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Study on the Effects of Adalimumab, Vedolizumab, and Tofacitinib on Heart Health in Patients with Ulcerative Colitis

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of certain medications on patients with ulcerative colitis, a chronic condition that causes inflammation and sores in the digestive tract. The medications being studied include adalimumab (also known as AMGEVITA), tofacitinib (known as XELJANZ), vedolizumab (known as Entyvio), infliximab (known as Inflectra), and golimumab (known as Simponi). These treatments are being evaluated for their impact on heart and blood vessel health, specifically looking at how they affect the stiffness of the aorta, the thickness of the carotid artery walls, and overall cardiovascular risk.

The purpose of the study is to compare the changes in the thickness of the carotid artery walls after three months of treatment with these medications in patients with ulcerative colitis. Participants will receive one of the medications or a placebo and will be monitored over a period of time to assess the effects on their cardiovascular health. The study will also look at other factors such as blood pressure, cholesterol levels, and the activity of ulcerative colitis symptoms.

Throughout the study, participants will undergo various assessments to measure the impact of the treatments on their cardiovascular health and ulcerative colitis symptoms. These assessments will include checking the thickness of the carotid artery walls, measuring the stiffness of the arteries, and evaluating the risk of cardiovascular disease. The study aims to provide valuable insights into how these medications can affect heart and blood vessel health in patients with ulcerative colitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Begin treatment with one of the following medications: infliximab, adalimumab, golimumab, vedolizumab, or tofacitinib.

    The choice of medication depends on individual medical assessment and suitability.

  2. Step 2

    Medication administration

    Infliximab and vedolizumab are administered as a solution for infusion, which means they are given through a vein (intravenous).

    Adalimumab and golimumab are provided as a solution for injection, typically in a pre-filled syringe or pen.

    Tofacitinib is taken orally in the form of film-coated tablets.

  3. Step 3

    Treatment duration

    The treatment is planned to last for a period of 3 months.

    Regular monitoring and assessments will be conducted throughout this period to evaluate the effects of the treatment.

  4. Step 4

    Primary assessment

    The main focus of the assessment is the carotid intima-media thickness (CIMT), which is a measure used to evaluate the thickness of the inner two layers of the carotid artery.

    This assessment helps in understanding the impact of the treatment on cardiovascular health.

  5. Step 5

    Secondary assessments

    Additional evaluations include measuring aortic pulse wave velocity (aPWV) and arterial stiffness, which provide insights into the condition of the arteries.

    Other assessments involve the augmentation index (AIx), cardiovascular risk scores, and the activity score for ulcerative colitis.

    Blood tests will be conducted to check lipid levels, including HDL, LDL, total cholesterol, and triglycerides.

    Blood pressure and endothelial function will also be monitored.

  6. Step 6

    Completion of trial

    The trial is expected to conclude by June 2, 2026.

    Final assessments will be conducted to determine the overall impact of the treatment on ulcerative colitis and cardiovascular health.

Who can join the trial?

5 criteria

  • The patient must have **ulcerative colitis**, which is a condition that affects the colon, for at least 6 months.
  • The patient must be older than 18 years.
  • The patient must be starting treatment with one of the following medications: infliximab, adalimumab, golimumab, vedolizumab, or tofacitinib. These are specific drugs used to treat ulcerative colitis.
  • The patient must be covered by French national health insurance.
  • The patient must provide written informed consent, which means they agree to participate in the study after being informed about it.

Who cannot join the trial?

3 criteria

  • Patients who do not have ulcerative colitis cannot participate. Ulcerative colitis is a condition that causes inflammation and sores in the large intestine.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

  • Anti-TNF

    medications are used to reduce inflammation by blocking a protein called tumor necrosis factor (TNF) in the body. These medications are often used to treat autoimmune conditions like ulcerative colitis, where the immune system attacks the body's own tissues, causing inflammation.

  • Vedolizumab

    is a medication that targets a specific protein in the gut to reduce inflammation. It is used to treat ulcerative colitis by preventing white blood cells from entering the gut and causing inflammation.

  • Tofacitinib

    is a medication that works by inhibiting certain enzymes in the body that contribute to inflammation. It is used to manage ulcerative colitis by reducing the immune system's activity, thereby decreasing inflammation in the colon.

What is already known about the treatment

  • Anti-TNF

    This medication is administered through injection and is used to treat ulcerative colitis by reducing inflammation. It is well-established in medical literature and is commonly used for managing autoimmune conditions. Anti-TNF works by blocking tumor necrosis factor, a substance in the body that causes inflammation. It is classified as a biologic therapy.

  • Vedolizumab

    Vedolizumab is given as an intravenous infusion and is used to treat ulcerative colitis by targeting specific proteins in the gut to reduce inflammation. It is recognized in medical literature as an effective treatment for inflammatory bowel diseases. The medication works by blocking the movement of white blood cells into the inflamed gut tissue. It is classified as a monoclonal antibody.

  • Tofacitinib

    Tofacitinib is taken orally in pill form and is used to manage ulcerative colitis by modulating the immune system. It is a newer addition to medical treatments for this condition and is gaining recognition in medical literature. Tofacitinib works by inhibiting certain enzymes known as Janus kinases, which play a role in the inflammatory process. It is classified as a small molecule drug.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission, where symptoms may worsen and then improve. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in genetically predisposed individuals. Environmental factors and gut microbiota may also play a role in its development and progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517314-15-00Protocol codePI2020_843_0114Estimated enrolment100 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie

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