ID

34300

Description

A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01166282

Link

https://clinicaltrials.gov/show/NCT01166282

Keywords

  1. 1/16/19 1/16/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 16, 2019

DOI

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License

Creative Commons BY 4.0

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Eligibility Enthesitis Related Arthritis (ERA) NCT01166282

Eligibility Enthesitis Related Arthritis (ERA) NCT01166282

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of enthesitis related arthritis (era) as defined by international league of associations for rheumatology (ilar);
Description

ID.1

Data type

boolean

disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
Description

ID.2

Data type

boolean

inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
Description

ID.3

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any ilar juvenile idiopathic arthritis (jia) subtype other than era;
Description

ID.4

Data type

boolean

psoriasis or a history of psoriasis in the patient or first-degree relative;
Description

ID.5

Data type

boolean

presence of immunoglobulin m (igm) rheumatoid factor;
Description

ID.6

Data type

boolean

presence of systemic jia,
Description

ID.7

Data type

boolean

history of inflammatory bowel disease, previous biologic therapy including anti-tnf therapy with a potential impact on pediatric era;
Description

ID.8

Data type

boolean

infection(s) requiring treatment with iv anti-infectives within 30 days prior to baseline or oral anti-infectives within 14 days prior to baseline
Description

ID.9

Data type

boolean

Similar models

Eligibility Enthesitis Related Arthritis (ERA) NCT01166282

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of enthesitis related arthritis (era) as defined by international league of associations for rheumatology (ilar);
boolean
ID.2
Item
disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location;
boolean
ID.3
Item
inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate.
boolean
Item Group
C0680251 (UMLS CUI)
ID.4
Item
any ilar juvenile idiopathic arthritis (jia) subtype other than era;
boolean
ID.5
Item
psoriasis or a history of psoriasis in the patient or first-degree relative;
boolean
ID.6
Item
presence of immunoglobulin m (igm) rheumatoid factor;
boolean
ID.7
Item
presence of systemic jia,
boolean
ID.8
Item
history of inflammatory bowel disease, previous biologic therapy including anti-tnf therapy with a potential impact on pediatric era;
boolean
ID.9
Item
infection(s) requiring treatment with iv anti-infectives within 30 days prior to baseline or oral anti-infectives within 14 days prior to baseline
boolean

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