AuthorisedTherapeutic use (Phase IV)Interventional

Methotrexate in paediatric and adolescent Crohn’s disease: an observational study

This research is looking into how effective a medicine called methotrexate is for children and teenagers who have Crohn's disease. The study will track how long patients continue to take methotrexate as their only treatment for Crohn's before they might need to switch to other medicines or have surgery. This is called 'drug survival'. Researchers will also measure how much methotrexate is present in the patient's red blood cells at different times. They want to understand what makes the treatment successful or why it might not work. This information could help doctors give the best possible care to young people with Crohn's disease in the future.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC Stichting

Enrolment target

215

Start

11 Apr 2026

Crohn’s disease

What is this study about?

This study is investigating a medicine called methotrexate, which is sometimes used to treat Crohn's disease in children and teenagers. Crohn's disease is a long-term condition that causes inflammation in the digestive system. When a medicine is used, doctors want to know how well it works and if it causes any problems. This study is an 'observational study', which means the researchers will be watching what happens to patients who are already taking methotrexate as part of their usual care, rather than giving them a new treatment.

The main goal of this study is to see how long young people with Crohn's disease can stay on methotrexate as their main treatment without needing to switch to other strong medications or have surgery. This is known as 'drug survival'. They also want to understand how the body handles the medicine by measuring the levels of methotrexate in red blood cells at different points in time. This helps them see if there's a link between how much medicine is in the body and how well it works or if there are side effects.

The researchers will also collect lots of other information, like the patient's age, weight, and general health, as well as whether they smoke. They'll also look at things like how much folic acid they take (which is often given with methotrexate to reduce side effects) and how active their Crohn's disease is. By putting all this information together, doctors hope to learn more about how methotrexate works best for young people with Crohn's disease and why some people might need to stop taking it.

Key takeaways

This study is for young people with Crohn's disease who are already taking methotrexate.
It aims to understand how well methotrexate works as a long-term treatment.
Researchers will collect information from your standard doctor's appointments over one year.
The study helps doctors learn how to give the best care to future patients.
Your treatment won't change because of your participation.
You can decide to stop participating at any time.

Who may be eligible?

This study is looking for young people who have Crohn's disease and are currently taking methotrexate as their treatment. They need to be at least 18 years old to join this particular study. Both male and female patients can take part.

Since it's an observational study, it means that you would already be receiving methotrexate as part of your normal care for Crohn's disease. You wouldn't be starting a new medicine just for the study.

If you're under 18, this specific study wouldn't be suitable for you, even if you have Crohn's disease and take methotrexate.

Quick self-check

Do you have Crohn's disease?
Are you currently taking methotrexate for your Crohn's disease?
Are you at least 18 years old?
Are you happy for your routine medical information to be used for research?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it would involve providing information from your regular doctor's visits over a period of one year. The researchers will look at medical information that is already being collected during your standard check-ups for Crohn's disease. This includes details about your methotrexate dose, any other medicines you take, and results from your usual blood tests. You might also be asked to complete some questionnaires about your symptoms and how you're feeling. There won't be any extra hospital visits or different medications specifically because of the study. The total duration of tracking your information for this study is one year.

Potential risks and benefits

Taking part in this study may not directly benefit you, as it gathers information from your routine care. However, the information learned could help doctors improve how they treat young people with Crohn's disease in the future. The risks of participating are minimal, as you'll be receiving your usual medical care, and no new treatments or procedures are involved. Your personal information will be kept confidential during the study. Remember, you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is Crohn's disease?

Crohn's disease is a condition that causes inflammation, or swelling, in your digestive system. This can lead to tummy pain, diarrhoea, and feeling very tired.

What is methotrexate?

Methotrexate is a medicine that helps to reduce inflammation in the body and can be used to treat conditions like Crohn's disease.

What does 'observational study' mean?

It means researchers are watching and collecting information about what happens during your usual medical care. They aren't asking you to take a new medicine or have any extra tests.

Will this study change my treatment?

No, your treatment will not change because of this study. You will continue to receive the standard care for your Crohn's disease as advised by your doctor.

Will my privacy be protected?

Yes, all your personal information collected for the study will be kept confidential and used only for research purposes.