ID

37281

Description

Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA; ODM derived from: https://clinicaltrials.gov/show/NCT02396212

Link

https://clinicaltrials.gov/show/NCT02396212

Keywords

Versions (1)
  1. 7/12/19 7/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Systemic Juvenile Idiopathic Arthritis NCT02396212

English

Eligibility Systemic Juvenile Idiopathic Arthritis NCT02396212

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Description

SJIA | Onset of illness Age | Arthritis Joints Quantity | Fever Duration | Exanthema Due to SJIA | Lymphadenopathy | Hepatomegaly | Splenomegaly | Serositis

Data type

boolean

Alias
UMLS CUI [1]
C1384600
UMLS CUI [2,1]
C0277793
UMLS CUI [2,2]
C0001779
UMLS CUI [3,1]
C0003864
UMLS CUI [3,2]
C0022417
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0015967
UMLS CUI [4,2]
C0449238
UMLS CUI [5,1]
C0015230
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1384600
UMLS CUI [6]
C0497156
UMLS CUI [7]
C0019209
UMLS CUI [8]
C0038002
UMLS CUI [9]
C0036749
active disease at the time of baseline defined as follows:
Description

Disease Active

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205177
at least 2 joints with active arthritis
Description

Joints Quantity Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0003864
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
Description

Spiking fever Intermittent Duration | Body temperature measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0424781
UMLS CUI [1,2]
C0205267
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C0886414
crp > 30 mg/l(3 mg/dl) (normal range < 10 mg/l(1 mg/dl))
Description

C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201657
negative tb screen (chest x-ray and t-spot test)
Description

Tuberculosis screening Negative | Chest X-ray | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0420004
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C0039985
UMLS CUI [3]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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).
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C1844383
UMLS CUI [3]
C0026946
UMLS CUI [4,1]
C0026946
UMLS CUI [4,2]
C2945760
UMLS CUI [5]
C0042769
UMLS CUI [6]
C1837066
UMLS CUI [7]
C0019693
UMLS CUI [8]
C0019163
UMLS CUI [9]
C0019196
UMLS CUI [10,1]
C0019163
UMLS CUI [10,2]
C1514893
UMLS CUI [11]
C0919711
UMLS CUI [12]
C0149708
UMLS CUI [13]
C0262506
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0025517
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0085393
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0085393
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0085393
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0085393
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C0085393
UMLS CUI [6,1]
C0025517
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C1444641
UMLS CUI [7,1]
C0022658
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C0023895
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C1444641
UMLS CUI [9,1]
C0009450
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1444641
UMLS CUI [10,1]
C0017178
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1444641
with neutropenia (absolute neutrophil count < 1500/mm3) at screening.
Description

Neutropenia | Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0948762
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Similar models

Eligibility Systemic Juvenile Idiopathic Arthritis NCT02396212

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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