ID

14367

Beschrijving

Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.; ODM derived from: https://clinicaltrials.gov/show/NCT00500539

Link

https://clinicaltrials.gov/show/NCT00500539

Trefwoorden

Versies (1)
  1. 12-04-16 12-04-16 -
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CC BY-NC 3.0

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12 april 2016

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00500539

Engels

Eligibility Asthma NCT00500539

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00500539
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients 12 years old or above with moderate to severe allergic asthma
Beschrijving

age, moderate to severe allergic asthma

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0155877
UMLS CUI [2,2]
C1299393
body weight greater than 30kg and less than 150 kg and total serum ige level greater than 30 to less than 700 iu/ml
Beschrijving

body weight, total serum IgE level

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C2229760
diagnosis of allergic asthma greater than 1 year duration, according to the american thoracic society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
Beschrijving

allergic asthma greater than 1 year duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0155877
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C1960047
UMLS CUI [3]
C1960048
positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
Beschrijving

skin prick test to at least one perennial allergen

Datatype

boolean

Alias
UMLS CUI [1]
C0430561
UMLS CUI [2,1]
C0002092
UMLS CUI [2,2]
C0330103
no clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (visit 1) and during screening period (between visit 1 and 2)
Beschrijving

asthma exacerbation

Datatype

boolean

Alias
UMLS CUI [1]
C0349790
UMLS CUI [2]
C0040223
UMLS CUI [3]
C4039704
demonstrated evidence of inadequate asthma symptom control, despite treatment with ics according to clinical features of moderate to severe persistent asthma.
Beschrijving

inadequate asthma symptom control

Datatype

boolean

Alias
UMLS CUI [1,1]
C1274136
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C3248292
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous exposure to omalizumab
Beschrijving

previous exposure to omalizumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0966225
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332157
previous exposure to other humanized proteins or monoclonal antibodies
Beschrijving

previous exposure to other humanized proteins or monoclonal antibodies

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003250
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332157
known haha to other monoclonal antibodies
Beschrijving

known haha to other monoclonal antibodies

Datatype

boolean

Alias
UMLS CUI [1]
C3641682
UMLS CUI [2]
C0003250
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Beschrijving

hypersensitivity to any of the study drugs or to drugs with similar chemical structures

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
Beschrijving

hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0966225
active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
Beschrijving

lung disease

Datatype

boolean

Alias
UMLS CUI [1]
C0024115
elevated serum ige levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin e syndrome, wiskott-aldrich syndrome or allergic bronchopulmonary aspergillosis)
Beschrijving

ige level

Datatype

boolean

Alias
UMLS CUI [1]
C2229760
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Similar models

Eligibility Asthma NCT00500539

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00500539
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
age, moderate to severe allergic asthma
Item
patients 12 years old or above with moderate to severe allergic asthma
boolean
C0001779 (UMLS CUI [1])
C0155877 (UMLS CUI [2,1])
C1299393 (UMLS CUI [2,2])
body weight, total serum IgE level
Item
body weight greater than 30kg and less than 150 kg and total serum ige level greater than 30 to less than 700 iu/ml
boolean
C0005910 (UMLS CUI [1])
C2229760 (UMLS CUI [2])
allergic asthma greater than 1 year duration
Item
diagnosis of allergic asthma greater than 1 year duration, according to the american thoracic society criteria (14) and at screening, a history consistent with clinical features of moderate to severe persistent asthma.
boolean
C0155877 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C1960047 (UMLS CUI [2])
C1960048 (UMLS CUI [3])
skin prick test to at least one perennial allergen
Item
positive skin prick test (diameter of wheel is greater than 3mm) to at least one perennial allergen within the previous one year to visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
boolean
C0430561 (UMLS CUI [1])
C0002092 (UMLS CUI [2,1])
C0330103 (UMLS CUI [2,2])
asthma exacerbation
Item
no clinically significant asthma exacerbations that required treatment with systemic corticosteroids during the four weeks immediately prior to screening visit (visit 1) and during screening period (between visit 1 and 2)
boolean
C0349790 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C4039704 (UMLS CUI [3])
inadequate asthma symptom control
Item
demonstrated evidence of inadequate asthma symptom control, despite treatment with ics according to clinical features of moderate to severe persistent asthma.
boolean
C1274136 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C3248292 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
previous exposure to omalizumab
Item
previous exposure to omalizumab
boolean
C0966225 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
previous exposure to other humanized proteins or monoclonal antibodies
Item
previous exposure to other humanized proteins or monoclonal antibodies
boolean
C0003250 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
known haha to other monoclonal antibodies
Item
known haha to other monoclonal antibodies
boolean
C3641682 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Item
history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab
Item
known hypersensitivity to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin)
boolean
C0020517 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0966225 (UMLS CUI [1,3])
lung disease
Item
active lung disease other than allergic asthma (e.g. cystic fibrosis, bronchiectasis)
boolean
C0024115 (UMLS CUI [1])
ige level
Item
elevated serum ige levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin e syndrome, wiskott-aldrich syndrome or allergic bronchopulmonary aspergillosis)
boolean
C2229760 (UMLS CUI [1])
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