Brief Summary

This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).

Conditions

• Crohn Disease (CD)

Intervention / Treatment

• Device: Epigenome-Guided Treatment Arm
• Other: Investigator-Guided Treatment Arm

Primary Outcome Measures

• To compare the efficacy of epigenome-guided treatment selection to usual SOC treatment selection for inducing clinical remission and endoscopic response at Week 26 in participants with active CD. (Baseline to Week 26)
  Corticosteroid-free clinical remission (Harvey-Bradshaw Index \[HBI\] score ≤ 4) and endoscopic response (≥ 50% decrease from baseline in the Simple Endoscopic Score for Crohn's Disease \[SES-CD\])

Countries

Belgium, Italy, Netherlands, Slovenia, United Kingdom

Locations and Investigators

• GZA Antwerpen, Antwerp, Belgium (Not yet recruiting)
  • Filip Couturier
• Imeldahospital, Bonheiden, Belgium (Recruiting)
  • Peter Bossuyt, Dr
• AZ Klina, Brasschaat, Belgium (Recruiting)
  • Evi Van Dyck, Dr
  • Evi Van Dyck, Dr (Principal Investigator)
• H.U.B. - Hôpital Erasme, Brussels, Belgium (Recruiting)
  • Denis Franchimont, Dr
  • Denis Franchimont, Dr (Principal Investigator)
• Universitair Ziekenhuis Antwerpen (UZA), Edegem, Belgium (Recruiting)
  • Michael Somers, Dr
  • Michael Somers, Dr (Principal Investigator)
• AZ Maria Middelares, Ghent, Belgium (Recruiting)
  • Nele Deprez, Dr
  • Nele Deprez, Dr (Principal Investigator)
• AZ Sint Lucas, Ghent, Belgium (Recruiting)
  • Harold Peeters, Dr
  • Harold Peeters, Dr (Principal Investigator)
• UZ Ghent, Ghent, Belgium (Recruiting)
  • Jeroen Geldof, Dr
  • Jeroen Geldof, Dr (Principal Investigator)
• UZ Leuven Gasthuisberg, Leuven, Belgium (Recruiting)
  • Bram Verstockt
• UZ Leuven, Leuven, Belgium (Recruiting)
  • Bram Verstockt, Dr
  • Bram Verstockt, Dr (Principal Investigator)
• Centre Hospitalier Universitaire (CHU) de Liege, Liège, Belgium (Recruiting)
  • Catharine Reenaers, Dr
  • Catharine Reenaers, Dr (Principal Investigator)
• Groupe sante CHC/Clique du MontLegia, Liège, Belgium (Recruiting)
  • Arnaud Colard, Dr
  • Arnaud Colard, Dr (Principal Investigator)
• AZ Oostende, Ostend, Belgium (Recruiting)
  • Guy Lambrecht, Dr
  • Guy Lambrecht, Dr (Principal Investigator)
• AZ Delta VZW, Roeselare, Belgium (Recruiting)
  • Filip Baert, Dr
  • Filip Baert, Dr (Principal Investigator)
• CHU UCL Namur asbl Site Godinne, Yvoir, Belgium (Recruiting)
  • Jean-Francois Rahier, Dr
  • Jean-Francois Rahier, Dr (Principal Investigator)
• IRCCS "Saverio de Bellis", National Institute of Gastroenterology, Castellana Grotte, Italy (Not yet recruiting)
  • Mauro Mastronardi
• Azienda Ospedaliero Universitaria Careggi Padiglione San Luca Nuovo, Florence, Italy (Recruiting)
  • Gabriele Dragoni
• IRCCS Ospedale San Raffaele, Milan, Italy (Recruiting)
  • Silvio Danese, Dr
  • Silvio Danese, Dr (Principal Investigator)
• Agostino Gemelli University Policlinic, Roma, Italy (Not yet recruiting)
  • Franco Scaldaferri
• San Camillo-Forlanini Hospital, Rome, Italy (Not yet recruiting)
  • Rocco Cosintino
• UOC di Gastroenterologia ed Endoscopia Digestiva, San Giovanni Rotondo, Italy (Not yet recruiting)
  • Fabrizio Bossa
• Flevoziekenhuis Hospitaalweg 1, Almere Stad, Netherlands (Not yet recruiting)
  • Marco Mundt
• Amsterdam UMC, Amsterdam, Netherlands (Recruiting)
  • Krisztina Gecse, Dr
  • Krisztina Gecse, Dr (Principal Investigator)
• OLVG Oost, Amsterdam, Netherlands (Recruiting)
  • Margien Seinen, Dr
  • Margien Seinen, Dr (Principal Investigator)
• Maastricht UMC, Maastricht, Netherlands (Recruiting)
  • Zlatan Majagic, Dr
  • Zlatan Majagic, Dr (Principal Investigator)
• Radboudumc, Nijmegen, Netherlands (Recruiting)
  • Marjolijn Duijvestein, Dr
  • Marjolijn Duijvestein, Dr (Principal Investigator)
• Elisabeth-TweeSteden Ziekenhuis (ETZ), Tilburg, Netherlands (Recruiting)
  • Maurice Lutgens, Dr
  • Maurice Lutgens, Dr (Principal Investigator)
• Universitair Medisch Centrum Utrecht, Utrecht, Netherlands (Recruiting)
  • Bas Oldenburg, Dr
  • Bas Oldenburg, Dr (Principal Investigator)
• UKC Ljubljana, Ljubljana, Slovenia (Not yet recruiting)
  • David Drobne
• Northern Care Alliance - Fairfield General Hospital, Bury, United Kingdom (Recruiting)
  • Jimmy Limdi, Dr
  • Jimmy Limdi, Dr (Principal Investigator)
• Cambridge University Hospitals NHS Trust, Cambridge, United Kingdom (Recruiting)
  • Sreedhar Subramanian, Dr
  • Sreedhar Subramanian, Dr (Principal Investigator)
• Hull University Teaching Hospital NHS Trust, Cottingham, United Kingdom (Recruiting)
  • Shaji Sebastian, Dr
  • Shaji Sebastian, Dr (Principal Investigator)
• The Dudley Group NHS Foundation Trust, Dudley, United Kingdom (Recruiting)
  • Shanika De Silva, Dr
  • Shanika De Silva, Dr (Principal Investigator)
• Cardiff & Vale UHB, Llandough, United Kingdom (Recruiting)
  • Dharmaraj Durai, Dr
  • Dharmaraj Durai, Dr (Principal Investigator)
• Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom (Recruiting)
  • Peter Irving, Dr
  • Peter Irving, Dr (Principal Investigator)
• King's College Hospital NHS Foundation Trust, London, United Kingdom (Recruiting)
  • Polychronis Pavlidis, Dr
  • Polychronis Pavlidis, Dr (Principal Investigator)
• Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom (Recruiting)
  • Jack Satsangi, Dr
  • Jack Satsangi, Dr (Principal Investigator)
• University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom (Recruiting)
  • Fraser Cummings, Dr
  • Fraser Cummings, Dr (Principal Investigator)
• Hampshire Hospital NHS Foundation Trust, Winchester, United Kingdom (Recruiting)
  • John Gordon, Dr
  • John Gordon, Dr (Principal Investigator)