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Study on Managing Moderate Postoperative Recurrence in Crohn's Disease with Infliximab for Patients After Ileocolonic Surgery

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 focuses on the management of moderate postoperative recurrence in Crohn's disease. Crohn's disease is a chronic inflammatory condition that affects the digestive tract. The study aims to evaluate the effectiveness of a treatment strategy called therapeutic escalation in patients who have experienced a recurrence of Crohn's disease after surgery. The treatment being studied involves the use of a medication called infliximab, which is available in two forms: a 120 mg solution for injection in a pre-filled pen, known as Remsima, and a 100 mg powder for concentrate for solution for infusion, also known as Remsima. Infliximab is a type of protein that helps reduce inflammation in the body.

The purpose of the study is to determine how well patients respond to the treatment over a period of 12 months. Participants in the study will be divided into two groups. One group will receive the therapeutic escalation treatment with infliximab, while the other group will continue with their current treatment plan. The study will monitor the participants' health and the recurrence of Crohn's disease symptoms through regular check-ups and assessments. The goal is to see if the therapeutic escalation approach can help prevent further recurrence of the disease after surgery.

Throughout the study, participants will receive either the infliximab treatment or a placebo, and their progress will be closely monitored by healthcare professionals. The study will last for a total of 12 months, during which time the effectiveness of the treatment will be evaluated based on specific criteria. The results of this study may provide valuable insights into the management of Crohn's disease and help improve treatment options for patients experiencing postoperative recurrence.

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

    Joining the study

    Eligibility is confirmed based on age (18-75 years) and a diagnosis of Crohn's disease.

    An intestinal resection with ileocolonic anastomosis must have been performed within the last 6-12 months.

    A postoperative endoscopy is conducted between 6 and 12 months after surgery to assess the condition of the neoterminal ileum.

  2. Step 2

    Initial assessment

    The endoscopic evaluation classifies the postoperative recurrence as i2 according to the Rutgeerts score.

    This classification is validated by a blinded central reading.

  3. Step 3

    Randomization

    Participants are randomly assigned to either the therapy escalation group or the status quo group.

  4. Step 4

    Treatment administration

    In the therapy escalation group, infliximab is administered.

    The medication is provided as Remsima 120 mg solution for injection using a pre-filled pen for subcutaneous administration.

    Alternatively, Remsima 100 mg powder is used to prepare a solution for infusion, administered intravenously.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for 12 months to evaluate the treatment's effectiveness.

    The primary goal is to achieve a modified Rutgeerts score of i0-i1 at 12 months.

    Secondary outcomes include various health assessments and quality of life evaluations.

  6. Step 6

    Final assessment

    At the end of the 12-month period, a final evaluation is conducted to determine the success of the treatment.

    The results are compared to the initial assessments to measure improvement or progression.

Who can join the trial?

5 criteria

  • Must be between 18 and 75 years old.
  • Must have a diagnosis of Crohn's disease based on standard criteria.
  • Must have had a surgery called intestinal resection with ileocolonic anastomosis to remove all Crohn's disease-related inflammation within the last 6 to 12 months. This surgery connects two parts of the intestine. If the surgery was done in two stages, the endoscopy must be done 6 to 12 months after the bowel function is restored.
  • Must have had a postoperative endoscopy (a procedure to look inside the intestines) done between 6 and 12 months, with a 2-month flexibility, after the surgery. This endoscopy should reach the new end of the small intestine.
  • Must have a postoperative endoscopic recurrence classified as i2 according to the Rutgeerts score (a system to evaluate Crohn's disease after surgery) at 6 to 12 months, confirmed by an independent review.

Who cannot join the trial?

5 criteria

  • Patients who have not had an ileocolonic anastomosis. This is a surgery where a part of the intestine is removed and the remaining ends are joined together.
  • Patients who do not have Crohn's disease.
  • Patients who have not experienced an endoscopic postoperative recurrence. This means that after surgery, the disease has not returned as seen through a special camera used to look inside the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Adalimumab

    is a medication used to reduce inflammation in the body. It is often prescribed for patients with Crohn's disease to help manage symptoms and prevent flare-ups. In this trial, it is being used to see if it can help prevent the recurrence of symptoms after surgery.

  • Azathioprine

    is an immunosuppressive medication that helps to lower the body's immune response. It is used in Crohn's disease to maintain remission and prevent the disease from coming back after surgery. The trial is testing its effectiveness in preventing postoperative recurrence.

  • Ustekinumab

    is a medication that targets specific proteins in the immune system to reduce inflammation. It is used in Crohn's disease to help control symptoms and maintain remission. This trial is evaluating its role in preventing the return of symptoms after surgery.

What is already known about the treatment

Infliximab – Infliximab is administered intravenously, typically through an infusion. It is currently well-established in medical literature as a treatment for Crohn's disease, particularly in managing moderate to severe cases. The main therapeutic indication for infliximab is to reduce inflammation and maintain remission in Crohn's disease patients. At the molecular level, infliximab works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as a biologic therapy, specifically a monoclonal antibody.

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 lead to complications such as strictures, fistulas, and malnutrition. The disease can affect any part of the digestive tract from the mouth to the anus, and its exact cause is unknown, though it involves an abnormal immune response. Over time, the inflammation can cause damage to the intestinal walls, leading to further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508242-18-00Protocol codeGETAID-2021-01Estimated enrolment205 patientsSponsorGroupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

sourced from the EU Clinical Trials Register and site verification

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