Authorised Therapeutic use (Phase IV) Crohn’s disease

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

EU CTIS ID: 2025-524129-42-00

What this study is testing

[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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • Not eligible to receive MTX, as in usual care
  • Co-treatment with a biologic agent other than infliximab
  • Inability to read and understand the patient and family information sheets
  • Informed consent of patient has not been obtained when required

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.