Active not recruitingPHASE4INTERVENTIONAL

Stopping Aminosalicylate Therapy in Inactive Crohn's Disease

If you have Crohn's disease and your symptoms are currently settled (in remission), you might be taking a medication called 5-ASA. This study wants to find out if it's safe and effective for people with Crohn's to stop taking 5-ASA, rather than continuing with it. While 5-ASA is very helpful for a similar condition called ulcerative colitis, its benefits for Crohn's disease are less clear, especially when symptoms are already under control. Participants will either keep taking their 5-ASA or stop it entirely. The researchers will then carefully watch for two years to see if those who stop the medication stay well, compared to those who continue taking it. The aim is to see if stopping 5-ASA is not much worse than continuing it for keeping Crohn's in remission.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Alimentiv Inc.

Enrolment target

334

Start

20 Nov 2017

Estimated completion

01 Jun 2026

Crohn Disease Remission

What is this study about?

This research study is about a medication commonly used for Crohn's disease called 5-ASA. If you have Crohn's, you might be taking 5-ASA, especially if your symptoms are currently settled and you're feeling well (this is called being in remission). While 5-ASA is known to be very effective for a similar condition called ulcerative colitis, doctors are not entirely sure how much it helps people with Crohn's disease when their symptoms are already under control. This study hopes to answer that question.

The main aim is to see if people with Crohn's disease who are in remission can safely stop taking their 5-ASA medication without their symptoms returning. In this study, some people will continue taking 5-ASA as usual, while others will stop. The researchers will then compare these two groups over a period of two years to see if there's a big difference in how well they stay. This is important because it could help doctors understand the best way to manage Crohn's disease in the long term, potentially reducing the number of medications some people need to take.

By comparing these two approaches, the study will help doctors and patients make more informed decisions about 5-ASA treatment for Crohn's disease. The ultimate goal is to improve care and quality of life for people living with this condition.

Key takeaways

This study evaluates stopping 5-ASA medication for Crohn's disease in remission.
It aims to see if stopping 5-ASA is as effective as continuing it over two years.
Participants will be randomly assigned to either stop or continue their medication.
The study helps understand the best long-term treatment for Crohn's disease.
You'll receive close monitoring and care during the two-year study period.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with a confirmed diagnosis of Crohn's disease for at least three months. You must currently be taking an oral 5-ASA medication for at least six months and be regularly taking it (at least 75% of your prescribed doses). Importantly, your Crohn's disease symptoms must be settled and under control (in remission) when you join the study. You also need to be able to fully take part in all study activities and give your written permission to join.

There are some reasons why you wouldn't be able to join. For example, if you have other bowel conditions like ulcerative colitis or diverticular disease, or if you have serious active problems with Crohn's like fistulas or active infections around your bottom. If you've had a recent flare-up of your Crohn's that needed new or increased medication, or if you've recently taken strong steroid medicines for your Crohn's, you wouldn't be eligible. Also, if you've had major bowel surgery for Crohn's in the last six months, or if you're unwilling to stop taking 5-ASA for the study, you wouldn't be able to take part. The study also cannot include you if you have other serious health problems or are currently in another research study that might get in the way.

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 18 years or older?
Do you have a diagnosis of Crohn's disease, confirmed at least 3 months ago?
Have you been taking oral 5-ASA medication for at least 6 months, and take it regularly?
Are your Crohn's disease symptoms currently settled and in remission?
Have you avoided major bowel surgery for Crohn's in the last 6 months?
Are you able to agree to either continue or stop your 5-ASA medicine as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first be assessed to make sure you meet all the requirements. Once you're in, you'll be randomly assigned to one of two groups: either you'll continue taking your current 5-ASA medication, or you'll stop taking it. This decision is made by chance, like flipping a coin. You won't know which group you're in until after this assignment.

You will need to attend regular check-ups and assessments over a period of two years (24 months). These visits will involve discussions about your health, any symptoms you might be experiencing, and possibly some tests to monitor your Crohn's disease. The researchers will be closely watching to see how your Crohn's disease behaves, whether you continue or stop your 5-ASA. The total commitment for this study will last for two years.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as a more thorough monitoring of your Crohn's disease by specialists. If stopping 5-ASA is found to be safe, it could lead to you taking fewer medications in the future. However, there are also potential risks; for example, if you stop taking 5-ASA, there's a chance your Crohn's symptoms could return sooner than if you continued. You will be closely monitored, and medical help will be available if your symptoms flare up. It is important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (46)

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

University of Calgary
Verified postcode
Calgary, Canada
University of Alberta
Verified postcode
Edmonton, Canada
Dr. Jesse Siffledeen Professional Medical Corporation
Verified postcode
Edmonton, Canada
(G.I.R.I.) GI Research Institute
Verified postcode
Vancouver, Canada
Discovery Clinical Services Ltd.
Verified postcode
Victoria, Canada
University of Manitoba - Health Sciences Centre
Verified postcode
Winnipeg, Canada
London Health Sciences Centre - University Hospital
Verified postcode
London, Canada
Scott Shulman Medical Professional Corporation
Verified postcode
North Bay, Canada
Taunton Surgical Center
Verified postcode
Oshawa, Canada
Mount Sinai Hospital
Verified postcode
Toronto, Canada
Dr. O. Tarabain Medicine Professional Corporation
Verified postcode
Windsor, Canada
McGill University Healthcare
Verified postcode
Montreal, Canada

Common questions

What is 5-ASA?

5-ASA is a type of medicine often used to manage inflammatory bowel conditions like Crohn's disease and ulcerative colitis.

What does 'remission' mean for Crohn's disease?

Remission means that your Crohn's disease symptoms are currently settled, and you're feeling well, without active inflammation.

Will I get to choose whether I stop or continue my medicine?

No, in this study, you will be randomly assigned to either stop or continue your 5-ASA, like how a flip of a coin works.

How long will the study last?

The study will involve regular check-ups and monitoring for a period of two years (24 months).

What if my Crohn's symptoms get worse during the study?

Your health will be closely monitored, and if your symptoms worsen, the study doctors will provide appropriate care and you can withdraw from the study.