Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF（Tumor Necrosis Factor）Therapy

December 17, 2020 updated by: Aida Habtezion, Stanford University

A Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab Therapy

A case-control study to evaluate the immunoinflammatory effect of prior exposure to anti-TNF therapy in patients with ulcerative colitis starting vedolizumab therapy

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Inflammatory bowel disease (IBD)- ulcerative colitis (UC) and Crohn's disease (CD)- are chronic conditions of the gastrointestinal tract. Treatment generally consists of immunosuppression to modify the dysregulated immune responses. Vedolizumab, an inhibitor of α4β7, is a highly effective therapy for treating IBD, that minimized adverse effects through its gut selective inhibition of lymphocyte trafficking. However, the mechanism of action remains incompletely characterized especially in those previously treated to other biologics and why some patients are either vedolizumab non-responders or fail to respond over time. We would like to address the question whether anti-TNF non-responders as well as those that either do not respond or fail overtime to respond to vedolizumab identifies a specific population with difficult to treat disease that have alternate trafficking patterns and whether prior exposure to anti-TNF alters the mucosal immune responses, and/or trafficking patterns when compared to anti-TNF naive patients that may help explain impaired response to vedolizumab induction therapy.

Study Type

Observational

Enrollment (Actual)

1

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • University of Western Ontario
  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

clinical indication for biologic therapy, adult patients (>18) with the diagnosis of inflammatory bowel disease (Ulcerative Colitis) who are naive or failed anti-TNF therapy previously.

Description

Inclusion Criteria:

  • adult patients (>18 years old)
  • clinical diagnosis of inflammatory bowel disease (Ulcerative Colitis)
  • clinical indication for biologic therapy
  • naive or failed anti-TNF therapy previously

Exclusion Criteria:

  • patients allergic or intolerant to vedolizumab,
  • past use of vedolizumab;
  • patient unable to give consent to enter the study

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
Intervention / Treatment
vedolizumab-UC-naïve to TNF-antagonist
standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy
Drug: Vedolizumab
standard vedolizumab induction (300mg IV at week 0, 2, 6)
Other Names:
  • Entyvio
vedolizumab-UC- previous TNF-antagonist
standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure
Drug: Vedolizumab
standard vedolizumab induction (300mg IV at week 0, 2, 6)
Other Names:
  • Entyvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells)
Time Frame: changes from enrollment to end of treatment (week 14)
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) in patients with and without prior anti-TNF exposure
changes from enrollment to end of treatment (week 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins)
Time Frame: changes from enrollment to end of treatment (week 14)
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins) in vedolizumab responders versus non-responders
changes from enrollment to end of treatment (week 14)
Analysis of the serum and tissue concentrations of vedolizumab
Time Frame: changes from enrollment to end of treatment (week 14)
Analysis of the serum and tissue concentrations of vedolizumab in patients with and without prior anti-TNF exposure
changes from enrollment to end of treatment (week 14)

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

University of California, San Diego
Takeda
University of Western Ontario, Canada

Investigators

  • Principal Investigator: Aida Habtezion, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 29, 2020

Primary Completion (Actual)

December 11, 2020

Study Completion (Actual)

December 11, 2020

Study Registration Dates

First Submitted

December 10, 2018

First Submitted That Met QC Criteria

January 9, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 17, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB48889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share the data through the publication of results. Individual participant data was not promised to be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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