ID

34300

Descrição

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

Palavras-chave

  1. 16/01/2019 16/01/2019 -
Titular dos direitos

see on clinicaltrials.gov

Transferido a

16 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Enthesitis Related Arthritis (ERA) NCT01166282

Eligibility Enthesitis Related Arthritis (ERA) NCT01166282

Inclusion Criteria
Descrição

Inclusion Criteria

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

ID.1

Tipo de dados

boolean

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

ID.2

Tipo de dados

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.
Descrição

ID.3

Tipo de dados

boolean

Exclusion Criteria
Descrição

Exclusion Criteria

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

ID.4

Tipo de dados

boolean

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

ID.5

Tipo de dados

boolean

presence of immunoglobulin m (igm) rheumatoid factor;
Descrição

ID.6

Tipo de dados

boolean

presence of systemic jia,
Descrição

ID.7

Tipo de dados

boolean

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

ID.8

Tipo de dados

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
Descrição

ID.9

Tipo de dados

boolean

Similar models

Eligibility Enthesitis Related Arthritis (ERA) NCT01166282

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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