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Study of adalimumab and infliximab dose adjustment guided by fecal calprotectin monitoring in adolescents and young adults with Crohn's disease or 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 study focuses on patients with Inflammatory Bowel Disease (IBD), specifically Crohn's disease and Ulcerative colitis. These are chronic conditions that cause inflammation in different parts of the digestive system. The study examines two medications: adalimumab and infliximab, which belong to a group of drugs called anti-TNF medications that help reduce inflammation in the body.

The purpose of this research is to determine if adjusting the timing between doses of these medications can be done safely while maintaining the disease under control. The study monitors inflammation levels using a test called fecal calprotectin, which measures inflammation markers in stool samples. Participants will receive their usual medication (infliximab through an intravenous infusion or adalimumab through an injection under the skin), but some will have their dosing schedule adjusted.

During the study, which lasts 48 weeks, participants will have their inflammation levels regularly monitored through stool tests. The study will track how well the adjusted medication schedule works in keeping the disease under control and will also monitor any side effects, particularly focusing on skin conditions and respiratory infections that might occur during the treatment period.

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 treatment phase

    You will continue your current treatment with either infliximab (given through intravenous infusion every 8 weeks) or adalimumab (given through subcutaneous injection every 2 weeks)

    Your current dosing schedule will be maintained while monitoring your condition

  2. Step 2

    Regular monitoring

    Your condition will be monitored through fecal calprotectin tests (a stool test that measures inflammation levels)

    For Crohn's disease, the target level is below 250 μg/g

    For ulcerative colitis, the target level is below 150 μg/g

  3. Step 3

    Treatment adjustment phase

    Based on your test results, your medication schedule may be adjusted

    Your symptoms and overall health will continue to be monitored throughout the 48-week study period

  4. Step 4

    Health monitoring

    You will be monitored for any side effects, particularly:

    Respiratory infections

    Skin-related changes (such as infections, psoriasis, or other skin conditions)

    Anti-TNF levels (medication levels) in your blood will be measured regularly

  5. Step 5

    Study completion

    The study will conclude after 48 weeks of monitoring

    Your final health assessment will include fecal calprotectin testing and evaluation of your overall condition

Who can join the trial?

10 criteria

  • Age between 12 and 25 years
  • Have been diagnosed with Crohn's disease or ulcerative colitis affecting the digestive tract
  • Currently receiving treatment with either:
    • Infliximab every 8 weeks, or
    • Adalimumab every 2 weeks
    • Must be using current anti-TNF medication as first treatment, or if previously used different anti-TNF medication, it was stopped for reasons other than lack of response
    • Never attempted to extend time between doses of current medication
    • Must have one of the following:
      • Three consecutive stool tests (fecal calprotectin) showing inflammation levels below target values in the past 6 months, or
      • A recent examination (endoscopy) within 2 months showing the disease is in remission
      • No current symptoms of active inflammatory bowel disease, as determined by the medical team
      • Must provide written informed consent to participate in the study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Current pregnancy or breastfeeding
  • Active infection or signs of infection
  • History of allergic reactions to anti-TNF medications (medications that reduce inflammation)
  • Recent surgery within the past 3 months
  • Active cancer or history of cancer in the past 5 years
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or abnormal kidney function
  • Presence of intestinal strictures (narrowing of the intestine)
  • Active fistulas (abnormal connections between organs)
  • Use of other biological medications in the past 3 months
  • Unstable medical conditions that could interfere with the study
  • Inability to provide informed consent
  • History of non-compliance with medical treatment
  • Participation in another clinical trial within the past 30 days
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Investigated drugs

  • Anti-TNF therapy

    (Tumor Necrosis Factor inhibitors) is a type of medication used to treat inflammatory bowel disease (IBD). These medications work by blocking a protein in the body that causes inflammation. They help reduce inflammation in the digestive tract and maintain remission in people with IBD. Common anti-TNF medications include adalimumab and infliximab, which are given either as injections under the skin or through an intravenous infusion.

  • Fecal Calprotectin

    is not a medication but a monitoring tool used in this trial. It's a protein marker measured in stool samples that helps doctors track inflammation levels in the intestines. This measurement helps determine how well the treatment is working and guides decisions about adjusting medication doses.

What is already known about the treatment

Anti-TNF medications - A class of biologic drugs administered via subcutaneous injection or intravenous infusion, primarily used in the treatment of inflammatory bowel diseases (IBD) including Crohn's disease and ulcerative colitis. These medications work by blocking tumor necrosis factor (TNF), a protein that causes inflammation in the body, thereby reducing inflammation in the digestive tract and helping to maintain disease remission. Anti-TNF drugs belong to the pharmacological class of immunosuppressants and have revolutionized the treatment of IBD, with extensive clinical evidence supporting their effectiveness in both adult and pediatric populations. Note: Since the specific anti-TNF medication is not named in the source data, I provided a general description of the anti-TNF class of medications that are commonly used in IBD treatment.

Investigated diseases

  • Crohn's Disease

    A chronic inflammatory condition that can affect any part of the digestive tract, from mouth to anus. The disease typically develops gradually, causing inflammation that spreads deep into affected tissues. Common changes include thickening of the intestinal wall, formation of ulcers, and development of patches of inflamed tissue. The inflammation can lead to abdominal pain, diarrhea, fatigue, and unintended weight loss. The condition can also cause complications outside the digestive tract, affecting joints, skin, or eyes.

  • Ulcerative Colitis

    A long-term inflammatory bowel condition that affects the large intestine (colon) and rectum. The disease begins in the rectum and can spread continuously through the colon. The inflammation causes the lining of the colon to develop tiny sores or ulcers that produce mucus and bleed. The condition typically develops over time, with symptoms that may come and go. The main characteristic is inflammation and ulcers in the digestive tract's innermost lining.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516277-68-00Estimated enrolment148 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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