Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
With
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Southwest Pediatric Nephrology Study Group
Age
2–19
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 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
2. 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
3. Male and female patients aged ≥ 2 to \< 20 years of age
4. 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)
5. Naïve to canakinumab
You may not be if
1. Pregnant or nursing (lactating) female patients
2. 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
3. History of hypersensitivity to study drug or to biologics.
4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
5. 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
