ID

30084

Beschrijving

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA); ODM derived from: https://clinicaltrials.gov/show/NCT00642460

Link

https://clinicaltrials.gov/show/NCT00642460

Trefwoorden

  1. 09-05-18 09-05-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 mei 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Juvenile Idiopathic Arthritis NCT00642460

Eligibility Juvenile Idiopathic Arthritis NCT00642460

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients aged 2-17 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
systemic juvenile idiopathic arthritis with >= 6 months persistent activity
Beschrijving

Juvenile arthritis Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C3495559
UMLS CUI [1,2]
C0872146
presence of active disease (>=5 active joints, or >=2 active joints + fever +
Beschrijving

Disease Active | Active joint count | Fever

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205177
UMLS CUI [2]
C4067216
UMLS CUI [3]
C0015967
steroids)
Beschrijving

Steroids

Datatype

boolean

Alias
UMLS CUI [1]
C0038317
inadequate clinical response to nonsteroidal anti-inflammatory drugs (nsaids) and corticosteroids due to toxicity or lack of efficacy
Beschrijving

NSAIDs Response Inadequate | Adrenal Cortex Hormones Response Inadequate | Etiology Toxicity | Etiology Lack of Efficacy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1704632
UMLS CUI [2,3]
C0205412
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0600688
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0235828
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
wheelchair-bound or bed-ridden
Beschrijving

Wheelchair bound | Bed-ridden

Datatype

boolean

Alias
UMLS CUI [1]
C0558195
UMLS CUI [2]
C0425251
any other autoimmune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
Beschrijving

Autoimmune Diseases | Rheumatism | Overlap syndrome | Exception Juvenile arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0035435
UMLS CUI [3]
C0410000
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3495559
intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study
Beschrijving

Adrenal Cortex Hormones Intravenous Active Long-term | Adrenal Cortex Hormones Intraarticular

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C0205177
UMLS CUI [1,4]
C0443252
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1522204
disease-modifying antirheumatic drugs (dmards), other than methotrexate
Beschrijving

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Datatype

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
previous treatment with tocilizumab
Beschrijving

tocilizumab

Datatype

boolean

Alias
UMLS CUI [1]
C1609165

Similar models

Eligibility Juvenile Idiopathic Arthritis NCT00642460

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients aged 2-17 years of age
boolean
C0001779 (UMLS CUI [1])
Juvenile arthritis Disease length
Item
systemic juvenile idiopathic arthritis with >= 6 months persistent activity
boolean
C3495559 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Disease Active | Active joint count | Fever
Item
presence of active disease (>=5 active joints, or >=2 active joints + fever +
boolean
C0012634 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C4067216 (UMLS CUI [2])
C0015967 (UMLS CUI [3])
Steroids
Item
steroids)
boolean
C0038317 (UMLS CUI [1])
NSAIDs Response Inadequate | Adrenal Cortex Hormones Response Inadequate | Etiology Toxicity | Etiology Lack of Efficacy
Item
inadequate clinical response to nonsteroidal anti-inflammatory drugs (nsaids) and corticosteroids due to toxicity or lack of efficacy
boolean
C0003211 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0235828 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Wheelchair bound | Bed-ridden
Item
wheelchair-bound or bed-ridden
boolean
C0558195 (UMLS CUI [1])
C0425251 (UMLS CUI [2])
Autoimmune Diseases | Rheumatism | Overlap syndrome | Exception Juvenile arthritis
Item
any other autoimmune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
boolean
C0004364 (UMLS CUI [1])
C0035435 (UMLS CUI [2])
C0410000 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3495559 (UMLS CUI [4,2])
Adrenal Cortex Hormones Intravenous Active Long-term | Adrenal Cortex Hormones Intraarticular
Item
intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study
boolean
C0001617 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,3])
C0443252 (UMLS CUI [1,4])
C0001617 (UMLS CUI [2,1])
C1522204 (UMLS CUI [2,2])
Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate
Item
disease-modifying antirheumatic drugs (dmards), other than methotrexate
boolean
C0242708 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
tocilizumab
Item
previous treatment with tocilizumab
boolean
C1609165 (UMLS CUI [1])

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