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ID

29129

Beschreibung

Screening, Baseline and Visit 1 CRFs of DIMAT-MS and ALAIN studies for semantic analysis of Multiple Sclerosis study documentation. Provided by Prof. Dr. Luisa Klotz of the Department of Neurology of the University Hospital Muenster.

Stichworte

Versionen (4)
  1. 27.02.18 27.02.18 -
  2. 29.01.19 29.01.19 - Sarah Riepenhausen
  3. 13.04.21 13.04.21 - Dr. rer. medic Philipp Neuhaus
  4. 20.09.21 20.09.21 -
Rechteinhaber

Prof. Dr. Luisa Klotz

Hochgeladen am

27. Februar 2018

DOI

10.21961/mdm:29129

Eine <abbr title="Digital Object Identifier">DOI</abbr> wurde bereits beantragt.

Lizenz

Creative Commons BY-NC 3.0
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    Multiple sclerosis studies NCT02461069, NCT02419378

    Englisch

    Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

    18 Formulare  
    Inclusion criteria
    Beschreibung

    Inclusion criteria

    Written informed consent must be obtained before any assessment is performed
    Beschreibung

    Code IN01

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Male and female subjects aged 18 - 60 years.
    Beschreibung

    Code IN02

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Patients with RRMS, defined by 2010 revised McDonald criteria
    Beschreibung

    rrms

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0751967
    Patients with an Expanded Disability Status Scale (EDSS) score of 0-6.0.
    Beschreibung

    EDSS

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3830336
    Patients with one of the following treatment status:
    Beschreibung

    ms treatment status

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0026769
    UMLS CUI [1,2]
    C0749659
    MRI-scan of the brain ≤ 3 months at screening.
    Beschreibung

    MRI-scan of the brain

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0024485
    Exclusion criteria
    Beschreibung

    Exclusion criteria

    Known hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera® (microcrystalline cellulose; croscarmellose-sodium; talcum; high dispersion, hydrophobic silicon dioxide; magnesiumstearate (Ph. Eur.); triethylcitrate; methacrylic acid-methacrylate copolymer (1:1) (Ph. Eur.); methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30% (Ph. Eur.), simeticon, sodiumdodecylsulfate, polysorbate 80, gelantine, titanium oxide (E171), brilliant blue (E133), hydrated Iron(III)-oxide hydroxide (E172), shellac, potassium hydroxide.
    Beschreibung

    hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0058218
    A MS-relapse within 30 days prior to screening.
    Beschreibung

    MS relapse

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0035020
    Known history of active tuberculosis or active tuberculosis determined by a positive QuantiFERON® TB Gold test.
    Beschreibung

    tuberculosis or active tuberculosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0041296
    Moderate to severe impairment of liver function or persisting elevations > 2 x ULN (confirmed by retest) of serum glutamic pyruvic transaminase/ alanine aminotransferase (SGPT/ALT), serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST), or direct bilirubin > 2 x ULN, except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
    Beschreibung

    severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0201899
    UMLS CUI [5]
    C0201916
    UMLS CUI [6]
    C0017551
    Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL).
    Beschreibung

    serum creatinine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia • Hematocrit <24% and/or hemoglobin < 8.0 g/dl and/or • Absolute white blood cell count < 4,000 cells/ mm³ (μL) and/or • Absolute neutrophils ≤ 1,500 cells/mm³ (μL) and/or • Platelet count < 150,000 cells/ mm³ (μL).
    Beschreibung

    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0018935
    UMLS CUI [2]
    C0518015
    UMLS CUI [3]
    C0023508
    UMLS CUI [4]
    C0948762
    UMLS CUI [5]
    C0032181
    UMLS CUI [6]
    C1254595
    Women of childbearing potential not utilizing highly effective contraception
    Beschreibung

    Women of childbearing potential not utilizing highly effective contraception

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    UMLS CUI [2]
    C0700589
    Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
    Beschreibung

    Mental condition

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C3840291
    Subjects unlikely to comply with protocol as determined by investigator, e.g., uncooperative attitude, inability to return for follow-up visits (e.g. major physical disability), and known unlikelihood of completing the study.
    Beschreibung

    Patient Non-Compliance

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0376405
    Clinically relevant cardiovascular, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study.
    Beschreibung

    Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0007222
    UMLS CUI [2]
    C0027765
    UMLS CUI [3]
    C0014130
    UMLS CUI [4]
    C0442893
    Subjects with ulcerative colitis or Crohn´s disease
    Beschreibung

    Crohn´s disease

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0010346
    Subjects with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymph proliferative disease, or any subject who has received lymphoid irradiation.
    Beschreibung

    Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021051
    UMLS CUI [2]
    C0006826
    UMLS CUI [3]
    C0024314
    UMLS CUI [4]
    C0007118
    UMLS CUI [5]
    C0024230
    Human immunodeficiency virus (HIV) positive, hepatitis B virus positive or hepatitis C virus positive subjects.
    Beschreibung

    HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    Acute or chronic infection
    Beschreibung

    Acute or chronic infection

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0009450
    History of drug or alcohol abuse.
    Beschreibung

    History of drug or alcohol abuse

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0681694
    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
    Beschreibung

    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149783
    UMLS CUI [2]
    C0149783
    Prior or concomitant use of cytokine therapy or intravenous immunoglobulins in the 3 months prior to screening.
    Beschreibung

    Cytokine therapy | Immunoglobulins, Intravenous

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0199974
    UMLS CUI [2]
    C0085297
    Prior use of alemtuzumab or cladribine.
    Beschreibung

    Prior use of alemtuzumab or cladribine

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0383429
    UMLS CUI [1,2]
    C2114510
    UMLS CUI [2,1]
    C0092801
    UMLS CUI [2,2]
    C2114510
    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
    Beschreibung

    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1699926
    UMLS CUI [2]
    C1172734
    UMLS CUI [3,1]
    C2114510
    UMLS CUI [3,2]
    C0021079
    Prior use (within 2 years) of mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate or mycophenolate mofetil.
    Beschreibung

    Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0026259
    UMLS CUI [2]
    C0004482
    UMLS CUI [3]
    C0010583
    UMLS CUI [4]
    C0010592
    UMLS CUI [5]
    C0025677
    UMLS CUI [6]
    C0209368
    UMLS CUI [7,1]
    C2114510
    UMLS CUI [7,2]
    C0021079
    UMLS CUI [7,2]
    C0205394
    Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 µg/ml.
    Beschreibung

    teriflunomide | leflunomide

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1718383
    UMLS CUI [2]
    C0063041
    Prior use of any investigational drug in the 6 months preceding screening
    Beschreibung

    Investigational New Drugs

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    Pregnant or breast-feeding women.
    Beschreibung

    Patient currently pregnant | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C0006147
    Signature Screening Visit 1
    Beschreibung

    Signature Screening Visit 1

    Signature Date
    Beschreibung

    Signature date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Signature investigator
    Beschreibung

    Signature investigator

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Medical Examination, DIMAT-MS, Relapsing Remitting Multiple Sclerosis NCT02461069

    18 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Inclusion criteria
    Written informed consent
    Item
    Written informed consent must be obtained before any assessment is performed
    boolean
    C0021430 (UMLS CUI [1])
    age
    Item
    Male and female subjects aged 18 - 60 years.
    boolean
    C0001779 (UMLS CUI [1])
    rrms
    Item
    Patients with RRMS, defined by 2010 revised McDonald criteria
    boolean
    C0751967 (UMLS CUI [1])
    EDSS
    Item
    Patients with an Expanded Disability Status Scale (EDSS) score of 0-6.0.
    boolean
    C3830336 (UMLS CUI [1])
    ms treatment status
    Item
    Patients with one of the following treatment status:
    boolean
    C0026769 (UMLS CUI [1,1])
    C0749659 (UMLS CUI [1,2])
    MRI-scan of the brain
    Item
    MRI-scan of the brain ≤ 3 months at screening.
    boolean
    C0024485 (UMLS CUI [1])
    Item Group
    Exclusion criteria
    hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera
    Item
    Known hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera® (microcrystalline cellulose; croscarmellose-sodium; talcum; high dispersion, hydrophobic silicon dioxide; magnesiumstearate (Ph. Eur.); triethylcitrate; methacrylic acid-methacrylate copolymer (1:1) (Ph. Eur.); methacrylic acid-ethylacrylate copolymer (1:1)-dispersion 30% (Ph. Eur.), simeticon, sodiumdodecylsulfate, polysorbate 80, gelantine, titanium oxide (E171), brilliant blue (E133), hydrated Iron(III)-oxide hydroxide (E172), shellac, potassium hydroxide.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0058218 (UMLS CUI [1,2])
    MS relapse
    Item
    A MS-relapse within 30 days prior to screening.
    boolean
    C0035020 (UMLS CUI [1])
    tuberculosis or active tuberculosis
    Item
    Known history of active tuberculosis or active tuberculosis determined by a positive QuantiFERON® TB Gold test.
    boolean
    C0041296 (UMLS CUI [1])
    severe impairment of liver function or persisting elevations except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
    Item
    Moderate to severe impairment of liver function or persisting elevations > 2 x ULN (confirmed by retest) of serum glutamic pyruvic transaminase/ alanine aminotransferase (SGPT/ALT), serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST), or direct bilirubin > 2 x ULN, except patients with confirmed Gilbert´s syndrome (Meulengracht´s disease).
    boolean
    C0232741 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    C0201916 (UMLS CUI [5])
    C0017551 (UMLS CUI [6])
    serum creatinine
    Item
    Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL).
    boolean
    C0201976 (UMLS CUI [1])
    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
    Item
    Patients with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia • Hematocrit <24% and/or hemoglobin < 8.0 g/dl and/or • Absolute white blood cell count < 4,000 cells/ mm³ (μL) and/or • Absolute neutrophils ≤ 1,500 cells/mm³ (μL) and/or • Platelet count < 150,000 cells/ mm³ (μL).
    boolean
    C0018935 (UMLS CUI [1])
    C0518015 (UMLS CUI [2])
    C0023508 (UMLS CUI [3])
    C0948762 (UMLS CUI [4])
    C0032181 (UMLS CUI [5])
    C1254595 (UMLS CUI [6])
    Women of childbearing potential not utilizing highly effective contraception
    Item
    Women of childbearing potential not utilizing highly effective contraception
    boolean
    C3831118 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Mental condition
    Item
    Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
    boolean
    C3840291 (UMLS CUI [1])
    Patient Non-Compliance
    Item
    Subjects unlikely to comply with protocol as determined by investigator, e.g., uncooperative attitude, inability to return for follow-up visits (e.g. major physical disability), and known unlikelihood of completing the study.
    boolean
    C0376405 (UMLS CUI [1])
    Cardiovascular Diseases | nervous system disorder | Endocrine System Diseases | Systemic disease
    Item
    Clinically relevant cardiovascular, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study.
    boolean
    C0007222 (UMLS CUI [1])
    C0027765 (UMLS CUI [2])
    C0014130 (UMLS CUI [3])
    C0442893 (UMLS CUI [4])
    Crohn´s disease
    Item
    Subjects with ulcerative colitis or Crohn´s disease
    boolean
    C0010346 (UMLS CUI [1])
    Immunologic Deficiency Syndromes | Malignant Neoplasms | Lymphoproliferative Disorders | Carcinoma, Basosquamous | Lymphatic Irradiation
    Item
    Subjects with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymph proliferative disease, or any subject who has received lymphoid irradiation.
    boolean
    C0021051 (UMLS CUI [1])
    C0006826 (UMLS CUI [2])
    C0024314 (UMLS CUI [3])
    C0007118 (UMLS CUI [4])
    C0024230 (UMLS CUI [5])
    HIV Seropositivity | Hepatitis B positive | Hepatitis C positive
    Item
    Human immunodeficiency virus (HIV) positive, hepatitis B virus positive or hepatitis C virus positive subjects.
    boolean
    C0019693 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    Acute or chronic infection
    Item
    Acute or chronic infection
    boolean
    C0009450 (UMLS CUI [1])
    C0009450 (UMLS CUI [2])
    History of drug or alcohol abuse
    Item
    History of drug or alcohol abuse.
    boolean
    C0681694 (UMLS CUI [1])
    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
    Item
    Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
    boolean
    C0149783 (UMLS CUI [1])
    C0149783 (UMLS CUI [2])
    Cytokine therapy | Immunoglobulins, Intravenous
    Item
    Prior or concomitant use of cytokine therapy or intravenous immunoglobulins in the 3 months prior to screening.
    boolean
    C0199974 (UMLS CUI [1])
    C0085297 (UMLS CUI [2])
    Prior use of alemtuzumab or cladribine
    Item
    Prior use of alemtuzumab or cladribine.
    boolean
    C0383429 (UMLS CUI [1,1])
    C2114510 (UMLS CUI [1,2])
    C0092801 (UMLS CUI [2,1])
    C2114510 (UMLS CUI [2,2])
    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
    Item
    Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysabri®).
    boolean
    C1699926 (UMLS CUI [1])
    C1172734 (UMLS CUI [2])
    C2114510 (UMLS CUI [3,1])
    C0021079 (UMLS CUI [3,2])
    Mitoxantrone | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | mycophenolate mofetil
    Item
    Prior use (within 2 years) of mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate or mycophenolate mofetil.
    boolean
    C0026259 (UMLS CUI [1])
    C0004482 (UMLS CUI [2])
    C0010583 (UMLS CUI [3])
    C0010592 (UMLS CUI [4])
    C0025677 (UMLS CUI [5])
    C0209368 (UMLS CUI [6])
    C2114510 (UMLS CUI [7,1])
    C0021079 (UMLS CUI [7,2])
    C0205394 (UMLS CUI [7,2])
    teriflunomide | leflunomide
    Item
    Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 µg/ml.
    boolean
    C1718383 (UMLS CUI [1])
    C0063041 (UMLS CUI [2])
    Investigational New Drugs
    Item
    Prior use of any investigational drug in the 6 months preceding screening
    boolean
    C0013230 (UMLS CUI [1])
    Patient currently pregnant | Breast Feeding
    Item
    Pregnant or breast-feeding women.
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Item Group
    Signature Screening Visit 1
    Signature date
    Item
    Signature Date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Signature investigator
    Item
    Signature investigator
    text
    C2346576 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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