Summary

for people ages 18 years and up (full criteria)
study started
estimated completion

Description

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

Official Title

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

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.

Keywords

Ulcerative ColitisColitisUlcerColitis, UlcerativeVedolizumabvedolizumab-UC-naïve to TNF-antagonist

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
ID
NCT03802214
Study Type
Observational
Last Updated