0 Avaliações
ID

34535

Descrição

Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01579006

Link

https://clinicaltrials.gov/show/NCT01579006

Palavras-chave

Versões (1)
  1. 19/01/2019 19/01/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de janeiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Rheumatoid Arthritis NCT01579006

    Inglês

    Eligibility Rheumatoid Arthritis NCT01579006

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

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

    Adult | Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001675
    UMLS CUI [2]
    C0001779
    moderate to severe rheumatoid arthritis
    Descrição

    Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2368567
    UMLS CUI [2,1]
    C0003873
    UMLS CUI [2,2]
    C0205082
    inadequate response (or intolerant) to non-biological dmards or one biologic agent
    Descrição

    Non-Biologic Disease-Modifying Antirheumatic Drug Poor response to treatment | Intolerance to Non-Biologic Disease-Modifying Antirheumatic Drug | Biological agent Quantity Poor response to treatment | Intolerance to Biological agent Quantity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C4054347
    UMLS CUI [1,2]
    C1320680
    UMLS CUI [2,1]
    C1744706
    UMLS CUI [2,2]
    C4054347
    UMLS CUI [3,1]
    C0005515
    UMLS CUI [3,2]
    C1265611
    UMLS CUI [3,3]
    C1320680
    UMLS CUI [4,1]
    C1744706
    UMLS CUI [4,2]
    C0005515
    UMLS CUI [4,3]
    C1265611
    patients initiating treatment with roactemra/actemra on their physician's decision (in accordance with the local label), including patients who started treatment with roactemra/actemra in the 8 weeks prior to the enrolment visit
    Descrição

    RoActemra | Actemra

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3272237
    UMLS CUI [2]
    C2740854
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    roactemra/actemra treatment more than 8 weeks prior to the enrolment visit
    Descrição

    RoActemra Previous | Actemra Previous

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3272237
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [2,1]
    C2740854
    UMLS CUI [2,2]
    C0205156
    previous roactemra/actemra treatment in a clinical trial or for compassionate use
    Descrição

    RoActemra Previous Clinical Trial | Actemra Previous Clinical Trial | RoActemra Previous Compassionate Use | Actemra Previous Compassionate Use

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3272237
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [2,1]
    C2740854
    UMLS CUI [2,2]
    C0205156
    UMLS CUI [2,3]
    C0008976
    UMLS CUI [3,1]
    C3272237
    UMLS CUI [3,2]
    C0205156
    UMLS CUI [3,3]
    C2718016
    UMLS CUI [4,1]
    C2740854
    UMLS CUI [4,2]
    C0205156
    UMLS CUI [4,3]
    C2718016
    enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra
    Descrição

    Study Subject Participation Status | Investigational New Drugs

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
    Descrição

    Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0004364
    UMLS CUI [2]
    C0683381
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0003873
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    Similar models

    Eligibility Rheumatoid Arthritis NCT01579006

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Adult | Age
    Item
    adult patients, >/= 18 years of age
    boolean
    C0001675 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe
    Item
    moderate to severe rheumatoid arthritis
    boolean
    C2368567 (UMLS CUI [1])
    C0003873 (UMLS CUI [2,1])
    C0205082 (UMLS CUI [2,2])
    Non-Biologic Disease-Modifying Antirheumatic Drug Poor response to treatment | Intolerance to Non-Biologic Disease-Modifying Antirheumatic Drug | Biological agent Quantity Poor response to treatment | Intolerance to Biological agent Quantity
    Item
    inadequate response (or intolerant) to non-biological dmards or one biologic agent
    boolean
    C4054347 (UMLS CUI [1,1])
    C1320680 (UMLS CUI [1,2])
    C1744706 (UMLS CUI [2,1])
    C4054347 (UMLS CUI [2,2])
    C0005515 (UMLS CUI [3,1])
    C1265611 (UMLS CUI [3,2])
    C1320680 (UMLS CUI [3,3])
    C1744706 (UMLS CUI [4,1])
    C0005515 (UMLS CUI [4,2])
    C1265611 (UMLS CUI [4,3])
    RoActemra | Actemra
    Item
    patients initiating treatment with roactemra/actemra on their physician's decision (in accordance with the local label), including patients who started treatment with roactemra/actemra in the 8 weeks prior to the enrolment visit
    boolean
    C3272237 (UMLS CUI [1])
    C2740854 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    RoActemra Previous | Actemra Previous
    Item
    roactemra/actemra treatment more than 8 weeks prior to the enrolment visit
    boolean
    C3272237 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C2740854 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    RoActemra Previous Clinical Trial | Actemra Previous Clinical Trial | RoActemra Previous Compassionate Use | Actemra Previous Compassionate Use
    Item
    previous roactemra/actemra treatment in a clinical trial or for compassionate use
    boolean
    C3272237 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C2740854 (UMLS CUI [2,1])
    C0205156 (UMLS CUI [2,2])
    C0008976 (UMLS CUI [2,3])
    C3272237 (UMLS CUI [3,1])
    C0205156 (UMLS CUI [3,2])
    C2718016 (UMLS CUI [3,3])
    C2740854 (UMLS CUI [4,1])
    C0205156 (UMLS CUI [4,2])
    C2718016 (UMLS CUI [4,3])
    Study Subject Participation Status | Investigational New Drugs
    Item
    enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis
    Item
    history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
    boolean
    C0004364 (UMLS CUI [1])
    C0683381 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0003873 (UMLS CUI [3,2])
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