Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)
Systemic Juvenile Idiopathic Arthritis
About this trial
This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis focused on measuring Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile Rheumatoid, Systemic juvenile idiopathic arthritis with active flare
Eligibility Criteria
Inclusion 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:
- 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:
- evanescent nonfixed erythematous rash,
- generalized lymph node enlargement,
- hepatomegaly and/ or splenomegaly,
- serositis
- Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
- Male and female patients aged ≥ 2 to < 20 years of age
Active disease at the time of enrollment 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 period within 1 week before first canakinumab/placebo dose
- C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
- Naïve to canakinumab
- Other protocol defined inclusion criteria may apply
Exclusion Criteria:
Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:
- Pregnant or nursing (lactating) female patients
- Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
- History of hypersensitivity to study drug or to biologics.
- Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
- With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection
- Other protocol defined exclusion criteria may apply
Sites / Locations
- University of Alabama at Birmingham
- Arkansas Children's Hospital Research Inst
- Children's Hospital Los Angeles
- Children's National Medical Center
- University of Chicago Medical Center
- University of Louisville
- Tufts Medical Center
- Tufts New England Medical Center-Dept. of Allergy
- St. Barnabas Ambulatory Care Center
- Children's Hospital Medical Center
- Children's Hospital/Neurology
- Nationwide Children's Hospital
- Legacy Emanuel Hospital
- Legacy Emanual Research
- Specially For Children
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Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Canakinumab
Placebo
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
Patients received a single dose matching placebo of canakinumab on day 1.