ID

43870

Description

Interleukin-1 Receptor Antagonist (IL-1RA) (ANAKINRA) IN SEVERE SYSTEMIC-ONSET JUVENILE IDIOPATHIC ARTHRITIS; ODM derived from: https://clinicaltrials.gov/show/NCT00339157

Link

https://clinicaltrials.gov/show/NCT00339157

Keywords

Versions (2)
  1. 6/27/17 6/27/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Systemic-Onset Juvenile Idiopathic Arthritis NCT00339157

English

Eligibility Systemic-Onset Juvenile Idiopathic Arthritis NCT00339157

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
so-jia (edmonton's revision of durban's consensus conference criteria)
Description

Systemic onset juvenile idiopathic arthritis

Data type

boolean

Alias
UMLS CUI [1]
C1384600
age: at least 2 years and less than 20 years at treatment initiation
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
disease duration of at least 6 months
Description

disease length

Data type

boolean

Alias
UMLS CUI [1]
C0872146
failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg)
Description

Adrenal Cortex Hormones | Therapeutic procedure failed | Adrenal Cortex Hormones U/day Patient need for | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0456683
UMLS CUI [3,3]
C0686904
UMLS CUI [4]
C0005910
active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric rheumatologists, with at least 3 of the following criteria when assessing giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a children health assessment questionnaire (chaq, ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (esr) equal to or higher than 20.
Description

Systemic symptoms Severe | Arthritis | Physician Global Assessment of Disease Activity | Disease Effect Overall Well Being Assessment | functional disability | Health status of children Assessment Questionnaire | Arthritis Joints Quantity | Limited range of motion in joints Quantity | Joint Damage Permanent | Ankylosis | Erythrocyte sedimentation rate measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C2039684
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003864
UMLS CUI [3]
C4050369
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1280500
UMLS CUI [4,3]
C3813622
UMLS CUI [4,4]
C1516048
UMLS CUI [5]
C0872173
UMLS CUI [6,1]
C1822480
UMLS CUI [6,2]
C1516048
UMLS CUI [6,3]
C0034394
UMLS CUI [7,1]
C0003864
UMLS CUI [7,2]
C0022417
UMLS CUI [7,3]
C1265611
UMLS CUI [8,1]
C3152018
UMLS CUI [8,2]
C1265611
UMLS CUI [9,1]
C0022417
UMLS CUI [9,2]
C1883709
UMLS CUI [9,3]
C0205355
UMLS CUI [10]
C0003090
UMLS CUI [11]
C1176468
in the absence of disease-related fever, either crp or first hour esr or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated.
Description

Fever Disease Related Absence | Raised C-reactive protein | ESR raised

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0332197
UMLS CUI [2]
C1833181
UMLS CUI [3]
C0151632
patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage.
Description

Polyarthritis | Inflammation joints Quantity | Limitation of motion

Data type

boolean

Alias
UMLS CUI [1]
C0162323
UMLS CUI [2,1]
C0574941
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0518456
informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough
Description

Informed Consent parent | Informed Consent Patient Representative | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
UMLS CUI [3]
C0021430
teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence
Description

Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036899
tuberculin test performed before day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment
Description

Tuberculin test negative | Tuberculin test positive Immunization Related | Tuberculin test positive Intensity Normal

Data type

boolean

Alias
UMLS CUI [1]
C0853313
UMLS CUI [2,1]
C0032739
UMLS CUI [2,2]
C0020971
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0032739
UMLS CUI [3,2]
C0522510
UMLS CUI [3,3]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with il-1ra
Description

anakinra

Data type

boolean

Alias
UMLS CUI [1]
C0245109
intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment
Description

Intra-Articular Injections | Non-Steroidal Anti-Inflammatory Agents Dose Changed | Adrenal Cortex Hormones Dose Changed

Data type

boolean

Alias
UMLS CUI [1]
C0021488
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0392747
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0392747
treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties)
Description

Immunosuppressive Agents | Pharmaceutical Preparations Disease Modification

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0392747
contra-indication to the use of anakinra including ongoing active infection or allergy to e coli's derivate or other components of the drug
Description

Medical contraindication anakinra | Medical contraindication Communicable Diseases | Hypersensitivity Escherichia coli Derivative

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0245109
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0009450
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0014834
UMLS CUI [3,3]
C1527240
previous history of malignancy or heart insufficiency
Description

Malignant Neoplasms | Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0018801
patients with asthma require to be previously assessed by a pneumonologist
Description

Asthma | Pneumonology Assessment Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0034060
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0686904
obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration
Description

Therapeutic Intervention Patient need for | Operative Surgical Procedures | Intra-Articular Injections | Live Vaccine Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0808232
UMLS CUI [1,2]
C0686904
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0021488
UMLS CUI [4,1]
C0042211
UMLS CUI [4,2]
C1533734
any of the following: leucocyte counts < 3.6 x 10e9/l, polymorphonuclear neutrophil counts < 1.5 x 10e9/l, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range
Description

White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Serum creatinine raised | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0700225
UMLS CUI [5]
C0151905
UMLS CUI [6]
C0151904
UMLS CUI [7]
C0741494
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Similar models

Eligibility Systemic-Onset Juvenile Idiopathic Arthritis NCT00339157

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Systemic onset juvenile idiopathic arthritis
Item
so-jia (edmonton's revision of durban's consensus conference criteria)
boolean
C1384600 (UMLS CUI [1])
Age
Item
age: at least 2 years and less than 20 years at treatment initiation
boolean
C0001779 (UMLS CUI [1])
disease length
Item
disease duration of at least 6 months
boolean
C0872146 (UMLS CUI [1])
Adrenal Cortex Hormones | Therapeutic procedure failed | Adrenal Cortex Hormones U/day Patient need for | Body Weight
Item
failure of corticosteroid treatment or requirement for corticosteroid treatment at a daily dose equal to or over 0.3 mg/kg (10 mg in patients whose weight is over 34 kg)
boolean
C0001617 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
C0005910 (UMLS CUI [4])
Systemic symptoms Severe | Arthritis | Physician Global Assessment of Disease Activity | Disease Effect Overall Well Being Assessment | functional disability | Health status of children Assessment Questionnaire | Arthritis Joints Quantity | Limited range of motion in joints Quantity | Joint Damage Permanent | Ankylosis | Erythrocyte sedimentation rate measurement
Item
active and severe systemic symptoms and/or arthritis as assessed by an experienced pediatric rheumatologists, with at least 3 of the following criteria when assessing giannini's core-set items: 1) physician global assessment of disease activity of at least 20/100; 2) parent/patient assessment of disease effect on overall well-being of at least 20/100; 3) functional disability with a children health assessment questionnaire (chaq, ref [9]) score equal to or higher than 0.375/3; 4) 2 joints or more with active arthritis 5) 2 joints or more with non-irreversible limited range of motion (irreversible limited range of motion will be defined by radiological evidence of irreversible joint damage and ankylosis) 6) erythrocyte sedimentation rate (esr) equal to or higher than 20.
boolean
C2039684 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003864 (UMLS CUI [2])
C4050369 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C1280500 (UMLS CUI [4,2])
C3813622 (UMLS CUI [4,3])
C1516048 (UMLS CUI [4,4])
C0872173 (UMLS CUI [5])
C1822480 (UMLS CUI [6,1])
C1516048 (UMLS CUI [6,2])
C0034394 (UMLS CUI [6,3])
C0003864 (UMLS CUI [7,1])
C0022417 (UMLS CUI [7,2])
C1265611 (UMLS CUI [7,3])
C3152018 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C0022417 (UMLS CUI [9,1])
C1883709 (UMLS CUI [9,2])
C0205355 (UMLS CUI [9,3])
C0003090 (UMLS CUI [10])
C1176468 (UMLS CUI [11])
Fever Disease Related Absence | Raised C-reactive protein | ESR raised
Item
in the absence of disease-related fever, either crp or first hour esr or both have to be over the upper limit of normal values so that treatment effect on the systemic part of the disease can be objectively evaluated.
boolean
C0015967 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
C1833181 (UMLS CUI [2])
C0151632 (UMLS CUI [3])
Polyarthritis | Inflammation joints Quantity | Limitation of motion
Item
patients with polyarthritis (at least 5 joints with inflammation and/or limitation of motion) will be eligible for this study only if at least 50% of the affected joints do not present radiological evidence of irreversible damage.
boolean
C0162323 (UMLS CUI [1])
C0574941 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0518456 (UMLS CUI [3])
Informed Consent parent | Informed Consent Patient Representative | Informed Consent
Item
informed consent signed by the parents or the person legally responsible for the patient if the patient is less than 18, and by the patient if old enough
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Childbearing Potential Contraceptive methods | Childbearing Potential Sexual Abstinence
Item
teenager girls or young women with childbearing potential must use a contraceptive method (including abstinence
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
Tuberculin test negative | Tuberculin test positive Immunization Related | Tuberculin test positive Intensity Normal
Item
tuberculin test performed before day 1 and must either be negative or positivity must be related to previous immunization and of normal intensity according to the investigator's judgment
boolean
C0853313 (UMLS CUI [1])
C0032739 (UMLS CUI [2,1])
C0020971 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0032739 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0205307 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
anakinra
Item
previous treatment with il-1ra
boolean
C0245109 (UMLS CUI [1])
Intra-Articular Injections | Non-Steroidal Anti-Inflammatory Agents Dose Changed | Adrenal Cortex Hormones Dose Changed
Item
intra-articular injection or change in the doses of non-steroidal anti-inflammatory drugs and corticosteroids in the 4 weeks preceding the initiation of anakinra treatment
boolean
C0021488 (UMLS CUI [1])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
C0001617 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
Immunosuppressive Agents | Pharmaceutical Preparations Disease Modification
Item
treatment with another immunosuppressive or disease-modifying drugs that could not be stopped before inclusion (for a duration depending on the drug pharmacokinetic properties)
boolean
C0021081 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0392747 (UMLS CUI [2,3])
Medical contraindication anakinra | Medical contraindication Communicable Diseases | Hypersensitivity Escherichia coli Derivative
Item
contra-indication to the use of anakinra including ongoing active infection or allergy to e coli's derivate or other components of the drug
boolean
C1301624 (UMLS CUI [1,1])
C0245109 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0014834 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
Malignant Neoplasms | Heart failure
Item
previous history of malignancy or heart insufficiency
boolean
C0006826 (UMLS CUI [1])
C0018801 (UMLS CUI [2])
Asthma | Pneumonology Assessment Patient need for
Item
patients with asthma require to be previously assessed by a pneumonologist
boolean
C0004096 (UMLS CUI [1])
C0034060 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Therapeutic Intervention Patient need for | Operative Surgical Procedures | Intra-Articular Injections | Live Vaccine Administration
Item
obvious need of therapeutic intervention before study completion such as surgery, intra-articular injection, life vaccine administration
boolean
C0808232 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C0021488 (UMLS CUI [3])
C0042211 (UMLS CUI [4,1])
C1533734 (UMLS CUI [4,2])
White Blood Cell Count procedure | Neutrophil count | Platelet Count measurement | Serum creatinine raised | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
any of the following: leucocyte counts < 3.6 x 10e9/l, polymorphonuclear neutrophil counts < 1.5 x 10e9/l, platelets < 150 000/mm3, serum creatinin > 1.5 the upper limit of normal range for age, serum alanine and aspartate transaminases > 2 times the upper limit of the normal range, serum bilirubin > 2 times the upper limit of the normal range
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0700225 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
C0741494 (UMLS CUI [7])
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