Objectives: To examine the effect of drug level-based personalized treatment of adalimumab in
children with Crohn's disease. Design: A prospective, randomized, open label study. Setting:
Pediatric gastroenterology centers. Participants: Children 6 year to 17 years who are
diagnosed with CD and are planned to receive adalimumab treatment. Main outcome measures:
Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures:
Corticosteroids free remission rates and on adalimumab at 48 and 72 weeks. The effect of
routine adalimumab drug monitoring-based treatment on trough levels and anti-adalimumab
antibodies during therapy.