At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 19 enrolled

Drug / intervention

Canakinumabbiological

Likely dose

Canakinumab 150 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02396212

NCT02396212Phase 3Completed

Compare CT.gov

An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

Novartis Pharmaceuticals·interventional·Posted Mar 24, 2015·Updated Sep 13, 2019

In Brief

A Phase 3 clinical trial evaluating Canakinumab for Systemic Juvenile Idiopathic Arthritis. Completed, enrolled 19 participants across 7 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSystemic Juvenile Idiopathic Arthritis

CountriesJapan

Collaborators--

Timeline

Phase 3CompletedFinished

201520162017201820192020202120222023202420252026

First PostedMar 2015

Enrollment StartMay 2015

Primary CompletionMar 2017

Study CompletionAug 2018

TodayJul 2026

First PostedMar 24, 2015

Enrollment StartMay 7, 2015

Primary CompletionMar 7, 2017

Study CompletionAug 1, 2018

TodayJul 2, 2026

Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

Canakinumabbiological

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