Ulcerative Colitis Clinical Trial
Official title:
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI In-vitro Diagnostics Device to Detect Treatment Response Measured by Endoscopic Healing in Moderate to Severe Ulcerative Colitis Patients Treated With Anti-TNF-a.
The purpose of this research study is to determine the efficacy and outcome of the UCRI (an in-vitro diagnostics device in the form of a blood test and an algorithm) as a tool to detect mucosal healing (level of inflammation in the colon) in people with moderate-to-severe ulcerative colitis treated with anti-TNFα. Another reason is to explore additional biomarkers in blood, stool or voice to detect disease activity and/or mucosal healing. A tool to detect the level of inflammation in the colon based on blood, stool or voice biomarkers may reduce the need or the number of invasive endoscopic procedures. This is an observational study and no treatment decision nor clinical intervention will be done based on results during this study and all collected data will be used only for the goal of the study and for obtaining FDA IDE for a follow-up study.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Ulcerative colitis patients with Mayo Endoscopic Subscore of 2-3 - Start/switch anti -TNFa treatment - Capable of at-home fCal testing Exclusion Criteria: - Pregnant women - anti -TNFa dose escalation/adjustment - Inability to undergo endoscopic assessments due to Proctitis - Diagnosed with infectious diseases - Steroid refractory |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Inflammatory Bowel Disease Center | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
Glycominds, LLC | Crohn's and Colitis Foundation, University of California, Davis, University of California, Irvine, University of Chicago, Weill Medical College of Cornell University |
United States,
de Bruyn M, Ringold R, Martens E, Ferrante M, Van Assche G, Opdenakker G, Dukler A, Vermeire S. The Ulcerative Colitis Response Index for Detection of Mucosal Healing in Patients Treated With Anti-tumour Necrosis Factor. J Crohns Colitis. 2020 Feb 10;14(2):176-184. doi: 10.1093/ecco-jcc/jjz125. — View Citation
Koon HW, Shih DQ, Chen J, Bakirtzi K, Hing TC, Law I, Ho S, Ichikawa R, Zhao D, Xu H, Gallo R, Dempsey P, Cheng G, Targan SR, Pothoulakis C. Cathelicidin signaling via the Toll-like receptor protects against colitis in mice. Gastroenterology. 2011 Nov;141(5):1852-63.e1-3. doi: 10.1053/j.gastro.2011.06.079. Epub 2011 Jul 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | UCRI prediction value | The UCRI prediction value as survival analysis (longrank tests) of MES following anti-TNFa treatment. Event will be defined as MES<2 | 0-14 weeks | |
Primary | UCRI panel validation | Accuracy as measured by ROC curve (receiver operating characteristic curve) | 24 weeks | |
Primary | UCRI panel validation | PPV - Positive Predicative Value: proportions of positive tests that are true positive. | 24 weeks | |
Primary | UCRI panel validation | NPV - Negative Predicative Value: proportions of negative tests that are true negative. | 24 weeks | |
Secondary | fCal comparison analysis | As a secondary outcome a comparison analysis with fecal Calprotectin (fCal) at 250 ug/g cut-off value will be performed | 24 weeks |
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