ID

14600

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00915460

Trefwoorden

Versies (1)
  1. 23-04-16 23-04-16 -
Geüploaded op

23 april 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00915460

Engels

Eligibility Multiple Sclerosis NCT00915460

1 Formulieren  
Inclusion Criteria
Beschrijving

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.
Beschrijving

Study participation status and inclusion Criteria

Datatype

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.
Beschrijving

Study completed

Datatype

boolean

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

Comorbidity affecting neurologic symptoms

Datatype

boolean

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

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.
Beschrijving

Comorbidity affecting interferon beta therapy

Datatype

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.
Beschrijving

Hypersensitivity to human albumin

Datatype

boolean

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

Seizure

Datatype

boolean

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

Laboratory tests

Datatype

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.
Beschrijving

Suicidal ideation or severe depression

Datatype

boolean

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

Inclusion or exclusion criteria

Datatype

boolean

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

Eligibility Multiple Sclerosis NCT00915460

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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