NCT06124287Recruiting
MRE Predictors of Disease Relapse After Stopping Biologics
MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR).
Source: ClinicalTrials.gov · Last updated 13 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 3 Nov 2023
- Start date
- 27 Feb 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- University College, London
- Diseases
- Crohn's disease
- NCT number
- NCT06124287
What you commit to
- Study type: Observational
- Planned participants: 150
- From 27 Feb 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Age
- \<16 years of age
Other
- No MRE with the time window defined by eligibility criteria
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.