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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05186623
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Byong Duk Ye, Asan Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Ulcerative Colitis Drug: Vedolizumab, Ustekinumab, or Tofacitinib

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Establishment of Prediction Model of Biologics and Small Molecular Agent for Patients With Ulcerative Colitis Using Longitudinal Data
Actual Study Start Date : February 5, 2022
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Drug administration and prospective follow-up for evaluating response


Outcome Measures
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Primary Outcome Measures :
  1. Response to induction therapy [ Time Frame: 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 Outcome Measures :
  1. Remission to induction therapy [ Time Frame: 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

  2. Complete Mayo endoscopic subscore remission to induction therapy [ Time Frame: Week 14 to Week 16 ]
    Mayo endoscopic subscore of 0

  3. Ulcerative colitis endoscopic index of severity remission to induction therapy [ Time Frame: Week 14 to Week 16 ]
    Ulcerative colitis endoscopic index of 0 to 1

  4. Response to maintenance therapy [ Time Frame: 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

  5. Remission to maintenance therapy [ Time Frame: 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

  6. Complete Mayo endoscopic subscore remission to maintenance therapy [ Time Frame: Week 52 ]
    Mayo endoscopic subscore of 0

  7. Ulcerative colitis endoscopic index of severity remission to maintenance therapy [ Time Frame: Week 52 ]
    Ulcerative colitis endoscopic index of 0 to 1


Biospecimen Retention:   Samples With DNA
Genomic DNA, serum, feces, colon tissue

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05186623


Contacts
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Contact: Byong Duk Ye, MD, PhD 82230103180 bdye@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Byong Duk Ye, MD, PhD       bdye@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
More Information
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Publications:

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Responsible Party: Byong Duk Ye, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT05186623    
Other Study ID Numbers: 2021-1718
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Byong Duk Ye, Asan Medical Center:
Response, Vedolizumab, Ustekinumab, Tofacitinib, Multiomics
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
 Ustekinumab
Vedolizumab
Tofacitinib
Dermatologic Agents
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents