At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- MR Enterography (MRE) (diagnostic test)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- MR Enterography (MRE) — diagnostic test: MRI scan
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 150
- Started
- 2024-02-27
- Last checked
- 2024-05
Plain English Summary
What is this study?
- • Testing a new treatment for crohn's disease
- • Clinical study - 150 participants
- • 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
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with crohn's disease
Where?
- • London - University College London Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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 clinically well. MRE is a safe MRI scan of the bowel, widely used in Crohn's disease patients. Using a network of British Society of Gastrointestinal and Abdominal Radiology (BSGAR) affiliated NHS hospitals, up to 200 patients who have stopped biologic treatment and recently underwent MRE as part of usual care will be identified. Detailed analysis will be performed on these MRI scans using scores measuring residual bowel inflammation, and retrospectively collect standard clinical data such as blood, stool and colonoscopy results. Using hospital records (accessed by each local care team before being pseudoanonymised) the study will see what happened to patients after one year, specifically if they relapsed or remained well off the biologics. Based on a literature review, the most promising predictors of early relapse will be identified, such as blood/stool tests, to build a statistical model that provides the risk of a patient relapsing within one year. MRE scores will be added to this model to see if it improves the ability to predict relapse. The results of the study could form part of a clinical decision support tool to help risk stratify patients and improved joint management decision making.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Luminal small bowel or colonic Crohn's disease in clinical remission
- ✓16 years or older
- ✓Biologic therapy stopped due to clinical remission only
Who cannot take part
- ✗\<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
See the full criteria
Where Is This Study? (1 UK site)
University College London Hospital
London NW1 2PG, United Kingdom
How to Get in Touch
Maira Hameed
Sponsor contactCONTACT
Elizabeth Isaac
Sponsor contactCONTACT
