Predicting treatment response for ulcerative colitis patients
Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data
Asan Medical Center · NCT05186623
This study is trying to see if doctors can better predict how Korean patients with ulcerative colitis will respond to certain treatments using information from their medical history and tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Drugs / interventions | vedolizumab, ustekinumab, tofacitinib |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05186623 on ClinicalTrials.gov |
What this trial studies
This prospective observational study aims to develop and validate a prediction model for how Korean patients with ulcerative colitis respond to biologic agents and small molecular agents like vedolizumab, ustekinumab, and tofacitinib. Eligible patients will undergo screening to collect demographic data, medical history, and disease characteristics, followed by baseline lower GI endoscopy and tissue collection. After treatment initiation, clinical and endoscopic responses will be evaluated at weeks 14 to 16 and 52, allowing researchers to create and validate models based on various clinical and biological data. The goal is to enhance personalized treatment strategies for ulcerative colitis.
Who should consider this trial
Good fit: Ideal candidates are Korean patients diagnosed with ulcerative colitis who are about to start treatment with vedolizumab, ustekinumab, or tofacitinib.
Not a fit: Patients who are not of Korean ethnicity, have inflammatory bowel disease unclassified, or have undergone colectomy for ulcerative colitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with ulcerative colitis.
How similar studies have performed: Other studies have shown promise in developing predictive models for treatment responses in similar conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Byong Duk Ye, MD, PhD
- Email: bdye@amc.seoul.kr
- Phone: 82230103180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics