Overview

Clinical Study of TA-650 in Pediatric Patients With Crohn's Disease

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy of TA-650 using Pediatric Crohn's Disease Activity Index (PCDAI) in pediatric patients with moderate to severe Crohn's disease after TA-650 administration at a dose of 5 mg/kg at week 0, 2, and 6, then every 8 week after week 14 up to week 46, and at a dose of 10 mg/kg if the effect is attenuated. The safety and pharmacokinetics are also evaluated.
Phase:
Phase 3
Details
Lead Sponsor:
Mitsubishi Tanabe Pharma Corporation
Treatments:
Infliximab