2014 American College of Clinical Pharmacology Annual Meeting September 14th-16th Atlanta, Georgia

摘要

Description of Methods and Materials: GO-KIDS is a randomized-withdrawal, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 trial of SC golimumab 30mg/m~2 (maximum 50 mg) q4w t MTX (10-30 mg/m~2/week) in pediatric patients with active JIA despite current MTX therapy. PK, safety and efficacy evaluations were performed q4w through Week 48. Serum trough concentrations were also obtained at Weeks 12, 16, 24 and 48 and were determined via a validated immunoassay. The relationships of ACR pediatric 30 response and disease flare status with steady-state trough levels at Week 48 were assessed.