ID

36463

Beschrijving

Studying the Effects of Copaxone on Retinal Health Using Optical Tomography Over 24 Months; ODM derived from: https://clinicaltrials.gov/show/NCT02017808

Link

https://clinicaltrials.gov/show/NCT02017808

Trefwoorden

Versies (1)
  1. 16-05-19 16-05-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

16 mei 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT02017808

Engels

Eligibility Multiple Sclerosis NCT02017808

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
ms patients diagnosed with clinically definite ms according to the mcdonald criteria (polman et al., 2005)
Beschrijving

Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0026769
starting ga monotherapy (20mg/day sc) at the time of the oct scan
Beschrijving

glatiramer acetate

Datatype

boolean

Alias
UMLS CUI [1]
C0289884
having baseline clinical oct scan that included rnflt and tmv assessment at the start of the ga
Beschrijving

Retinal nerve fiber layer Thickness OCT | Volume macular total OCT

Datatype

boolean

Alias
UMLS CUI [1,1]
C1517753
UMLS CUI [1,2]
C1280412
UMLS CUI [1,3]
C0920367
UMLS CUI [2,1]
C0449468
UMLS CUI [2,2]
C0332574
UMLS CUI [2,3]
C0439810
UMLS CUI [2,4]
C0920367
having baseline clinical oct scan that included rnflt and tmv assessment (healthy controls)
Beschrijving

Retinal nerve fiber layer Thickness OCT | Volume macular total OCT | Healthy Control

Datatype

boolean

Alias
UMLS CUI [1,1]
C1517753
UMLS CUI [1,2]
C1280412
UMLS CUI [1,3]
C0920367
UMLS CUI [2,1]
C0449468
UMLS CUI [2,2]
C0332574
UMLS CUI [2,3]
C0439810
UMLS CUI [2,4]
C0920367
UMLS CUI [3]
C2986479
ms patients having a rr disease course (lublin and reingold, 1996)
Beschrijving

Multiple Sclerosis, Relapsing-Remitting

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
age 18-65 (healthy controls will be matched to ms patients for age and sex)
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
signed informed consent at the 24-month follow-up
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
none of the exclusion criteria
Beschrijving

Exclusion Criteria None

Datatype

boolean

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

Exclusion Criteria

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

Recurrent disease

Datatype

boolean

Alias
UMLS CUI [1]
C0277556
patients who received steroid treatment within 30 days prior to oct scan date
Beschrijving

Steroid therapy

Datatype

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
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datatype

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 follow-up (e.g., ifn-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, ivig, cellcept, natalizumab, etc.)
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1,1]
C1963758
UMLS CUI [1,2]
C0026769
UMLS CUI [2,1]
C1096650
UMLS CUI [2,2]
C0026769
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 NCT02017808

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
ms patients diagnosed with clinically definite ms according to the mcdonald criteria (polman et al., 2005)
boolean
C0026769 (UMLS CUI [1])
glatiramer acetate
Item
starting ga monotherapy (20mg/day sc) at the time of the oct scan
boolean
C0289884 (UMLS CUI [1])
Retinal nerve fiber layer Thickness OCT | Volume macular total OCT
Item
having baseline clinical oct scan that included rnflt and tmv assessment at the start of the ga
boolean
C1517753 (UMLS CUI [1,1])
C1280412 (UMLS CUI [1,2])
C0920367 (UMLS CUI [1,3])
C0449468 (UMLS CUI [2,1])
C0332574 (UMLS CUI [2,2])
C0439810 (UMLS CUI [2,3])
C0920367 (UMLS CUI [2,4])
Retinal nerve fiber layer Thickness OCT | Volume macular total OCT | Healthy Control
Item
having baseline clinical oct scan that included rnflt and tmv assessment (healthy controls)
boolean
C1517753 (UMLS CUI [1,1])
C1280412 (UMLS CUI [1,2])
C0920367 (UMLS CUI [1,3])
C0449468 (UMLS CUI [2,1])
C0332574 (UMLS CUI [2,2])
C0439810 (UMLS CUI [2,3])
C0920367 (UMLS CUI [2,4])
C2986479 (UMLS CUI [3])
Multiple Sclerosis, Relapsing-Remitting
Item
ms patients having a rr disease course (lublin and reingold, 1996)
boolean
C0751967 (UMLS CUI [1])
Age
Item
age 18-65 (healthy controls will be matched to ms patients for age and sex)
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
signed informed consent at the 24-month follow-up
boolean
C0021430 (UMLS CUI [1])
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)
Recurrent disease
Item
patients who had a relapse within 30 days prior to oct scan date
boolean
C0277556 (UMLS CUI [1])
Steroid therapy
Item
patients who received steroid treatment within 30 days prior to oct 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 Multiple Sclerosis | Immunosuppressant drug therapy Multiple Sclerosis | 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 follow-up (e.g., ifn-β, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, ivig, cellcept, natalizumab, etc.)
boolean
C1963758 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C1096650 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
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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