Prediction Model for Response to Biologics and Small Molecular Agent for UC

Ulcerative Colitis Clinical Trial

Official title:

Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05186623
• Other study ID #: 2021-1718
• Status: Recruiting
• Start date: February 5, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2022
• Source: Asan Medical Center
• Contact: Byong Duk Ye, MD, PhD
• Phone: 82230103180
• Email: bdye[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Vedolizumab, Ustekinumab, or Tofacitinib
Drug administration and prospective follow-up for evaluating response

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (21)

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Kim J, Yoon H, Kim N, Lee KM, Jung SA, Choi CH, Kim ES, Jung Y, Eun CS, Kim TO, Kang SB, Kim YS, Seo GS, Lee CK, Im JP, Park SJ, Park DI, Ye BD. Clinical Outcomes and Response Predictors of Vedolizumab Induction Treatment for Korean Patients With Inflammatory Bowel Diseases Who Failed Anti-TNF Therapy: A KASID Prospective Multicenter Cohort Study. Inflamm Bowel Dis. 2021 Nov 15;27(12):1931-1941. doi: 10.1093/ibd/izaa361. — View Citation

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to induction therapy	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	Week 14 to Week 16
Secondary	Remission to induction therapy	Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1	Week 14 to Week 16
Secondary	Complete Mayo endoscopic subscore remission to induction therapy	Mayo endoscopic subscore of 0	Week 14 to Week 16
Secondary	Ulcerative colitis endoscopic index of severity remission to induction therapy	Ulcerative colitis endoscopic index of 0 to 1	Week 14 to Week 16
Secondary	Response to maintenance therapy	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	Week 52
Secondary	Remission to maintenance therapy	Full Mayo score 0 to 2 + Any component of full Mayo score of 1 or less + Mayo endoscopic subscore of 0 to 1	Week 52
Secondary	Complete Mayo endoscopic subscore remission to maintenance therapy	Mayo endoscopic subscore of 0	Week 52
Secondary	Ulcerative colitis endoscopic index of severity remission to maintenance therapy	Ulcerative colitis endoscopic index of 0 to 1	Week 52