MRE Predictors of Disease Relapse After Stopping Biologics

Recruiting now

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID: NCT06124287
Run by: University College, London
People needed: 150
Starts: 2024-02-27
Expected to finish: 2027-02-01
Last updated by the study team: 2024-05-13

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

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

Where it is running

University College London Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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