An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab

March 3, 2025 updated by: Second Affiliated Hospital of Wenzhou Medical University
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Chinese ulcerative colitis treated with Vedolizumab

Description

Inclusion Criteria:

  • UC patients Treated with Vedolizumab

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The partial Mayo score was applied to evaluate the clinical activity UC patients
Time Frame: 16 week and 34 week
16 week and 34 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2020

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

February 2, 2024

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2025-01-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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