ID

36481

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02308670

Nyckelord

Versioner (1)
  1. 2019-05-16 2019-05-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 maj 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Multiple Sclerosis NCT02308670

Engelsk

Eligibility Multiple Sclerosis NCT02308670

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Multiple Sclerosis

Datatyp

boolean

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

Multiple sclerosis relapse

Datatyp

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
Beskrivning

glatiramer acetate | Status pre- Standard of Care MRI

Datatyp

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
Beskrivning

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

Datatyp

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)
Beskrivning

Screening procedure MRI

Datatyp

boolean

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

Exclusion Criteria None

Datatyp

boolean

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

Exclusion Criteria

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

Relapse

Datatyp

boolean

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

Steroid therapy

Datatyp

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
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datatyp

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.)
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Multiple Sclerosis NCT02308670

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial