MRE Predictors of Disease Relapse After Stopping Biologics (METEOR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Diagnostic test: MR Enterography (MRE)

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Maira Hameed; Phone Number: 020 7679 9274; Email: maira.hameed@ucl.ac.uk
• Study Contact Backup: Name: Elizabeth Isaac; Phone Number: 02034474415; Email: e.isaac@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College London Hospital
    • Contact: Maira Hameed; Email: uclh.meteor@nhs.net
    • Contact: Elizabebeth Isaac; Email: uclh.meteor@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn's Disease patients stopping biologic therapy; 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); MRI scan

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
To investigate the association of biologic treatment duration on relapse at one year.	1 year
To investigate the association of concurrent medication use after stopping biologics on relapse at one year.	1 year
To establish the most common criteria for diagnosing disease relapse used by multidisciplinary consensus panels.	1 year

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: British Society of Gastrointestinal and Abdominal Radiology (BSGAR)
• Investigators: Principal Investigator: Maira Hameed, University College London Centre for Medical Imaging

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Crohn's
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 162205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No