Informações:
Falhas:
ID
22947
Descrição
Etanercept SFP in RA Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00413452
Link
https://clinicaltrials.gov/show/NCT00413452
Palavras-chave
Versões (1)
- 18/06/2017 18/06/2017 -
Transferido a
18 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00413452
Eligibility Rheumatoid Arthritis NCT00413452
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00413452
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age | Rheumatoid Arthritis
Item
men and women 18 years of age or older who have ra, as defined by the acr criteria for classification of ra
boolean
C0001779 (UMLS CUI [1])
C0003873 (UMLS CUI [2])
C0003873 (UMLS CUI [2])
Etanercept therapy naive
Item
naïve to etanercept therapy
boolean
C4075969 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0919936 (UMLS CUI [1,2])
Investigational New Drug Injection Self Ability | Investigational New Drug Injection Ability Patient Representative
Item
able to self-inject investigational product or have a designee who can do so
boolean
C0013230 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
C0013230 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0030701 (UMLS CUI [2,4])
C1533685 (UMLS CUI [1,2])
C0036588 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
C0013230 (UMLS CUI [2,1])
C1533685 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
C0030701 (UMLS CUI [2,4])
Informed Consent | Exclusion Criteria
Item
ethical - before any study-specific procedure, the appropriate written informed consent must be obtained exclusion criteria
boolean
C0021430 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
C0680251 (UMLS CUI [2])
Adrenal Cortex Hormones | Prednisone U/day | Prednisone equivalent
Item
receipt of corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
Methotrexate
Item
receipt of mtx witin 30 days of 1st dose of investigational product
boolean
C0025677 (UMLS CUI [1])
Investigational New Drugs
Item
receipt of an other investigational drug within 30 days of 1st dose
boolean
C0013230 (UMLS CUI [1])
TNF inhibitors
Item
receipt of tnf inhibitor therapy within 90 days of 1st dose
boolean
C3653350 (UMLS CUI [1])
Cyclophosphamide
Item
receipt of cyclophosphamide within 6 mo of 1st dose
boolean
C0010583 (UMLS CUI [1])
Non-Steroidal Anti-Inflammatory Agents Dose Greater Than Recommendation
Item
current use of nonsteroidal anti-inflammatory drugs (nsaids) greather than the maximum recommended dose in the product info sheet
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0439093 (UMLS CUI [1,3])
C0034866 (UMLS CUI [1,4])
C0178602 (UMLS CUI [1,2])
C0439093 (UMLS CUI [1,3])
C0034866 (UMLS CUI [1,4])
Insulin
Item
current use of insulin
boolean
C0021641 (UMLS CUI [1])
Comorbidity Significant
Item
gnificant concurrent medical condition
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])