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Study on Predictive Factors for Response to Tofacitinib in Patients with Active 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 ulcerative colitis, a condition that causes inflammation and sores in the lining of the large intestine and rectum. The treatment being investigated is a medication called Tofacitinib, which is also known by its brand name, XELJANZ. This medication is taken as a 10 mg film-coated tablet and is administered orally. The purpose of the study is to research factors that might predict how patients with ulcerative colitis will respond to treatment with Tofacitinib.

Participants in the study will receive Tofacitinib over a period of time to observe its effects on their condition. The study aims to gather information on how the immune system of patients with active ulcerative colitis responds to the treatment. This information could help in understanding which patients are more likely to benefit from Tofacitinib therapy. The study will involve taking biopsies, which are small samples of tissue, from patients to analyze these immune responses.

The study is designed to last for a specific period, during which patients will be monitored for changes in their condition. The goal is to identify predictive factors that could help doctors determine the best treatment options for individuals with ulcerative colitis in the future. This research is important for improving the management and outcomes of patients with this chronic inflammatory disease.

The research process

The trial runs in 4 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 eligibility. This includes verifying a diagnosis of ulcerative colitis and ensuring the disease is moderately to severely active, as defined by specific clinical scores.

    Participants must have experienced failure or intolerance to certain medications, such as glucocorticoids or specific biologics. Women of childbearing age must use effective contraception throughout the study and for 15 weeks after stopping the medication.

  2. Step 2

    Medication administration

    Participants will begin taking XELJANZ 10 mg film-coated tablets. This medication contains the active substance tofacitinib and is taken orally.

    The dosage and frequency of administration will be determined by the study protocol and monitored by the research team.

  3. Step 3

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the participant's response to the medication. These visits may include clinical evaluations and laboratory tests.

    The primary focus is on the immunological characterization to assess the response to the treatment.

  4. Step 4

    Completion of study

    The study is expected to conclude by December 31, 2026. Participants will be informed about the end of their involvement and any necessary follow-up actions.

    Final assessments will be conducted to gather data on the long-term effects and efficacy of the treatment.

Who can join the trial?

7 criteria

  • Must provide written informed consent, which means you agree to participate after being fully informed about the study.
  • Must be over 18 years old.
  • Must have a confirmed diagnosis of **ulcerative colitis**, a condition affecting the colon, according to international guidelines.
  • Must have moderately-to-severely active disease, which is measured by a **Mayo score** of 6-12. This score assesses the severity of the condition, including a rectal bleeding score between 1 and 3.
  • Must have an **endoscopic Mayo subscore** of 2-3, which is a part of the Mayo score that looks at the colon through a camera.
  • Must have experienced failure or intolerance to at least one of the following treatments: oral or intravenous **glucocorticoids** (a type of steroid), **azathioprine** or **6-mercaptopurine** (medications that suppress the immune system), or biologic drugs like **infliximab**, **golimumab**, or **adalimumab**.
  • Women of childbearing age must avoid pregnancy because the effects of **Tofacitinib** on pregnancy are not fully understood. They must use a suitable contraceptive method, such as a diaphragm, spiral, or contraceptive pill, before joining the study, during the study, and for 15 weeks after stopping the medication.

Who cannot join the trial?

9 criteria

  • Patients who are not diagnosed with ulcerative colitis cannot participate. Ulcerative colitis is a condition that causes inflammation and sores in the colon and rectum.
  • Individuals who are not within the specified age range for the study are excluded. The study is open to certain age groups only.
  • Participants who are not able to follow the study procedures or provide informed consent are not eligible.
  • People with other significant health conditions that might interfere with the study or its results are excluded.
  • Individuals who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Anyone with a known allergy or adverse reaction to the study medication, Tofacitinib, is excluded. Tofacitinib is a medication used to treat certain inflammatory conditions.
  • Participants who are taking medications that might interfere with the study drug are not eligible.
  • Individuals with a history of certain infections or diseases that could affect the study outcomes are excluded.
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Investigated drugs

Tofacitinib is a medication used in this study to treat patients with active ulcerative colitis. It works by reducing inflammation in the colon, which can help alleviate symptoms such as abdominal pain and diarrhea. The study aims to understand how this medication affects the immune system and to identify factors that predict how well patients will respond to the treatment.

What is already known about the treatment

Tofacitinib – Tofacitinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating ulcerative colitis, a chronic inflammatory condition of the colon. The medication works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. By blocking these enzymes, Tofacitinib helps reduce inflammation and alleviate symptoms associated with ulcerative colitis. It is classified as a Janus kinase inhibitor in pharmacology.

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. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518577-34-00Estimated enrolment60 patientsSponsorUniversita' Degli Studi Di Roma Tor Vergata

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