Prediction Model for Response to Biologics and Small Molecular Agent for UC
Observational · No treatment assigned · 1 site · Asan Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Ulcerative Colitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 79
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2022-02-05.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in South Korea.
Main thing being measured
- Response to induction therapy (Week 14 to Week 16)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Asan Medical Center |
| Enrollment | 300 (estimated) |
| Start date | 2022-02-05 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2022-01-11 |
| Last updated | 2022-02-15 |
| Official title | Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data |
| ClinicalTrials.gov ID | NCT05186623 |
Interventions
- Vedolizumab, Ustekinumab, or Tofacitinib (Drug)
Drug administration and prospective follow-up for evaluating response
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center | Seoul | South Korea | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.