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

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: Vedolizumab

• Registration Number: NCT03802214
• Lead Sponsor: Stanford University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-14
• Study Start: 2020-10-29
• Status Verified: 2020-12
• Primary Completion: 2020-12-11
• Study Completion: 2020-12-11
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vedolizumab-UC-naïve to TNF-antagonist	Vedolizumab	standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy
vedolizumab-UC- previous TNF-antagonist	Vedolizumab	standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure

Primary Outcome Measures

Name	Time	Method
Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells)	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

Secondary Outcome Measures

Name	Time	Method
Analysis of the serum and tissue concentrations of inflammatory markers (interleukins)	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
Analysis of the serum and tissue concentrations of vedolizumab	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

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Stanford, California, United States

University of Western Ontario; 🇨🇦 London, Ontario, Canada