An Exploration of the Relationship Between Serum Cytokine Levels and the Clinical Efficacy of Vedolizumab
1 other identifier
observational
105
1 country
1
Brief 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. These patients were detected the levels of cytokines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2024
CompletedFirst Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedMarch 4, 2025
March 1, 2025
3.2 years
February 24, 2025
March 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The partial Mayo score was applied to evaluate the clinical activity UC patients
16 week and 34 week
Study Arms (2)
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
Eligibility Criteria
Chinese ulcerative colitis treated with Vedolizumab
You may qualify if:
- UC patients Treated with Vedolizumab
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2025
First Posted
March 4, 2025
Study Start
November 5, 2020
Primary Completion
February 2, 2024
Study Completion
February 2, 2024
Last Updated
March 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share