ID

15251

Description

Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00078806

Link

https://clinicaltrials.gov/show/NCT00078806

Keywords

Versions (1)
  1. 5/23/16 5/23/16 -
Uploaded on

May 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Juvenile Rheumatoid Arthritis NCT00078806

English

Eligibility Juvenile Rheumatoid Arthritis NCT00078806

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
2 - 18 years of age
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sojra for at least 3 months, with stable systemic features
Description

SOJRA

Data type

boolean

Alias
UMLS CUI [1]
C1384600
if taking methotrexate, hydroxychloroquine, or nsaids, dose must be stable
Description

stable dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C0025677
UMLS CUI [2,1]
C0678766
UMLS CUI [2,2]
C0020336
UMLS CUI [3,1]
C0678766
UMLS CUI [3,2]
C0003211
must take prednisone at a stable dose
Description

prednisone

Data type

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0178602
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
need for other dmards or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
Description

need for other dmards

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0038317
pregnant or nursing female
Description

pregnant or nursing female

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
Description

abnormal laboratory test

Data type

boolean

Alias
UMLS CUI [1]
C0438215
previous receipt of any tnf inhibitor
Description

tnf inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C3653350
live virus vaccine within 12 weeks of study entry
Description

live virus vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0042742
participation in another study requiring informed consent within 12 weeks of entry
Description

participation in another study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
diabetes that requires insulin treatment
Description

diabetes that requires insulin treatment

Data type

boolean

Alias
UMLS CUI [1]
C0011854
infection, chronic, recurrent, or currently active
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
any serious medical or psychiatric condition or history of alcohol or drug abuse
Description

serious medical condition or drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0013146
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Similar models

Eligibility Juvenile Rheumatoid Arthritis NCT00078806

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
2 - 18 years of age
boolean
C0001779 (UMLS CUI [1])
SOJRA
Item
sojra for at least 3 months, with stable systemic features
boolean
C1384600 (UMLS CUI [1])
stable dose
Item
if taking methotrexate, hydroxychloroquine, or nsaids, dose must be stable
boolean
C0678766 (UMLS CUI [1,1])
C0025677 (UMLS CUI [1,2])
C0678766 (UMLS CUI [2,1])
C0020336 (UMLS CUI [2,2])
C0678766 (UMLS CUI [3,1])
C0003211 (UMLS CUI [3,2])
prednisone
Item
must take prednisone at a stable dose
boolean
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
need for other dmards
Item
need for other dmards or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
boolean
C0242708 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0038317 (UMLS CUI [2])
pregnant or nursing female
Item
pregnant or nursing female
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
abnormal laboratory test
Item
clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
boolean
C0438215 (UMLS CUI [1])
tnf inhibitor
Item
previous receipt of any tnf inhibitor
boolean
C3653350 (UMLS CUI [1])
live virus vaccine
Item
live virus vaccine within 12 weeks of study entry
boolean
C0042742 (UMLS CUI [1])
participation in another study
Item
participation in another study requiring informed consent within 12 weeks of entry
boolean
C2348568 (UMLS CUI [1])
diabetes that requires insulin treatment
Item
diabetes that requires insulin treatment
boolean
C0011854 (UMLS CUI [1])
infection
Item
infection, chronic, recurrent, or currently active
boolean
C0009450 (UMLS CUI [1])
serious medical condition or drug abuse
Item
any serious medical or psychiatric condition or history of alcohol or drug abuse
boolean
C0009488 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
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