Ongoing, recruitingTherapeutic use (Phase IV)Interventional

VERDICT: In actiVE ulcerative colitis, a RanDomIzed Controlled Trial for determination of the optimal treatment target

The VERDICT study is exploring the most effective ways to treat ulcerative colitis, a long-term condition affecting the bowel. It uses a medication called Entyvio, which is already approved and used by many patients. The study is comparing three different treatment approaches, each with a different goal. One goal is simply to ease symptoms, another is to also heal the lining of the bowel, and the third aims for healing without needing steroid medication. Researchers want to find out which of these approaches best helps people with ulcerative colitis avoid future complications, such as surgery or severe flare-ups. This study will help doctors understand how to get the most benefit from treatments for ulcerative colitis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Alimentiv Inc.

Enrolment target

391

Start

12 Sep 2024

Ulcerative colitis

What is this study about?

The VERDICT study is focused on improving the care of people with ulcerative colitis. This condition causes inflammation and sores in the large bowel, leading to symptoms like tummy pain, bloody diarrhoea, and tiredness. While there are treatments available, including Entyvio which this study uses, doctors are still learning the best way to use them to keep people well for the longest time.

This study is trying to understand if aiming for different levels of wellness makes a difference. For example, some people might feel better even if their bowel still shows some inflammation when looked at with a camera (endoscopy). Others might only feel truly well when the bowel has completely healed. The study is comparing three specific treatment goals to see which one leads to fewer problems related to ulcerative colitis in the long run.

By comparing these different goals, researchers hope to discover how to guide treatment more effectively. This could mean that in the future, doctors can choose the most beneficial treatment target for each patient, helping them to stay healthier and avoid complications like needing surgery or repeated hospital stays due to their ulcerative colitis.

Key takeaways

The VERDICT study is looking for the best way to treat ulcerative colitis using Entyvio.
It compares three different treatment goals, ranging from easing symptoms to healing the gut lining.
The main aim is to see which approach helps patients avoid complications for the longest time.
Entyvio is a medication already used for ulcerative colitis.
Participation involves regular check-ups, potentially including blood tests and camera examinations (endoscopies).

Who may be eligible?

To be part of this study, you need to have ulcerative colitis that is currently active, meaning you are experiencing symptoms. You also need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

It's important to remember that this is a general idea of who might be able to join. There will be other specific health checks and requirements that your doctor will discuss with you. These checks are to make sure the study is safe for you and that the results will be clear and helpful for others.

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.

Do you have active ulcerative colitis?
Are you 18 years old or older?
Are you able to commit to regular hospital visits and tests?
Are you comfortable with the possibility of receiving either an injection or an infusion?

Answer every question to see your result.

What does participation involve?

If you join the VERDICT study, you would be assigned to one of three treatment goals, and you would receive Entyvio, either as an injection you give yourself or as an infusion given by a healthcare professional. You would have regular appointments for check-ups and to see how your treatment is progressing. These appointments would involve physical examinations, blood tests, and potentially stool (poo) sample tests. You might also have endoscopies, which are camera tests of your bowel, at certain points during the study. The study looks at how your condition changes over a long period, potentially up to 96 weeks (about 1 year and 10 months).

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit of joining this study is that you would receive active treatment and be closely monitored by a healthcare team specializing in ulcerative colitis. This close monitoring could help manage your condition effectively. However, like all medications, Entyvio can have side effects, and some tests involve discomfort or minor risks. You would be fully informed about these before deciding to join. Remember, taking part in any study is completely voluntary, and you are free to withdraw at any time without affecting your usual medical care.

Locations (5)

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

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Unverified
Italy
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Unverified
Belgium
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Unverified
France
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Unverified
Netherlands
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Unverified
Poland

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops small ulcers. This can cause symptoms like tummy pain, diarrhoea, and bleeding.

What is Entyvio?

Entyvio (also known by its medicine name, vedolizumab) is a type of medical treatment for inflammatory bowel diseases like ulcerative colitis. It works by targeting specific cells that cause inflammation in your gut.

What does 'optimal treatment target' mean?

It refers to the best goal for treating your ulcerative colitis. This could mean just easing your symptoms, or it could mean making sure the inflammation in your bowel has healed when doctors look with a camera.

Will I know which treatment goal I'm aiming for?

Yes, if you join, you will be told which of the three treatment goals you have been assigned to, and how your treatment will try to achieve this.

How long will the study last?

The study will observe participants for up to 96 weeks, which is about a year and ten months, to understand the long-term effects of the different treatment approaches.