ID

15280

Description

Study documentation part: Visits 1 (Screening), Study week -4 to 0 Study Details: A 24-week, multicenter, exploratory, two arm study to assess the effect of Dimethyl fumarate on ImmuneModulatory Action on T cells in patients with relapsing remitting Multiple Sclerosis. Principal Investigator PD Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Keywords

Versions (3)
  1. 9/17/15 9/17/15 - Julian Varghese
  2. 9/22/15 9/22/15 - Julian Varghese
  3. 5/24/16 5/24/16 -
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May 24, 2016

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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    Visit 1 (Screening) Part 1/2, DIMAT-MS, Relapsing Remitting Multiple Sclerosis DRKS00008037 NCT02461069

    English

    NON-MS Treatment and symptomatic MS Treatment

    4 forms  
    General Instructions
    Description

    General Instructions

    Instructions
    Description

    Please document medications which are taken within 30 days prior to Screening on the Concomitant Medication Form. Please document significant non-drug therapies which are performed after signing the informed consent on the Concomitant Medication Form.

    Data type

    text

    Medical Examination
    Description

    Medical Examination

    Medical Examination performed at:
    Description

    Medical Examination performed at:

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0582103
    UMLS CUI [1,2]
    C0011008
    Heart rate (in bpm):
    Description

    HEART RATE

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Systolic blood pressure
    Description

    Systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic
    Description

    Diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0039476
    °C
    Body weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Height
    Description

    Height

    Data type

    float

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Expanded disability status scale (EDSS)
    Description

    Expanded disability status scale (EDSS)

    EDSS performed at
    Description

    EDSS performed at

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0011008
    Visual testing
    Description

    Converted FS Score

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0042789
    Brianstem testing
    Description

    Brianstem testing

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0006121
    Pyramidal testing
    Description

    Pyramidal testing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0228060
    Cerebellar testing
    Description

    Cerebellar testing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0742034
    Bowel/Bladder
    Description

    Bowel/Bladder

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C2707247
    Cerebral testing
    Description

    Cerebral testing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0006104
    Ambulation Score
    Description

    Ambulation Score

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0451246
    UMLS CUI [1,2]
    C0080331
    EDSS step
    Description

    EDSS score

    Data type

    float

    Alias
    UMLS CUI [1]
    C0451246
    Signature
    Description

    Signature

    Date
    Description

    Investigator Signature Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Name/Signature Investigator
    Description

    Name/Signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Back to the top of the page

    Similar models

    NON-MS Treatment and symptomatic MS Treatment

    4 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    General Instructions
    Instructions
    Item
    Instructions
    text
    Item Group
    Medical Examination
    Medical Examination performed at:
    Item
    Medical Examination performed at:
    date
    C0582103 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    HEART RATE
    Item
    Heart rate (in bpm):
    integer
    C0018810 (UMLS CUI [1])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0039476 (UMLS CUI [1])
    Weight
    Item
    Body weight
    float
    C0005910 (UMLS CUI [1])
    Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Item Group
    Expanded disability status scale (EDSS)
    EDSS performed at
    Item
    EDSS performed at
    date
    C0451246 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Visual testing
    integer
    C0451246 (UMLS CUI [1,1])
    C0042789 (UMLS CUI [1,2])
    Visual testing
    Code List
    Visual testing
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 (3)
    CL Item
    3 (4)
    CL Item
    4 (5)
    CL Item
    5 (6)
    CL Item
    6 (7)
    Item
    Brianstem testing
    integer
    C0451246 (UMLS CUI [1,1])
    C0006121 (UMLS CUI [1,2])
    Brianstem testing
    Code List
    Brianstem testing
    CL Item
    0 (1)
    CL Item
    1 (2)
    CL Item
    2 (3)
    CL Item
    3 (4)
    CL Item
    4 (5)
    CL Item
    5 (6)
    Item
    Pyramidal testing
    text
    C0451246 (UMLS CUI [1,1])
    C0228060 (UMLS CUI [1,2])
    Pyramidal testing
    Code List
    Pyramidal testing
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    Item
    Cerebellar testing
    text
    C0451246 (UMLS CUI [1,1])
    C0742034 (UMLS CUI [1,2])
    Cerebellar testing
    Code List
    Cerebellar testing
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    X (X)
    Item
    Bowel/Bladder
    integer
    C0451246 (UMLS CUI [1,1])
    C2707247 (UMLS CUI [1,2])
    Bowel/Bladder
    Code List
    Bowel/Bladder
    CL Item
    Cerebellar testing (1)
    Item
    Cerebral testing
    text
    C0451246 (UMLS CUI [1,1])
    C0006104 (UMLS CUI [1,2])
    Cerebral testing
    Code List
    Cerebral testing
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    Item
    Ambulation Score
    text
    C0451246 (UMLS CUI [1,1])
    C0080331 (UMLS CUI [1,2])
    Ambulation Score
    Code List
    Ambulation Score
    CL Item
    0 (0)
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    EDSS score
    Item
    EDSS step
    float
    C0451246 (UMLS CUI [1])
    Item Group
    Signature
    Investigator Signature Date
    Item
    Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Name/Signature Investigator
    Item
    Name/Signature Investigator
    text
    C2346576 (UMLS CUI [1])
    Back to the top of the page 

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