At a glance
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Risk-stratified Randomized Controlled Trial in Paediatric Crohn Disease:Methotrexate Vs Azathioprine or Adalimumab for Maintaining Remission in Patients At Low or High Risk for Aggressive Disease Course, Respectively-a Treatment Strategy
In Brief
A Phase 4 clinical trial evaluating Methotrexate, Adalimumab, and 1 other intervention for Crohn's Disease. Completed, enrolled 192 participants across 1 site.
Detailed Summary
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: * daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease * subcutaneously administered adalimumab in high risk paediatric Crohn's disease
Study Details
Timeline
Interventions
Subcutaneous methotrexate once weekly 15mg/m2 body surface area (19, 30), with a maximal dose of 25mg/week. Odansetron (Zofran) premedication (4-8mg 1Hour prior to injection) is recommended, folate acid substitution (15mg po, 3 days after Methotrexate injection, for children \<20kg: 1x 5mg) is recommended.
Subcutaneous Adalimumab started at a dose of 160mg followed by 80mg 2 weeks later and then 40mg every 2 weeks in patients over 40kg. In patients \< 40kg sc doses of Adalimumab are as follows: induction 160mg/1,73m2 BSA (max 160mg), followed by 80mg/1,73m2 Body surface area (max 80mg) 2 weeks later and maintenance of 40mg/1,73m2 Body surface area (max 40mg) every 2 weeks, all doses rounded up to the nearest 5 multiplications.
Oral Azathioprine /6mercaptopurine at a dose of 2.5 mg/kg once daily rounded to the nearest multiplication of 12.5mg or oral 6mercaptopurine at a dose of 1.5mg/kg once daily rounded to the nearest multiplication of 12.5mg.