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The purpose of this study is to compare the effectiveness of weekly subcutaneously administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition -free 1-year remission compared with:
Full description
In this randomized controlled trial PIBDNet (pediatric inflammatory bowel diseases network) aims to compare the following treatment strategy by dividing patients into two risk groups for aggressive disease evolution: the effectiveness of Methotrexate versus Azathioprine / 6 mercaptopurine for the maintenance of remission in Crohn's disease in children who are at low risk for aggressive disease and the effectiveness of Methotrexate versus adalimumab in the high risk group. PIBDNet hypothesizes that Methotrexate is superior to Azathioprine / 6 mercaptopurine for maintaining remission in Crohn's disease in the low risk strata and adalimumab is superior to Methotrexate in the high risk strata. In addition, the ancillary study is planned to analyse of Adalimumab treated patients from inclusion (TOP-Down) versus patients switched to Adalimumab due to failure of immunomodulator therapy (STEP-Up).
Enrollment
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Inclusion criteria
Children 6-17, with a new-onset Crohn Disease diagnosed using established criteria (37, 38), requiring a steroid-based or Enteral nutrition based induction therapy
At initial diagnosis, wPCDAI >40 or CRP>2 times upper limit at diagnosis
all wPCDAI scores (0-120) are possible at inclusion (patients in remission and patients with active disease)
Luminal active Crohn Disease (B1) with or without B2 and/or B3 disease behavior
Initial exposure to 5-ASA and derivate is tolerated
Exposure to antibiotics is tolerated
If one of the following criteria is present, patients are allocated to the high risk group prior randomization:
Informed and signed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
312 participants in 3 patient groups
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Central trial contact
Laetitia BIGOT, PhD; Christine NGUYEN-DEMANGE
Data sourced from clinicaltrials.gov
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