MRE Predictors of Disease Relapse After Stopping Biologics
Recruiting · NCT06124287 · Observational (researchers observe without assigning treatment) · Lead sponsor: University College, London
View the official record on ClinicalTrials.gov →Interventions studied
MR Enterography (MRE)
What this trial is about
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.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
1 location listed.
- University College London Hospital - London, United Kingdom