We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Elizabeth
Isaac
e.isaac@nhs.net
Stuart
Taylor
stuart.taylor@ucl.ac.uk
James
Pratt
james.pratt9@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
Noninfective enteritis and colitis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Crohn’s disease patients are often prescribed powerful medication to reduce bowel inflammation- “biologics”. The drugs are effective but are usually injected and have side effects such as increased infection risk. They are also expensive. For this reason, patients and their doctors often consider stopping biologics when the patient is well and their disease controlled. Unfortunately, in a proportion the disease comes back quickly (relapses), often within 1 year. We currently have limited ability to predict which patients stopping biologics will relapse quickly and need to restart the drugs. Currently doctors and patients consider blood and stool tests looking for inflammation, colonoscopy looking at the bowel lining, and symptoms before making a joint decision. However, there is considerable uncertainty around this decision which needs addressing.
This study aims to establish if MR enterography (MRE) improves our ability to predict which patients will relapse quickly after stopping biologics. MRE is a safe MRI scan of the bowel, widely used in Crohn’s disease patients.
Using a network of NHS British Society of Gastrointestinal and Abdominal Radiology (BSGAR) affiliated hospitals, we will identify 200 patients who have stopped biologics and recently underwent MRE as part of usual care. We will perform detailed analysis on these MRI scans using scores measuring residual bowel inflammation, and collect clinical data such as blood, stool and colonoscopy results. We will see what happened to patients after 1 year, specifically if they relapsed or remained well off the biologics. Based on a review of scientific journals we will identify the most promising predictors of early relapse and build a statistical model that provides a risk of a patient relapsing within 1 year. We will then add the MRE variables to this model to see if it improves our ability to predict relapse, leading to more personalised, informed management decisions.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
• < 18 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
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Stuart
Taylor
stuart.taylor@ucl.ac.uk
James
Pratt
james.pratt9@nhs.net
Miss
Elizabeth
Isaac
e.isaac@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University College London and funded by British Society of Gastrointestinal and Abdominal Radiology (BSGAR) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 60480
You can print or share the study information with your GP/healthcare provider or contact the research team directly.