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Study Comparing Infliximab Alone or with Immunosuppressive Drugs for Moderate to Severe Crohn's Disease Patients

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 treatment of Crohn's disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study is investigating the effectiveness of a medication called infliximab, which is administered as a solution for injection using a pre-filled pen. Infliximab is a type of protein that helps reduce inflammation in the body.

The purpose of this study is to compare two treatment approaches for moderate to severe Crohn's disease: using infliximab injections alone or in combination with other drugs that suppress the immune system, known as immunosuppressive drugs. Participants in the study will receive either infliximab alone or infliximab with these additional medications. The study aims to determine which approach is more effective in managing the disease.

Throughout the study, participants will receive regular injections and will be monitored over a period of time to assess their response to the treatment. The goal is to see if patients can achieve a state where they no longer need corticosteroids, a type of medication often used to reduce inflammation, and to observe improvements in their digestive tract as seen through medical examinations. The study will last until the end of 2025, with participants being observed for changes in their condition and overall health.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide written consent to participate.

    Eligibility is confirmed based on criteria such as age, diagnosis of Crohn's disease, and previous treatment history.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of Crohn's disease using the Crohn's Disease Activity Index (CDAI) and endoscopic examination.

    The CDAI score should be between 220 and 450, and endoscopic evidence of inflammation is required.

  3. Step 3

    Treatment allocation

    The patient is randomly assigned to one of two treatment groups: subcutaneous infliximab monotherapy or subcutaneous infliximab with additional immunosuppressive medication.

    The medication used is Remsima 120 mg solution for injection, administered via subcutaneous injection.

  4. Step 4

    Treatment administration

    The patient receives the assigned treatment. Infliximab is administered as a subcutaneous injection.

    The frequency and duration of the treatment are determined by the study protocol and the patient's response to the medication.

  5. Step 5

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the patient's response to treatment and any side effects.

    Assessments include clinical evaluations and endoscopic examinations to measure disease activity and response.

  6. Step 6

    Evaluation at week 26

    At week 26, the patient's condition is evaluated to determine if they have achieved corticosteroid-free clinical remission and endoscopic response.

    Clinical remission is defined as a CDAI score of less than 150, and endoscopic response is a reduction of at least 50% in the SES-CD score.

  7. Step 7

    Study completion

    Upon completion of the study, the patient's overall response to the treatment is assessed.

    The study aims to compare the effectiveness of infliximab alone versus in combination with immunosuppressive drugs in managing Crohn's disease.

Who can join the trial?

8 criteria

  • Patients must be **18 years or older**.
  • Must have been diagnosed with **Crohn's disease**.
  • Should have **moderate to severely active Crohn's disease**. This means a Crohn's Disease Activity Index (CDAI) score between **220 to 450**. The CDAI is a tool used to measure the severity of Crohn's disease.
  • Must show **objective evidence of inflammation**. This means there should be visible signs of inflammation, like ulcers, in the **terminal ileum** (the last part of the small intestine), **colon**, or both. The **SES-CD** score, which measures the severity of inflammation seen during an endoscopy, should be **6 or more** for colonic or ileocolonic disease, or **4 or more** for isolated ileal disease.
  • Should have had no response to, or experienced unacceptable side effects from, one or more of the following treatments: **glucocorticoids**, **thiopurines** (such as azathioprine, 6-mercaptopurine, or 6-thioguanine), **methotrexate**, or **adalimumab**. Alternatively, the treating doctor may decide that the patient should start treatment with IFX right away.
  • The investigator must believe the patient is capable of understanding and following the study requirements.
  • The patient must sign and date a written, informed consent form and any necessary privacy authorization before starting any study procedures.
  • Participants can be **male** or **non-pregnant, non-lactating females**. Female participants should not plan to become pregnant in the next 26 weeks.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of cancer, except for certain types of skin cancer.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have been diagnosed with a mental health condition that might affect their ability to participate in the study.
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Investigated drugs

  • Infliximab

    This medication is used to treat moderate to severe Crohn's disease. It works by reducing inflammation in the body, which helps to relieve symptoms such as pain and diarrhea. In this study, Infliximab is administered as a subcutaneous injection, meaning it is injected under the skin. The trial is investigating the effectiveness of using Infliximab alone compared to using it in combination with other medications that suppress the immune system.

  • Concomitant Immunosuppression

    This therapy involves using additional medications that suppress the immune system alongside Infliximab. The purpose of these medications is to enhance the effect of Infliximab by further reducing the immune system's activity, which may help in controlling Crohn's disease more effectively. The study aims to determine whether adding these immunosuppressive medications provides any additional benefit over using Infliximab alone.

What is already known about the treatment

Infliximab – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating moderate to severe Crohn's disease. Infliximab is primarily used to reduce inflammation in conditions like Crohn's disease by targeting and neutralizing a specific protein in the body called tumor necrosis factor-alpha (TNF-alpha). It belongs to a class of drugs known as biologics, which are designed to interfere with specific components of the immune system.

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 disease can affect any part of the digestive tract from the mouth to the anus, but it most commonly impacts the end of the small intestine and the beginning of the colon. The exact cause of Crohn's disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517171-20-00Protocol codeNL76663.018.21Estimated enrolment158 patientsSponsorAmsterdam UMC Stichting

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