Prediction Model for Response to Biologics and Small Molecular Agent for UC
- Sponsor
- Asan Medical Center
- Study ID
- NCT05186623
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 79 Years
- Healthy Volunteers
- Not accepted
Interventions
- Vedolizumab, Ustekinumab, or Tofacitinib — DRUGDrug administration and prospective follow-up for evaluating response
Study Details
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.
Key Dates
- Start date
- Feb 5, 2022
- Status verified
- Feb 2022
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: Patients with confirmed ulcerative colitisPatients 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 Measure
Response to induction therapy [ Time Frame: Week 14 to Week 16 ]
Central Contacts
- Byong Duk Ye, MD, PhD82230103180
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