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Clinical trial of subcutaneous infliximab in patients with perianal fistulizing Crohn’s disease

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

The study focuses on perianal fistulizing Crohn’s disease, a form of Crohn’s disease that creates abnormal tunnels (fistulas) around the anus and can cause pain, drainage, and infection. The medication being tested is infliximab, which is given first by two short‑term IV (intravenous) infusions and then by regular injections under the skin (subcutaneous) for almost a year. The aim is to see how well this treatment works to close the fistulas and improve patients’ quality of life.

The purpose of the study is to determine whether changes seen on MRI scans are linked to the amount of drug present in the blood after 52 weeks of therapy. Participants will receive the first two doses through an IV line at the start of the study, followed by weekly subcutaneous injections for the next 46 weeks. Throughout the year, they will have scheduled visits for blood tests, scans, and questionnaires to track symptoms and any side effects.

During the study, a simple blood draw will measure the drug level just before the next dose, which helps understand how much medication remains in the body. An MRI scan, a painless imaging test that creates detailed pictures of the internal area, will be performed at the beginning and at the end of the study to see if the fistulas have healed. Participants will also answer short surveys about how they feel and any changes in their daily activities.

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

    Baseline Visit (Week 0)

    You attend the first clinic visit after joining the study. During this visit you receive a IV infusion of infliximab at a dose of 5 mg per kilogram of your body weight. The medication is delivered through a vein over a short period of time.

    A magnetic resonance imaging scan (MRI) of the pelvic area is performed to document the condition of the fistulas before treatment begins.

    Blood is drawn to measure baseline levels of infliximab and other laboratory markers. You also complete health questionnaires that will be used to track your symptoms and quality of life during the study.

  2. Step 2

    Second Infusion Visit (Week 2)

    Two weeks after the baseline visit you return to the clinic for a second IV infusion of infliximab, using the same dose of 5 mg per kilogram.

    Additional blood samples are taken to monitor the drug level in your bloodstream (known as the trough concentration) and to check other safety parameters.

    You may be asked to answer follow‑up questions about any changes in symptoms since the first visit.

  3. Step 3

    Start of Subcutaneous Infliximab Injections

    After the second infusion you begin a series of subcutaneous (under the skin) injections of infliximab. Each injection contains 120 mg of the medication.

    The injections are given once each week for a total of 46 weeks, completing a 52‑week treatment period when combined with the two initial infusions.

    Injections may be administered by a healthcare professional at the clinic or self‑administered at home after you have been trained on the proper technique.

  4. Step 4

    Routine Monitoring Visits

    Throughout the 46‑week injection phase you attend scheduled clinic visits, typically at week 12 and at the end of treatment (week 52).

    During these visits you undergo repeat MRI scans to assess radiological improvement or healing of the fistulas.

    Blood samples are collected at each visit to measure infliximab trough concentrations and laboratory markers such as C‑reactive protein (CRP) and faecal calprotectin (FC).

    You complete the same health questionnaires as at baseline, allowing comparison of symptoms, quality of life, and functional scores over time.

  5. Step 5

    Final Assessment (Week 52)

    At the end of the 52‑week study period you receive a final MRI scan, a final set of blood tests, and complete the final questionnaires.

    The results are used to determine whether radiological improvement, radiological healing, and clinical fistula closure have been achieved.

    Any adverse events that occurred during the study are recorded, and the decision about continuing or stopping infliximab therapy is made based on the overall findings.

Who can join the trial?

5 criteria

  • Provide a voluntary written informed consent before any screening procedures begin.
  • Have active fistulizing perianal Crohn’s disease that is confirmed by an MRI (a special scan that creates detailed pictures of the inside of the body). You may also have any of the following: a discharge (fluid leaking from the area), a seton (a tiny tube placed to keep a fistula open so it can drain), or drainage that occurred in the last four weeks.
  • Be 18 years of age or older, regardless of gender.
  • Start treatment with IFX (infliximab) using the following schedule: two intravenous (IV) infusions at week 0 and week 2, then receive subcutaneous (under‑the‑skin) injections beginning at week 6 and continue every other week as recommended.
  • Be able to speak and read fluently in Dutch, French, or English.

Who cannot join the trial?

11 criteria

  • Having a pelvic infection (pelvic sepsis) shown on an MRI scan as a collection that is 2 cm or larger, unless that collection has been drained before starting the study medication.
  • Already receiving the medication infliximab through an IV (intravenous) and planning to switch to the under‑the‑skin (subcutaneous) form.
  • Being pregnant at the time of screening.
  • Having a reason that makes an MRI scan unsafe or not possible (a contraindication to MRI).
  • Having taken infliximab at any time during the past 12 months.
  • Being unable to receive infliximab because of a previous allergic reaction, serious infections such as active or untreated latent tuberculosis (TB), multiple sclerosis, or heart failure.
  • Having already used the under‑the‑skin (subcutaneous) form of infliximab before.
  • Having a current recto‑vaginal fistula (an abnormal connection between the rectum and the vagina).
  • Needing or planning to have surgery to close the fistula during the study period.
  • Having a surgical opening called a stoma (used to allow waste to leave the body).
  • Showing complete healing on the MRI scan at the start of the study (radiological healing).
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Investigated drugs

  • Infliximab

    given as a subcutaneous injection is a medication that is injected just under the skin. In this trial it is used to treat people with Crohn’s disease who have troublesome perianal fistulas. The injection helps the medicine get into the bloodstream steadily over time, which may improve healing of the fistulas and reduce disease activity. Participants receive this injection regularly for about a year as part of the study.

  • Infliximab

    given by intravenous infusion is the same medicine, but it is delivered directly into a vein through a drip. In the study, patients receive two of these infusions at the very beginning (the first dose at the start of the trial and a second dose two weeks later). The IV doses are used to quickly raise the amount of medicine in the body before the regular subcutaneous injections begin.

What is already known about the treatment

  • Infliximab

    This medication is given as a subcutaneous injection of 120 mg, placed under the skin using a small needle. It is an approved biologic drug that has been widely studied and is used to treat Crohn’s disease, especially when fistulas develop around the anus. Infliximab works by attaching to a protein called tumor‑necrosis factor‑alpha (TNF‑α) and stopping it from causing inflammation in the gut. It belongs to the class of TNF‑α inhibitors, which are a type of biologic disease‑modifying therapy.

  • Infliximab

    In this form the drug is delivered by intravenous infusion, typically 5 mg per kilogram of body weight, slowly dripped into a vein. It is also an approved and well‑researched treatment for Crohn’s disease with perianal fistulas. The molecule is a monoclonal antibody that binds to TNF‑α, preventing this inflammatory signal from acting on cells in the intestine. Like the subcutaneous version, it is classified as a TNF‑α inhibitor biologic therapy.

Investigated diseases

Fistulizing perianal Crohn’s disease - It is a type of Crohn’s disease that causes chronic inflammation around the anus, leading to the development of abnormal tunnels called fistulas. These fistulas connect the bowel to the skin or other nearby organs, often resulting in persistent drainage. The condition usually begins with inflammation of the intestinal lining and can progress to tissue breakdown and fistula formation. Over time, the fistulas may enlarge or multiply, making the affected area more painful and difficult to heal. Symptoms can fluctuate, with periods of increased activity followed by quieter phases.
Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-525879-41-00Protocol codeALBATROSEstimated enrolment50 patientsSponsorCentre hospitalier universitaire de Liege

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