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

NCT05186623 | Recruiting FDA Drug

• 1 other identifier: 2021-1718
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Remission to induction therapy

  Week 14 to Week 16

• Complete Mayo endoscopic subscore remission to induction therapy

  Week 14 to Week 16

• Ulcerative colitis endoscopic index of severity remission to induction therapy

  Week 14 to Week 16

• Response to maintenance therapy

  Week 52

• Remission to maintenance therapy

  Week 52

Study Arms (1)

Patients with confirmed ulcerative colitis

Patients 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.

Drug: Vedolizumab, Ustekinumab, or Tofacitinib

Interventions

Vedolizumab, Ustekinumab, or Tofacitinib DRUG

Drug administration and prospective follow-up for evaluating response

Patients with confirmed ulcerative colitis

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an established diagnosis of ulcerative colitis and who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled in this study. Patients who give a voluntary informed consent will be eligible.

You may qualify if:

• 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

You may not qualify if:

• Not Korean ethnicity by family history
• Inflammatory Bowel Disease Unclassified
• Patients who already received colectomy due to ulcerative colitis

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Related Publications (21)

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Biospecimen

Retention: SAMPLES WITH DNA

Genomic DNA, serum, feces, colon tissue

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab; Ustekinumab; tofacitinib

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Byong Duk Ye, MD, PhD

CONTACT

82230103180; bdye@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: February 5, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)