Pediatric Rheumatology · 2011 · 10 citations · 0 references
Long-term EfficacyPaediatric MedicinePsoriatic ArthritisInflammatory ArthritisRheumatoid DisorderAdverse EventChildhood ArthritisOsteoarthritisMethods PatientsInflammatory Rheumatic DiseaseRheumatoid ArthritisRheumatologyAutoimmune DiseaseRheumatic DiseasesPaediatric RheumatologyPhysical TherapyAdverse EventsJuvenile Idiopathic ArthritisPediatricsPolyarticular Course JiaMedicinePharmacoepidemiologySystemic Juvenile Idiopathic Arthritis
Methods Patients with polyarticular course JIA (N=171) were enrolled in a phase 3, randomized-withdrawal, doubleblind (DB), stratified, parallel-group study, which consisted of a 16-wk open-label (OL) lead-in, a 32-wk DB phase, and an up to 5 year OL extension phase that included BSA dosing prior to a switch to fixed dose (FD). Patients on ADA (24 mg/m; max dose, 40 mg) were evaluated based on ACR pediatric response criteria for improvement (ACR Pedi 30/50/70/90) and monitored for adverse events (AEs).