ID

34549

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

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

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

Inclusion Criteria
Description

Inclusion Criteria

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

ID.1

Data type

boolean

subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
Description

ID.2

Data type

boolean

subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
Description

ID.3

Data type

boolean

other protocol defined inclusion criteria could apply
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

ID.5

Data type

boolean

allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
Description

ID.6

Data type

boolean

any requirement for continuous systemic glucocorticoid administration during the trial period. (note: treatment with interferons such as avonex®, rebif®, or betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
Description

ID.7

Data type

boolean

contraindication to copaxone use
Description

ID.8

Data type

boolean

other protocol defined exclusion criteria could apply
Description

ID.9

Data type

boolean

Similar models

Eligibility Relapsing Remitting Multiple Sclerosis NCT01963611

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
male or female, between the ages of 18 and 60 years
boolean
ID.2
Item
subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
boolean
ID.3
Item
subjects must have a current diagnosis of relapsing remitting multiple sclerosis (rrms) (according to the 2010 mcdonald ms diagnostic criteria)
boolean
ID.4
Item
other protocol defined inclusion criteria could apply
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
boolean
ID.6
Item
allergy to mannitol, plovamer acetate, copaxone (glatiramer acetate), gd contrast for mri
boolean
ID.7
Item
any requirement for continuous systemic glucocorticoid administration during the trial period. (note: treatment with interferons such as avonex®, rebif®, or betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
boolean
ID.8
Item
contraindication to copaxone use
boolean
ID.9
Item
other protocol defined exclusion criteria could apply
boolean

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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