ID

44216

Description

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.

Keywords

Versions (4)
  1. 2/27/18 2/27/18 -
  2. 1/29/19 1/29/19 - Sarah Riepenhausen
  3. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  4. 9/20/21 9/20/21 -
Copyright Holder

Prof. Dr. Luisa Klotz

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Multiple sclerosis studies NCT02461069 NCT02419378

English

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

18 forms  
Inclusion criteria
Description

Inclusion criteria

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

Code IN01

Data type

boolean

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

Code IN02

Data type

boolean

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

rrms

Data type

boolean

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

EDSS

Data type

boolean

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

ms treatment status

Data type

boolean

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

MRI-scan of the brain

Data type

boolean

Alias
UMLS CUI [1]
C0024485
Exclusion criteria
Description

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.
Description

hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera

Data type

boolean

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

MS relapse

Data type

boolean

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

tuberculosis or active tuberculosis

Data type

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).
Description

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

Data type

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).
Description

serum creatinine

Data type

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).
Description

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

Data type

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
Description

Women of childbearing potential not utilizing highly effective contraception

Data type

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.
Description

Mental condition

Data type

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.
Description

Patient Non-Compliance

Data type

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.
Description

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

Data type

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
Description

Crohn´s disease

Data type

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.
Description

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

Data type

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.
Description

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Data type

boolean

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

Acute or chronic infection

Data type

boolean

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

History of drug or alcohol abuse

Data type

boolean

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

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

Data type

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.
Description

Cytokine therapy | Immunoglobulins, Intravenous

Data type

boolean

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

Prior use of alemtuzumab or cladribine

Data type

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®).
Description

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

Data type

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.
Description

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

Data type

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 [7,3]
C0205394
Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 µg/ml.
Description

teriflunomide | leflunomide

Data type

boolean

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

Investigational New Drugs

Data type

boolean

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

Patient currently pregnant | Breast Feeding

Data type

boolean

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

Signature Screening Visit 1

Signature Date
Description

Signature date

Data type

date

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

Signature investigator

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

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

18 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 [7,3])
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])
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