Ulcerative Colitis (UC)NCT06855862
An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab
An observational study of Ulcerative Colitis (UC), run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
It is uncertain the relationship between serum cytokine levels and the clinical efficacy of vedolizumab in the treatment of ulcerative colitis. The effects of cytokines on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with UC were recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC)
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2020to 2 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Chinese ulcerative colitis treated with Vedolizumab
Who may be able to join
- UC patients Treated with Vedolizumab
Who cannot join
- pregnant
- had cognitive/developmental disorders that affected their ability to complete the study procedures
- had medical illness or therapies potentially affecting bone, nutrition or growth status
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
It is uncertain the relationship between serum cytokine levels and the clinical efficacy of vedolizumab in the treatment of ulcerative colitis. The effects of cytokines on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with UC were recorded. These patients were detected the levels of cytokines.
- Conditions
- Ulcerative Colitis (UC)
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| clinical remission group | partial Mayo score ≤2 points and no subscore >1 point at week 16 | |
| non-clinical remission group | partial Mayo score >2 points at week 16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The partial Mayo score was applied to evaluate the clinical activity UC patients
Measured: 16 week and 34 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start5 Nov 2020
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical 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
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855862
- Sponsor's protocol ID
- SAHoWMU-CR2025-01-207
- Status last verified
- Mar 2025
- First submitted
- 24 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab
- ClinicalTrials.gov ID
- NCT06855862
- Acronym / sponsor ID
- SAHoWMU-CR2025-01-207
- Conditions
- Ulcerative Colitis (UC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 4 Mar 2025 (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.
It is uncertain the relationship between serum cytokine levels and the clinical efficacy of vedolizumab in the treatment of ulcerative colitis. The effects of cytokines on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with UC were recorded. These patients were detected the levels of cytokines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinical remission group | – | –partial Mayo score ≤2 points and no subscore >1 point at week 16 |
| non-clinical remission group | – | –partial Mayo score >2 points at week 16 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese ulcerative colitis treated with Vedolizumab
Key inclusion criteria (1 listed)
- UC patients Treated with Vedolizumab
Key exclusion criteria (3 listed)
- pregnant
- had cognitive/developmental disorders that affected their ability to complete the study procedures
- had medical illness or therapies potentially affecting bone, nutrition or growth status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The partial Mayo score was applied to evaluate the clinical activity UC patients
Time frame: 16 week and 34 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Second Affiliated Hospital of Wenzhou Medical University at 1 site 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The partial Mayo score was applied to evaluate the clinical activity UC patients (time frame: 16 week and 34 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.