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ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab

CompletedPhase 3NCT02296424
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.

Brief summary (from the registry)

The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

Study details

Official title
β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
Conditions
  • Systemic Juvenile Idiopathic Arthritis (SJIA)
Interventions
  • Drug: ACZ885 150 mg (Canakinumab)
Sponsor
Novartis Pharmaceuticals
Organization
Novartis
Start date
2014-11-17
Primary completion
2016-10-14
Sex
All
Age range
from 2 Years to 20 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, Turkey (Türkiye), United States
Total sites listed
50

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Cohort 1: • Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1 Cohort 2: * Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with an onset of disease \< 16 years of age. * Active SJIA defined as having 2 or more of the following: * Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day within 1 week before first canakinumab dose; * At least 2 joints with active arthritis * C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L) * Rash due to SJIA * Serositis * Lymphadenopathy * Hepatosplenomegaly * Negative TB screen (QuantiFERON or, if required by local guidelines, Purified Protein Derivative). 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. * 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.

Canadian sites (2)

FacilityCityProvince
Novartis Investigative SiteVancouverBritish Columbia
Novartis Investigative SiteTorontoOntario
Canadian sites for NCT02296424VancouverToronto
Canadian sites for NCT02296424. 2 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02296424