Development of Prediction Model for Response to Biologics and Small Molecular Agent for UC
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006979
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Patients with confirmed ulcerative colitis (at the study center or other hospitals) and who are going to start TNF inhibitors, vedolizumab, ustekinumab, or tofacitinib therapy (at the study center). Patients who provide an informed consent will be enrolled in this study.
- Diagnostic criteria for ulcerative colitis
1) Having a), b), or c) for 4 weeks or longer: a) Diarrhea b) mucoid and bloody stool, c) a) + b)
2) Typical colonoscpic or sigmoidoscopic features (diffuse granular mucosa, friability, and mucosal ulcerations involving rectum with a continuous pattern) or typical radiologic features (continuous granular mucosa or ulcers)
3) Typical histologic features of colon showing chronic inflammation (structural change of crypt and/or basal lymphoplasmacytosis)
- Not Korean ethnicity by the family history
- Inflammatory bowel disease (IBD) unclassified (IBD-U): IBD limited to colorectum, which is having characteristics of both ulcerative colitis and Crohn's disease. IBD-U is diagnosed when it is difficult to be classified into ulcerative colitis or Crohn's disease based on clinical features, endoscopic features, radiologic features, pathologic features and overall assessment of treating physicians.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive model for response to TNF inhibitors, vedolizumab, ustekinumab, or tofacitinib induction therapy
- Secondary Outcome Measures
Name Time Method Predictive model for response to TNF inhibitors, vedolizumab, ustekinumab, or tofacitinib maintenance therapy