Crohn's DiseaseMETEORNCT06124287
MRE Predictors of Disease Relapse After Stopping Biologics
An observational study of Crohn's Disease, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- MR Enterography (MRE)
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Feb 2024to Feb 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Crohn's disease patients will be identified after the clinical decision to stop biologics including during outpatient clinics, multidisciplinary meetings, any local patient databases, and imaging investigation requests.
Who may be able to join
- 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.
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2PG
Maira Hameed, uclh.meteor@nhs.net
Elizabebeth Isaac, uclh.meteor@nhs.net
About this study
Official title: MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR).
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.
Read the detailed description
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.
- Conditions
- Crohn's Disease
- Being tested
- MR Enterography (MRE)
- Keywords
- Crohn's
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Enterography (MRE)Diagnostic test
MRI scan
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease patients stopping biologic therapy | Crohn's Disease patients stopping biologic therapy and undergoing MR Enterography 3 months before or 1 month after this decision as part of standard clinical care. Receives: Diagnostic Test: MR Enterography (MRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy
To develop and internally evaluate a multivariable prediction model for early (within one year) disease relapse in patients stopping biological therapy, combining pre-existing clinical parameters with MRE parameters and compare to a baseline model incorporating clinical variables alone
Measured: 1 year prediction
Secondary outcomes (1)
Establish which individual MRE finding/combination of findings best predicts disease relapse after stopping biologic therapy, including complete transmural healing.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start27 Feb 2024
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Society of Gastrointestinal and Abdominal Radiology (BSGAR)
- Responsible party
- Sponsor
- Investigators
- Maira Hameed, Principal investigator, University College London Centre for Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124287
- Sponsor's protocol ID
- 162205
- Acronym
- METEOR
- Status last verified
- May 2024
- First submitted
- 3 Nov 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Enterography Predictors of Disease Relapse After Stopping Biologic Therapy in Crohn's Disease (METEOR).
- ClinicalTrials.gov ID
- NCT06124287
- Acronym / sponsor ID
- METEOR / 162205
- Conditions
- Crohn's Disease
- Keywords
- Crohn's
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Society of Gastrointestinal and Abdominal Radiology (BSGAR)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease patients stopping biologic therapy | – | Diagnostic Test: MR Enterography (MRE)Crohn's Disease patients stopping biologic therapy and undergoing MR Enterography 3 months before or 1 month after this decision as part of standard clinical care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Crohn's disease patients will be identified after the clinical decision to stop biologics including during outpatient clinics, multidisciplinary meetings, any local patient databases, and imaging investigation requests.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR Enterography (MRE)MRI scan | Diagnostic test | Crohn's Disease patients stopping biologic therapy |
Primary outcome
To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy
Time frame: 1 year prediction
To develop and internally evaluate a multivariable prediction model for early (within one year) disease relapse in patients stopping biological therapy, combining pre-existing clinical parameters with MRE parameters and compare to a baseline model incorporating clinical variables alone
1 secondary outcome
Establish which individual MRE finding/combination of findings best predicts disease relapse after stopping biologic therapy, including complete transmural healing.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maira Hameed principal investigator
University College London Centre for Medical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maira Hameed (020 7679 9274, maira.hameed@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop and internally evaluate a multivariable prediction model for early disease relapse in patients stopping biological therapy (time frame: 1 year prediction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.