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ID

41606

Description

An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab; ODM derived from: https://clinicaltrials.gov/show/NCT02507752

Link

https://clinicaltrials.gov/show/NCT02507752

Keywords

Versions (1)
  1. 11/24/20 11/24/20 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

November 24, 2020

DOI

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License

Creative Commons BY 4.0
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    Eligibility Rheumatoid Arthritis NCT02507752

    English

    Eligibility Rheumatoid Arthritis NCT02507752

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    adult participants of both genders who are 18 years or older
    Description

    gender, age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    diagnosis of ra for at least 6 months according to the criteria of the american college of rheumatology (acr) of 1987 for the ra classification
    Description

    ra for min. 6 months according to criteria of the american college of rheumatology (acr) for the ra classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0003873
    UMLS CUI [1,3]
    C0008902
    UMLS CUI [1,4]
    C3273740
    participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
    Description

    recent medically prescribed or infusion of rituximab

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0278329
    UMLS CUI [1,2]
    C0332185
    UMLS CUI [1,3]
    C0393022
    UMLS CUI [2,1]
    C0574032
    UMLS CUI [2,2]
    C0332185
    UMLS CUI [2,3]
    C0393022
    ability to meet the program's requirements and to voluntarily sign the informed consent term.
    Description

    fulfill program's requirements and informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1550543
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
    Description

    recent investigational medication

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332185
    UMLS CUI [1,2]
    C0304229
    participants with an active infection
    Description

    active infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3714514
    UMLS CUI [1,2]
    C0205177
    participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
    Description

    conditions interfering with ability to understand requests of data collection and with protocol compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C1273101
    UMLS CUI [1,4]
    C1272683
    UMLS CUI [1,5]
    C0010995
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C0525058
    functional class iv defined based on the acr functionality criteria for ra
    Description

    acr functionality criteria for ra: functional class IV

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0003873
    UMLS CUI [1,2]
    C3273747
    UMLS CUI [1,3]
    C0598463
    UMLS CUI [1,4]
    C0456387
    participants who can not or who do not want, for any reason, to answer the questionnaires.
    Description

    unwilling or unable to answer questionaires

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1299582
    UMLS CUI [1,2]
    C0034394
    UMLS CUI [2,1]
    C0558080
    UMLS CUI [2,2]
    C0034394
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    Eligibility Rheumatoid Arthritis NCT02507752

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    gender, age
    Item
    adult participants of both genders who are 18 years or older
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    ra for min. 6 months according to criteria of the american college of rheumatology (acr) for the ra classification
    Item
    diagnosis of ra for at least 6 months according to the criteria of the american college of rheumatology (acr) of 1987 for the ra classification
    boolean
    C0332185 (UMLS CUI [1,1])
    C0003873 (UMLS CUI [1,2])
    C0008902 (UMLS CUI [1,3])
    C3273740 (UMLS CUI [1,4])
    recent medically prescribed or infusion of rituximab
    Item
    participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
    boolean
    C0278329 (UMLS CUI [1,1])
    C0332185 (UMLS CUI [1,2])
    C0393022 (UMLS CUI [1,3])
    C0574032 (UMLS CUI [2,1])
    C0332185 (UMLS CUI [2,2])
    C0393022 (UMLS CUI [2,3])
    fulfill program's requirements and informed consent
    Item
    ability to meet the program's requirements and to voluntarily sign the informed consent term.
    boolean
    C1550543 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    recent investigational medication
    Item
    participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
    boolean
    C0332185 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    active infection
    Item
    participants with an active infection
    boolean
    C3714514 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    conditions interfering with ability to understand requests of data collection and with protocol compliance
    Item
    participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
    boolean
    C0348080 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C1273101 (UMLS CUI [1,3])
    C1272683 (UMLS CUI [1,4])
    C0010995 (UMLS CUI [1,5])
    C0348080 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C0525058 (UMLS CUI [2,3])
    acr functionality criteria for ra: functional class IV
    Item
    functional class iv defined based on the acr functionality criteria for ra
    boolean
    C0003873 (UMLS CUI [1,1])
    C3273747 (UMLS CUI [1,2])
    C0598463 (UMLS CUI [1,3])
    C0456387 (UMLS CUI [1,4])
    unwilling or unable to answer questionaires
    Item
    participants who can not or who do not want, for any reason, to answer the questionnaires.
    boolean
    C1299582 (UMLS CUI [1,1])
    C0034394 (UMLS CUI [1,2])
    C0558080 (UMLS CUI [2,1])
    C0034394 (UMLS CUI [2,2])
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