Clinical trial NCT06124287: MRE Predictors of Disease Relapse After Stopping Biologics
Official title: MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn's Disease
Keywords: Crohn's
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: British Society of Gastrointestinal and Abdominal Radiology (BSGAR)
First posted: 2023-11-09
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Crohn's disease patients will be identified after the clinical decision to stop biologics including during outpatient clinics, multidisciplinary meetings, any local patient databases, and imaging investigation requests.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy
timeFrame: 1 year prediction
Secondary outcomes:
measure: Establish which individual MRE finding/combination of findings best predicts disease relapse after stopping biologic therapy, including complete transmural healing.
timeFrame: 1 year
Other outcomes:
measure: To investigate the association of biologic treatment duration on relapse at one year.
timeFrame: 1 year
measure: To investigate the association of concurrent medication use after stopping biologics on relapse at one year.
timeFrame: 1 year
measure: To establish the most common criteria for diagnosing disease relapse used by multidisciplinary consensus panels.
timeFrame: 1 year
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: University College London Centre for Medical Imaging
name: Maira Hameed
role: PRINCIPAL_INVESTIGATOR
References: