ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
Completed · Phase 3
Conditions studied: Systemic Juvenile Idiopathic Arthritis (SJIA)
In brief
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.
Key facts
- Study ID
- NCT02296424
- Run by
- Novartis Pharmaceuticals
- People needed
- 182
- Starts
- 2014-11-17
- Expected to finish
- 2017-09-25
- Last updated by the study team
- 2019-07-09
Who can join
Age: 2 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Novartis Investigative Site — Los Angeles, California, United States
- Novartis Investigative Site — Columbus, Ohio, United States
- Novartis Investigative Site — Vienna, Austria
- Novartis Investigative Site — Brussels, Belgium
- Novartis Investigative Site — Laken, Belgium
- Novartis Investigative Site — Leuven, Belgium
- Novartis Investigative Site — Curitiba, Paraná, Brazil
- Novartis Investigative Site — Rio de Janeiro, Rio de Janeiro, Brazil
- Novartis Investigative Site — São Paulo, São Paulo, Brazil
- Novartis Investigative Site — Vancouver, British Colombia, Canada
- Novartis Investigative Site — Toronto, Ontario, Canada
- Novartis Investigative Site — Bron, France
- Novartis Investigative Site — Le Kremlin-Bicêtre, France
- Novartis Investigative Site — Paris, France
- Novartis Investigative Site — Sankt Augustin, North Rhine-Westphalia, Germany
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Freiburg im Breisgau, Germany
- Novartis Investigative Site — Giessen, Germany
- Novartis Investigative Site — Hamburg, Germany
- Novartis Investigative Site — Hamburg, Germany
- Novartis Investigative Site — Heidelberg, Germany
- Novartis Investigative Site — Tübingen, Germany
- Novartis Investigative Site — Budapest, Hungary
- Novartis Investigative Site — Budapest, Hungary
Full record on ClinicalTrials.gov
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