ID

14600

Descripción

Open-Label Safety Extension Study of Avonex; ODM derived from: https://clinicaltrials.gov/show/NCT00915460

Link

https://clinicaltrials.gov/show/NCT00915460

Palabras clave

Versiones (1)
  1. 23/4/16 23/4/16 -
Subido en

23 de abril de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00915460

Inglés

Eligibility Multiple Sclerosis NCT00915460

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have completed (as defined below) one of the following biogen avonex® clinical studies and meet the other criteria indicated.
Descripción

Study participation status and inclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C1512693
subjects enrolled from studies c95-812 and c97-830 must have completed their respective study within 12 months prior to enrollment in c98-838. subjects enrolled from study c96-823 must have completed the study within 24 months prior to enrollment in c98-838.
Descripción

Study completed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348577
have not been diagnosed with any other disease that accounts for their neurologic symptoms.
Descripción

Comorbidity affecting neurologic symptoms

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0235031
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
Descripción

Comorbidity affecting interferon beta therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0854622
history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
Descripción

Hypersensitivity to human albumin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304925
history of seizure within the 3 months prior to enrollment.
Descripción

Seizure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0036572
abnormal laboratory results at the screening visit:
Descripción

Laboratory tests

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022885
history of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
Descripción

Suicidal ideation or severe depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0588008
other inclusion and exclusion criteria apply as per biogen idec protocol
Descripción

Inclusion or exclusion criteria

Tipo de datos

boolean

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

Eligibility Multiple Sclerosis NCT00915460

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Study participation status and inclusion Criteria
Item
must have completed (as defined below) one of the following biogen avonex® clinical studies and meet the other criteria indicated.
boolean
C2348568 (UMLS CUI [1])
C1512693 (UMLS CUI [2])
Study completed
Item
subjects enrolled from studies c95-812 and c97-830 must have completed their respective study within 12 months prior to enrollment in c98-838. subjects enrolled from study c96-823 must have completed the study within 24 months prior to enrollment in c98-838.
boolean
C2348577 (UMLS CUI [1])
Comorbidity affecting neurologic symptoms
Item
have not been diagnosed with any other disease that accounts for their neurologic symptoms.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0235031 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity affecting interferon beta therapy
Item
history of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0854622 (UMLS CUI [1,3])
Hypersensitivity to human albumin
Item
history of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
boolean
C0020517 (UMLS CUI [1,1])
C0304925 (UMLS CUI [1,2])
Seizure
Item
history of seizure within the 3 months prior to enrollment.
boolean
C0036572 (UMLS CUI [1])
Laboratory tests
Item
abnormal laboratory results at the screening visit:
boolean
C0022885 (UMLS CUI [1])
Suicidal ideation or severe depression
Item
history of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.
boolean
C0424000 (UMLS CUI [1])
C0588008 (UMLS CUI [2])
Inclusion or exclusion criteria
Item
other inclusion and exclusion criteria apply as per biogen idec protocol
boolean
C1512693 (UMLS CUI [1])
C0680251 (UMLS CUI [2])
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