MRE Predictors of Disease Relapse After Stopping Biologics

NCT06124287 | Recruiting

• 1 other identifier: 162205
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Crohn's

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 year

Other Outcomes (3)

• 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

Study Arms (1)

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)

Interventions

MR Enterography (MRE) DIAGNOSTIC_TEST

MRI scan

Crohn's Disease patients stopping biologic therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Luminal small bowel or colonic Crohn's disease in clinical remission
• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• University College, London: lead
• British Society of Gastrointestinal and Abdominal Radiology (BSGAR): collaborator

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Maira Hameed

  University College London Centre for Medical Imaging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maira Hameed

CONTACT

020 7679 9274; maira.hameed@ucl.ac.uk

Elizabeth Isaac

CONTACT

02034474415; e.isaac@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: February 27, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

GB (1)