Prediction Model for Response to Biologics and Small Molecular Agent for UC

Asan Medical Center

Status: Enrolling

Conditions: Ulcerative Colitis

Treatments: Drug: Vedolizumab, Ustekinumab, or Tofacitinib

Study type: Observational

Funder types: Other

Identifiers

NCT05186623

2021-1718

Details and patient eligibility

About

This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis.

Full description

In this prospective observational study, patients with confirmed ulcerative colitis, who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled after an informed consent. In the screening period, inclusion/exclusion criteria will be checked and if eligible and consented, demographic data, medical history, disease characteristics and disease activity data will be collected. Before drug administration (week 0), baseline lower GI endoscopy will be performed and colon tissues will be collected. Blood sample and fecal sample will also be collected. After induction therapy with each drug, clinical and endoscopic response will be evaluated at week 14 to week 16 and patients will be classified into responders non-responders. Combing clinical data, blood laboratory data, fecal inflammatory biomarker, genetic data, and colonic transcriptomic data, a prediction model for response to induction therapy will be developed and it will be validated in another patient group. Similarly, based on evaluation at week 52, a prediction model for maintenance response will also be developed and validated.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with an established diagnosis of ulcerative colitis based on clinical symptoms, endoscopic features and histopathologic features
• Patients who are going to receive vedolizumab, ustekinumab, or tofacitinib treatment

Exclusion criteria

• Not Korean ethnicity by family history
• Inflammatory Bowel Disease Unclassified
• Patients who already received colectomy due to ulcerative colitis

Trial design

300 participants in 1 patient group

Patients with confirmed ulcerative colitis

Description:

Patients with confirmed ulcerative colitis, who are going to receive vedolizumab therapy (n=100: development cohort n=70 and validation cohort n=30), ustekinumab therapy (n=100: development cohort n=70 and validation cohort n=30), or tofacitinib therapy (n=100: development cohort n=70 and validation cohort n=30), will be enrolled.

Treatment:

Drug: Vedolizumab, Ustekinumab, or Tofacitinib