ID

21716

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00297232

Palabras clave

Versiones (1)
  1. 27/4/17 27/4/17 -
Subido en

27 de abril de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232

Inglés

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232

1 formularios  
Criteria
Descripción

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
Descripción

Study Participation Status

Tipo de datos

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.
Descripción

Progressive mulitfocal leukoencephalopathy, Immunosuppresion, Immunomodulatory treatment, Natalizumab

Tipo de datos

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).
Descripción

Study Participation Status Specification

Tipo de datos

boolean

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

Exclusion Criteria

Tipo de datos

boolean

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

Immunocompromised

Tipo de datos

boolean

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

Anti-natalizumab antibodies

Tipo de datos

boolean

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

Comorbidity

Tipo de datos

boolean

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

Hypersensitivity to Natalizumab

Tipo de datos

boolean

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

Inclusion/ Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512693
UMLS CUI [2]
C0680251
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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