ID

15217

Beskrivning

Study documentation part: Visits 1 (Screening)/Visit 2 (Core study), Study week -4 to 0 Study Details: DIMAT-MS, 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. Principle Investigator: PF Dr. Luisa Klotz, University Hospital Münster EudraCT - No.: 2014-003481-25. Clinical Trial No.r: NCT02461069.

Nyckelord

Versioner (2)
  1. 2016-05-21 2016-05-21 -
  2. 2016-05-23 2016-05-23 -
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23 maj 2016

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Eligibility criteria, Relapsing Remitting Multiple Sclerosis, DIMAT-MS, DRKS00008037 NCT02461069

Engelsk

Inclusion and exclusion criteria, Relapsing Remitting Multiple Sclerosis, DIMAT-MS, NCT02461069

1 Formulär  
Inclusion criteria
Beskrivning

Inclusion criteria

Written informed consent must be obtained before any assessment is performed.
Beskrivning

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

Datatyp

boolean

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

Male and female subjects aged 18 - 60 years.

Datatyp

boolean

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

Patients with RRMS, defined by 2010 revised McDonald criteria.

Datatyp

boolean

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

EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
Patients with one of the following treatment status: • naïve to disease modifying (DM) treatment, • no DM treatment for at least 6 months, • currently on MS therapy with interferon β-1 or glatiramer acetate and willing to switch to dimethyl fumarate (Tec dera®).
Beskrivning

Treatment status

Datatyp

boolean

Alias
UMLS CUI [1]
C0749659
MRI-scan of the brain ≤ 3 months at screening.
Beskrivning

MRI-scan of the brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0412675
Exclusion criteria
Beskrivning

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.
Beskrivning

Known hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera®

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0058218
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3556178
A MS-relapse within 30 days prior to screening.
Beskrivning

MS relapse

Datatyp

boolean

Alias
UMLS CUI [1]
C0856120
Known history of active tuberculosis or active tuberculosis determined by a positive QuantiFERON® TB Gold test.
Beskrivning

Active tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0151332
UMLS CUI [2,1]
C1739367
UMLS CUI [2,2]
C1875713
Moderate to severe impairment of liver function or persisting elevations > 2 x ULN (con rmed 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 con rmed Gilbert ́s syndrome (Meulengracht ́s disease).
Beskrivning

Liver function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232744
UMLS CUI [2]
C0001899
UMLS CUI [3]
C0004002
UMLS CUI [4]
C0201916
Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL).
Beskrivning

Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232807
UMLS CUI [2]
C0600061
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).
Beskrivning

Bone marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C1389329
UMLS CUI [2]
C0002871
UMLS CUI [3]
C0023530
UMLS CUI [4]
C0027947
UMLS CUI [5]
C0040034
Women of childbearing potential not utilizing highly effective contraception.
Beskrivning

Contraception

Datatyp

text

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

Mental condition

Datatyp

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.
Beskrivning

Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1321605
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.
Beskrivning

Cardiovascular, neurological, endocrine or other major systemic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0014130
UMLS CUI [4,1]
C0442893
UMLS CUI [4,2]
C0205394
Subjects with ulcerative colitis or Crohn ́s disease.
Beskrivning

Ulcerative colitis or Crohn ́s disease.

Datatyp

boolean

Alias
UMLS CUI [1]
C0009324
UMLS CUI [2]
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.
Beskrivning

Immunodeficiency, history of cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C0853602
UMLS CUI [2]
C0596032
UMLS CUI [3]
C0455471
UMLS CUI [4]
C0024230
Human immunodeficiency virus (HIV) positive, hepatitis B virus positive or hepatitis C virus positive subjects.
Beskrivning

hiv, hepatitis b, hepatitis c

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
Acute or chronic infection.
Beskrivning

Acute or chronic infection.

Datatyp

boolean

Alias
UMLS CUI [1]
C0275518
UMLS CUI [2]
C0151317
History of drug or alcohol abuse.
Beskrivning

History of drug or alcohol abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237123
UMLS CUI [1,2]
C0038586
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
Beskrivning

ACTH or systemic corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1]
C0001655
UMLS CUI [2]
C4053960
Prior or concomitant use of cytokine therapy or intravenous immunoglobulins in the 3 months prior to screening.
Beskrivning

Cytokine therapy or intravenous immunoglobulins

Datatyp

boolean

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

Prior use of alemtuzumab or cladribine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0383429
UMLS CUI [1,2]
C0092801
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysab- ri®).
Beskrivning

Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysab- ri®).

Datatyp

boolean

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

Mitoxantrone or other immunosuppressant agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0026259
UMLS CUI [2,1]
C0021081
UMLS CUI [2,2]
C0205394
Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 μg/ml.
Beskrivning

Teriflunomide or leflunomide treatment

Datatyp

boolean

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

Prior use of any investigational drug in the 6 months preceding screening.

Datatyp

boolean

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

Pregnant or breast-feeding women.

Datatyp

text

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
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Similar models

Inclusion and exclusion criteria, Relapsing Remitting Multiple Sclerosis, DIMAT-MS, NCT02461069

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria
Written informed consent must be obtained before any assessment is performed.
Item
Written informed consent must be obtained before any assessment is performed.
boolean
C0021430 (UMLS CUI [1])
Male and female subjects aged 18 - 60 years.
Item
Male and female subjects aged 18 - 60 years.
boolean
C0001779 (UMLS CUI [1])
Patients with RRMS, defined by 2010 revised McDonald criteria.
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
C0451246 (UMLS CUI [1])
Treatment status
Item
Patients with one of the following treatment status: • naïve to disease modifying (DM) treatment, • no DM treatment for at least 6 months, • currently on MS therapy with interferon β-1 or glatiramer acetate and willing to switch to dimethyl fumarate (Tec dera®).
boolean
C0749659 (UMLS CUI [1])
MRI-scan of the brain
Item
MRI-scan of the brain ≤ 3 months at screening.
boolean
C0412675 (UMLS CUI [1])
Item Group
Exclusion criteria
Known 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])
C0020517 (UMLS CUI [2,1])
C3556178 (UMLS CUI [2,2])
MS relapse
Item
A MS-relapse within 30 days prior to screening.
boolean
C0856120 (UMLS CUI [1])
Active tuberculosis
Item
Known history of active tuberculosis or active tuberculosis determined by a positive QuantiFERON® TB Gold test.
boolean
C0151332 (UMLS CUI [1])
C1739367 (UMLS CUI [2,1])
C1875713 (UMLS CUI [2,2])
Liver function
Item
Moderate to severe impairment of liver function or persisting elevations > 2 x ULN (con rmed 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 con rmed Gilbert ́s syndrome (Meulengracht ́s disease).
boolean
C0232744 (UMLS CUI [1])
C0001899 (UMLS CUI [2])
C0004002 (UMLS CUI [3])
C0201916 (UMLS CUI [4])
Renal function
Item
Moderate to severe impairment of renal function, as shown by serum creatinine > 133 μmol/L (or > 1.5 mg/dL).
boolean
C0232807 (UMLS CUI [1])
C0600061 (UMLS CUI [2])
Bone marrow function
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
C1389329 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
C0023530 (UMLS CUI [3])
C0027947 (UMLS CUI [4])
C0040034 (UMLS CUI [5])
Item
Women of childbearing potential not utilizing highly effective contraception.
text
C0700589 (UMLS CUI [1])
Contraception
Code List
Women of childbearing potential not utilizing highly effective contraception.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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])
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
C2348568 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Cardiovascular, neurological, endocrine or other major 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 [4,1])
C0205394 (UMLS CUI [4,2])
Ulcerative colitis or Crohn ́s disease.
Item
Subjects with ulcerative colitis or Crohn ́s disease.
boolean
C0009324 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
Immunodeficiency, history of cancer
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
C0853602 (UMLS CUI [1])
C0596032 (UMLS CUI [2])
C0455471 (UMLS CUI [3])
C0024230 (UMLS CUI [4])
hiv, hepatitis b, hepatitis c
Item
Human immunodeficiency virus (HIV) positive, hepatitis B virus positive or hepatitis C virus positive subjects.
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Acute or chronic infection.
Item
Acute or chronic infection.
boolean
C0275518 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
History of drug or alcohol abuse
Item
History of drug or alcohol abuse.
boolean
C0237123 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
ACTH or systemic corticosteroids
Item
Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 4 weeks prior to screening.
boolean
C0001655 (UMLS CUI [1])
C4053960 (UMLS CUI [2])
Cytokine therapy or intravenous immunoglobulins
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])
C0092801 (UMLS CUI [1,2])
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysab- ri®).
Item
Prior use (within 1 year) of fingolimod (Gilenya®) or natalizumab (Tysab- ri®).
boolean
C1699926 (UMLS CUI [1])
C1172734 (UMLS CUI [2])
Mitoxantrone or other immunosuppressant agents
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])
C0021081 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Teriflunomide or leflunomide treatment
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])
Prior use of any investigational drug in the 6 months preceding screening.
Item
Prior use of any investigational drug in the 6 months preceding screening.
boolean
C0013230 (UMLS CUI [1])
Item
Pregnant or breast-feeding women.
text
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Pregnant or breast-feeding women.
Code List
Pregnant or breast-feeding women.
CL Item
yes (1)
CL Item
no (2)
CL Item
NA (3)
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