/L or less were not included in the denominator for this outcome.
Measured: 8th-week
Endoscopic remission rate at the 8th week
Endoscopic remission is defined as Mayo endoscopic score(MES) =0
Measured: 8th-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2023
- Primary completion30 Nov 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayin Yao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442045
- Sponsor's protocol ID
- 2026ZSLYEC-079
- Status last verified
- Jul 2026
- First submitted
- 20 Feb 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policies and patient privacy considerations. The dataset contains identifiable clinical information from multiple centers, and data sharing is restricted by local ethics committee regulations.
Publications
Yao J, Wu H, Wu L, Yu Q, Cao X, Xie T, Zhong X, Chen H, Wu J, Liu X, Shi L, Zhang M, Peng X, Deng J, Wang W, Liu T, Su T, Yang H, Xia D, Zhi M. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 May 22:S1542-3565(26)00388-5. doi: 10.1016/j.cgh.2026.05.010. Online ahead of print.
PubMed 42173298Gilmore R, Murali A, Etchegaray A, Swe E, An YK, Begun J. Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn's disease. Intest Res. 2025 Oct;23(4):475-482. doi: 10.5217/ir.2024.00174. Epub 2025 Jun 9.
PubMed 40490017Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.
PubMed 35644166
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2026ZSLYEC-079
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- Ulcerative Colitis, Upadacitinib, Vedolizumab, Combination Therapy, Real-World Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter retrospective comparative cohort study was conducted at six tertiary inflammatory bowel disease referral centers in China. Consecutive adults with moderate-to-severe ulcerative colitis who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, between January 2023 and September 2025 were screened for eligibility.
The index date was defined as the date of upadacitinib initiation. Treatment exposure was classified according to the regimen initiated at the index date: upadacitinib monotherapy or upadacitinib plus vedolizumab. The same eligibility criteria, treatment exposure definitions, assessment windows, outcome definitions, and statistical procedures were applied to both treatment groups.
Patients in the combination-therapy group received oral upadacitinib 45 mg once daily for 8 weeks and intravenous vedolizumab 300 mg at weeks 0, 2, and 6. Patients in the monotherapy group received oral upadacitinib 45 mg once daily for 8 weeks without concomitant vedolizumab or another advanced therapy.
Baseline clinical and biochemical assessments were defined as the most recent eligible assessments obtained before or on the index date. Week-8 clinical, biochemical, and endoscopic assessments were defined as the eligible assessments closest to day 56 after upadacitinib initiation. Endoscopic recordings were centrally reviewed by blinded gastroenterologists, and disagreements were resolved by a third blinded adjudicator.
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 was assessed from the index date through the week-8 assessment.
The primary analysis used propensity score-based stabilized inverse probability of treatment weighting, targeting the average treatment effect in the study population. Adjusted risk differences were estimated using survey-weighted linear probability models, and adjusted risk ratios were estimated using survey-weighted quasi-Poisson regression models with robust design-based standard errors. Sensitivity analyses included stabilized weights truncated at the 1st and 99th percentiles, overlap weighting, and conventional multivariable logistic regression without propensity-score weighting.
The protocol was reviewed and approved by the Research Ethics Committee of The Sixth Affiliated Hospital, Sun Yat-sen University (approval number 2026ZSLYEC-079). The requirement for informed consent was waived because the study involved retrospective analysis of de-identified clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib Plus Vedolizumab | – | Drug: Upadacitinib, Drug: VedolizumabPatients received oral upadacitinib 45 mg once daily for 8 weeks and intravenous vedolizumab 300 mg at weeks 0, 2, and 6 during induction. |
| Upadacitinib Monotherapy | – | Drug: UpadacitinibPatients received oral upadacitinib 45 mg once daily for 8 weeks without concomitant vedolizumab or another advanced therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of consecutive adults aged 18 years or older with an established diagnosis of moderate-to-severe ulcerative colitis who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, at six tertiary inflammatory bowel disease referral centers in China between January 2023 and September 2025. The index date was defined as the date of upadacitinib initiation. Treatment was selected by the treating physician as part of routine clinical care.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibOral Upadacitinib 45mg/d for 8 weeks in the induction therapy. | Drug | Upadacitinib Monotherapy, Upadacitinib Plus Vedolizumab |
| VedolizumabVedolizumab 300mg intravenously on weeks 0, 2, 6. | Drug | Upadacitinib Plus Vedolizumab |
Primary outcome
Clinical remission rate at the 8th-week
Time frame: 8th-week
Clinical remission is defined as a total Mayo score ≤2, with no individual subscore >1 and a rectal bleeding subscore of 0.
3 secondary outcomes
Clincial response rate at the 8th week
Time frame: 8th-week
C-Reactive Protein normalization rate at the 8th week
Time frame: 8th-week
Endoscopic remission rate at the 8th week
Time frame: 8th-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 42173298Yao J, Wu H, Wu L, Yu Q, Cao X, Xie T, Zhong X, Chen H, Wu J, Liu X, Shi L, Zhang M, Peng X, Deng J, Wang W, Liu T, Su T, Yang H, Xia D, Zhi M. Combined Upadacitinib and Vedolizumab as 8-Week Induction Therapy for Moderate-to-Severe Ulcerative Colitis: A Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 May 22:S1542-3565(26)00388-5. doi: 10.1016/j.cgh.2026.05.010. Online ahead of print.
- Background: PubMed 40490017Gilmore R, Murali A, Etchegaray A, Swe E, An YK, Begun J. Upadacitinib and vedolizumab combination therapy for the management of refractory ulcerative colitis and Crohn's disease. Intest Res. 2025 Oct;23(4):475-482. doi: 10.5217/ir.2024.00174. Epub 2025 Jun 9.
- Background: PubMed 35644166Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policies and patient privacy considerations. The dataset contains identifiable clinical information from multiple centers, and data sharing is restricted by local ethics committee regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC), run by Sixth Affiliated Hospital, Sun Yat-sen University at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayin Yao (13826462890, yjyin@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate at the 8th-week (time frame: 8th-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07442045, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.