AuthorisedPhase III and phase IV (Integrated)Interventional

IMPACT OF ANTI-TNF, VEDOLIZUMAB AND TOFACITINIB ON AORTIC STIFFNESS, CAROTID INTIMA-MEDIA THICKNESS AND CARDIOVASCULAR RISK OF PATIENTS WITH ULCERATIVE COLITIS

This research is investigating how different treatments for ulcerative colitis impact heart and blood vessel health. Specifically, it's looking at whether medicines like Amgevita, Xeljanz, Entyvio, Inflectra, and Simponi affect the thickness of the artery walls in the neck (called carotid intima-media thickness) and the stiffness of the aorta, which is the body's largest artery. These measurements help us understand the risk of heart disease. Ulcerative colitis can sometimes be linked to a higher risk of heart problems, so understanding how treatments influence this risk is very important. The study aims to provide clearer information for doctors and patients about the long-term effects of these common ulcerative colitis medications on cardiovascular health.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

100

Start

10 Sep 2024

ulcerative colitis

What is this study about?

This study is designed to understand how some common medications for ulcerative colitis might affect your heart and blood vessels. Ulcerative colitis is a long-term condition that causes inflammation in your large intestine. While the main focus of treatment is to manage gut symptoms, there's growing interest in how these treatments might also influence other parts of your body, including your heart.

The researchers are particularly interested in two key measurements. Firstly, they will look at the thickness of a major artery in your neck (called the carotid artery). A small increase in this thickness can sometimes be an early sign of a higher risk for heart problems. Secondly, they will measure how stiff your body's largest artery, the aorta, is. Stiffer arteries can also be a sign of increased cardiovascular risk. By looking at patients already taking these specific medications, the study hopes to see if there are any changes in these measurements over time related to the treatment.

Understanding these effects is really important because people with long-term inflammatory conditions like ulcerative colitis can sometimes have a higher risk of heart and circulation problems. This study aims to help doctors and patients make more informed decisions about treatment, by providing clear information on how these medicines might impact heart health in the long run. The goal is to ensure that while managing ulcerative colitis, patients also receive the best possible care for their overall health.

Key takeaways

Researches how current ulcerative colitis medicines affect heart health.
Focuses on measuring neck artery thickness and main artery stiffness.
Aims to understand long-term cardiovascular risks in patients.
Compares several established ulcerative colitis treatments.
No new medicines are given; existing treatments are observed.
Helps improve patient care by linking gut treatment to heart health.

Who may be eligible?

To be able to take part in this study, you must be 18 years old or older. There is no upper age limit, meaning both younger and older adults are welcome to participate.

The study is open to both men and women. Your gender does not affect whether you can join.

Further details about your specific medical history, including your ulcerative colitis diagnosis, how severe it is, and what other medical conditions you might have, will be checked by the study team to make sure it's safe and appropriate for you to participate.

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 old or older?
Do you have a diagnosis of ulcerative colitis?
Are you currently taking or planning to take Amgevita, Xeljanz, Entyvio, Inflectra, or Simponi?
Are you comfortable with regular clinic visits and health checks?
Do you live in the UK and fit other general health criteria for the study?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would likely have regular appointments at a clinic. These appointments will involve tests to measure the thickness of the artery in your neck and the stiffness of your main heart artery. You would continue to take your prescribed ulcerative colitis medication (Amgevita, Xeljanz, Entyvio, Inflectra, or Simponi) as advised by your doctor, as the study is observing the effects of these existing treatments rather than providing new ones. Other assessments, such as blood pressure checks and blood tests to look at cholesterol levels, might also be part of the visits. The study will likely involve a series of visits over a period, but the total number and duration will be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this provides important information that can help improve care for future patients with ulcerative colitis. You will receive close monitoring of your health, specifically related to heart and blood vessel health, which you might not otherwise get. As the study observes treatments you might already be taking, there are no additional risks from new medications. However, there are routine risks associated with clinic visits, blood tests, and medical procedures, which will be fully explained to you. You are free to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where your large intestine (colon) becomes inflamed and develops small sores (ulcers).

What does 'aortic stiffness' mean?

Aortic stiffness refers to how flexible your body's main artery, the aorta, is. Less flexibility can sometimes be linked to heart health.

What is 'carotid intima-media thickness'?

This is a measurement of the thickness of the inner layers of the carotid artery in your neck. It helps doctors assess your risk factors for heart disease.

Will I receive a new medicine as part of this study?

No, this study is looking at the effects of medicines you might already be taking for your ulcerative colitis, such as Amgevita, Xeljanz, Entyvio, Inflectra, or Simponi. It's observing them, not testing new ones.

Why is heart health important in ulcerative colitis?

People with long-term inflammatory conditions like ulcerative colitis can sometimes have a slightly higher risk of heart disease, so understanding how treatments affect this is crucial for overall health.