MRE Predictors of Disease Relapse After Stopping Biologics
Observational · No treatment assigned · 1 site · University College, London
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 16 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
Plus 2 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 150 participants are expected to take part.
- Start date: 2024-02-27.
- Main results expected around 2026-08 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy (1 year prediction)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease |
| Lead sponsor | University College, London |
| Collaborators | British Society of Gastrointestinal and Abdominal Radiology (BSGAR) |
| Enrollment | 150 (estimated) |
| Start date | 2024-02-27 |
| Primary completion (est.) | 2026-08 |
| First posted | 2023-11-09 |
| Last updated | 2024-05-13 |
| Official title | MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR). |
| ClinicalTrials.gov ID | NCT06124287 |
Interventions
- MR Enterography (MRE) (Diagnostic Test)
MRI scan
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospital | London | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.