An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
With
Pediatric Rheumatology International Trials Organization
Age
2–19
Sex
ALL
Healthy volunteers
Not accepted
You may not be if
Treatment-naïve patients need to meet the following criteria:
* Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease \< 16 years of age
* Male and female patients aged ≥ 2 to \< 20 years of age
* Active disease at the time of enrollment defined as having 2 or more of the following:
* Documented spiking, intermittent fever (body temperature \> 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose
* At least 2 joints with active arthritis
* AND C-reactive protein (CRP) \> 30 mg/L (normal range \< 10 mg/L) Rash Serositis Lymphadenopathy Hepatosplenomegaly
* Naïve to canakinumab
History of allergy or hypersensitivity to study drug
With active or recurrent bacterial, fungal or viral infections at time of enrollment
