{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T13:25:32Z","timestamp":1787405132595,"version":"build-2736575974"},"reference-count":10,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T00:00:00Z","timestamp":1785801600000},"content-version":"vor","delay-in-days":34,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>While biologic and small molecule therapies have expanded treatment options for moderate to severe ulcerative colitis (UC), prior research revealed that only 26% of patients in routine practice would have qualified for pivotal randomized controlled trials (RCTs) due to stringent eligibility criteria. This study aimed to evaluate contemporary clinical trial eligibility for UC patients in a tertiary care setting based on more recently approved therapies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a retrospective cohort study of adult patients with moderate to severe UC (total Mayo score \u22656) seen between January 2022 and February 2023. Inclusion and exclusion criteria from seven phase III RCTs conducted between 2012 and 2022 (eg, VARSITY, UNIFI, OCTAVE, LUCENT) were applied to determine patient eligibility and identify reasons for ineligibility.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 150 patients (mean age 44.9\u2009years; 55.7% male), only 42.7% were eligible for at least one RCT. The most common exclusion factor was current or prior medication use, followed by anemia, dysplasia, and disease extent. Trial eligibility did not significantly differ by age, gender, or disease duration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Despite modest improvements since 2012, over half of real-world UC patients remain ineligible for current RCTs. Expanding inclusion criteria, especially regarding prior medication exposure, and adopting more inclusive trial designs may enhance external validity. Addressing disparities in trial access and participation remains essential to ensuring equitable representation and improving clinical applicability of RCT findings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/crocol\/otag092","type":"journal-article","created":{"date-parts":[[2026,8,4]],"date-time":"2026-08-04T11:38:34Z","timestamp":1785843514000},"source":"Crossref","is-referenced-by-count":0,"title":["Most of moderate to severe ulcerative colitis patients in academic clinical practice still do not qualify for randomized controlled trials"],"prefix":"10.1093","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-0350-6199","authenticated-orcid":false,"given":"Sandra","family":"Elmasry","sequence":"first","affiliation":[{"name":"Department of Medicine, Mayo Clinic Arizona , 13400 East Shea Boulevard Scottsdale, AZ 85259,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shabana","family":"Pasha","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 East Shea Boulevard Scottsdale AZ 85259,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manreet","family":"Kaur","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 East Shea Boulevard Scottsdale AZ 85259,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan A","family":"Leighton","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 East Shea Boulevard Scottsdale AZ 85259,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suryakanth R","family":"Gurudu","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 East Shea Boulevard Scottsdale AZ 85259,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3897-7370","authenticated-orcid":false,"given":"Christina","family":"Ha","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, 13400 East Shea Boulevard Scottsdale AZ 85259,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,8,4]]},"reference":[{"key":"2026082209213236400_otag092-B1","doi-asserted-by":"crossref","first-page":"1570","DOI":"10.1053\/j.gastro.2020.12.031","article-title":"STRIDE-II: an update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD","volume":"160","author":"Turner","year":"2021","journal-title":"Gastroenterology"},{"key":"2026082209213236400_otag092-B2","doi-asserted-by":"crossref","first-page":"1002","DOI":"10.1016\/j.cgh.2012.02.004","article-title":"Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population","volume":"10","author":"Ha","year":"2012","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026082209213236400_otag092-B3","doi-asserted-by":"crossref","first-page":"2113","DOI":"10.1016\/S0140-6736(22)00581-5","article-title":"Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials","volume":"399","author":"Danese","year":"2022","journal-title":"Lancet"},{"key":"2026082209213236400_otag092-B4","doi-asserted-by":"crossref","first-page":"1280","DOI":"10.1056\/NEJMoa2033617","article-title":"Ozanimod as induction and maintenance therapy for ulcerative colitis","volume":"385","author":"Sandborn","year":"2021","journal-title":"N Engl J Med"},{"key":"2026082209213236400_otag092-B5","doi-asserted-by":"crossref","first-page":"1159","DOI":"10.1016\/S0140-6736(23)00061-2","article-title":"Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies","volume":"401","author":"Sandborn","year":"2023","journal-title":"Lancet"},{"key":"2026082209213236400_otag092-B6","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.1056\/NEJMoa1900750","article-title":"Ustekinumab as induction and maintenance therapy for ulcerative colitis","volume":"381","author":"Sands","year":"2019","journal-title":"N Engl J Med"},{"key":"2026082209213236400_otag092-B7","first-page":"93","article-title":"Vedolizumab versus adalimumab for moderate-to-severe ulcerative colitis. Reply","volume":"382","author":"Sands","year":"2020","journal-title":"N Engl J Med"},{"key":"2026082209213236400_otag092-B8","doi-asserted-by":"publisher","first-page":"2444","DOI":"10.1056\/NEJMoa2207940","article-title":"Mirikizumab as induction and maintenance therapy for ulcerative colitis (LUCENT\u20111 and LUCENT\u20112)","volume":"388","author":"D\u2019Haens","year":"2023","journal-title":"N Engl J Med"},{"key":"2026082209213236400_otag092-B9","doi-asserted-by":"crossref","first-page":"913","DOI":"10.1016\/j.cgh.2023.12.005","article-title":"Meeting summary: AGA roundtable on clinical trial design in inflammatory bowel disease","volume":"22","author":"Singh","year":"2024","journal-title":"Clin Gastroenterol Hepatol"},{"key":"2026082209213236400_otag092-B10","doi-asserted-by":"crossref","first-page":"338","DOI":"10.1053\/j.gastro.2021.09.054","article-title":"Underrepresentation of minorities and underreporting of race and ethnicity in Crohn\u2019s disease clinical trials","volume":"162","author":"Sedano","year":"2022","journal-title":"Gastroenterology"}],"container-title":["Crohn\u2019s &amp; Colitis 360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/8\/3\/otag092\/70478750\/otag092.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article-pdf\/8\/3\/otag092\/70478750\/otag092.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T13:21:37Z","timestamp":1787404897000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/crohnscolitis360\/article\/doi\/10.1093\/crocol\/otag092\/8750955"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":10,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,7,8]]}},"URL":"https:\/\/doi.org\/10.1093\/crocol\/otag092","relation":{},"ISSN":["2631-827X"],"issn-type":[{"value":"2631-827X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,7]]},"published":{"date-parts":[[2026,7]]},"article-number":"otag092"}}