ID

21716

Description

Natalizumab (Tysabri) Re-Initiation of Dosing; ODM derived from: https://clinicaltrials.gov/show/NCT00297232

Link

https://clinicaltrials.gov/show/NCT00297232

Keywords

Versions (1)
  1. 4/27/17 4/27/17 -
Uploaded on

April 27, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0
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.

Back to model comments
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 NCT00297232

English

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232

1 forms  
Criteria
Description

Criteria

ms subjects who completed study c-1801 (nct00027300), c-1802 (nct00030966), or c-1803 (nct00097760) and a dosing suspension safety evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the ima 04001 (stars) study
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
subjects who are considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including ifn-beta and glatiramer acetate) while being treated with natalizumab during the study.
Description

Progressive mulitfocal leukoencephalopathy, Immunosuppresion, Immunomodulatory treatment, Natalizumab

Data type

boolean

Alias
UMLS CUI [1]
C0023524
UMLS CUI [2]
C0021079
UMLS CUI [3]
C1963758
UMLS CUI [4]
C1172734
in addition, subjects who completed 48 weeks of treatment in study 101-ms-322 (nct00306592) in canada will be allowed to enter this study at the start of the long-term treatment period (week 52 - 480).
Description

Study Participation Status Specification

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2348235
key exclusion criteria
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
considered by the investigator to be immunocompromised
Description

Immunocompromised

Data type

boolean

Alias
UMLS CUI [1]
C0085393
history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
Description

Anti-natalizumab antibodies

Data type

boolean

Alias
UMLS CUI [1]
C1977362
history of any major disease or malignancy
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
discontinued natalizumab in a previous study due to allergic reaction
Description

Hypersensitivity to Natalizumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1172734
note: other protocol defined inclusion/exclusion criteria may apply.
Description

Inclusion/ Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
Back to the top of the page

Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study Participation Status
Item
ms subjects who completed study c-1801 (nct00027300), c-1802 (nct00030966), or c-1803 (nct00097760) and a dosing suspension safety evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the ima 04001 (stars) study
boolean
C2348568 (UMLS CUI [1])
Progressive mulitfocal leukoencephalopathy, Immunosuppresion, Immunomodulatory treatment, Natalizumab
Item
subjects who are considered by the investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including ifn-beta and glatiramer acetate) while being treated with natalizumab during the study.
boolean
C0023524 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C1963758 (UMLS CUI [3])
C1172734 (UMLS CUI [4])
Study Participation Status Specification
Item
in addition, subjects who completed 48 weeks of treatment in study 101-ms-322 (nct00306592) in canada will be allowed to enter this study at the start of the long-term treatment period (week 52 - 480).
boolean
C2348568 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Exclusion Criteria
Item
key exclusion criteria
boolean
C0680251 (UMLS CUI [1])
Immunocompromised
Item
considered by the investigator to be immunocompromised
boolean
C0085393 (UMLS CUI [1])
Anti-natalizumab antibodies
Item
history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
boolean
C1977362 (UMLS CUI [1])
Comorbidity
Item
history of any major disease or malignancy
boolean
C0009488 (UMLS CUI [1])
Hypersensitivity to Natalizumab
Item
discontinued natalizumab in a previous study due to allergic reaction
boolean
C0020517 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Inclusion/ Exclusion Criteria
Item
note: other protocol defined inclusion/exclusion criteria may apply.
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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