NCT06124287

MRE Predictors of Disease Relapse After Stopping Biologics

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MR Enterography (MRE)	MRI scan

Timeline

• Start date: 2024-02-27
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2023-11-09
• Last updated: 2024-05-13

Locations

1 site across 1 country: United Kingdom