ID

32500

Description

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA); ODM derived from: https://clinicaltrials.gov/show/NCT00889863

Link

https://clinicaltrials.gov/show/NCT00889863

Keywords

Versions (1)
  1. 11/5/18 11/5/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 5, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Systemic Juvenile Idiopathic Arthritis With Active Flare NCT00889863

English

Eligibility Systemic Juvenile Idiopathic Arthritis With Active Flare NCT00889863

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of systemic juvenile idiopathic arthritis as per international league against rheumatism (ilar) definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age.
Description

Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1384600
UMLS CUI [1,2]
C0872146
UMLS CUI [2]
C2599446
arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
Description

Arthritis Joints Quantity | Fever Daily Duration | Associated symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0015967
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0449238
UMLS CUI [3]
C0521989
active disease at the time of enrollment defined as follows:
Description

Active disease

Data type

boolean

Alias
UMLS CUI [1]
C2707252
at least 2 joints with active arthritis (using american college of rheumatology) acr definition of active joint)
Description

Arthritis Joints Quantity | Active joint count ACR Improvement Criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C4067216
UMLS CUI [2,2]
C3273747
documented spiking, intermittent fever (body temperature > 38oc) for at least 1 day during the screening period within 1 week before first study drug dose
Description

Spiking temperature Intermittent fever Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0424781
UMLS CUI [1,2]
C0277799
UMLS CUI [1,3]
C0449238
c-reactive protein > 30 mg/l (normal range < 10 mg/l)
Description

C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201657
no concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
Description

Second line Pharmaceutical Preparations Excluded | Biological Response Modifiers Excluded | Immunosuppressive Agents Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C0021081
UMLS CUI [3,2]
C0332196
stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
Description

Exception | Methotrexate Dose Stable | Folic Acid | Folinic acid

Data type

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0016410
UMLS CUI [4]
C0023413
stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
Description

Exception | Non-Steroidal Anti-Inflammatory Agents Quantity Dose Stable

Data type

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
Description

Exception | Steroid therapy Dose Stable | Prednisone Oral U/day | Prednisone Oral U/day Equivalent

Data type

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0149783
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C3216040
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C3216040
UMLS CUI [4,2]
C0456683
UMLS CUI [4,3]
C0205163
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
diagnosis of active macrophage-activation syndrome (mas) within the last 6 months
Description

Macrophage Activation Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C1096155
risk factors for tuberculosis
Description

Tuberculosis risk factors

Data type

boolean

Alias
UMLS CUI [1]
C0749721
patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of hiv infection, hepatitis b and hepatitis c infection
Description

Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0026946
UMLS CUI [3]
C0042769
UMLS CUI [4]
C1844383
UMLS CUI [5]
C1844384
UMLS CUI [6]
C1837066
UMLS CUI [7]
C0019693
UMLS CUI [8]
C0019163
UMLS CUI [9]
C0019196
other protocol inclusion/exclusion criteria may apply
Description

Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Systemic Juvenile Idiopathic Arthritis With Active Flare NCT00889863

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systemic juvenile idiopathic arthritis Disease length | Age range at onset of disease
Item
confirmed diagnosis of systemic juvenile idiopathic arthritis as per international league against rheumatism (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 | Associated symptoms
Item
arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
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])
C0521989 (UMLS CUI [3])
Active disease
Item
active disease at the time of enrollment defined as follows:
boolean
C2707252 (UMLS CUI [1])
Arthritis Joints Quantity | Active joint count ACR Improvement Criteria
Item
at least 2 joints with active arthritis (using american college of rheumatology) acr definition of active joint)
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C4067216 (UMLS CUI [2,1])
C3273747 (UMLS CUI [2,2])
Spiking temperature Intermittent fever Duration
Item
documented spiking, intermittent fever (body temperature > 38oc) for at least 1 day during the screening period within 1 week before first study drug dose
boolean
C0424781 (UMLS CUI [1,1])
C0277799 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C-reactive protein measurement
Item
c-reactive protein > 30 mg/l (normal range < 10 mg/l)
boolean
C0201657 (UMLS CUI [1])
Second line Pharmaceutical Preparations Excluded | Biological Response Modifiers Excluded | Immunosuppressive Agents Excluded
Item
no concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
boolean
C1710038 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Exception | Methotrexate Dose Stable | Folic Acid | Folinic acid
Item
stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
boolean
C1705847 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0016410 (UMLS CUI [3])
C0023413 (UMLS CUI [4])
Exception | Non-Steroidal Anti-Inflammatory Agents Quantity Dose Stable
Item
stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
boolean
C1705847 (UMLS CUI [1])
C0003211 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Exception | Steroid therapy Dose Stable | Prednisone Oral U/day | Prednisone Oral U/day Equivalent
Item
stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent
boolean
C1705847 (UMLS CUI [1])
C0149783 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C3216040 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C3216040 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Macrophage Activation Syndrome
Item
diagnosis of active macrophage-activation syndrome (mas) within the last 6 months
boolean
C1096155 (UMLS CUI [1])
Tuberculosis risk factors
Item
risk factors for tuberculosis
boolean
C0749721 (UMLS CUI [1])
Bacterial Infections | Mycoses | Virus Diseases | Recurrent bacterial infection | Recurrent fungal infections | Recurrent viral infection | HIV Infection | Hepatitis B | Hepatitis C
Item
patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of hiv infection, hepatitis b and 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])
Eligibility Criteria Study Protocol
Item
other protocol inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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