An observational study on the use of methotrexate in children and adolescents with Crohn’s disease

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Azmuigyor Ugm Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.02.2026

Trial locations

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.

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.

Trial ID:
2025-524129-42-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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