Informações:
Falhas:
ID
21716
Descrição
Natalizumab (Tysabri) Re-Initiation of Dosing; ODM derived from: https://clinicaltrials.gov/show/NCT00297232
Link
https://clinicaltrials.gov/show/NCT00297232
Palavras-chave
Versões (1)
- 27/04/2017 27/04/2017 -
Transferido a
27 de abril de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232
Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232
- StudyEvent: Eligibility
Similar models
Eligibility Relapsing-Remitting Multiple Sclerosis NCT00297232
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
C0680251 (UMLS CUI [2])