MRE Predictors of Disease Relapse After Stopping Biologics

Study Overview
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Brief Summary
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This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse quickly (disease comes back) after stopping biologic medication. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients.

Detailed Description
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This study aims to investigate if MR Enterography (MRE) improves the ability to predict which Crohn's disease patients will relapse (disease comes back) after stopping biologic medication when clinically well. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients. Using a network of British Society of Gastrointestinal and Abdominal Radiology (BSGAR) affiliated NHS hospitals, up to 200 patients who have stopped biologic treatment and recently underwent MRE as part of usual care will be identified. Detailed analysis will be performed on these MRI scans using scores measuring residual bowel inflammation, and retrospectively collect standard clinical data such as blood, stool and colonoscopy results. Using hospital records (accessed by each local care team before being pseudoanonymised) the study will see what happened to patients after one year, specifically if they relapsed or remained well off the biologics. Based on a literature review, the most promising predictors of early relapse will be identified, such as blood/stool tests, to build a statistical model that provides the risk of a patient relapsing within one year. MRE scores will be added to this model to see if it improves the ability to predict relapse. The results of the study could form part of a clinical decision support tool to help risk stratify patients and improved joint management decision making.

Official Title
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MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR).

Conditions
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Crohn's Disease

Intervention / Treatment
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* Diagnostic Test: MR Enterography (MRE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Luminal small bowel or colonic Crohn's disease in clinical remission 16 years or older MRE as part of routine care performed within three months prior, or one month after the decision to stop biologic therapy Anti-TNF (Adalimumab, infliximab, Certolizumab) IL-23 or IL-12 antagonists (Ustekinumab) Anti-integrin biologics (Natalizumab, Vedolizumab) Biologic therapy stopped due to clinical remission only Definition of clinical remission: There is no agreed consensus on how clinical remission is defined and practice differs between hospitals and patients. To mirror current clinical practice, no strict definition of clinical remission will therefore be used. Detailed clinical parameters the time of stopping biologic agents will be collected. Exclusion Criteria: <16 years of age Non-biological therapy, unless part of combination therapy with biologic agents Biological therapy stopped for other reasons e.g. loss of effect, side effects Resection of diseased segment(s) after MRE but before stopping biologic agent. No MRE with the time window defined by eligibility criteria

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crohn's Disease patients stopping biologic therapy<br>Crohn's Disease patients stopping biologic therapy and undergoing MR Enterography 3 months before or 1 month after this decision as part of standard clinical care. | Diagnostic Test: MR Enterography (MRE)<br>* MRI scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy | To develop and internally evaluate a multivariable prediction model for early (within one year) disease relapse in patients stopping biological therapy, combining pre-existing clinical parameters with MRE parameters and compare to a baseline model incorporating clinical variables alone | 1 year prediction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish which individual MRE finding/combination of findings best predicts disease relapse after stopping biologic therapy, including complete transmural healing. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's