ID

30096

Beschreibung

A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00988221

Link

https://clinicaltrials.gov/show/NCT00988221

Stichworte

Versionen (1)
  1. 09.05.18 09.05.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Mai 2018

DOI

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Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT00988221

Englisch

Eligibility Juvenile Idiopathic Arthritis NCT00988221

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
children/juveniles, 2-17 years of age.
Beschreibung

Children | Juvenile | Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C3146221
UMLS CUI [3]
C0001779
polyarticular-course juvenile idiopathic arthritis (pcjia) ≥ 6 months duration.
Beschreibung

Juvenile arthritis Course Polyarticular Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3495559
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0240789
UMLS CUI [1,4]
C0449238
active disease (≥ 5 active joints, ≥ 3 with limitation of motion).
Beschreibung

Disease Active | Active joint count | Joints Quantity Limitation of motion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205177
UMLS CUI [2]
C4067216
UMLS CUI [3,1]
C0022417
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231589
inadequate response to or inability to tolerate methotrexate.
Beschreibung

Methotrexate Disease Response Inadequate | Intolerance to Methotrexate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025677
methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (nsaid) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.
Beschreibung

Methotrexate Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | NSAIDs Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1527415
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic.
Beschreibung

Biological agents Discontinued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C1444662
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
auto-immune, rheumatic disease or overlap syndrome other than pcjia.
Beschreibung

Autoimmune Diseases | Rheumatism | Overlap syndrome | Exception Juvenile arthritis Course Polyarticular

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0035435
UMLS CUI [3]
C0410000
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C3495559
UMLS CUI [4,3]
C0750729
UMLS CUI [4,4]
C0240789
wheelchair bound or bedridden.
Beschreibung

Wheelchair bound | Bed-ridden

Datentyp

boolean

Alias
UMLS CUI [1]
C0558195
UMLS CUI [2]
C0425251
intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1522204
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1556154
UMLS CUI [3,1]
C0001617
UMLS CUI [3,2]
C1522726
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0205177
UMLS CUI [4,3]
C0443252
disease-modifying anti-rheumatic drugs (dmard) (other than methotrexate) within 4 weeks prior to baseline.
Beschreibung

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Datentyp

boolean

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

tocilizumab

Datentyp

boolean

Alias
UMLS CUI [1]
C1609165
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Ähnliche Modelle

Eligibility Juvenile Idiopathic Arthritis NCT00988221

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Children | Juvenile | Age
Item
children/juveniles, 2-17 years of age.
boolean
C0008059 (UMLS CUI [1])
C3146221 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Juvenile arthritis Course Polyarticular Duration
Item
polyarticular-course juvenile idiopathic arthritis (pcjia) ≥ 6 months duration.
boolean
C3495559 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0240789 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Disease Active | Active joint count | Joints Quantity Limitation of motion
Item
active disease (≥ 5 active joints, ≥ 3 with limitation of motion).
boolean
C0012634 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C4067216 (UMLS CUI [2])
C0022417 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231589 (UMLS CUI [3,3])
Methotrexate Disease Response Inadequate | Intolerance to Methotrexate
Item
inadequate response to or inability to tolerate methotrexate.
boolean
C0025677 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Methotrexate Dose Stable | Adrenal Cortex Hormones Oral Dose Stable | NSAIDs Dose Stable
Item
methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (nsaid) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
C0003211 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Biological agents Discontinued
Item
biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic.
boolean
C0005515 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Diseases | Rheumatism | Overlap syndrome | Exception Juvenile arthritis Course Polyarticular
Item
auto-immune, rheumatic disease or overlap syndrome other than pcjia.
boolean
C0004364 (UMLS CUI [1])
C0035435 (UMLS CUI [2])
C0410000 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C3495559 (UMLS CUI [4,2])
C0750729 (UMLS CUI [4,3])
C0240789 (UMLS CUI [4,4])
Wheelchair bound | Bed-ridden
Item
wheelchair bound or bedridden.
boolean
C0558195 (UMLS CUI [1])
C0425251 (UMLS CUI [2])
Adrenal Cortex Hormones Intraarticular | Adrenal Cortex Hormones Intramuscular | Adrenal Cortex Hormones Intravenous | Adrenal Cortex Hormones Active Long-term
Item
intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline.
boolean
C0001617 (UMLS CUI [1,1])
C1522204 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C1556154 (UMLS CUI [2,2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate
Item
disease-modifying anti-rheumatic drugs (dmard) (other than methotrexate) within 4 weeks prior to baseline.
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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