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An observational study on the use of methotrexate in children and adolescents with 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

This study is focused on Crohn’s disease, a type of long-term inflammation of the digestive tract. The research involves patients using the medication methotrexate, which is administered either through subcutaneous injection, meaning it is injected under the skin, or by taking oral tablets. The purpose of the study is to understand how the medication builds up in the body over time and how these levels relate to how well the treatment works or if it causes side effects.

During the study, researchers will monitor levels of a specific substance, MTX-PG, in the red blood cells. This substance is a byproduct of the medication that stays in the blood and can indicate how much medicine is actually active in the body. Participants will undergo regular check-ups to track their health and the effectiveness of the treatment over several months.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study start and baseline measurements
At the beginning of the study, several measurements are taken to establish a starting point. these include recording age, weight, height, body mass index (bmi), and body surface area.
Information regarding smoking status, including vaping and parental smoking, is collected. medical history, such as previous medications for inflammatory bowel disease (ibd), other health conditions, and current medications, is documented.
Medical tests are performed, including kidney function tests and blood tests to measure liver function and a complete blood count (cbc), which checks the different types of cells in the blood.
Samples are collected to measure disease activity through faecal calprotectin (a marker of inflammation in the stool), c-reactive protein (crp) (a marker of inflammation in the blood), and the pediatric inflammatory bowel disease questionnaire (sibdq).
Additional biological samples are collected, such as blood for genetic testing, plasma (the liquid part of the blood), and stool to study the microbiome (the bacteria living in the gut).
Step 2
Medication administration
The medication methotrexate is used to treat crohn's disease. this medication is administered either as a tablet taken by mouth or as an injection under the skin.
The specific dose and method of administration are determined based on the individual treatment plan.
Step 3
Follow-up monitoring
At 1 month, 3 months, and 6 months, follow-up assessments are conducted. these include blood tests to measure methotrexate levels in red blood cells (rbc) and peripheral blood mononuclear cells (pbmc), which are specific types of white blood cells.
During these visits, disease activity scores, faecal calprotectin, c-reactive protein (crp), and the sibdq questionnaire are recorded to monitor how the disease is behaving.
Routine blood counts and liver function tests are also performed at these intervals.
Step 4
Long-term monitoring
At 12 months, final routine assessments are conducted, including blood counts, liver function tests, disease activity scores, faecal calprotectin, c-reactive protein (crp), and the sibdq questionnaire.
If methotrexate treatment is stopped, a miss questionnaire is completed to assess how well the medication was tolerated.

Who can join the trial?

5 criteria

You must be between 4 and 28 years old.
If you are a minor, both you and your parents or guardians must provide written informed consent, which is a signed document showing you agree to take part in the study.
You must have a confirmed diagnosis of Crohn’s disease. This diagnosis must be proven through endoscopy (looking inside the body with a small camera), radiology (using imaging like X-rays or scans), and histology (looking at tissue samples under a microscope).
You must be starting a treatment using MTX (methotrexate), which is a type of medication used to manage the disease.
You will be taking MTX either by itself, known as monotherapy, or combined with another medicine called infliximab.

Who cannot join the trial?

4 criteria

You are not allowed to take MTX (a type of medication used for treatment) as part of your normal medical care.
You are currently taking a biologic agent (a type of medicine made from living organisms used to treat certain diseases) other than infliximab.
You are unable to read and understand the information sheets provided to patients and their families.
The required informed consent (a formal agreement where a person agrees to participate in a study after understanding all the details) has not been obtained.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

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Investigated drugs

Methotrexate is a medication used to treat inflammatory conditions. In this study, it is being used to observe how it works in children and adolescents with Crohn's disease and how it builds up in the body over time.

Methotrexate

What is already known about the treatment

Methotrexate - This medication is an anti-metabolite used to treat inflammatory conditions like Crohn's disease. It is available as an oral tablet or as a solution for injection administered under the skin. The drug works at a molecular level by blocking specific enzymes that cells need to produce DNA, which helps slow down the overactive immune system.

Investigated diseases

Crohn’s disease - This is a type of inflammatory bowel disease that causes inflammation in the digestive tract. The inflammation can affect any part of the gastrointestinal tract from the mouth to the anus. It often occurs in patches, where inflamed areas are separated by sections of healthy tissue. Over time, the inflammation can cause swelling and damage to the lining of the digestive system. This condition may involve multiple layers of the intestinal wall. It can lead to periods of increased activity followed by periods of relative calm.