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

Stanford University

Status: Terminated

Conditions: Ulcerative Colitis

Treatments: Drug: Vedolizumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03802214

IRB48889

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

1 participants in 2 patient groups

vedolizumab-UC-naïve to TNF-antagonist

Description:

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

Treatment:

Drug: Vedolizumab

vedolizumab-UC- previous TNF-antagonist

Description:

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

Treatment:

Drug: Vedolizumab