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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Response to induction therapy [Срок оценки: Week 14 to Week 16]

Вторичные конечные точки (7)

• Remission to induction therapy [Срок оценки: Week 14 to Week 16]
• Complete Mayo endoscopic subscore remission to induction therapy [Срок оценки: Week 14 to Week 16]
• Ulcerative colitis endoscopic index of severity remission to induction therapy [Срок оценки: Week 14 to Week 16]
• Response to maintenance therapy [Срок оценки: Week 52]
• Remission to maintenance therapy [Срок оценки: Week 52]
• Complete Mayo endoscopic subscore remission to maintenance therapy [Срок оценки: Week 52]
• Ulcerative colitis endoscopic index of severity remission to maintenance therapy [Срок оценки: Week 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

South Korea · 1 центр

• Asan Medical Center — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT05186623 · 2021-1718

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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