Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA

Sponsor: Novartis Pharmaceuticals
Study ID: NCT02396212
Phase: PHASE3
Status: Completed

Conditions

Systemic Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex: ALL
Age: 2 Years - 19 Years
Healthy Volunteers: Not accepted

Interventions

Canakinumab — BIOLOGICAL
canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.

Study Details

This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.

Key Dates

Start date: May 7, 2015
Status verified: Aug 2019
Primary completion: Mar 7, 2017
Completion: Aug 1, 2018

Study Design

Enrollment: 19 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Canakinumab
All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg.

Primary Outcome Measure

Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria [ Time Frame: Week 8 ]