This study investigates the effectiveness of adding low-dose oral methotrexate (MTX) to anti-TNF biological therapy in children with Crohn's disease. Anti-TNF therapy involves medications that block a protein called tumor necrosis factor, which can cause inflammation. The study aims to see if MTX helps maintain remission without the use of steroids over a period of two years.
Participants will be randomly assigned to receive either MTX or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor the effectiveness of MTX in improving patient-reported outcomes and maintaining remission.
- Who can participate: Children aged X to Y diagnosed with Crohn's disease who are starting anti-TNF therapy are eligible to participate.
- Study details: Participants will receive either low-dose oral methotrexate or a placebo alongside their anti-TNF therapy. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines: The study will last two years.
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