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Study on the Effects of Tofacitinib and Drug Combination on Blood Clotting 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 the medication tofacitinib on blood clotting and platelet function in patients with ulcerative colitis. Ulcerative colitis is a chronic condition that causes inflammation and sores in the digestive tract, primarily affecting the colon and rectum. The study will also involve other medications, including infliximab, adalimumab, and golimumab, which are used to treat similar conditions by targeting specific proteins in the body that cause inflammation.

The purpose of the study is to evaluate how tofacitinib affects platelet function and blood clotting in patients with ulcerative colitis. Participants will receive one of the medications, and their platelet activity will be monitored before and after starting the treatment. The study will last for up to 12 months, during which time the effects of the medication on the participants' condition will be observed and recorded.

Throughout the study, the activity of the disease will be assessed using a method called the Mayo endoscopic sub-score, which helps determine the severity of the inflammation in the colon. The study aims to understand better how these medications can help manage ulcerative colitis and improve patient outcomes by reducing inflammation and preventing complications related to blood clotting.

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 will be conducted to confirm eligibility. This includes verifying the diagnosis of ulcerative colitis and ensuring that the condition meets the required criteria.

    The assessment will also involve a review of medical history and current health status to ensure suitability for the trial.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of the medication tofacitinib. This medication is taken orally.

    The dosage and frequency will be determined by the study protocol and communicated to the patient at the start of this phase.

  3. Step 3

    Ongoing monitoring

    Regular monitoring will be conducted to assess the effect of the medication on platelet function and coagulation. This involves taking blood samples at specified intervals.

    The monitoring will also include evaluating the endoscopic activity of the ulcerative colitis using the Mayo endoscopic sub-score.

  4. Step 4

    Follow-up assessments

    Follow-up assessments will occur at regular intervals to track progress and any changes in the condition.

    These assessments will help determine the endoscopic response and remission status, defined by changes in the Mayo endoscopic sub-score.

  5. Step 5

    Completion of trial

    Upon completion of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment.

    The results will contribute to understanding the effect of tofacitinib on patients with ulcerative colitis.

Who can join the trial?

9 criteria

  • Must be over 18 years old.
  • Must have a diagnosis of ulcerative colitis (UC) according to the criteria of the European Crohn’s and Colitis Organisation (ECCO).
  • Must need treatment with anti-TNFα (such as infliximab, adalimumab, or golimumab) or tofacitinib. Anti-TNFα are medications that help reduce inflammation by blocking a protein called tumor necrosis factor alpha.
  • Must be receiving a JAK-inhibitor or anti-TNFα for the first time. JAK-inhibitors are medications that help reduce inflammation by blocking certain enzymes.
  • Must have endoscopic activity of UC within 1 month of starting the treatment, with a Mayo endoscopic sub-index of 2 or higher. This means that a recent examination of the colon shows active disease.
  • Women of childbearing age must use contraceptive methods with an error rate of less than 1% per year. Examples include:
    • Intrauterine device (IUD)
    • Bilateral tubal occlusion (a type of permanent birth control)
    • Partner with vasectomy (a permanent form of male birth control)
    • Sexual abstinence (not having sexual intercourse)

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 colon and rectum.
  • Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

Tofacitinib is a medication used in this clinical trial to study its effects on blood clotting and platelet function. It is commonly used to treat ulcerative colitis, which is a condition that causes inflammation and sores in the digestive tract. In this trial, researchers are interested in understanding how tofacitinib might influence the risk of developing blood clots, which are known as thromboembolic events. By examining its impact on the blood's ability to clot and how platelets, which are small blood cells that help with clotting, function, the study aims to provide insights into the safety and effects of tofacitinib in patients with ulcerative colitis.

What is already known about the treatment

Tofacitinib – Tofacitinib is taken orally in the form of a tablet. It is currently being studied for its effects on blood clotting and platelet function in patients with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. This medication is already used in medicine to treat ulcerative colitis and other inflammatory conditions. It works by blocking certain enzymes in the body that contribute to inflammation, helping to reduce symptoms. Tofacitinib belongs to a class of drugs known as Janus kinase (JAK) inhibitors, which help to control the immune system's response.

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. The disease typically begins in the rectum and may extend continuously to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can lead to the formation of ulcers, which may cause pus and mucus in the stool. The severity of symptoms can vary, with periods of exacerbation and remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518434-83-01Protocol codeGIS-2021-JAKihemoEstimated enrolment60 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

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