SJIA | Onset of illness Age | Arthritis Joints Quantity | Fever Duration | Exanthema Due to SJIA | Lymphadenopathy | Hepatomegaly | Splenomegaly | Serositis
Item
confirmed diagnosis of sjia as per ilar definition (petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an 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: rash due to sjia,lymphadenopathy, hepatomegaly/splenomegaly, serositis
boolean
C1384600 (UMLS CUI [1])
C0277793 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0003864 (UMLS CUI [3,1])
C0022417 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0015967 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
C0015230 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1384600 (UMLS CUI [5,3])
C0497156 (UMLS CUI [6])
C0019209 (UMLS CUI [7])
C0038002 (UMLS CUI [8])
C0036749 (UMLS CUI [9])
Disease Active
Item
active disease at the time of baseline defined as follows:
boolean
C0012634 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Joints Quantity Arthritis
Item
at least 2 joints with active arthritis
boolean
C0022417 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003864 (UMLS CUI [1,3])
Spiking fever Intermittent Duration | Body temperature measurement
Item
documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day during the screening epoch and within 1 week before first canakinumab dose
boolean
C0424781 (UMLS CUI [1,1])
C0205267 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0886414 (UMLS CUI [2])
C-reactive protein measurement
Item
crp > 30 mg/l(3 mg/dl) (normal range < 10 mg/l(1 mg/dl))
boolean
C0201657 (UMLS CUI [1])
Tuberculosis screening Negative | Chest X-ray | Other Coding
Item
negative tb screen (chest x-ray and t-spot test)
boolean
C0420004 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C0039985 (UMLS CUI [2])
C3846158 (UMLS CUI [3])
Bacterial Infection | Recurrent bacterial infection | Mycoses | Mycoses Recurrent | Virus Disease | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C | Hepatitis B resolved | Hepatitis B surface antigen negative | Hepatitis B surface antibody positive | Hepatitis B core antibody positive
Item
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. patients with resolved/previous hepatitis b infection (a negative hbs antigen, but a positive anti-hbs antibody and/or anti-hbc antibody).
boolean
C0004623 (UMLS CUI [1])
C1844383 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0026946 (UMLS CUI [4,1])
C2945760 (UMLS CUI [4,2])
C0042769 (UMLS CUI [5])
C1837066 (UMLS CUI [6])
C0019693 (UMLS CUI [7])
C0019163 (UMLS CUI [8])
C0019196 (UMLS CUI [9])
C0019163 (UMLS CUI [10,1])
C1514893 (UMLS CUI [10,2])
C0919711 (UMLS CUI [11])
C0149708 (UMLS CUI [12])
C0262506 (UMLS CUI [13])
Metabolic Disease Causing Immunocompromised patient | Kidney Disease Causing Immunocompromised patient | Liver disease Causing Immunocompromised patient | Communicable Disease Causing Immunocompromised patient | Gastrointestinal Disease Causing Immunocompromised patient | Metabolic Disease Study Subject Participation Status At risk | Kidney Disease Study Subject Participation Status At risk | Liver disease Study Subject Participation Status At risk | Communicable Disease Study Subject Participation Status At risk | Gastrointestinal Disease Study Subject Participation Status At risk
Item
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.
boolean
C0025517 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0085393 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0085393 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0085393 (UMLS CUI [3,3])
C0009450 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0085393 (UMLS CUI [4,3])
C0017178 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0085393 (UMLS CUI [5,3])
C0025517 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0022658 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0023895 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0009450 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1444641 (UMLS CUI [9,3])
C0017178 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1444641 (UMLS CUI [10,3])
Neutropenia | Absolute neutrophil count
Item
with neutropenia (absolute neutrophil count < 1500/mm3) at screening.
boolean
C0027947 (UMLS CUI [1])
C0948762 (UMLS CUI [2])