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

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

Detailed Description
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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.

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Vedolizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| vedolizumab-UC-naïve to TNF-antagonist<br>standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy | Drug: Vedolizumab<br>* standard vedolizumab induction (300mg IV at week 0, 2, 6)<br>* Other names: Entyvio;|
| vedolizumab-UC- previous TNF-antagonist<br>standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure | Drug: Vedolizumab<br>* standard vedolizumab induction (300mg IV at week 0, 2, 6)<br>* Other names: Entyvio;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) | 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) | 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 | 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) |