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IOIBD Recommendations for Clinical Trials in Ulcerative Proctitis: The PROCTRIAL Consensus.

Clin Gastroenterol Hepatol

November 2022

Nancy University Hospital, Department of Gastroenterology and University of Lorraine, Inserm, Nutrition-Génétique et Exposition aux Risques Environnementaux, F-54000 Nancy, France. Electronic address:

Background & Aims: Clinical trials evaluating biologics and small molecules in patients with ulcerative colitis are predominantly excluding ulcerative proctitis. The objective of the 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.

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