Using MRI to predict Crohn's disease relapse after stopping biologics
MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR).
University College, London · NCT06124287
This study is testing if MRI scans can help predict when people with Crohn's disease might have a relapse after stopping their medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University College, London (other) |
| Drugs / interventions | Adalimumab, infliximab, Certolizumab, Ustekinumab, Natalizumab, Vedolizumab |
| Locations | 1 site (London) |
| Trial ID | NCT06124287 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of MR Enterography (MRE) in predicting relapse in Crohn's disease patients who have stopped biologic medication while in clinical remission. By analyzing MRI scans and collecting clinical data from up to 200 patients across NHS hospitals, the study aims to identify predictors of early relapse, including blood and stool tests. The goal is to develop a statistical model that incorporates MRE scores to enhance the prediction of relapse risk within one year. The findings could contribute to a clinical decision support tool for better patient management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 16 and older with luminal small bowel or colonic Crohn's disease in clinical remission who have recently undergone MRE as part of routine care.
Not a fit: Patients who have stopped biologic therapy for reasons other than clinical remission or those under 16 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify Crohn's disease patients at high risk of relapse, allowing for more personalized treatment plans.
How similar studies have performed: Other studies have explored the use of imaging techniques in predicting disease outcomes, but this specific approach using MRE for Crohn's disease relapse prediction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- University College London Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Maira Hameed — University College London Centre for Medical Imaging
- Study coordinator: Maira Hameed
- Email: maira.hameed@ucl.ac.uk
- Phone: 020 7679 9274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn's Disease, Crohn's