MRE Predictors of Disease Relapse After Stopping Biologics

Crohn's Disease Clinical Trial

— METEOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124287
• Other study ID #: 162205
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: February 2027

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: Maira Hameed
• Phone: 020 7679 9274
• Email: maira.hameed[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2027
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Diagnostic Test:
• MR Enterography (MRE)
MRI scan

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	British Society of Gastrointestinal and Abdominal Radiology (BSGAR)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To investigate the association of biologic treatment duration on relapse at one year.		1 year
Other	To investigate the association of concurrent medication use after stopping biologics on relapse at one year.		1 year
Other	To establish the most common criteria for diagnosing disease relapse used by multidisciplinary consensus panels.		1 year
Primary	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	Establish which individual MRE finding/combination of findings best predicts disease relapse after stopping biologic therapy, including complete transmural healing.		1 year