ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
CompletedPhase 3NCT02296424
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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)
| Facility | City | Province |
|---|---|---|
| Novartis Investigative Site | Vancouver | British Columbia |
| Novartis Investigative Site | Toronto | Ontario |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02296424