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Study on the Effectiveness of Infliximab, Ustekinumab, and Vedolizumab for Patients with Resistant Crohn's Disease

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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 evaluating the effectiveness and safety of a dual biological therapy for patients with Crohn's disease, a chronic inflammatory condition of the digestive tract. The study involves the use of medications such as Infliximab, Ustekinumab, and Vedolizumab. These medications are known as monoclonal antibodies, which are proteins designed to target specific parts of the immune system that contribute to inflammation. The purpose of the study is to compare the effects of using these medications alone versus in combination to achieve remission, which means reducing or eliminating symptoms without the use of steroids.

Participants in the study will receive either a single medication or a combination of these medications. Infliximab is administered as a powder that is mixed into a solution for infusion, meaning it is given directly into a vein. Ustekinumab can be given as a solution for injection under the skin or as an infusion. Vedolizumab is provided as a solution for infusion. The study will monitor the participants over a period of time to see how well the treatments work in reducing the symptoms of Crohn's disease and maintaining remission without the need for steroids.

The trial will assess the percentage of patients who achieve and maintain remission, as well as the occurrence of any side effects. The study aims to provide valuable information on whether combining these treatments offers better outcomes for patients who have not responded to previous therapies. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments.

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

    Initial treatment phase

    The trial begins with the administration of ustekinumab or infliximab as a single therapy. These medications are given through an intravenous infusion. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

  2. Step 2

    Combination therapy phase

    If the initial treatment does not achieve the desired results, a combination therapy may be introduced. This involves the use of vedolizumab in addition to either ustekinumab or infliximab. Vedolizumab is also administered through an intravenous infusion.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular assessments will be conducted to monitor the effectiveness of the treatment. This includes evaluating the Crohn's Disease Activity Index (CDAI) score to determine clinical response and remission.

    Assessments occur at specific intervals: Week 8, Week 22, and Week 52. The goal is to achieve a sustained corticosteroid-free remission, defined as a CDAI score of less than 150 points.

  4. Step 4

    Endoscopic evaluation

    Endoscopic evaluations are performed to assess the condition of the intestinal lining. This helps in determining endoscopic remission, which is defined by specific criteria including a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 4 points or less.

  5. Step 5

    Quality of life assessment

    Quality of life is measured using various questionnaires such as SIBDQ, PROMIS-29 v.2.1, WPAI:GH v.2.2, and PSQI. These assessments occur at Week 8, Week 22, and Week 52 to evaluate the impact of the treatment on daily living.

  6. Step 6

    Safety monitoring

    Safety is closely monitored throughout the trial. This includes tracking any adverse events, both severe and non-severe, as well as any occurrences of serious conditions such as cardiovascular events or infections.

Who can join the trial?

10 criteria

  • The patient must have given written permission to participate in the clinical trial.
  • The patient must be between 18 and 75 years old.
  • The patient must have been diagnosed with Crohn's disease at least 3 months before joining the study. This diagnosis could have been confirmed by tests like X-rays, tissue samples, or a camera test inside the body.
  • The patient must have active Crohn's disease that is at least moderately severe, as shown by a specific score called the CDAI score of 220 or higher, even after 12 weeks of treatment with a medication called vedolizumab.
  • The patient can be on certain treatments for Crohn's disease if they have been taking them at a stable dose for a specific time before joining the study. These treatments include:
    • Azathioprine, 6-mercaptopurine, or methotrexate for more than 8 weeks.
    • Budesonide taken by mouth at a dose not more than 9 mg per day for at least 2 weeks.
    • Other corticosteroids taken by mouth at a dose not more than 20 mg per day of prednisone for at least 2 weeks.
    • 5-Aminosalicylates for at least 4 weeks.
    • Female patients who can have children and male patients with partners who can have children must agree to use a reliable method of birth control during the study and for 6 months after stopping the study medication. These methods include:
      • Long-lasting options like hormone implants or devices placed inside the body.
      • Methods that depend on the user, like hormone pills, patches, or injections.

Who cannot join the trial?

5 criteria

  • Patients who have not failed vedolizumab treatment cannot participate. This means if vedolizumab, a medication used to treat Crohn's disease, is still working for you, you cannot join the study.
  • Patients who are not within the specified age range cannot participate. The study is only for certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with specific characteristics or conditions.
  • Patients who are not male or female cannot participate. The study is open to both men and women.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.
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Investigated drugs

  • Infliximab

    is a medication used to reduce inflammation in the body. It is often used to treat autoimmune diseases like Crohn's disease by blocking a protein called tumor necrosis factor (TNF), which is involved in causing inflammation.

  • Ustekinumab

    is a medication that helps to control inflammation by targeting specific proteins in the immune system. It is used to treat conditions like Crohn's disease by interfering with the activity of certain proteins that can cause inflammation.

  • Vedolizumab

    is a medication that works by blocking a protein that allows white blood cells to enter the gut. This helps to reduce inflammation in the digestive tract, making it useful for treating conditions like Crohn's disease.

What is already known about the treatment

  • Infliximab

    Infliximab is administered through intravenous infusion and is currently used in the treatment of Crohn's disease, particularly in cases where other treatments have failed. It is a well-established medication in medical literature, known for its ability to reduce inflammation by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. Infliximab is classified as a biologic therapy and is often used to help achieve and maintain remission in patients with Crohn's disease.

  • Ustekinumab

    Ustekinumab is given by subcutaneous injection and is used to treat Crohn's disease, especially in patients who have not responded to other treatments. It is recognized in medical literature for its role in blocking specific proteins, interleukin-12 and interleukin-23, which are involved in inflammatory processes. Ustekinumab is classified as a monoclonal antibody and is used to help reduce symptoms and induce remission in Crohn's disease patients.

  • Vedolizumab

    Vedolizumab is administered via intravenous infusion and is used for treating Crohn's disease, particularly when other treatments have not been effective. It is known in medical literature for its mechanism of action, which involves blocking the movement of white blood cells into the gut, thereby reducing inflammation. Vedolizumab is classified as an integrin receptor antagonist and is used to help achieve and maintain remission in patients with Crohn's disease.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease is unpredictable, with some people experiencing long periods of remission and others having frequent relapses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506626-37-00Protocol codeABM/FLAMING/2023Estimated enrolment192 patientsSponsorAgencja Badań Medycznych

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