ID

37280

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02296424

Nyckelord

Versioner (1)
  1. 2019-07-12 2019-07-12 -
Rättsinnehavare

See clinicaltrials.gov

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12 juli 2019

DOI

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

Engelsk

Eligibility Systemic Juvenile Idiopathic Arthritis (SJIA) NCT02296424

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
cohort 1:
Beskrivning

Cohort Number

Datatyp

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
Beskrivning

Canakinumab Dose | Systemic juvenile idiopathic arthritis

Datatyp

boolean

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

Cohort Number

Datatyp

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.
Beskrivning

SJIA | Onset of illness Age

Datatyp

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:
Beskrivning

SJIA | Criteria Quantity

Datatyp

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;
Beskrivning

Spiking fever Intermittent Duration | Body temperature measurement

Datatyp

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
Beskrivning

Joints Quantity Arthritis

Datatyp

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)
Beskrivning

C-reactive protein measurement

Datatyp

boolean

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

Exanthema Due to SJIA

Datatyp

boolean

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

Serositis

Datatyp

boolean

Alias
UMLS CUI [1]
C0036749
lymphadenopathy
Beskrivning

Lymphadenopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0497156
hepatosplenomegaly
Beskrivning

Hepatosplenomegaly

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0420004
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C1875713
UMLS CUI [3]
C0034131
Exclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Neutropenia | Absolute neutrophil count

Datatyp

boolean

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

Eligibility Systemic Juvenile Idiopathic Arthritis (SJIA) NCT02296424

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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