0 Evaluaciones
ID

39677

Descripción

An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab); ODM derived from: https://clinicaltrials.gov/show/NCT01667458

Link

https://clinicaltrials.gov/show/NCT01667458

Palabras clave

Versiones (2)
  1. 19/1/19 19/1/19 -
  2. 9/2/20 9/2/20 - Christian Arras
Titular de derechos de autor

Hoffmann-La Roche

Subido en

9 de febrero de 2020

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Eligibility Rheumatoid Arthritis NCT01667458

    Inglés

    Eligibility Rheumatoid Arthritis NCT01667458

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult patients, >/= 18 years of age
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
    Descripción

    moderate to severe active rheumatoid arthritis, disease activity, DAS28

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2368567
    UMLS CUI [2,1]
    C0003873
    UMLS CUI [2,2]
    C0205082
    UMLS CUI [3]
    C4481729
    inadequate clinical response to current treatment with >/= 2 non-biologic dmards, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-tnf therapy
    Descripción

    Clinical response to DMARD + Methotrexate or Anti-TNF therapy, inadequate

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0242708
    UMLS CUI [1,2]
    C0332257
    UMLS CUI [1,3]
    C0025677
    UMLS CUI [1,4]
    C1704632
    UMLS CUI [1,5]
    C0205412
    UMLS CUI [2,1]
    C0281481
    UMLS CUI [2,2]
    C1704632
    UMLS CUI [2,3]
    C0205412
    eligible for roactemra/actemra treatment in daily clinical practice
    Descripción

    Eligible Roactemra, Eligible Actemra

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1548635
    UMLS CUI [1,2]
    C3272237
    UMLS CUI [2,1]
    C1548635
    UMLS CUI [2,2]
    C2740854
    absence of evolutive tuberculosis (tb)
    Descripción

    Tuberculosis, Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0041296
    UMLS CUI [1,2]
    C0332197
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    hypersensitivity to tocilizumab or any of the excipients
    Descripción

    Hypersensitivity, Tocilicumab or other excipients

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1609165
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0015237
    active, severe infections
    Descripción

    Active Infections

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205082
    pregnant or lactating women
    Descripción

    Pregnant, lactating

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    participation in any other interventional study
    Descripción

    Study Participation, Interventional Study

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C3274035
    patients with major depression
    Descripción

    Depression

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1269683
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    Similar models

    Eligibility Rheumatoid Arthritis NCT01667458

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    adult patients, >/= 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    moderate to severe active rheumatoid arthritis, disease activity, DAS28
    Item
    moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
    boolean
    C2368567 (UMLS CUI [1])
    C0003873 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    C4481729 (UMLS CUI [3])
    Clinical response to DMARD + Methotrexate or Anti-TNF therapy, inadequate
    Item
    inadequate clinical response to current treatment with >/= 2 non-biologic dmards, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-tnf therapy
    boolean
    C0242708 (UMLS CUI [1,1])
    C0332257 (UMLS CUI [1,2])
    C0025677 (UMLS CUI [1,3])
    C1704632 (UMLS CUI [1,4])
    C0205412 (UMLS CUI [1,5])
    C0281481 (UMLS CUI [2,1])
    C1704632 (UMLS CUI [2,2])
    C0205412 (UMLS CUI [2,3])
    Eligible Roactemra, Eligible Actemra
    Item
    eligible for roactemra/actemra treatment in daily clinical practice
    boolean
    C1548635 (UMLS CUI [1,1])
    C3272237 (UMLS CUI [1,2])
    C1548635 (UMLS CUI [2,1])
    C2740854 (UMLS CUI [2,2])
    Tuberculosis, Absent
    Item
    absence of evolutive tuberculosis (tb)
    boolean
    C0041296 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    Hypersensitivity, Tocilicumab or other excipients
    Item
    hypersensitivity to tocilizumab or any of the excipients
    boolean
    C0020517 (UMLS CUI [1,1])
    C1609165 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0015237 (UMLS CUI [2,2])
    Active Infections
    Item
    active, severe infections
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Pregnant, lactating
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Study Participation, Interventional Study
    Item
    participation in any other interventional study
    boolean
    C2348568 (UMLS CUI [1,1])
    C3274035 (UMLS CUI [1,2])
    Depression
    Item
    patients with major depression
    boolean
    C1269683 (UMLS CUI [1])
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