RecruitingOBSERVATIONAL

MRE Predictors of Disease Relapse After Stopping Biologics

This research is investigating if a special type of MRI scan, called MR Enterography (MRE), can improve our ability to predict which people with Crohn's disease might have their symptoms return soon after they stop taking biologic medications. Biologic medications are powerful drugs used to treat Crohn's. MRE is a safe scan of the bowel that doctors already use for Crohn's patients. The study will look back at information from up to 200 patients across several UK hospitals who have already stopped their biologic treatment and had an MRE scan. By combining detailed analysis of these scans with other standard health information like blood and stool tests, researchers hope to develop a better way to predict who is most likely to stay well after stopping these medicines.

At a glance

Status

Recruiting

Sponsor

University College, London

Enrolment target

150

Start

27 Feb 2024

Estimated completion

01 Feb 2027

Crohn's Disease

What is this study about?

Imagine you have Crohn's disease and your doctor says you're doing really well on your current medication, called biologics. You might wonder if it's possible to stop taking them. This study is all about helping doctors understand who can safely stop these powerful medicines without their Crohn's symptoms quickly returning.

The research focuses on a special type of scan called MR Enterography, or MRE. It's a safe MRI scan that specifically looks at your bowel. Doctors already use MRE scans for people with Crohn's disease. The study wants to find out if looking closely at these MRE scans, along with other information like blood and stool test results, can give doctors a better idea of whether your Crohn's might come back if you stop your biologic treatment.

Researchers will be looking back at the health records of people with Crohn's disease who have already stopped their biologic medication because they were feeling well. They will gather information from MRE scans and other tests these patients had. By comparing this information to how patients were doing a year later, the study hopes to create a tool that helps doctors and patients make informed decisions about stopping biologic treatments, potentially allowing more people to take a break from these medications if it's safe for them.

Key takeaways

This study explores if a special MRI scan (MRE) can predict Crohn's relapse after stopping biologics.
It could help doctors decide who can safely stop their Crohn's medication.
The study looks at existing medical records, not new tests or treatments.
It aims to improve decision-making for patients and doctors.
Your data, if used, would be anonymised to protect your privacy.

Who may be eligible?

To be part of this study, you would generally need to be at least 16 years old and have Crohn's disease that affects your small bowel or colon. You would have been feeling well, meaning your Crohn's was in 'remission', when you decided to stop taking your biologic medication.

Crucially, you would have had an MRE scan (a special MRI scan of your bowel) either up to three months before or one month after you decided to stop your biologic treatment. The biologic medications they are interested in include those like Adalimumab, Infliximab, Ustekinumab, or Vedolizumab, which you would have stopped specifically because you were feeling well.

You wouldn't be able to be part of the study if you are under 16, if you stopped your biologic medication for other reasons (like it wasn't working or caused side effects), or if you had surgery on your bowel after your MRE scan but before stopping the medicine.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Do you have Crohn's disease affecting your small bowel or colon?
Did you stop a biologic medication (like Adalimumab, Infliximab, Ustekinumab, Vedolizumab) because your Crohn's was well controlled?
Did you have an MRE scan of your bowel around the time you stopped your biologic medication (up to 3 months before, or 1 month after)?
Was your biologic medication stopped only because you were feeling well, not due to side effects or it no longer working?

Answer every question to see your result.

What does participation involve?

This study is different because you wouldn't actually be 'taking part' in the usual sense by having new tests or visits. Instead, this study will be looking back at information already collected from your medical records if you meet certain criteria. If you previously had Crohn's disease, stopped a biologic medication because you were feeling well, and had an MRE scan around that time, the researchers might look at your existing, anonymised records from your NHS hospital. You wouldn't need to do anything extra, as all the information would be gathered from past hospital visits and scans. The researchers would then look to see how you were doing about a year after stopping the medication.

Potential risks and benefits

Since this study looks at existing, anonymised medical records, there are no direct physical risks to you from participating. You wouldn't undergo any new procedures or tests. The potential benefit is that the study could improve how doctors decide who can safely stop biologic medications for Crohn's disease, potentially leading to fewer medications for some patients in the future. You have the right to withdraw your consent for your anonymised data to be used at any point.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Crohn's disease?

Crohn's disease is a condition where parts of your digestive system become inflamed. This can cause symptoms like tummy pain, diarrhoea, and weight loss.

What are 'biologics'?

Biologics are a type of medicine that target specific parts of your immune system to help reduce the inflammation caused by Crohn's disease.

What is an MRE scan?

MRE stands for MR Enterography. It's a special type of MRI scan that takes detailed pictures of your bowel to check for inflammation or other changes.

Why is this study important?

This study is important because it could help doctors predict who can safely stop biologic medicines for their Crohn's disease without it coming back quickly, potentially allowing some people to take a break from their medication.

Will I have to do anything if I'm included in the study?

No, if your past records are used, you wouldn't need to do anything at all. The study only looks at information that has already been collected from your previous hospital visits and scans.

How to find out more

Maira Hameed

maira.hameed@ucl.ac.uk 020 7679 9274 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.