Ulcerative Colitis
Conditions
Keywords
Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics
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.
Interventions
DRUGVedolizumab, Ustekinumab, or Tofacitinib
Drug administration and prospective follow-up for evaluating response
Sponsors
Asan Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to induction therapy | Week 14 to Week 16 | A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Mayo endoscopic subscore remission to induction therapy | Week 14 to Week 16 | Mayo endoscopic subscore of 0 |
| Ulcerative colitis endoscopic index of severity remission to induction therapy | Week 14 to Week 16 | Ulcerative colitis endoscopic index of 0 to 1 |
| Response to maintenance therapy | Week 52 | A decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1, together with Mayo endoscopic subscore of 0 to 1 |
| Remission to induction therapy | Week 14 to Week 16 | Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1 |
| Complete Mayo endoscopic subscore remission to maintenance therapy | Week 52 | Mayo endoscopic subscore of 0 |
| Ulcerative colitis endoscopic index of severity remission to maintenance therapy | Week 52 | Ulcerative colitis endoscopic index of 0 to 1 |
| Remission to maintenance therapy | Week 52 | Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1 |
Countries
South Korea
Contacts
Primary ContactByong Duk Ye, MD, PhD
Outcome results
None listed