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Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015;12(4):205–17.
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2018;390(10114):2769–78.
Bitton A, Buie D, Enns R, Feagan BG, Jones JL, Marshall JK, et al. Treatment of hospitalized adult patients with severe ulcerative colitis: Toronto consensus statements. Am J Gastroenterol. 2012;107(2):179–94 author reply 95.
Lutgens MW, van Oijen MG, van der Heijden GJ, Vleggaar FP, Siersema PD, Oldenburg B. Declining risk of colorectal cancer in inflammatory bowel disease: an updated meta-analysis of population-based cohort studies. Inflamm Bowel Dis. 2013;19(4):789–99.
Ben-Horin S, Kopylov U, Chowers Y. Optimizing anti-TNF treatments in inflammatory bowel disease. Autoimmun Rev. 2014;13(1):24–30.
Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699–710.
Narula N, Peerani F, Meserve J, Kochhar G, Chaudrey K, Hartke J, et al. Vedolizumab for ulcerative colitis: treatment outcomes from the VICTORY Consortium. Am J Gastroenterol. 2018;113(9):1345.
Colombel JF, Keir ME, Scherl A, Zhao R, de Hertogh G, Faubion WA, et al. Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC. Gut. 2016;66(12):2063–8.
Regueiro M, Rodemann J, Kip KE, Saul M, Swoger J, Baidoo L, et al. Physician assessment of ulcerative colitis activity correlates poorly with endoscopic disease activity. Inflamm Bowel Dis. 2011;17(4):1008–14.
Jairath V, Zou GY, Parker CE, MacDonald JK, AlAmeel T, Al Beshir M, et al. Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis. Cochrane Database Syst Rev. 2017;9:CD011572.
Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987;317(26):1625–9.
Halpin SJ, Ford AC. Prevalence of symptoms meeting criteria for irritable bowel syndrome in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2012;107:1474.
•• Feagan BG, Sandborn WJ, D’Haens G, Pola S, McDonald JWD, Rutgeerts P, et al. The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis. Gastroenterology. 2013;145(1):149–57 e2. This was the first study to demonstrate the power of centralized reading of ulcerative colitis endoscopy videos to minimize observation bias and faciliate more accurate estimation of effect size in clinical trials.
Shah SC, Colombel JF, Sands BE, Narula N. Mucosal healing is associated with improved long-term outcomes of patients with ulcerative colitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol : the official clinical practice journal of the American Gastroenterological Association. 2016;14(9):1245–55 e8.
Ma C, Guizzetti L, Panaccione R, Fedorak RN, Pai RK, Parker CE, et al. Systematic review with meta-analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis. Aliment Pharmacol Ther. 2018;47(12):1578–96.
Food U, Administration D. Ulcerative colitis: clinical trial endpoints guidance for industry 2016.
Bitton A, Peppercorn MA, Antonioli DA, Niles JL, Shah S, Bousvaros A, et al. Clinical, biological, and histologic parameters as predictors of relapse in ulcerative colitis. Gastroenterology. 2001;120(1):13–20.
Bessissow T, Lemmens B, Ferrante M, Bisschops R, Van Steen K, Geboes K, et al. Prognostic value of serologic and histologic markers on clinical relapse in ulcerative colitis patients with mucosal healing. Am J Gastroenterol. 2012;107(11):1684–92.
Park S, Abdi T, Gentry M, Laine L. Histological disease activity as a predictor of clinical relapse among patients with ulcerative colitis: systematic review and meta-analysis. Am J Gastroenterol. 2016;111(12):1692–701.
Christensen B, Hanauer SB, Erlich J, Kassim O, Gibson PR, Turner JR, et al. Histologic normalization occurs in ulcerative colitis and is associated with improved clinical outcomes. Clin Gastroenterol Hepatol. 2017;15(10):1557–64.e1.
Bryant RV, Burger DC, Delo J, Walsh AJ, Thomas S, von Herbay A, et al. Beyond endoscopic mucosal healing in UC: histological remission better predicts corticosteroid use and hospitalisation over 6 years of follow-up. Gut. 2016;65(3):408–14.
Marchal-Bressenot A, Salleron J, Boulagnon-Rombi C, Bastien C, Cahn V, Cadiot G, et al. Development and validation of the Nancy histological index for UC. Gut. 2017;66(1):43–9.
•• Mosli MH, Feagan BG, Zou G, Sandborn WJ, D’Haens G, Khanna R, et al. Development and validation of a histological index for UC. Gut. 2017;66(1):50–8 This study describes the development and operating characteristics of a histopathology index that is being incorporated into contemporary clinical trials.
Mosli MH, Feagan BG, Zou G, Sandborn WJ, D’Haens G, Khanna R, et al. Development and validation of a histological index for UC. Gut. 2015;66(1):50–8.
Mosli MH, Feagan BG, Zou G, Sandborn WJ, D’Haens G, Khanna R, et al. Reproducibility of histological assessments of disease activity in UC. Gut. 2015;64(11):1765–73.
Jairath V, Jeyarajah J, Zou G, Parker CE, Olson A, Khanna R, et al. A composite disease activity index for early drug development in ulcerative colitis: development and validation of the UC-100 score. Lancet Gastroenterol Hepatol. 2019;4(1):63–70.
Cobb WS, Heniford BT, Sigmon LB, Hasan R, Simms C, Kercher KW, et al. Colonoscopic perforations: incidence, management, and outcomes. Am Surg. 2004;70(9):750–7 discussion 7-8.
Buisson A, Gonzalez F, Poullenot F, Nancey S, Sollellis E, Fumery M, et al. Comparative acceptability and perceived clinical utility of monitoring tools: a nationwide survey of patients with inflammatory bowel disease. Inflamm Bowel Dis. 2017;23(8):1425–33.
Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, et al. Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: a systematic review for development of a core outcome set. Clin Gastroenterol Hepatol. 2018;16(5):637–47 e13.
Sutherland LR, Martin F, Greer S, Robinson M, Greenberger N, Saibil F, et al. 5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology. 1987;92(6):1894–8.
Turner D, Seow CH, Greenberg GR, Griffiths AM, Silverberg MS, Steinhart AH. A systematic prospective comparison of noninvasive disease activity indices in ulcerative colitis. Clin Gastroenterol Hepatol. 2009;7(10):1081–8.
Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008;14(12):1660–6.
Sutherland LR, Martin F. 5-Aminosalicylic acid enemas in treatment of distal ulcerative colitis and proctitis in Canada. Dig Dis Sci. 1987;32(12 Suppl):64S–6S.
Higgins PD, Schwartz M, Mapili J, Krokos I, Leung J, Zimmermann EM. Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis. Gut. 2005;54(6):782–8.
Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2—assessing respondent understanding. Value Health. 2011;14(8):978–88.
Varma R, Richman EA, Ferris FL, Bressler NM. Use of patient-reported outcomes in medical product development: a report from the 2009 NEI/FDA Clinical Trial Endpoints Symposium. Invest Ophthalmol Vis Sci. 2010;51(12):6095–103.
• Jairath V, Khanna R, Zou G, Stitt L, Mosli M, Vandervoort M, et al. Development of interim patient-reported outcome measures for the assessment of ulcerative colitis disease activity in clinical trials. Aliment Pharmacol Ther. 2015;42(10):1200–10 This study describes the development and operating characteristics of thulcerative colitis patient-reported outcome measures when used alone or in conjuction with endoscopic scoring indices.
Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees K, Barrett K, et al. Randomised trial of once- or twice-daily MMX mesalazine for maintenance of remission in ulcerative colitis. Gut. 2008;57(7):893–902.
Feagan BG, Greenberg GR, Wild G, Fedorak RN, Pare P, McDonald JW, et al. Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin. N Engl J Med. 2005;352(24):2499–507.
Peyrin-Biroulet L, Sandborn W, Sands BE, Reinisch W, Bemelman W, Bryant RV, et al. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): determining therapeutic goals for treat-to-target. Am J Gastroenterol. 2015;110(9):1324–38.
Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723–36.
Sandborn WJ, Feagan BG, Wolf DC, D’Haens G, Vermeire S, Hanauer SB, et al. Ozanimod induction and maintenance treatment for ulcerative colitis. N Engl J Med. 2016;374(18):1754–62.
Samaan MA, Mosli MH, Sandborn WJ, Feagan BG, D’Haens GR, Dubcenco E, et al. A systematic review of the measurement of endoscopic healing in ulcerative colitis clinical trials: recommendations and implications for future research. Inflamm Bowel Dis. 2014;20(8):1465–71.
Mohammed Vashist N, Samaan M, Mosli MH, Parker CE, MacDonald JK, Nelson SA, et al. Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis. Cochrane Database Syst Rev. 2018;1:Cd011450.
Scherl EJ, Pruitt R, Gordon GL, Lamet M, Shaw A, Huang S, et al. Safety and efficacy of a new 3.3 g b.i.d. tablet formulation in patients with mild-to-moderately-active ulcerative colitis: a multicenter, randomized, double-blind, placebo-controlled study. Am J Gastroenterol. 2009;104(6):1452–9.
Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, et al. Developing an instrument to assess the endoscopic severity of ulcerative colitis: the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Gut. 2012;61(4):535–42.
Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, et al. Reliability and initial validation of the ulcerative colitis endoscopic index of severity. Gastroenterology. 2013;145(5):987–95.
• Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials? Inflamm Bowel Dis. 2012;18(11):2056–62 This study describes the operating characteristics of the endoscopic subscore of the Mayo Clinic Score using clinical trial data.
Osada T, Ohkusa T, Yokoyama T, Shibuya T, Sakamoto N, Beppu K, et al. Comparison of several activity indices for the evaluation of endoscopic activity in UC: inter- and intraobserver consistency. Inflamm Bowel Dis. 2010;16(2):192–7.
Daperno M, Comberlato M, Bossa F, Biancone L, Bonanomi AG, Cassinotti A, et al. Inter-observer agreement in endoscopic scoring systems: preliminary report of an ongoing study from the Italian Group for Inflammatory Bowel Disease (IG-IBD). Dig Liver Dis: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2014;46(11):969–73.
Levesque BG, Loftus EV, Panaccione R, McDonald JW, Van Assche GA, Zou G, et al. Responsiveness of endoscopic indices in the evaluation of ulcerative colitis. Gastroenterology. 2014;146(5):S-226–S-7.
Ma C, Panaccione R, Fedorak RN, Parker CE, Nguyen TM, Khanna R, et al. Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: a systematic review for development of a core outcome set. Clin Gastroenterol Hepatol. 2017;16(5):637–47. e13.
Colombel JF, Rutgeerts P, Reinisch W, Esser D, Wang Y, Lang Y, et al. Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis. Gastroenterology. 2011;141(4):1194–201.
Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, et al. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009;137(4):1250–60 quiz 520.
Barreiro-de Acosta M, Vallejo N, de la Iglesia D, Uribarri L, Baston I, Ferreiro-Iglesias R, et al. Evaluation of the risk of relapse in ulcerative colitis according to the degree of mucosal healing (Mayo 0 vs 1): a longitudinal cohort study. J Crohn’s Colitis. 2016;10(1):13–9.
Ikeya K, Sugimoto K, Kawasaki S, Iida T, Maruyama Y, Watanabe F, et al. Tacrolimus for remission induction in ulcerative colitis: Mayo endoscopic subscore 0 and 1 predict long-term prognosis. Dig Liver Dis: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2015;47(5):365–71.
Manginot C, Baumann C, Peyrin-Biroulet L. An endoscopic Mayo score of 0 is associated with a lower risk of colectomy than a score of 1 in ulcerative colitis. Gut. 2015;64(7):1181–2.
Meucci G, Fasoli R, Saibeni S, Valpiani D, Gullotta R, Colombo E, et al. Prognostic significance of endoscopic remission in patients with active ulcerative colitis treated with oral and topical mesalazine: a prospective, multicenter study. Inflamm Bowel Dis. 2012;18(6):1006–10.
Nakarai A, Kato J, Hiraoka S, Inokuchi T, Takei D, Moritou Y, et al. Prognosis of ulcerative colitis differs between patients with complete and partial mucosal healing, which can be predicted from the platelet count. World J Gastroenterol. 2014;20(48):18367–74.
Yokoyama K, Kobayashi K, Mukae M, Sada M, Koizumi W. Clinical study of the relation between mucosal healing and long-term outcomes in ulcerative colitis. Gastroenterol Res Pract. 2013;2013:192794.
Battat R, Duijvestein M, Guizzetti L, Choudhary D, Boland BS, Dulai PS, et al. Histologic healing rates of medical therapies for ulcerative colitis: a systematic review and meta-analysis of randomized controlled trials. Am J Gastroenterol. 2019;114(5):733–45.
Scott CB, Nelson JS, Farnan NC, Curran WJ, Murray KJ, Fischbach AJ, et al. Central pathology review in clinical trials for patients with malignant glioma. A report of radiation therapy oncology group 83-02. Cancer. 1995;76(2):307–13.
Bernstein CN, Shanahan F, Anton PA, Weinstein WM. Patchiness of mucosal inflammation in treated ulcerative colitis: a prospective study. Gastrointest Endosc. 1995;42(3):232–7.
Atreya R, Bloom S, Scaldaferri F, Gerardi V, Admyre C, Karlsson A, et al. Clinical effects of a topically applied toll-like receptor 9 agonist in active moderate-to-severe ulcerative colitis. J Crohn's Colitis. 2016;10(11):1294–302.
Sandborn WJ, Bhandari BR, Fogel R, Onken J, Yen E, Zhao X, et al. Randomised clinical trial: a phase 1, dose-ranging study of the anti-matrix metalloproteinase-9 monoclonal antibody GS-5745 versus placebo for ulcerative colitis. Aliment Pharmacol Ther. 2016;44(2):157–69.
Sandborn WJ, Colombel JF, Ghosh S, Sands BE, Dryden G, Hebuterne X, et al. Eldelumab [Anti-IP-10] induction therapy for ulcerative colitis: a randomised, placebo-controlled, phase 2b study. J Crohn's Colitis. 2016;10(4):418–28.
Geboes K, Riddell R, Ost A, Jensfelt B, Persson T, Lofberg R. A reproducible grading scale for histological assessment of inflammation in ulcerative colitis. Gut. 2000;47(3):404–9.
Jairath V, Peyrin-Biroulet L, Zou G, Mosli M, Vande Casteele N, Pai RK, et al. Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial. Gut. 2018;68(7):1162–8.
Pai RK, Geboes K. Disease activity and mucosal healing in inflammatory bowel disease: a new role for histopathology? Virchows Arch. 2017;472(1):99–110.
Pai RK, Khanna R, D’Haens GR, Sandborn WJ, Jeyarajah J, Feagan BG, et al. Definitions of response and remission for the Robarts Histopathology Index. Gut. 2018;68(11):2101–2 gutjnl-2018-317547.
Group F-NBW. BEST (Biomarkers, EndpointS, and other Tools) Resource [Internet] Silver Spring (MD): Food and Drug Administration (US) and National Institutes of Health (US), Bethesda (MD). 2016
Mosli MH, Zou G, Garg SK, Feagan SG, MacDonald JK, Chande N, et al. C-reactive protein, fecal calprotectin, and stool lactoferrin for detection of endoscopic activity in symptomatic inflammatory bowel disease patients: a systematic review and meta-analysis. Am J Gastroenterol. 2015;110(6):802–19 quiz 20.
Magro F, Lopes J, Borralho P, Lopes S, Coelho R, Cotter J, et al. Comparison of different histological indexes in the assessment of UC activity and their accuracy regarding endoscopic outcomes and faecal calprotectin levels. Gut. 2018;68(4):594–603.
Reinisch W, Bressler B, Curtis R, Parikh A, Yang H, Rosario M, et al. Fecal calprotectin responses following induction therapy with vedolizumab in moderate to severe ulcerative colitis: a post hoc analysis of GEMINI 1. Inflamm Bowel Dis. 2018;25(4):803–10.
Sandborn WJ, Panes J, Zhang H, Yu D, Niezychowski W, Su C. Correlation between concentrations of fecal calprotectin and outcomes of patients with ulcerative colitis in a phase 2 trial. Gastroenterology. 2016;150(1):96–102.
Zhulina Y, Cao Y, Amcoff K, Carlson M, Tysk C, Halfvarson J. The prognostic significance of faecal calprotectin in patients with inactive inflammatory bowel disease. Aliment Pharmacol Ther. 2016;44(5):495–504.
Molander P, Farkkila M, Ristimaki A, Salminen K, Kemppainen H, Blomster T, et al. Does fecal calprotectin predict short-term relapse after stopping TNFalpha-blocking agents in inflammatory bowel disease patients in deep remission? J Crohn’s Colitis. 2015;9(1):33–40.
D’Inca R, Dal Pont E, Di Leo V, Benazzato L, Martinato M, Lamboglia F, et al. Can calprotectin predict relapse risk in inflammatory bowel disease? Am J Gastroenterol. 2008;103(8):2007–14.
De Vos M, Louis EJ, Jahnsen J, Vandervoort JG, Noman M, Dewit O, et al. Consecutive fecal calprotectin measurements to predict relapse in patients with ulcerative colitis receiving infliximab maintenance therapy. Inflamm Bowel Dis. 2013;19(10):2111–7.
Osterman MT, Aberra FN, Cross R, Liakos S, McCabe R, Shafran I, et al. Mesalamine dose escalation reduces fecal calprotectin in patients with quiescent ulcerative colitis. Clin Gastroenterol Hepatol : the official clinical practice journal of the American Gastroenterological Association. 2014;12(11):1887–93 e3.
Pornet C, Denis B, Perrin P, Gendre I, Launoy G. Predictors of adherence to repeat fecal occult blood test in a population-based colorectal cancer screening program. Br J Cancer. 2014;111(11):2152–5.
Osborne J, Wilson C, Moore V, Gregory T, Flight I, Young G. Sample preference for colorectal cancer screening tests: Blood or stool? Open J Prev Med. 2012;2(03):326–31.
Conflict of Interest
Christopher Ma reports working as an academic research consultant for Robarts Clinical Trials, Inc., outside the submitted work.
Brian Feagan reports grants and personal fees from Abbvie, Amgen, Astra Zeneca, Bristol-Myers Squibb, Janssen Biotech/Centocor, JmJ/Janseen, Pfizer, Receptos, and Takeda; and personal fees from Avaxia Biologics, Atlantic Pharma, Baxter Healthcare Corporation, Biogen Idec, Boehringer,-Ingelheim, Calypso Biotech, Celgene, Elan/Biogen, EnGene, Ferring, Genetech/Roche, GiCare Pharma, Gilead, Given Imaging, GSK, Ironwood, Kyowa Kakko Kirin Co Ltd., Lilly, Lycera Biotech, Merck, Mesoblast Pharma, Millennium, Nestles, Novo Nordisk, Novartis, Prometheus Therapeutics and Diagnostics, Protagonist, Receptos, Salix, Shire, Sigmoid Pharma, Synergy Pharma, Teva Pharma, TiGenix, Tillotts, UCB, Vertex, VHsquared, Wyeth, Zealand, Zyngenia, Galapagos, Inception IBD INc., Lexicon, Vivelix Pharma, Japan Tobacco Company, Ablynx, Progenity, NextBiotix, Gossamer, Pharma, and Qu Biologics; and a grant from Sanofi.
Vipul Jairath declares personal fees from Abbvie, Takeda, Pfizer, Sandoz, Janssen, Arena Pharma, GSK, Eli Lilly, Ferring, Shire, Robarts Clinical Trials Inc., Genentech, Merck, Topivert, and Celltrion.
Reena Khanna reports personal fees from Abbvie, Janssen, Pfozer, Shire, Takeda, Encycle, Merck, Pendopharm, Roche, and Robarts Clinical Trials.
Robert Battat, Parambir S. Dulai, and William J Sandborn declare that they no conflict of interest.
Parambir S. Dulai reports other from Takeda, other from Janssen, other from Pfizer, other from Polymedco, other from Crohn's and Colitis Foundation, other from American College of Gastroenterology, personal fees from Takeda, personal fees from Janssen, personal fees from Pfizer, personal fees from Takeda, other from Takeda, other from Janssen, outside the submitted work.
WIlliam Sandborn reports grants and personal fees from Abbvie, personal fees from Allergan, grants and personal fees from Amgen, personal fees from Arena Pharmaceuticals, grants from Atlantic Pharmaceuticals, personal fees from Avexegen Therapeutics, personal fees from Biogen Idec, personal fees and other from BeiGene, personal fees from Boehringer Ingelheim, personal fees from Bristol Meyers Squibb, grants and personal fees from Celgene, personal fees from Celltrion, personal fees from Conatus, personal fees from Cosmo Technologies, personal fees and other from Escalier Biosciences, personal fees from Ferring Pharmaceuticals, personal fees from Forbion, personal fees from Forward Pharma, grants and personal fees from Genentech, grants and personal fees from Gilead Sciences, personal fees and other from Gossamer Bio, personal fees from Immune Pharmaceuticals, personal fees from Incyte, grants and personal fees from Janssen, personal fees from Kyowa Hakko Kirin Pharma, personal fees from Landos Biopharma, grants and personal fees from Lilly, personal fees from Miraca Life Sciences, personal fees from Nivalis Therapeutics, personal fees from Novartis, personal fees from Nutrition Science Partners, personal fees and other from Oppilan Pharma, personal fees from Otsuka, personal fees from Paul Hastings, grants and personal fees from Pfizer, personal fees and other from Precision IBD, personal fees and other from Progenity, grants and personal fees from Prometheus Laboratories, personal fees from Reistone, personal fees and other from Ritter Pharmaceuticals, grants and personal fees from Robarts Clinical Trials (owned by Health Academic Research Trust or HART), grants and personal fees from Salix Pharmaceuticals, personal fees from Series Therapeutics, grants and personal fees from Shire, personal fees from Sienna Biopharmaceuticals, personal fees from Sigmoid Biotechnologies, personal fees from Sterna Biologicals, personal fees from Sublimity Therapeutics, grants and personal fees from Takeda, personal fees from Theravance Biopharma, personal fees from Tigenix, personal fees from Tillotts Pharma, personal fees from UCB Pharma, other from Ventyx Biosciences, personal fees and other from Vimalan Biosciences, personal fees from Vivelix Pharmaceuticals, outside the submitted work; and Spouse: Opthotech - consultant, stock options; Progenity - consultant, stock; Oppilan Pharma - employee, stock options; Escalier Biosciences - employee, stock options; Precision IBD - employee, stock options; Ventyx Biosciences – employee, stock options; Vimalan Biosciences – employee, stock options.
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Battat, R., Dulai, P.S., Ma, C. et al. Current Endpoints of Clinical Trials in Ulcerative Colitis: Are They Valid?. Curr Treat Options Gastro 18, 15–32 (2020). https://doi.org/10.1007/s11938-019-00259-w
- Ulcerative colitis
- Clinical trial