Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease
Item
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:
boolean
C1384600 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C2599446 (UMLS CUI [2])
Arthritis Joints Quantity | Fever Daily Duration
Item
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:
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0015967 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Rash erythematous
Item
evanescent nonfixed erythematous rash,
boolean
C0234913 (UMLS CUI [1])
Generalized enlarged lymph nodes
Item
generalized lymph node enlargement,
boolean
C0476486 (UMLS CUI [1])
Hepatomegaly | Splenomegaly
Item
hepatomegaly and/ or splenomegaly,
boolean
C0019209 (UMLS CUI [1])
C0038002 (UMLS CUI [2])
Serositis
Item
serositis
boolean
C0036749 (UMLS CUI [1])
Informed Consent Parent | Informed Consent Legal Guardian | Assent Child | Informed Consent
Item
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
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
C1879749 (UMLS CUI [3,1])
C0008059 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4])
Age
Item
3. male and female patients aged ≥ 2 to < 20 years of age
boolean
C0001779 (UMLS CUI [1])
Active disease
Item
4. active disease at the time of enrollment defined as follows:
boolean
C2707252 (UMLS CUI [1])
Arthritis Joints Quantity
Item
at least 2 joints with active arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Spiking temperature | Intermittent fever
Item
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
boolean
C0424781 (UMLS CUI [1])
C0277799 (UMLS CUI [2])
C-reactive protein measurement
Item
c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l)
boolean
C0201657 (UMLS CUI [1])
Therapy naive Canakinumab
Item
5. naïve to canakinumab
boolean
C0919936 (UMLS CUI [1,1])
C2718773 (UMLS CUI [1,2])
Inclusion criteria Study Protocol
Item
6. other protocol defined inclusion criteria may apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Criteria Fulfill
Item
patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
1. pregnant or nursing (lactating) female patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential | Exception Coitus Absent | Exception Use of Contraceptive methods
Item
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
boolean
C3831118 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0009253 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Biological agents
Item
3. history of hypersensitivity to study drug or to biologics.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
Macrophage Activation Syndrome
Item
4. diagnosis of active macrophage-activation syndrome (mas) (ravelli, magni-manzoni and pistorio 2005) within the last 6 months
boolean
C1096155 (UMLS CUI [1])
Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C
Item
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
boolean
C0004623 (UMLS CUI [1])
C0026946 (UMLS CUI [2])
C0042769 (UMLS CUI [3])
C1844383 (UMLS CUI [4])
C1844384 (UMLS CUI [5])
C1837066 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
C0019163 (UMLS CUI [8])
C0019196 (UMLS CUI [9])
Exclusion Criteria Study Protocol
Item
6. other protocol defined exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])