Overview

This trial is active, not recruiting.

Condition systemic juvenile idiopathic arthritis
Treatment canakinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date May 2015
End date October 2018
Trial size 19 participants
Trial identifier NCT02396212, CACZ885G1301

Summary

This is 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 will support a registration submission of canakinumab in the indication of SJIA in Japan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
All patients will receive canakinumab (ACZ885) as open-label study medication. Patients will be administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed is 300 mg.
canakinumab
Canakinumab 4mg/kg every 4 weeks

Primary Outcomes

Measure
Proportion pf patients who achieved a minimum adapted ACR Pediatric 30 criteria
time frame: Week 8
Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully
time frame: Week 28

Secondary Outcomes

Measure
Proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over time
time frame: Week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Change from baseline in components of the adapted ACR pediatric criteria of canakinumab over time
time frame: Baseline, Day3 (NA for CHAQ valuables), Week2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Proportion of patients who had flares with canakinumab treatment over time
time frame: Day3, Week2,4,8,12,16,20,24,28,32,36,40,44,48, 52,56,60,64,68,72,76,80,84,88,92,96,100,104,108,112,116,120,124,end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Proportion of patients who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time
time frame: Day3, Week2,4,8,12,16,20,24,28,32,36,40,44,48, 52,56,60,64,68,72,76,80,84,88,92,96,100,104,108,112,116,120,124,end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Changes from baseline in CRP levels with canakinumab treatment over time
time frame: Baseline, Day3, Week2,4,8,12,16,20,24,28,32,36,40,44,48, 52,56,60,64,68,72,76,80,84,88,92,96,100,104,108,112,116,120,124,end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully over time
time frame: Week12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Corticosteroids dose reduction with canakinumab treatment over time
time frame: Week12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Number and percentage of patients with adverse events
time frame: Participants will be followed for the duration until approval, an expected average of 30 months.
Percentage of patients with notable abnormalities in laboratory parameters newly occurred after baseline
time frame: Participants will be followed for the duration until approval, an expected average of 30 months.
Percentage of patients with notable abnormalities in vital sign newly occurred after baseline
time frame: Participants will be followed for the duration until approval, an expected average of 30 months.
Serum concentration of canakinumab and total IL-1 beta
time frame: Baseline, Day3, Week2, 4, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months.
Immunogenicity of canakinumab
time frame: Baseline, Week24, 48, 72, 96, 120, end of study. Participants will be followed for the duration until approval, an expected average of 30 months.

Eligibility Criteria

Male or female participants from 2 years up to 19 years old.

Inclusion Criteria - Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an onset of disease < 16 years of age: Arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following: Rash due to SJIA,lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis - Active disease at the time of baseline defined as follows: - At least 2 joints with active arthritis - Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose - CRP > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL)) - Negative TB screen (Chest X-ray and T-SPOT test) Exclusion Criteria: - With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody). - With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation. - With neutropenia (absolute neutrophil count < 1500/mm3) at screening.

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.