0 Ratings
ID

15424

Description

Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

Link

https://clinicaltrials.gov/ct2/show/NCT02325440

Keywords

Versions (3)
  1. 5/27/16 5/27/16 -
  2. 5/31/16 5/31/16 -
  3. 5/31/16 5/31/16 -
Uploaded on

May 31, 2016

DOI

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License

Creative Commons BY 4.0
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    ToFingo Screening V1 Pre-examination NCT02325440

    English

    ToFingo Screening V1 Pre-examination NCT02325440

    1 forms  
    Study administration
    Description

    Study administration

    Data entry for this CRF completed
    Description

    Data entry for this CRF completed

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3899518
    Assessment date
    Description

    Assessment Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Current patient (ID)
    Description

    Current patient (ID)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    MSFC (Multiple Sclerosis Functional Composite Measure)
    Description

    MSFC (Multiple Sclerosis Functional Composite Measure)

    Alias
    UMLS CUI-1
    C0026769
    UMLS CUI-2
    C0449820
    Endscore
    Description

    Endscore

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0450973
    UMLS CUI [1,3]
    C0449820
    Last natalizumab dose
    Description

    Last natalizumab dose

    Alias
    UMLS CUI-1
    C1762893
    UMLS CUI-2
    C1172734
    Last natalizumab dose taken (300mg)
    Description

    Last natalizumab dose taken (300mg)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1762893
    UMLS CUI [1,2]
    C1172734
    Ophthalmologic examination
    Description

    Ophthalmologic examination

    Alias
    UMLS CUI-1
    C0200149
    Opthalmologic examination: Result
    Description

    Opthalmologic examination: Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0200149
    Opthalmologic examination: Comment
    Description

    Opthalmologic examination: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0200149
    UMLS CUI [1,2]
    C0947611
    History of uveitis or diabetes mellitus: Result
    Description

    History of uveitis or diabetes melitus: Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C0042164
    UMLS CUI [2]
    C0011849
    History of uveitis or diabetes mellitus: Comment
    Description

    History of uveitis or diabetes mellitus: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042164
    UMLS CUI [1,2]
    C0947611
    UMLS CUI [2,1]
    C0011849
    UMLS CUI [2,2]
    C0947611
    Abnormalities: Result
    Description

    Abnormalities: Result

    Data type

    text

    Alias
    UMLS CUI [1]
    C1704258
    Abnormalities: Comment
    Description

    Abnormalities: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C0947611
    Virus antibody status
    Description

    Virus antibody status

    Alias
    UMLS CUI-1
    C0201278
    Anti-JCV-IgG: Result
    Description

    Anti-JCV-IgG: Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C3511565
    Anti-JCV-IgG: Comment
    Description

    Anti-JCV-IgG: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3511565
    UMLS CUI [1,2]
    C0047611
    Anti-VZV-IgG: Result
    Description

    Anti-VZV-IgG: Result

    Data type

    float

    Measurement units
    • mU/ml
    Alias
    UMLS CUI [1]
    C0443710
    mU/ml
    Anti-VZV-IgG: Comment
    Description

    Anti-VZV-IgG: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0443710
    UMLS CUI [1,2]
    C0947611
    Anti-HIV 1+2: Result
    Description

    Anti-HIV 1+2: Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0019683
    Anti-HIV 1+2: Comment
    Description

    Anti-HIV 1+2: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0019683
    UMLS CUI [1,2]
    C0947611
    HBsAg (Hepatitis B Surface Antigen): Result
    Description

    HBsAg (Hepatitis B Surface Antigen): Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201477
    HBsAg (Hepatitis B Surface Antigen): Comment
    Description

    HBsAg (Hepatitis B Surface Antigen): Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0201477
    UMLS CUI [1,2]
    C0947611
    Anti-HCV: Result
    Description

    Anti-HCV: Result

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0166049
    UMLS CUI [1,2]
    C0242485
    Anti-HCV: Comment
    Description

    Anti-HCV: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0201485
    UMLS CUI [1,2]
    C0947611
    Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
    Description

    Anti-HSV 1/2-IgG (Herpes Simplex virus): Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0919754
    Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
    Description

    Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0919754
    UMLS CUI [1,2]
    C0947611
    Anti-Rubeola-IgG (Measles virus): Result
    Description

    Anti-Rubeola-IgG (Measles virus): Result

    Data type

    float

    Alias
    UMLS CUI [1]
    C0523315
    Anti-Rubeola-IgG (Measles virus): Comment
    Description

    Anti-Rubeola-IgG (Measles virus): Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0523315
    UMLS CUI [1,2]
    C0947611
    ECG
    Description

    ECG

    Alias
    UMLS CUI-1
    C1623258
    AV-Block 2nd degree, Type II: Result
    Description

    AV-Block 2nd degree, Type II: Result

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0155700
    AV-Block 2nd degree, Type II: Comment
    Description

    AV-Block 2nd degree, Type II: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0155700
    UMLS CUI [1,2]
    C0947611
    AV-Block 3rd degree: Result
    Description

    AV-Block 3rd degree: Result

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0151517
    AV-Block 3rd degree: Comment
    Description

    AV-Block 3rd degree: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0151517
    UMLS CUI [1,2]
    C0947611
    QTc intervall: Result
    Description

    QTc intervall: Result

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    QTc intervall: Comment
    Description

    QTc intervall: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0489625
    UMLS CUI [1,2]
    C0947611
    Abnormalities: Result
    Description

    Abnormalities: Result

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C1623258
    Abnormalities: Comment
    Description

    Abnormalities: Comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1704258
    UMLS CUI [1,2]
    C1623258
    UMLS CUI [1,3]
    C0947611
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    Similar models

    ToFingo Screening V1 Pre-examination NCT02325440

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Study administration
    Data entry for this CRF completed
    Item
    Data entry for this CRF completed
    boolean
    C3899518 (UMLS CUI [1])
    Assessment Date
    Item
    Assessment date
    date
    C0011008 (UMLS CUI [1])
    Current patient (ID)
    Item
    Current patient (ID)
    text
    C2348585 (UMLS CUI [1])
    Item Group
    MSFC (Multiple Sclerosis Functional Composite Measure)
    C0026769 (UMLS CUI-1)
    C0449820 (UMLS CUI-2)
    Endscore
    Item
    Endscore
    integer
    C0026769 (UMLS CUI [1,1])
    C0450973 (UMLS CUI [1,2])
    C0449820 (UMLS CUI [1,3])
    Item Group
    Last natalizumab dose
    C1762893 (UMLS CUI-1)
    C1172734 (UMLS CUI-2)
    Last natalizumab dose taken (300mg)
    Item
    Last natalizumab dose taken (300mg)
    date
    C1762893 (UMLS CUI [1,1])
    C1172734 (UMLS CUI [1,2])
    Item Group
    Ophthalmologic examination
    C0200149 (UMLS CUI-1)
    Opthalmologic examination: Result
    Item
    Opthalmologic examination: Result
    text
    C0200149 (UMLS CUI [1])
    Opthalmologic examination: Comment
    Item
    Opthalmologic examination: Comment
    text
    C0200149 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    History of uveitis or diabetes melitus: Result
    Item
    History of uveitis or diabetes mellitus: Result
    text
    C0042164 (UMLS CUI [1])
    C0011849 (UMLS CUI [2])
    History of uveitis or diabetes mellitus: Comment
    Item
    History of uveitis or diabetes mellitus: Comment
    text
    C0042164 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    C0011849 (UMLS CUI [2,1])
    C0947611 (UMLS CUI [2,2])
    Abnormalities: Result
    Item
    Abnormalities: Result
    text
    C1704258 (UMLS CUI [1])
    Abnormalities: Comment
    Item
    Abnormalities: Comment
    text
    C1704258 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    Virus antibody status
    C0201278 (UMLS CUI-1)
    Anti-JCV-IgG: Result
    Item
    Anti-JCV-IgG: Result
    float
    C3511565 (UMLS CUI [1])
    Anti-JCV-IgG: Comment
    Item
    Anti-JCV-IgG: Comment
    text
    C3511565 (UMLS CUI [1,1])
    C0047611 (UMLS CUI [1,2])
    Anti-VZV-IgG: Result
    Item
    Anti-VZV-IgG: Result
    float
    C0443710 (UMLS CUI [1])
    Anti-VZV-IgG: Comment
    Item
    Anti-VZV-IgG: Comment
    text
    C0443710 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Anti-HIV 1+2: Result
    Item
    Anti-HIV 1+2: Result
    float
    C0019683 (UMLS CUI [1])
    Anti-HIV 1+2: Comment
    Item
    Anti-HIV 1+2: Comment
    text
    C0019683 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    HBsAg (Hepatitis B Surface Antigen): Result
    Item
    HBsAg (Hepatitis B Surface Antigen): Result
    float
    C0201477 (UMLS CUI [1])
    HBsAg (Hepatitis B Surface Antigen): Comment
    Item
    HBsAg (Hepatitis B Surface Antigen): Comment
    text
    C0201477 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Anti-HCV: Result
    Item
    Anti-HCV: Result
    float
    C0166049 (UMLS CUI [1,1])
    C0242485 (UMLS CUI [1,2])
    Anti-HCV: Comment
    Item
    Anti-HCV: Comment
    text
    C0201485 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
    Item
    Anti-HSV 1/2-IgG (Herpes Simplex virus): Result
    float
    C0919754 (UMLS CUI [1])
    Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
    Item
    Anti-HSV 1/2-IgG (Herpes Simplex virus): Comment
    text
    C0919754 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Anti-Rubeola-IgG (Measles virus): Result
    Item
    Anti-Rubeola-IgG (Measles virus): Result
    float
    C0523315 (UMLS CUI [1])
    Anti-Rubeola-IgG (Measles virus): Comment
    Item
    Anti-Rubeola-IgG (Measles virus): Comment
    text
    C0523315 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item Group
    ECG
    C1623258 (UMLS CUI-1)
    AV-Block 2nd degree, Type II: Result
    Item
    AV-Block 2nd degree, Type II: Result
    boolean
    C0155700 (UMLS CUI [1])
    AV-Block 2nd degree, Type II: Comment
    Item
    AV-Block 2nd degree, Type II: Comment
    text
    C0155700 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    AV-Block 3rd degree: Result
    Item
    AV-Block 3rd degree: Result
    boolean
    C0151517 (UMLS CUI [1])
    AV-Block 3rd degree: Comment
    Item
    AV-Block 3rd degree: Comment
    text
    C0151517 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    QTc intervall: Result
    Item
    QTc intervall: Result
    float
    C0489625 (UMLS CUI [1])
    QTc intervall: Comment
    Item
    QTc intervall: Comment
    text
    C0489625 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Abnormalities: Result
    Item
    Abnormalities: Result
    boolean
    C1704258 (UMLS CUI [1,1])
    C1623258 (UMLS CUI [1,2])
    Abnormalities: Comment
    Item
    Abnormalities: Comment
    text
    C1704258 (UMLS CUI [1,1])
    C1623258 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
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