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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.
Dr
Gordon
Moran
gordon.moran@nottingham.ac.uk
Salvatore
Di Forti
Salvatore.Diforti@alimentiv.com
Jennifer
Francis
jennifer.francis@robartsinc.com
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.
Aminosalicylate (5-ASA) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (UC) and thus are commonly used as first-line agents for patients with Crohn's disease (CD) in remission. However, there is uncertainty regarding their effectiveness for CD.
In this open-label (where both the researchers and participants know which treatment is being administered), randomized study, participants with CD in remission will be allocated to either continue their 5-ASA therapy or withdraw their 5-ASA. The purpose is to investigate if withdrawal of 5-ASA therapy is not unacceptably less effective than continuing on 5-ASA in maintaining CD remission over a 24-month period.
There will be a 2 year follow up period to see if participants develop any flares or complications of their CD, to monitor their quality of life and assess the impact on the cost associated with their assigned treatment. The results of the study may help to improve evidence based treatment guidelines and the approach to patient care.
Participants will be randomly assigned by a computer to one of two groups:
1. Group 1: Continuation of 5-ASA treatment
2. Group 2: Discontinuation of 5-ASA treatment
At the end of the study, half of the participants will be in Group 1 and half of the participants in Group 2. After participants have been assigned to one of these two study groups, they will continue in that group for the duration of their time in the study.
Approximately 1580 participants will be taking part in this study.
Participants will be asked to attend hospital visits for a total of 5 times over a two-year period, where they will undergo the following procedures at most or all study visits: Blood taking, Physical Exam(only at first visit), vital signs, medication review, side effects review, urine sample, questionnaires and stool samples.
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:
Type: Management of Care;
You can take part if:
You may not be able to take part if:
1. A current diagnosis of UC, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis 2. A diagnosis of short-bowel syndrome 3. Active perianal disease (note: a history of perianal disease is permitted) 4. Active fistulizing disease (note: a history of fistulizing disease is permitted) 5. A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery 6. Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment 7. Any major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment 8. Unwillingness to stop taking aminosalicylates for the duration of the trial 9. Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment 10. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participants’s ability to participate fully in the study. 11. History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Jennifer
Francis
jennifer.francis@robartsinc.com
Salvatore
Di Forti
Salvatore.Diforti@alimentiv.com
Dr
Gordon
Moran
gordon.moran@nottingham.ac.uk
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 NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST and funded by Academic Medical Organization of Southwestern Ontario .
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 38687
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