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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03802214
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stanford University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Aida Habtezion, MD
Principal Investigator Affiliation Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustryOtherOther
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

: vedolizumab-UC-naïve to TNF-antagonist

standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy

: vedolizumab-UC- previous TNF-antagonist

standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure

Interventions

Drug: - Vedolizumab

standard vedolizumab induction (300mg IV at week 0, 2, 6)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Stanford, California

Status

Recruiting

Address

Stanford University

Stanford, California, 94305

Site Contact

John Gubatan, MD

jgubatan@stanford.edu

650-736-5555

International Sites

University of Western Ontario, London, Ontario, Canada

Status

Active, not recruiting

Address

University of Western Ontario

London, Ontario, N6A5A5

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