NCT06855862

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

3.2 years

First QC Date

February 24, 2025

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

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

Locations