0 Bedömningar
ID

42663

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02090348

Nyckelord

Versioner (2)
  1. 20/11/2015 20/11/2015 -
  2. 17/09/2021 17/09/2021 -
Uppladdad den

17 de setembro de 2021

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

    Engelsk

    Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

    1 Formulär  
    Criteria
    Beskrivning

    Criteria

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

    Relapsing-Remitting Multiple Sclerosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0751967 (Multiple Sclerosis, Relapsing-Remitting)
    SNOMED
    426373005
    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.
    Beskrivning

    Expanded Disability Status Scale

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0451246 (Kurtzke multiple sclerosis rating scale)
    SNOMED
    273554001
    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.
    Beskrivning

    Clinically stable

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    fsmc total score ≥43 (mild fatigue) at baseline.
    Beskrivning

    Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2733557 (Fatigue impact scale)
    SNOMED
    443226002
    as perceived by the investigator, have the ability to comply with all requirements of the study protocol.
    Beskrivning

    Ability to comply with all requirements of the study protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    key exclusion criteria:
    Beskrivning

    Exclusion Criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0680251 (Exclusion Criteria)
    diagnosis of major depression, as identified by the investigator.
    Beskrivning

    Major depression

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1269683 (Major Depressive Disorder)
    SNOMED
    370143000
    diagnosis of primary progressive, secondary progressive, or progressive relapsing multiple sclerosis.
    Beskrivning

    Relapsing Multiple Sclerosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0751967 (Multiple Sclerosis, Relapsing-Remitting)
    SNOMED
    426373005
    UMLS CUI [2]
    C0393666 (Multiple Sclerosis, Progressive Relapsing)
    SNOMED
    724778008
    UMLS CUI [3]
    C0393664 (Multiple Sclerosis, Acute Relapsing)
    SNOMED
    230372003
    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.
    Beskrivning

    History of malignancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058 (Protocol Compliance)
    UMLS CUI [1,2]
    C0009488 (Comorbidity)
    UMLS CUI [1,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    treatment of ms relapse within 90 days prior to study enrollment.
    Beskrivning

    Multiple sclerosis relapse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0856120 (Multiple sclerosis relapse)
    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.
    Beskrivning

    History of a positive infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [2]
    C0166049 (Hepatitis C Antibodies)
    SNOMED
    72165005
    LOINC
    LP38332-0
    UMLS CUI [3]
    C0149708 (Hepatitis B surface antibody positive)
    impaired hepatic or renal function, as perceived by the investigator.
    Beskrivning

    Impaired hepatic or renal function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0086565 (Liver Dysfunction)
    SNOMED
    75183008
    UMLS CUI [2]
    C3279454 (Renal dysfunction)
    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.
    Beskrivning

    Any prior treatment with dmf

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0012426 (Dimethylformamide)
    SNOMED
    782426003
    LOINC
    LP14354-2
    UMLS CUI [2]
    C0024230 (Lymphatic Irradiation)
    current enrollment in any other clinical studies.
    Beskrivning

    Current enrollment in any other clinical studies

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    known to suffer from narcolepsy or another significant sleep disorder.
    Beskrivning

    Narcolepsy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027404 (Narcolepsy)
    SNOMED
    60380001
    UMLS CUI [2]
    C0851578 (Sleep Disorders)
    SNOMED
    39898005
    comorbidity that may have an impact on fatigue.
    Beskrivning

    Comorbidity

    Datatyp

    boolean

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

    Unsuitable for enrollment.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058 (Protocol Compliance)
    UMLS CUI [1,2]
    C0009488 (Comorbidity)
    UMLS CUI [1,3]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    note: other protocol-defined inclusion/exclusion criteria may apply
    Beskrivning

    Inclusion/exclusion criteria

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2827031 (Trial Inclusion Exclusion Criteria Rule)
    Tillbaka till toppen

    Similar models

    Eligibility Relapsing-Remitting Multiple Sclerosis NCT02090348

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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])
    Tillbaka till toppen 

    Kontakt

    Använd detta formulär för feedback, frågor och förslag på förbättringar.

    Fält markerade med * är obligatoriska.

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial