ID

36481

Descrição

Evaluate the Effect of Switching From Daily Injections of 20mg Glatiramer Acetate (GA) to 40mg GA Three Times a Week in Subjects With Relapsing-remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT02308670

Link

https://clinicaltrials.gov/show/NCT02308670

Palavras-chave

Versões (1)
  1. 16/05/2019 16/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02308670

Inglês

Eligibility Multiple Sclerosis NCT02308670

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
ms patients diagnosed with ms according to the mcdonald criteria
Descrição

Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
ms patients having a relapsing disease course
Descrição

Multiple sclerosis relapse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0856120
being on ga monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care mri at the time of switch to ga 40mg x 3/weekly
Descrição

glatiramer acetate | Status pre- Standard of Care MRI

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0289884
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C0024485
having standard of care 3t mri scan while on ga 20mg/daily treatment for at least 12-18 months prior to the start day of the of the ga 40mg x 3/weekly and at the time of switch to ga 40mg x 3/weekly age over 18
Descrição

Standard of Care 3T MRI scan | Glatiramer acetate Dose U/day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C2985394
UMLS CUI [2,1]
C0289884
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0456683
pass mri health screening (in case of egfr <59, the contrast will not be applied)
Descrição

Screening procedure MRI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0024485
none of the exclusion criteria
Descrição

Exclusion Criteria None

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0549184
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who had a relapse within 30 days prior to mri scan date
Descrição

Relapse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035020
patients who received steroid treatment within 30 days prior to the mri scan date
Descrição

Steroid therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0149783
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
ms patients who used other imunomodulatory or immunosuppressant treatment other than ga during the 12 months prior to start of ga 40mg 3/weekly (e.g., ifn-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, ivig, cellcept, natalizumab, etc.)
Descrição

Immunomodulation | Immunosuppressant drug therapy | Exception Glatiramer acetate | Interferon-beta | Mitoxantrone | Cyclophosphamide | Cladribine | fludarabine | Cyclosporine | Whole-Body Irradiation | Azathioprine | Methotrexate | Immunoglobulins, Intravenous | Cellcept | natalizumab

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C1096650
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0289884
UMLS CUI [4]
C0015980
UMLS CUI [5]
C0026259
UMLS CUI [6]
C0010583
UMLS CUI [7]
C0092801
UMLS CUI [8]
C0059985
UMLS CUI [9]
C0010592
UMLS CUI [10]
C0043162
UMLS CUI [11]
C0004482
UMLS CUI [12]
C0025677
UMLS CUI [13]
C0085297
UMLS CUI [14]
C0592558
UMLS CUI [15]
C1172734
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Similar models

Eligibility Multiple Sclerosis NCT02308670

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
ms patients diagnosed with ms according to the mcdonald criteria
boolean
C0026769 (UMLS CUI [1])
Multiple sclerosis relapse
Item
ms patients having a relapsing disease course
boolean
C0856120 (UMLS CUI [1])
glatiramer acetate | Status pre- Standard of Care MRI
Item
being on ga monotherapy (20mg/daily sc) for at least 12 months prior to the standard of care mri at the time of switch to ga 40mg x 3/weekly
boolean
C0289884 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Standard of Care 3T MRI scan | Glatiramer acetate Dose U/day
Item
having standard of care 3t mri scan while on ga 20mg/daily treatment for at least 12-18 months prior to the start day of the of the ga 40mg x 3/weekly and at the time of switch to ga 40mg x 3/weekly age over 18
boolean
C2936643 (UMLS CUI [1,1])
C2985394 (UMLS CUI [1,2])
C0289884 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
Screening procedure MRI
Item
pass mri health screening (in case of egfr <59, the contrast will not be applied)
boolean
C0220908 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Exclusion Criteria None
Item
none of the exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Relapse
Item
patients who had a relapse within 30 days prior to mri scan date
boolean
C0035020 (UMLS CUI [1])
Steroid therapy
Item
patients who received steroid treatment within 30 days prior to the mri scan date
boolean
C0149783 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
Immunomodulation | Immunosuppressant drug therapy | Exception Glatiramer acetate | Interferon-beta | Mitoxantrone | Cyclophosphamide | Cladribine | fludarabine | Cyclosporine | Whole-Body Irradiation | Azathioprine | Methotrexate | Immunoglobulins, Intravenous | Cellcept | natalizumab
Item
ms patients who used other imunomodulatory or immunosuppressant treatment other than ga during the 12 months prior to start of ga 40mg 3/weekly (e.g., ifn-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, ivig, cellcept, natalizumab, etc.)
boolean
C1963758 (UMLS CUI [1])
C1096650 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0289884 (UMLS CUI [3,2])
C0015980 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C0010583 (UMLS CUI [6])
C0092801 (UMLS CUI [7])
C0059985 (UMLS CUI [8])
C0010592 (UMLS CUI [9])
C0043162 (UMLS CUI [10])
C0004482 (UMLS CUI [11])
C0025677 (UMLS CUI [12])
C0085297 (UMLS CUI [13])
C0592558 (UMLS CUI [14])
C1172734 (UMLS CUI [15])
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