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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Vedolizumab, Ustekinumab, or Tofacitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with confirmed ulcerative colitis<br>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. | Drug: Vedolizumab, Ustekinumab, or Tofacitinib<br>* Drug administration and prospective follow-up for evaluating response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to induction therapy | A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1 | Week 14 to Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission to induction therapy | Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1 | Week 14 to Week 16 | 
| Complete Mayo endoscopic subscore remission to induction therapy | Mayo endoscopic subscore of 0 | Week 14 to Week 16 | 
| Ulcerative colitis endoscopic index of severity remission to induction therapy | Ulcerative colitis endoscopic index of 0 to 1 | Week 14 to Week 16 | 
| Response to maintenance therapy | A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1 | Week 52 | 
| Remission to maintenance therapy | Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1 | Week 52 | 
| Complete Mayo endoscopic subscore remission to maintenance therapy | Mayo endoscopic subscore of 0 | Week 52 | 
| Ulcerative colitis endoscopic index of severity remission to maintenance therapy | Ulcerative colitis endoscopic index of 0 to 1 | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics