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  • Caron, BénédicteDepartment of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France (author)

IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis : the PROCTRIAL Consensus

  • Article/chapterEnglish2022

Publisher, publication year, extent ...

  • Elsevier,2022
  • printrdacarrier

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  • LIBRIS-ID:oai:DiVA.org:oru-97625
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-97625URI
  • https://doi.org/10.1016/j.cgh.2022.02.032DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

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  • Funding agencies:Prometheus Takeda Pharmaceutical Company Ltd  AbbVie Johnson & Johnson USA Janssen Biotech Inc  Amgen Arena Pharmaceuticals BiogenBoehringer IngelheimBristol-Myers Squibb Celgene Corporation  Celltrion Cosmos Pharmaceuticals Eisai Co Ltd  Elan Eli Lilly Ferring Pharmaceuticals  Galapagos NV  Fresenius Kabi Roche Holding Genentech  Gilead Sciences GlaxoSmithKline  Merck & Company  Mylan Dexcel Pharma  ProgenityProtagonist TherapeuticsRoche Holding  Novartis  Satisfai HealthSublimity TherapeuticsJanssen OrthoLLCPrometheus BiosciencesMicrobaBristol-Myers Squibb  Focus MedicalTheravance Biopharma RDCalibrCapella BioscienceCelltrion HealthcareClostraBioEntheraHoffmann-La Roche  Gilead Sciences  GlaxoSmithKline  GossamerBioImmunicIndex PharmaceuticalsInnovation PharmaceuticalsIronwood PharmaceuticalsKaleidoKallyopeMiroBioMorphic TherapeuticOSE ImmunotherapeuticsOtsuka Pharmaceutical  Palatin TechnologiesPrometheus LaboratoriesPharmaceuticalsSeres TherapeuticsSienna BiopharmaceuticalsSun PharmaSurrozenLLC (HCP Live Institutional Perspectives in GI)Teva Pharmaceutical Industries  TheliumTheravance Biopharma RDTLL PharmaUSWM EnterprisesVentyx BiosciencesViela BioVivante HealthVivelix PharmaceuticalsBacainn TherapeuticsBoehringer Ingelheim  Boston PharmaceuticalsQ32 BioRedhill BiopharmaRheos MedicinesSalix PharmaceuticalsCambridge HealthcareFood Industries OrganiszationJanssen NestleRandox Laboratories  Roche Holding Genentech  Sublimity Wild Bio Innate Pharma MSD Astelas Nestle SA  Aesca Centocor Falk Pharma GmbH Immundiagnostik Ardeypharm Augurix Calypso 
  • BACKGROUND AND AIMS: Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the PROCTRIAL (Definition and endpoints for ulcerative PROCtitis in clinical TRIALs) initiative was to develop consensus statements for definitions, inclusion criteria, and endpoints for the evaluation of ulcerative proctitis in adults.METHODS: Thirty-five international experts held a consensus meeting to define ulcerative proctitis, and the endpoints to use in clinical trials. Based on a systematic review of the literature, statements were generated, discussed, and approved by the working group participants using a modified Delphi method. Consensus was defined as at least 75% agreement among voters.RESULTS: The group agreed that the diagnosis of ulcerative proctitis should be made by ileocolonoscopy and confirmed by histopathology, with the exclusion of infections, drug-induced causes, radiation, trauma, and Crohn's disease. Ulcerative proctitis was defined as macroscopic extent of lesions limited to 15 cm distance from the anal verge in adults. Primary and secondary endpoints were identified to capture response of ulcerative proctitis to therapy. A combined clinical and endoscopic primary endpoint for the evaluation of ulcerative proctitis disease activity is proposed. Secondary endpoints which should be evaluated include endoscopic remission, histological remission, mucosal healing, histologic endoscopic mucosal improvement, disability, fecal incontinence, urgency, constipation, and health-related quality of life.CONCLUSION: In response to the need for guidance on the design of clinical trials in patients with ulcerative proctitis, the PROCTRIAL consensus provides recommendations on the definition and endpoints for ulcerative proctitis clinical trials.

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  • Abreu, Maria T.Division of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA (author)
  • Siegel, Corey A.Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA (author)
  • Panaccione, RemoDivision of Gastroenterology & Hepatology, University of Calgary, Calgary, Alberta, Canada (author)
  • Sands, Bruce E.Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA (author)
  • Dignass, AxelDepartment of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany (author)
  • Turner, DanJuliet Keidan Institute of Pediatric Gastroenterology Hepatology and Nutrition, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel (author)
  • Dotan, IrisDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel (author)
  • Hart, Ailsa L.Inflammatory Bowel Disease Unit, St. Mark's Hospital, Harrow, UK (author)
  • Ahuja, VineetDepartment of Gastroenterology & Human Nutrition, All India Institute of Medical Sciences, New Delhi, India (author)
  • Allez, MatthieuDepartment of Gastroenterology, Hôpital Saint-Louis, APHP, INSERM U1160, Université de Paris, Paris, Île-de-France, France (author)
  • Ananthakrishnan, Ashwin N.Division of Gastroenterology, Massachusetts General Hospital & Harvard Medical School, Boston, MA, USA (author)
  • Ghosh, SubrataCollege of Medicine and Health, University College Cork, Cork, Ireland (author)
  • Griffiths, Anne M.SickKids Inflammatory Bowel Disease Center, Division of Gastroenterology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada (author)
  • Halfvarson, Jonas,1970-Örebro universitet,Institutionen för medicinska vetenskaper,Department of Gastroenterology(Swepub:oru)jshn (author)
  • Kaser, ArthurUniversity of Cambridge and Cambridge University Hospitals - Addenbrooke's Hospital, Cambridge, UK (author)
  • Kotze, Paulo G.IBD outpatient clinics, Colorectal Surgery Unit, Catholic University of Paraná (PUCPR), Curitiba, Brazil (author)
  • Koutroubakis, Ioannis E.Department of Gastroenterology, University Hospital of Heraklion, Medical School, University of Crete, Greece (author)
  • Lakatos, Peter L.Department of Medicine and Oncology, Semmelweis University, Budapest, Hungary; McGill University Health Center, Montreal General Hospital, Canada (author)
  • Levine, AriePediatric Gastroenterology Unit, PIBD research center, Wolfson Medical Center, Holon, Israel (author)
  • Lewis, James D.Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (author)
  • Magro, FernandoDepartment of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal; Department of Clinical Pharmacology, São João University Hospital Center (CHUSJ), Porto, Portugal; Faculty of Medicine, University of Porto, Portugal; Center for Health Technology and Services Research (CINTESIS), Porto, Portugal (author)
  • Mantzaris, Gerassimos J.Department of Gastroenterology, Evangelismos-Polykliniki General Hospital of Athens, Greece (author)
  • O'Morain, ColmFaculty of Health Sciences, University of Dublin, Trinity College, Dublin, Ireland (author)
  • Ran, ZhihuaDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Inflammatory Bowel Disease Research Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China (author)
  • Reinisch, WalterDepartment of Internal Medicine III, Medical University of Vienna, Vienna, Austria (author)
  • Rogler, GerhardDepartment of Gastroenterology and Hepatology, University Hospital Zurich and University of Zurich, Zurich, Switzerland (author)
  • Sachar, David B.Icahn School of Medicine at Mount Sinai, New York, New York, USA (author)
  • Siegmund, BrittaCharité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Department of Gastroenterology, Rheumatology and Infectious Disease, Campus Benjamin Franklin, Berlin, Germany (author)
  • Silverberg, Mark S.Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, ON, Canada (author)
  • Sood, AjitDepartment of Gastroenterology, Dayanand Medical College & Hospital, Ludhiāna, Punjab, India (author)
  • Spinelli, AntoninoDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy (author)
  • Steinwurz, FlavioDepartment of Gastroenterology, Albert Einstein Israelite Hospital, São Paulo, Brazil (author)
  • Tysk, CurtDepartment of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden (author)
  • Yamamoto-Furusho, Jesus K.Inflammatory Bowel Disease Clinic, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico (author)
  • Schreiber, StefanDepartment of Internal Medicine, University Hospital Schleswig-Holstein, Kiel, Germany (author)
  • Rubin, David T.University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA (author)
  • Sandborn, William J.Division of Gastroenterology, University of California San Diego, La Jolla, California, USA (author)
  • Danese, SilvioHumanitas Research Hospital and University Vita-Salute San Raffaele, Milano, Italy (author)
  • Peyrin-Biroulet, LaurentDepartment of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, France (author)
  • Department of Gastroenterology and Inserm NGERE U1256, Nancy University Hospital, University of Lorraine, Vandoeuvre-lès-Nancy, FranceDivision of Gastroenterology, Department of Medicine, University of Miami Miller School of Medicine, Miami, USA (creator_code:org_t)

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  • In:Clinical Gastroenterology and Hepatology: Elsevier20:11, s. 2169-2627.e11542-35651542-7714

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