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2025-524129-42-00RecruitingPhase 4

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Jul 2026

Next steps

Brief summary (registry, in English)

[PK] Determination of MTX-PG concentrations and identification of accumulation patterns over time in RBCs. [PD] Association of MTX-PG concentration with MTX discontinuation due to a lack of efficacy or toxicity.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
215 (estimated)
First submitted
30 Dec 2025
Start date
15 Jul 2026
Lead sponsor
Amsterdam UMC Stichting
EU CT number
2025-524129-42-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 215
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children, teenagers and young adults with Crohn's disease who are about to start methotrexate (MTX), alone or together with infliximab.

Age
4-28 years
Sex
Women and men can join.
Disease stage
Crohn's disease proven by endoscopic, radiological and histologic findings.
Earlier treatment
Must be about to start MTX treatment, either alone or together with infliximab. Cannot be treated with a biologic agent other than infliximab.

Main reasons for not taking part

  • Not able to receive MTX, as in usual care
  • Treatment with a biologic agent other than infliximab
  • Cannot read and understand the patient and family information sheets
  • Informed consent of the patient not obtained when required

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Co-treatment with a biologic agent other than infliximab

Other

  • Not eligible to receive MTX, as in usual care
  • Inability to read and understand the patient and family information sheets
  • Informed consent of patient has not been obtained when required

Who the study is looking for

  • Age of 4-28 years
  • Written informed consent of patient (if indicated) and parents (if indicated) has been obtained
  • Proven diagnosis of Crohn’s disease based on endoscopic, radiological and histologic findings
  • Will start MTX treatment monotherapy or combination therapy with infliximab

Age in the registry: - to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC StichtingAmsterdamNetherlandsRecruiting
Medisch Spectrum TwenteEnschedeNetherlandsRecruiting
Universitair Medisch Centrum GroningenGroningenNetherlandsRecruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsRecruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.