ID

39635

Description

Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1); ODM derived from: https://clinicaltrials.gov/show/NCT01963611

Link

https://clinicaltrials.gov/show/NCT01963611

Keywords

Versions (2)
  1. 1/19/19 1/19/19 -
  2. 2/6/20 2/6/20 - Christian Arras
Copyright Holder

EMD Serono

Uploaded on

February 6, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

English

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, between the ages of 18 and 60 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
subject is able to learn and self-administer subcutaneous injections or a care-giver may be trained to inject the subject
Description

Subcutaneous injections, self-administration, ability | administration procedure, caregiver

Data type

boolean

Alias
UMLS CUI [1,1]
C0021499
UMLS CUI [1,2]
C0036589
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0021499
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0085537
subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
Description

Diagnosis of RRMS

Data type

boolean

Alias
UMLS CUI [1,1]
C0751967
UMLS CUI [1,2]
C0679228
other protocol defined inclusion criteria could apply
Description

Inclusion criteria, Study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
Description

Multiple Sclerosis Primary Progressive, Multiple Sclerosis Secondary Progressive, Multiple Sclerosis Progressive Relapsing

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
Description

Hypersensitivity, Mannitol, Plovamer acetate, Copaxone, Gadolinium

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0024730
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C3272845
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0528175
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0016911
any requirement for continuous systemic glucocorticoid administration during the trial period.
Description

note: treatment with interferons such as avonex®, rebif®, or betaseron® will be allowed until the baseline visit, as no wash-out period is needed

Data type

boolean

Alias
UMLS CUI [1,1]
C0744425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C2347804
contraindication to copaxone use
Description

Contraindiction Copaxone

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0528175
other protocol defined exclusion criteria could apply
Description

Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender, Age
Item
male or female, between the ages of 18 and 60 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Subcutaneous injections, self-administration, ability | administration procedure, caregiver
Item
subject is able to learn and self-administer subcutaneous injections or a care-giver may be trained to inject the subject
boolean
C0021499 (UMLS CUI [1,1])
C0036589 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0021499 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0085537 (UMLS CUI [2,3])
Relapsing remitting multiple sclerosis, current diagnosis, McDonald diagnostic criteria
Item
subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
boolean
C0751967 (UMLS CUI [1,1])
C0679228 (UMLS CUI [1,2])
Inclusion criteria, Study protocol
Item
other protocol defined inclusion criteria could apply
boolean
C1512693 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Multiple Sclerosis Primary Progressive, Multiple Sclerosis Secondary Progressive, Multiple Sclerosis Progressive Relapsing
Item
any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
Hypersensitivity, Mannitol, Plovamer acetate, Copaxone, Gadolinium
Item
allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
boolean
C0020517 (UMLS CUI [1,1])
C0024730 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C3272845 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0528175 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0016911 (UMLS CUI [4,2])
Glucocorticoid therapy, Clinical trial period
Item
any requirement for continuous systemic glucocorticoid administration during the trial period.
boolean
C0744425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Contraindiction Copaxone
Item
contraindication to copaxone use
boolean
C1301624 (UMLS CUI [1,1])
C0528175 (UMLS CUI [1,2])
Exclusion criteria
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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