Conditions: Pediatric Crohn's Disease
Keywords: Infliximab REMICADE TA-650 pediatric Crohn's disease
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief 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.

Detailed description:
This is an open-label, uncontrolled, multicenter Phase 3 study conducted in Japan.

Arms:
arm 1: Responder criteria: Case where PCDAI score on the evaluation day was decreased by at least 15 points from that in the screening period and was ≤30.

Criteria for dose-increasing: When either of the following 2 items was satisfied after Week 14, the relevant patient would be considered to satisfy the criteria for dose increasing to 10 mg/kg.

1. PCDAI score on the evaluation day was increased by at least 15 points compared to the lowest PCDAI score observed at Week 2, 6 or 10
2. PCDAI score on the evaluation day exceeds 30

Interventions: intervention 1: TA-650
Intervention descriptions: intervention 1: TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.

Protocol document: