Clinical trial NCT05186623: Prediction Model for Response to Biologics and Small Molecular Agent for UC
Official title: Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Keywords: Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an established diagnosis of ulcerative colitis and who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled in this study.

Patients who give a voluntary informed consent will be eligible.

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.

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

Primary outcomes:
measure: Response to induction therapy
timeFrame: Week 14 to Week 16
Secondary outcomes:
measure: Remission to induction therapy
timeFrame: Week 14 to Week 16
measure: Complete Mayo endoscopic subscore remission to induction therapy
timeFrame: Week 14 to Week 16
measure: Ulcerative colitis endoscopic index of severity remission to induction therapy
timeFrame: Week 14 to Week 16
measure: Response to maintenance therapy
timeFrame: Week 52
measure: Remission to maintenance therapy
timeFrame: Week 52
measure: Complete Mayo endoscopic subscore remission to maintenance therapy
timeFrame: Week 52
measure: Ulcerative colitis endoscopic index of severity remission to maintenance therapy
timeFrame: Week 52
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
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