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

CompletedPhase 3NCT02396212
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

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)
Conditions
  • Systemic Juvenile Idiopathic Arthritis
Interventions
  • Biological: Canakinumab
Sponsor
Novartis Pharmaceuticals
Organization
Novartis
Start date
2015-05-07
Primary completion
2017-03-07
Sex
All
Age range
from 2 Years to 19 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Japan
Total sites listed
7

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria \- Confirmed diagnosis of SJIA as per International League Against Rheumatism (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 * C-Reactive Protein (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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02396212