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ID

42663

Beschrijving

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate; ODM derived from: https://clinicaltrials.gov/show/NCT02090348

Link

https://clinicaltrials.gov/show/NCT02090348

Trefwoorden

Versies (2)
  1. 20-11-15 20-11-15 -
  2. 17-09-21 17-09-21 -
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17 september 2021

DOI

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Licentie

Creative Commons BY 4.0
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    Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

    Engels

    Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

    1 Formulieren  
    Criteria
    Beschrijving

    Criteria

    have a confirmed diagnosis of rrms and satisfies the therapeutic indication as described in the local label.
    Beschrijving

    Relapsing-Remitting Multiple Sclerosis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0751967
    have a stable edss (as assessed by the investigator) and been on the same (type and dosage) standard of care (soc) first-line treatment for at least 6 months.
    Beschrijving

    Expanded Disability Status Scale

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0451246
    if taking antidepressants, amphetamine, modafinil, or fampridine (fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the baseline visit.
    Beschrijving

    Clinically stable

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0205360
    fsmc total score ≥43 (mild fatigue) at baseline.
    Beschrijving

    Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2733557
    as perceived by the investigator, have the ability to comply with all requirements of the study protocol.
    Beschrijving

    Ability to comply with all requirements of the study protocol

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1321605
    key exclusion criteria:
    Beschrijving

    Exclusion Criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    diagnosis of major depression, as identified by the investigator.
    Beschrijving

    Major depression

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1269683
    diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
    Beschrijving

    Relapsing Multiple Sclerosis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0751967
    UMLS CUI [2]
    C0393666
    UMLS CUI [3]
    C0393664
    history of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
    Beschrijving

    History of malignancy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0009488
    UMLS CUI [1,3]
    C0439801
    treatment of ms relapse within 90 days prior to study enrollment.
    Beschrijving

    Multiple sclerosis relapse

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0856120
    history of a positive test result for human immunodeficiency virus, hepatitis c virus antibody, or hepatitis b virus (defined as positive for hepatitis b surface antigen or hepatitis b core antibody.
    Beschrijving

    History of a positive infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0166049
    UMLS CUI [3]
    C0149708
    impaired hepatic or renal function, as perceived by the investigator.
    Beschrijving

    Impaired hepatic or renal function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C3279454
    any prior treatment with dmf (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, t cell or t-cell receptor vaccination, or any therapeutic monoclonal antibody.
    Beschrijving

    Any prior treatment with dmf

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0012426
    UMLS CUI [2]
    C0024230
    current enrollment in any other clinical studies.
    Beschrijving

    Current enrollment in any other clinical studies

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    known to suffer from narcolepsy or another significant sleep disorder.
    Beschrijving

    Narcolepsy

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0027404
    UMLS CUI [2]
    C0851578
    comorbidity that may have an impact on fatigue.
    Beschrijving

    Comorbidity

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment.
    Beschrijving

    Unsuitable for enrollment.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C0009488
    UMLS CUI [1,3]
    C0439801
    note: other protocol-defined inclusion/exclusion criteria may apply
    Beschrijving

    Inclusion/exclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C2827031
    Terug naar het begin van de pagina

    Similar models

    Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Relapsing-Remitting Multiple Sclerosis
    Item
    have a confirmed diagnosis of rrms and satisfies the therapeutic indication as described in the local label.
    boolean
    C0751967 (UMLS CUI [1])
    Expanded Disability Status Scale
    Item
    have a stable edss (as assessed by the investigator) and been on the same (type and dosage) standard of care (soc) first-line treatment for at least 6 months.
    boolean
    C0451246 (UMLS CUI [1])
    Clinically stable
    Item
    if taking antidepressants, amphetamine, modafinil, or fampridine (fampyra), subject must be assessed as having been clinically stable for at least 3 months prior to the baseline visit.
    boolean
    C0205360 (UMLS CUI [1])
    Fatigue Scale for Motor and Cognitive Functions (FSMC)
    Item
    fsmc total score ≥43 (mild fatigue) at baseline.
    boolean
    C2733557 (UMLS CUI [1])
    Ability to comply with all requirements of the study protocol
    Item
    as perceived by the investigator, have the ability to comply with all requirements of the study protocol.
    boolean
    C1321605 (UMLS CUI [1])
    Exclusion Criteria
    Item
    key exclusion criteria:
    boolean
    C0680251 (UMLS CUI [1])
    Major depression
    Item
    diagnosis of major depression, as identified by the investigator.
    boolean
    C1269683 (UMLS CUI [1])
    Relapsing Multiple Sclerosis
    Item
    diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
    boolean
    C0751967 (UMLS CUI [1])
    C0393666 (UMLS CUI [2])
    C0393664 (UMLS CUI [3])
    History of malignancy
    Item
    history of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    Multiple sclerosis relapse
    Item
    treatment of ms relapse within 90 days prior to study enrollment.
    boolean
    C0856120 (UMLS CUI [1])
    History of a positive infection
    Item
    history of a positive test result for human immunodeficiency virus, hepatitis c virus antibody, or hepatitis b virus (defined as positive for hepatitis b surface antigen or hepatitis b core antibody.
    boolean
    C0019682 (UMLS CUI [1])
    C0166049 (UMLS CUI [2])
    C0149708 (UMLS CUI [3])
    Impaired hepatic or renal function
    Item
    impaired hepatic or renal function, as perceived by the investigator.
    boolean
    C0086565 (UMLS CUI [1])
    C3279454 (UMLS CUI [2])
    Any prior treatment with dmf
    Item
    any prior treatment with dmf (or other fumarate derivative), total lymphoid irradiation, cladribine, fingolimod, t cell or t-cell receptor vaccination, or any therapeutic monoclonal antibody.
    boolean
    C0012426 (UMLS CUI [1])
    C0024230 (UMLS CUI [2])
    Current enrollment in any other clinical studies
    Item
    current enrollment in any other clinical studies.
    boolean
    C2348568 (UMLS CUI [1])
    Narcolepsy
    Item
    known to suffer from narcolepsy or another significant sleep disorder.
    boolean
    C0027404 (UMLS CUI [1])
    C0851578 (UMLS CUI [2])
    Comorbidity
    Item
    comorbidity that may have an impact on fatigue.
    boolean
    C0009488 (UMLS CUI [1])
    Unsuitable for enrollment.
    Item
    other unspecified reasons that, in the opinion of the investigator or biogen idec, make the subject unsuitable for enrollment.
    boolean
    C0525058 (UMLS CUI [1,1])
    C0009488 (UMLS CUI [1,2])
    C0439801 (UMLS CUI [1,3])
    Inclusion/exclusion criteria
    Item
    note: other protocol-defined inclusion/exclusion criteria may apply
    boolean
    C2827031 (UMLS CUI [1])
    Terug naar het begin van de pagina 

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