ID

13196

Description

Copaxone® Study to Follow Patients From the First Original Study for Safety and Effectiveness.; ODM derived from: https://clinicaltrials.gov/show/NCT00203021

Link

https://clinicaltrials.gov/show/NCT00203021

Keywords

Versions (1)
  1. 1/23/16 1/23/16 -
Uploaded on

January 23, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00203021

English

Eligibility Multiple Sclerosis NCT00203021

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have participated (been randomized) in the copaxone double-blind placebo controlled study (protocol 01-9001).
Description

copaxone study participation

Data type

boolean

Alias
UMLS CUI [1]
C0528175
UMLS CUI [2]
C2348568
gender: patients may be male or female. women of childbearing potential must practice an acceptable method of birth control.
Description

Gender, birth control

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0700589
patients must meet the criteria of clinically definite ms as defined by poser.5
Description

multiple sclerosis diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
the patient's signs and symptoms cannot be better explained by another disease process.
Description

multiple sclerosis diagnosis

Data type

boolean

Alias
UMLS CUI [1]
C0026769
patients must sign an approved informed consent prior to initiating the study.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must be psychologically and physically stable to participate in the trial as judged by the investigator.
Description

psychologically and physically stable

Data type

boolean

Alias
UMLS CUI [1]
C0009488
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or lactation.
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
medical or psychiatric conditions that affect the patient's ability to give informed consent or complete the study.
Description

nformed consent or study completion limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C0439801
UMLS CUI [1,5]
C0009488
inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
Description

subcutaneous medication

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0021499
use of interferons, experimental ms therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or total lymphoid irradiation within 30 days of study entry.
Description

interferons, experimental ms therapies, immunosuppression or lymphoid irradiation

Data type

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0392920 | C0024230
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Similar models

Eligibility Multiple Sclerosis NCT00203021

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
copaxone study participation
Item
patients must have participated (been randomized) in the copaxone double-blind placebo controlled study (protocol 01-9001).
boolean
C0528175 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Gender, birth control
Item
gender: patients may be male or female. women of childbearing potential must practice an acceptable method of birth control.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
multiple sclerosis diagnosis
Item
patients must meet the criteria of clinically definite ms as defined by poser.5
boolean
C0026769 (UMLS CUI [1])
multiple sclerosis diagnosis
Item
the patient's signs and symptoms cannot be better explained by another disease process.
boolean
C0026769 (UMLS CUI [1])
informed consent
Item
patients must sign an approved informed consent prior to initiating the study.
boolean
C0021430 (UMLS CUI [1])
psychologically and physically stable
Item
patients must be psychologically and physically stable to participate in the trial as judged by the investigator.
boolean
C0009488 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pregnancy or lactation
Item
pregnancy or lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
nformed consent or study completion limited
Item
medical or psychiatric conditions that affect the patient's ability to give informed consent or complete the study.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0009488 (UMLS CUI [1,5])
subcutaneous medication
Item
inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
boolean
C1321605 (UMLS CUI [1])
C0021499 (UMLS CUI [2])
interferons, experimental ms therapies, immunosuppression or lymphoid irradiation
Item
use of interferons, experimental ms therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine), or total lymphoid irradiation within 30 days of study entry.
boolean
C0021747 (UMLS CUI [1])
C0021079 (UMLS CUI [2,1])
C0392920 | C0024230 (UMLS CUI [2,2])
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