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

NCT ID: NCT05186623

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed 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.

Conditions

Ulcerative Colitis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with confirmed ulcerative colitis

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.

Vedolizumab, Ustekinumab, or Tofacitinib

Intervention Type: DRUG

Drug administration and prospective follow-up for evaluating response

Interventions

Vedolizumab, Ustekinumab, or Tofacitinib

Drug administration and prospective follow-up for evaluating response

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Byong Duk Ye

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Byong Duk Ye, MD, PhD

Role: CONTACT

bdye@amc.seoul.kr

82230103180

Facility Contacts

Byong Duk Ye, MD, PhD

Role: primary

bdye@amc.seoul.kr

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Other Identifiers

2021-1718

Identifier Type: -

Identifier Source: org_study_id