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Recruiting NCT05186623

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

— Observational Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vedolizumab, Ustekinumab, or Tofacitinib.
Who it may be relevant to
Registry conditions: Ulcerative Colitis. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • Response to induction therapy [Time frame: Week 14 to Week 16]
Secondary outcome measures (7)
  • Remission to induction therapy [Time frame: Week 14 to Week 16]
  • Complete Mayo endoscopic subscore remission to induction therapy [Time frame: Week 14 to Week 16]
  • Ulcerative colitis endoscopic index of severity remission to induction therapy [Time frame: Week 14 to Week 16]
  • Response to maintenance therapy [Time frame: Week 52]
  • Remission to maintenance therapy [Time frame: Week 52]
  • Complete Mayo endoscopic subscore remission to maintenance therapy [Time frame: Week 52]
  • Ulcerative colitis endoscopic index of severity remission to maintenance therapy [Time frame: Week 52]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 1 center
  • Asan Medical Center — Seoul

Publications

  • Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005. PMID 17653185
  • Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14. PMID 22001864
  • Park SH, Kim YJ, Rhee KH, Kim YH, Hong SN, Kim KH, Seo SI, Cha JM, Park SY, Jeong SK, Lee JH, Park H, Kim JS, Im JP, Yoon H, Kim SH, Jang J, Kim JH, Suh SO, Kim YK, Ye BD, Yang SK; Songpa-Kangdong Inflammatory Bowel Disease [SK-IBD] Study Group. A 30-year Trend Analysis in the Epidemiology of Inflammatory Bowel Disease in the Songpa-Kangdong District of Seoul, Korea in 1986-2015. J Crohns Colitis. PMID 30989166
  • Lee JC, Lyons PA, McKinney EF, Sowerby JM, Carr EJ, Bredin F, Rickman HM, Ratlamwala H, Hatton A, Rayner TF, Parkes M, Smith KG. Gene expression profiling of CD8+ T cells predicts prognosis in patients with Crohn disease and ulcerative colitis. J Clin Invest. 2011 Oct;121(10):4170-9. doi: 10.1172/JCI59255. Epub 2011 Sep 26. PMID 21946256
  • Biasci D, Lee JC, Noor NM, Pombal DR, Hou M, Lewis N, Ahmad T, Hart A, Parkes M, McKinney EF, Lyons PA, Smith KGC. A blood-based prognostic biomarker in IBD. Gut. 2019 Aug;68(8):1386-1395. doi: 10.1136/gutjnl-2019-318343. Epub 2019 Apr 27. PMID 31030191
  • Sandborn WJ. Current directions in IBD therapy: what goals are feasible with biological modifiers? Gastroenterology. 2008 Nov;135(5):1442-7. doi: 10.1053/j.gastro.2008.09.053. Epub 2008 Oct 9. No abstract available. PMID 18848556
  • Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516. PMID 16339095
  • Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734. PMID 23964932

Identifiers

NCT: NCT05186623 · 2021-1718

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗