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Study on the Effectiveness of Infliximab, Tofacitinib, and Vedolizumab in Patients with Ulcerative Colitis Resistant to Initial Treatment

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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 effectiveness and safety of different treatment combinations for patients with ulcerative colitis, a chronic condition that causes inflammation and sores in the digestive tract. The study will explore the use of several medications, including infliximab, tofacitinib, and vedolizumab. Infliximab is a medication that works by blocking a protein called tumor necrosis factor alpha, which is involved in inflammation. Tofacitinib is a medication that inhibits the activity of certain enzymes known as JAK kinases, which play a role in the body's immune response. Vedolizumab is a monoclonal antibody that targets a specific protein involved in the movement of white blood cells to the gut, helping to reduce inflammation.

The purpose of this study is to compare the effectiveness of using infliximab or tofacitinib alone versus combining them with vedolizumab. The goal is to see if these combinations can help patients achieve and maintain remission without the need for steroids, especially after previous treatment with vedolizumab has not been successful. Participants in the study will receive their assigned treatments and will be monitored over a period of time to assess their response to the therapy.

Throughout the study, participants will undergo regular assessments to track their progress and any changes in their condition. The study aims to provide valuable insights into the potential benefits of combining these medications for individuals with ulcerative colitis, ultimately seeking to improve treatment outcomes and quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm the diagnosis of ulcerative colitis. This includes reviewing previous medical records and ensuring the condition is confirmed by endoscopic or radiographic and histological criteria.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups. The objective is to compare the effectiveness of different therapies in achieving remission of ulcerative colitis.

  3. Step 3

    Treatment phase

    Participants receive one of the following treatments:

    1. Infliximab administered through intravenous infusion.

    2. Tofacitinib taken orally.

    3. Combination therapy with Infliximab and Vedolizumab administered through intravenous infusion.

    4. Combination therapy with Tofacitinib taken orally and Vedolizumab administered through intravenous infusion.

    The treatment aims to induce sustained steroid-free remission in patients who have not responded to previous Vedolizumab treatment.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored at regular intervals to assess their response to the treatment. This includes clinical evaluations and possibly endoscopic assessments to measure the Mayo score, which evaluates disease activity.

    The primary goal is to achieve sustained corticosteroid-free remission by week 52, with assessments at weeks 8, 22, and 52.

  5. Step 5

    Completion of trial

    At the end of the trial, participants undergo a final assessment to evaluate the overall effectiveness of the treatment. This includes measuring the percentage of patients who achieved clinical remission and other health outcomes.

Who can join the trial?

10 criteria

  • The patient must have given written permission to join the clinical trial.
  • The patient must be a male or female between the ages of 18 and 75.
  • The patient must have **ulcerative colitis**, which is a condition confirmed by certain medical tests like endoscopy or imaging, and a tissue sample report must be available before starting the trial.
  • The patient must not have achieved **clinical remission** after 8 weeks of treatment with vedolizumab. Clinical remission means having a total **Mayo score** of 2 or less, with all subscores of 1 or less, and a **Mayo rectal bleeding subscore** of 0. The Mayo score is a system used to measure the severity of ulcerative colitis.
  • The patient can be on certain treatments for ulcerative colitis, such as:
    • **Budesonide** taken by mouth, not more than 9 mg per day, if the dose has been stable for at least 2 weeks before starting the trial.
    • Other **corticosteroids** taken by mouth, not more than 20 mg per day of **prednisone**, if the dose has been stable for at least 2 weeks before starting the trial.
    • **5-Aminosalicylates (5-ASA)**, if the dose has been stable for at least 4 weeks before starting the trial.
    • Female patients who can have children and male patients and their 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 drug. These methods include:
      • Methods that do not depend on the user, like an implant or an **intrauterine device (IUD)**, or a procedure like **bilateral tubal occlusion** or **vasectomy**.
      • Methods that depend on the user, like certain hormone pills, injections, or patches.
      • Women who have gone through menopause, meaning they have not had a period for more than 12 months, or those who have had surgical sterilization more than 6 months before joining the trial, are considered not able to have children.

Who cannot join the trial?

10 criteria

  • Patients who have not experienced failure of vedolizumab treatment cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to give informed consent cannot participate.
  • Patients with other medical conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients with a history of severe allergic reactions to any of the study medications cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients with a history of certain types of cancer cannot participate.
  • Patients with significant liver or kidney problems cannot participate.
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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 ulcerative colitis by blocking a protein called tumor necrosis factor (TNF), which plays a role in causing inflammation.

  • Tofacitinib

    is a medication that helps to reduce inflammation by inhibiting certain enzymes known as Janus kinases (JAKs). It is used to treat ulcerative colitis by interfering with the pathway that leads to inflammation.

  • Vedolizumab

    is a medication that targets a specific protein on white blood cells, preventing them from moving into the gut and causing inflammation. It is used to treat ulcerative colitis by reducing the immune response in the gut.

What is already known about the treatment

  • Infliximab

    Infliximab is administered through intravenous infusion and is currently used in the treatment of various inflammatory conditions, including ulcerative colitis. It is well-documented in medical literature as a biologic therapy that targets and neutralizes tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. Infliximab is classified as a monoclonal antibody and is primarily indicated for patients who have not responded adequately to conventional therapies.

  • Tofacitinib

    Tofacitinib is taken orally in tablet form and is recognized in medical literature as a treatment option for ulcerative colitis. It works by inhibiting Janus kinases (JAKs), which are enzymes that play a role in the inflammatory process. This medication is classified as a small molecule drug and is used to reduce inflammation and manage symptoms in patients who have not responded to other treatments.

  • Vedolizumab

    Vedolizumab is administered via intravenous infusion and is used in the management of ulcerative colitis, as documented in medical literature. It functions by blocking the interaction of specific proteins that allow white blood cells to enter the gut, thereby reducing inflammation. Vedolizumab is classified as a monoclonal antibody and is indicated for patients who have not achieved remission with other therapies.

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 flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause of ulcerative colitis is unknown, but it is believed to involve an abnormal immune response. The condition can significantly impact a person's quality of life due to its chronic nature and the unpredictability of symptom flare-ups.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506628-98-00Protocol codeABM/RESPECT/2023Estimated enrolment180 patientsSponsorAgencja Badań Medycznych

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