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MRE Predictors of Disease Relapse After Stopping Biologics

Sponsor: University College, London

NCT ID: NCT06124287

View on ClinicalTrials.gov ↗

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.

Crohn's Disease

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What we know so far

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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
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 Is This Study? (1 UK site)

University College London Hospital

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Elizabebeth Isaacuclh.meteor@nhs.net

How to Get in Touch

Maira Hameed

Sponsor contact

CONTACT

020 7679 9274 maira.hameed@ucl.ac.uk

Elizabeth Isaac

Sponsor contact

CONTACT

02034474415 e.isaac@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2024-05