Status:
RECRUITING
MRE Predictors of Disease Relapse After Stopping Biologics
Lead Sponsor:
University College, London
Collaborating Sponsors:
British Society of Gastrointestinal and Abdominal Radiology (BSGAR)
Conditions:
Crohn's Disease
Eligibility:
All Genders
16+ years
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...
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 clinica...
Eligibility Criteria
Inclusion
- 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
- \<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
Key Trial Info
Start Date :
February 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06124287
Start Date
February 27 2024
End Date
February 1 2027
Last Update
May 13 2024
Active Locations (1)
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1
University College London Hospital
London, United Kingdom, NW1 2PG