ID

15280

Descrição

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.

Palavras-chave

Versões (3)
  1. 17/09/2015 17/09/2015 - Julian Varghese
  2. 22/09/2015 22/09/2015 - Julian Varghese
  3. 24/05/2016 24/05/2016 -
Transferido a

24 de maio de 2016

DOI

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Licença

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

Inglês

Eligibility

4 Formulários  
Inclusion criteria
Descrição

Inclusion criteria

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

Code IN01

Tipo de dados

boolean

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

Code IN02

Tipo de dados

boolean

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

rrms

Tipo de dados

boolean

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

EDSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
Patients with one of the following treatment status:
Descrição

ms treatment status

Tipo de dados

boolean

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

MRI-scan of the brain

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0412675
Exclusion criteria
Descrição

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.
Descrição

hypersensitivity to dimethyl fumarate or any ingredients of Tecfidera

Tipo de dados

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.
Descrição

MS relapse

Tipo de dados

boolean

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

tuberculosis or active tuberculosis

Tipo de dados

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).
Descrição

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

Tipo de dados

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).
Descrição

serum creatinine

Tipo de dados

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).
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0019046
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0027950
UMLS CUI [5]
C0005821
Women of childbearing potential not utilizing highly effective contraception
Descrição

Women of childbearing potential not utilizing highly effective contraception

Tipo de dados

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.
Descrição

Mental condition

Tipo de dados

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.
Descrição

Patient Non-Compliance

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

Crohn´s disease

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

HIV Seropositivity | Hepatitis B positive | Hepatitis C positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0856706
UMLS CUI [3]
C1112419
Acute or chronic infection
Descrição

Acute or chronic infection

Tipo de dados

boolean

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

History of drug or alcohol abuse

Tipo de dados

boolean

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

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001655
UMLS CUI [2]
C0001617
Prior or concomitant use of cytokine therapy or intravenous immunoglobulins in the 3 months prior to screening.
Descrição

Cytokine therapy | Immunoglobulins, Intravenous

Tipo de dados

boolean

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

Prior use of alemtuzumab or cladribine

Tipo de dados

boolean

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

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Prior treatment with teriflunomide or leflunomide, unless successful washout, confirmed by plasma concentration of < 0.02 µg/ml.
Descrição

teriflunomide | leflunomide

Tipo de dados

boolean

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

Investigational New Drugs

Tipo de dados

boolean

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

Patient currently pregnant | Breast Feeding

Tipo de dados

boolean

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

Signature Screening Visit 1

Signature Date
Descrição

Signature date

Tipo de dados

date

Alias
UMLS CUI [1]
C0807937
Signature investigator
Descrição

Signature investigator

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Eligibility

4 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
C0451246 (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
C0412675 (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])
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])
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
C0518014 (UMLS CUI [1])
C0019046 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0027950 (UMLS CUI [4])
C0005821 (UMLS CUI [5])
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
C0019699 (UMLS CUI [1])
C0856706 (UMLS CUI [2])
C1112419 (UMLS CUI [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])
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
C0001655 (UMLS CUI [1])
C0001617 (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])
C0092801 (UMLS CUI [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])
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])
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
C0807937 (UMLS CUI [1])
Signature investigator
Item
Signature investigator
text
C2346576 (UMLS CUI [1])
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