METRIC-EF: magnetic resonance enterography to predict disabling disease in newly diagnosed Crohn's disease-protocol for a multicentre, non-randomised, single-arm, prospective study.

Crohn's disease (CD) is characterised by discontinuous, relapsing enteric inflammation. Instituting advanced therapies at an early stage to suppress inflammation aims to prevent future complications such as stricturing or penetrating disease, and subsequent surgical resection. Therapeutics are effective but associated with certain side-effects and relatively expensive. There is therefore an urgent need for robust methods to predict which newly diagnosed patients will develop disabling disease, to identify patients who are most likely to benefit from early, advanced therapies. We aim to determine if magnetic resonance enterography (MRE) features at diagnosis improve prediction of disabling CD within 5 years of diagnosis. We describe the protocol for a multicentre, non-randomised, single-arm, prospective study of adult patients with newly diagnosed CD. We will use patients already recruited to the METRIC study and extend their clinical follow-up, as well as a separate group of newly diagnosed patients who were not part of the METRIC trial (MRE within 3 months of diagnosis), to ensure an adequate sample size. Follow-up will extend for at least 4 years. The primary outcome is to evaluate the comparative predictive ability of prognostic models incorporating MRE severity scores (Magnetic resonance Enterography Global Score (MEGS), simplified MAgnetic Resonance Index of Activity (sMaRIA) and Lémann Index) versus models using standard characteristics alone to predict disabling CD (modified Beaugerie definition) within 5 years of new diagnosis. This study protocol achieved National Health Service Research Ethics Committee (NHS REC), London-Hampstead Research Ethics Committee approval (IRAS 217422). Our findings will be disseminated via conference presentations and peer-reviewed publications. ISRCTN76899103.

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© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

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Competing interests: SK—nothing to declare. AP—NIHR HTA, grants from NIHR Fellowships programme; and personal fees from Acelity, Actavis, Dr Falk, Janssen-Cilag and Takeda. SM, GB, SB, CSC, JH, ALH, IJ and RV—none. STr—Grants/Research Support: AbbVie, Buhlmann, Celgene, ECCO, Helmsley Trust, IOIBD, Janssen, Lilly, Pfizer, Takeda, UCB, UKIERI, Vifor and Norman Collisson Foundation. Consulting Fees: Abacus; AbbVie; Actial; ai4gi; Alcimed; Allergan; Amgen; Apexian; Aptel; Arena; Asahi; Aspen; Astellas; Atlantic; AstraZeneca; Barco; Biocare; Biogen; BLPharma; Boehringer Ingelheim; BMS; Buhlmann; Calcico; Celgene; Cellerix; Cerimon; ChemoCentryx; Chiesi; CisBio; ComCast; Coronado; Cosmo; Ducentis; Dynavax; Elan; Enterome; EQrX; Equillium; Falk; Ferring; FPRT Bio; Galapagos; Genentech/Roche; Genzyme; Gilead; Glenmark; Grunenthal; GSK; GW Pharmaceuticals; Immunocore; Immunometabolism; Indigo; Janssen; Lexicon; Lilly; Medarex; Medtrix; Merck; Merrimack; Mestag; Millenium; Neovacs; Novartis; Novo Nordisk; NPS-Nycomed; Ocera; Optima; Origin; Otsuka; Palau; Pentax; Pfizer; Pharmaventure; Phesi; Phillips; P&G; Pronota; Protagonist; Proximagen; Resolute; Robarts; Sandoz; Santarus; Satisfai; Sensyne Health; Shire; SigmoidPharma; Sorriso; Souffinez; Syndermix; Synthon; Takeda; Theravance; Tigenix; Tillotts; Topivert; Trino Therapeutics with Wellcome Trust; TxCell; UCB Pharma; Vertex; VHsquared; Vifor; Warner Chilcott and Zeria. Speaker fees: AbbVie, Amgen, Biogen, Falk; Ferring, Janssen, Pfizer, Shire, Takeda, UCB. No stocks or share options. SH—grants from the NIHR. SAT—personal fees from Robarts, shareholding in Motilent and grants from the NIHR.