About this trial
Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).
Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.
Indication for MRE based on routine clinical practice validated by the treating physician
Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).
Disqualifiers
Pregnancy during the study
People unable to give consent (because of their physical or mental state)
Absence of written consent
Ulcerative colitis or unclassified IBD
Trial population
Patients diagnosed with CD for more than 6 months with histological confirmation available in his medical record, with an indication for MRE based on routine clinical practice validated by the treating physician
Trial design
Cohort
Prospective
Treatments tested in this trial
Magnetic Resonance Enterography (MRE)
Procedure/SurgeryMRE performed as part of the standard of care follow up of the patient, the exam will be recorded for the study and analysed by central readers.
Treatment groups
Trial outcomes
Primary outcomes
Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD
An index (depth of remission) or score (grade of remission) will be constructed through multiple linear or logistic mixed regression models.
Secondary outcomes
Intra- and inter-observer variability of lesions observed per segment during MRE in CD
Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.
Intra- and inter-observer variability of depth and grade of global transmural healing in CD
Variations in MRE readings images between the CR will be quantified through the Kappa coefficient for qualitative items and through the intraclass correlation coefficient for quantitative items.
Sponsors and contacts
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