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

Recruiting

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Patients with confirmed ulcerative colitis	Vedolizumab, Ustekinumab, or Tofacitinib	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.

Primary Outcome Measures

Name	Time	Method
Response to induction therapy	Week 14 to Week 16	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

Secondary Outcome Measures

Name	Time	Method
Remission to induction therapy	Week 14 to Week 16	Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1
Complete Mayo endoscopic subscore remission to induction therapy	Week 14 to Week 16	Mayo endoscopic subscore of 0
Ulcerative colitis endoscopic index of severity remission to induction therapy	Week 14 to Week 16	Ulcerative colitis endoscopic index of 0 to 1
Response to maintenance therapy	Week 52	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
Remission to maintenance therapy	Week 52	Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1
Complete Mayo endoscopic subscore remission to maintenance therapy	Week 52	Mayo endoscopic subscore of 0
Ulcerative colitis endoscopic index of severity remission to maintenance therapy	Week 52	Ulcerative colitis endoscopic index of 0 to 1