ID

22920

Beskrivning

Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).; ODM derived from: https://clinicaltrials.gov/show/NCT00337779

Länk

https://clinicaltrials.gov/show/NCT00337779

Nyckelord

Versioner (1)
  1. 2017-06-16 2017-06-16 -
Uppladdad den

16 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT00337779

Engelsk

Eligibility Relapsing Remitting Multiple Sclerosis NCT00337779

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of confirmed and documented ms defined by the revised mcdonald criteria.
Beskrivning

Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
2. subjects must be of the relapsing-remitting (r-r) type.
Beskrivning

Multiple Sclerosis, Relapsing-Remitting

Datatyp

boolean

Alias
UMLS CUI [1]
C0751967
3. subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented t1-gd enhancing lesion in the mri performed 12 months prior screening.
Beskrivning

Relapse Quantity | Gadolinium-Enhancing Lesion Quantity Magnetic Resonance Imaging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1333400
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0024485
4. disease duration for at least 6 months.
Beskrivning

disease length

Datatyp

boolean

Alias
UMLS CUI [1]
C0872146
5. ambulatory with converted kurtzke edss score of 0 - 5.
Beskrivning

Ambulatory Kurtzke multiple sclerosis rating scale

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439841
UMLS CUI [1,2]
C0451246
6. relapse free and stable neurological condition at least for 30 days prior screening.
Beskrivning

Condition Neurologic Stable | Relapse Free of

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205494
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0035020
UMLS CUI [2,2]
C0332296
7. age - 18-55 (inclusive)
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous use of copaxone (glatiramer acetate)
Beskrivning

Copaxone | glatiramer acetate

Datatyp

boolean

Alias
UMLS CUI [1]
C0528175
UMLS CUI [2]
C0289884
2. treatment with corticosteroids within 30 days prior screening or between screening and baseline.
Beskrivning

Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1]
C0001617
3. chronic corticosteroids treatment - more than 30 consecutive days.
Beskrivning

Adrenal Cortex Hormones chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
4. subject with any clinically significant or unstable medical condition.
Beskrivning

Medical condition Clinical Significance | Medical condition Unstable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
5. subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
6. known history of sensitivity to gadolinium and inability to successfully undergo mri scanning.
Beskrivning

Hypersensitivity Gadolinium | Magnetic Resonance Imaging Receive Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016911
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT00337779

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
1. diagnosis of confirmed and documented ms defined by the revised mcdonald criteria.
boolean
C0026769 (UMLS CUI [1])
Multiple Sclerosis, Relapsing-Remitting
Item
2. subjects must be of the relapsing-remitting (r-r) type.
boolean
C0751967 (UMLS CUI [1])
Relapse Quantity | Gadolinium-Enhancing Lesion Quantity Magnetic Resonance Imaging
Item
3. subject has experienced prior to screening at least one documented relapse in 12 months or at least 2 documented relapses in the 24 months or one documented relapse between 12 - 24 months with at least 1 documented t1-gd enhancing lesion in the mri performed 12 months prior screening.
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1333400 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
disease length
Item
4. disease duration for at least 6 months.
boolean
C0872146 (UMLS CUI [1])
Ambulatory Kurtzke multiple sclerosis rating scale
Item
5. ambulatory with converted kurtzke edss score of 0 - 5.
boolean
C0439841 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Condition Neurologic Stable | Relapse Free of
Item
6. relapse free and stable neurological condition at least for 30 days prior screening.
boolean
C0348080 (UMLS CUI [1,1])
C0205494 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0035020 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Age
Item
7. age - 18-55 (inclusive)
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Copaxone | glatiramer acetate
Item
1. previous use of copaxone (glatiramer acetate)
boolean
C0528175 (UMLS CUI [1])
C0289884 (UMLS CUI [2])
Adrenal Cortex Hormones
Item
2. treatment with corticosteroids within 30 days prior screening or between screening and baseline.
boolean
C0001617 (UMLS CUI [1])
Adrenal Cortex Hormones chronic
Item
3. chronic corticosteroids treatment - more than 30 consecutive days.
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Medical condition Clinical Significance | Medical condition Unstable
Item
4. subject with any clinically significant or unstable medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Study Subject Participation Status
Item
5. subjects participating in any other clinical trial (within 12 weeks prior to screening and thereafter).
boolean
C2348568 (UMLS CUI [1])
Hypersensitivity Gadolinium | Magnetic Resonance Imaging Receive Unable
Item
6. known history of sensitivity to gadolinium and inability to successfully undergo mri scanning.
boolean
C0020517 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
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