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ID

37280

Description

ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab; ODM derived from: https://clinicaltrials.gov/show/NCT02296424

Link

https://clinicaltrials.gov/show/NCT02296424

Keywords

Versions (1)
  1. 7/12/19 7/12/19 -
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See clinicaltrials.gov

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July 12, 2019

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Creative Commons BY 4.0
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    Eligibility Systemic Juvenile Idiopathic Arthritis (SJIA) NCT02296424

    English

    Eligibility Systemic Juvenile Idiopathic Arthritis (SJIA) NCT02296424

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    cohort 1:
    Description

    Cohort Number

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0599755
    UMLS CUI [1,2]
    C0237753
    • patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for systemic juvenile idiopathic arthritis (sjia) and have inactive disease at the last visit in study cacz885g2301e1
    Description

    Canakinumab Dose | Systemic juvenile idiopathic arthritis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2718773
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [2]
    C1384600
    cohort 2:
    Description

    Cohort Number

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0599755
    UMLS CUI [1,2]
    C0237753
    confirmed diagnosis of sjia as per international league against rheumatism (ilar) definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age.
    Description

    SJIA | Onset of illness Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1384600
    UMLS CUI [2,1]
    C0277793
    UMLS CUI [2,2]
    C0001779
    active sjia defined as having 2 or more of the following:
    Description

    SJIA | Criteria Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1384600
    UMLS CUI [2,1]
    C0243161
    UMLS CUI [2,2]
    C1265611
    documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day 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
    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
    c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l)
    Description

    C-reactive protein measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201657
    rash due to sjia
    Description

    Exanthema Due to SJIA

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0678226
    UMLS CUI [1,3]
    C1384600
    serositis
    Description

    Serositis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0036749
    lymphadenopathy
    Description

    Lymphadenopathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0497156
    hepatosplenomegaly
    Description

    Hepatosplenomegaly

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019214
    negative tb screen (quantiferon or, if required by local guidelines, purified protein derivative).
    Description

    Tuberculosis screening Negative | QUANTIFERON-TB GOLD | Purified Protein Derivative

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0420004
    UMLS CUI [1,2]
    C1513916
    UMLS CUI [2]
    C1875713
    UMLS CUI [3]
    C0034131
    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.
    Description

    Bacterial Infection | Recurrent bacterial infection | Mycoses | Mycoses Recurrent | Virus Disease | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C

    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
    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 (SJIA) NCT02296424

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Cohort Number
    Item
    cohort 1:
    boolean
    C0599755 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Canakinumab Dose | Systemic juvenile idiopathic arthritis
    Item
    • patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for systemic juvenile idiopathic arthritis (sjia) and have inactive disease at the last visit in study cacz885g2301e1
    boolean
    C2718773 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1384600 (UMLS CUI [2])
    Cohort Number
    Item
    cohort 2:
    boolean
    C0599755 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    SJIA | Onset of illness Age
    Item
    confirmed diagnosis of sjia as per international league against rheumatism (ilar) definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age.
    boolean
    C1384600 (UMLS CUI [1])
    C0277793 (UMLS CUI [2,1])
    C0001779 (UMLS CUI [2,2])
    SJIA | Criteria Quantity
    Item
    active sjia defined as having 2 or more of the following:
    boolean
    C1384600 (UMLS CUI [1])
    C0243161 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    Spiking fever Intermittent Duration | Body temperature measurement
    Item
    documented spiking, intermittent fever (body temperature > 38°c) for at least 1 day 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])
    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])
    C-reactive protein measurement
    Item
    c-reactive protein (crp) > 30 mg/l (normal range < 10 mg/l)
    boolean
    C0201657 (UMLS CUI [1])
    Exanthema Due to SJIA
    Item
    rash due to sjia
    boolean
    C0015230 (UMLS CUI [1,1])
    C0678226 (UMLS CUI [1,2])
    C1384600 (UMLS CUI [1,3])
    Serositis
    Item
    serositis
    boolean
    C0036749 (UMLS CUI [1])
    Lymphadenopathy
    Item
    lymphadenopathy
    boolean
    C0497156 (UMLS CUI [1])
    Hepatosplenomegaly
    Item
    hepatosplenomegaly
    boolean
    C0019214 (UMLS CUI [1])
    Tuberculosis screening Negative | QUANTIFERON-TB GOLD | Purified Protein Derivative
    Item
    negative tb screen (quantiferon or, if required by local guidelines, purified protein derivative).
    boolean
    C0420004 (UMLS CUI [1,1])
    C1513916 (UMLS CUI [1,2])
    C1875713 (UMLS CUI [2])
    C0034131 (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
    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.
    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])
    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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