ID

14371

Beschreibung

A Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00512863

Link

https://clinicaltrials.gov/show/NCT00512863

Stichworte

Versionen (1)
  1. 12.04.16 12.04.16 -
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CC BY-NC 3.0

Hochgeladen am

12. April 2016

DOI

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Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00512863

Englisch

Eligibility Asthma NCT00512863

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00512863
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented history of refractory asthma, as defined by the american thoracic society,31 defined as 1 major and at least 2 minor criteria
Beschreibung

refractory asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205269
actual or documented history of reversible airway obstruction
Beschreibung

reversible airway obstruction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001883
UMLS CUI [1,2]
C0205343
baseline fev1 of 40% − 80% of the predicted for height, age, and sex at screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
Beschreibung

fev1

Datentyp

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1373132
history of at least 1 asthma exacerbation leading to oral, iv or im corticosteroid or er/urgent care center visit or hospitalization within the past year prior to screening. this asthma exacerbation should not have been within 30 days prior to screening
Beschreibung

asthma exacerbation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0349790
UMLS CUI [1,2]
C0040223
UMLS CUI [2]
C4039704
UMLS CUI [3]
C2065041
UMLS CUI [4]
C0583237
UMLS CUI [5]
C0019993
adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
Beschreibung

renal and hepatic function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication
Beschreibung

subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1533685
UMLS CUI [1,2]
C1321605
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease [copd], interstitial lung disease, pulmonary fibrosis) other than asthma
Beschreibung

lung diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0024115
current treatment for corticosteroid-resistant asthma (e.g., methotrexate [mtx], cyclosporine, gold salts, troleandomycin, immune globulin intravenous [igiv], mycophenolate mofetil)
Beschreibung

corticosteroid resistant asthma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0001617
UMLS CUI [1,3]
C0332325
UMLS CUI [2]
C0087111
history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma −
Beschreibung

cancer history

Datentyp

boolean

Alias
UMLS CUI [1]
C1512706
UMLS CUI [2]
C0007117
in-situ of the cervix.
Beschreibung

cervix carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0302592
UMLS CUI [1,2]
C0851135
history of listeria, human immunodeficiency virus (hiv), chronic or active hepatitis b, an immunodeficiency syndrome, central nervous system (cns) demyelinating disease or active tb
Beschreibung

listeria, hiv, hepatitis b, immunodeficiency syndrome, cns demyelinating disease or active tb

Datentyp

boolean

Alias
UMLS CUI [1]
C0023859
UMLS CUI [2]
C0019682
UMLS CUI [3]
C0019163
UMLS CUI [4]
C0019163
UMLS CUI [5]
C0011303
UMLS CUI [6]
C0041296
females who are pregnant or will not discontinue breast-feeding.
Beschreibung

pregnancy or lactation

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subject with a history of clinically significant drug or alcohol abuse in the last year
Beschreibung

drug or alcohol abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
subjects with a poorly controlled medical condition.
Beschreibung

poorly controlled medical condition

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
abnormal, clinically significant screening laboratory and other analyses (including ecg).
Beschreibung

abnormal laboratory values

Datentyp

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0009488
subjects with any prior exposure to tysabri® (natalizumab)
Beschreibung

exposure to tysabri

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1172734
prior treatment with any tnf antagonist, including adalimumab
Beschreibung

prior treatment with any tnf antagonist, including adalimumab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1122087
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Ähnliche Modelle

Eligibility Asthma NCT00512863

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00512863
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
refractory asthma
Item
documented history of refractory asthma, as defined by the american thoracic society,31 defined as 1 major and at least 2 minor criteria
boolean
C0004096 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
reversible airway obstruction
Item
actual or documented history of reversible airway obstruction
boolean
C0001883 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
fev1
Item
baseline fev1 of 40% − 80% of the predicted for height, age, and sex at screening, as demonstrated 6 or more hours after a short-acting -agonist and/or 24 or more hours after a long-acting -agonist
boolean
C0748133 (UMLS CUI [1])
C1373132 (UMLS CUI [2])
asthma exacerbation
Item
history of at least 1 asthma exacerbation leading to oral, iv or im corticosteroid or er/urgent care center visit or hospitalization within the past year prior to screening. this asthma exacerbation should not have been within 30 days prior to screening
boolean
C0349790 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C4039704 (UMLS CUI [2])
C2065041 (UMLS CUI [3])
C0583237 (UMLS CUI [4])
C0019993 (UMLS CUI [5])
renal and hepatic function
Item
adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication
Item
subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication
boolean
C1533685 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
lung diseases
Item
active lung diseases (e.g., bronchitis, chronic obstructive pulmonary disease [copd], interstitial lung disease, pulmonary fibrosis) other than asthma
boolean
C0024115 (UMLS CUI [1])
corticosteroid resistant asthma
Item
current treatment for corticosteroid-resistant asthma (e.g., methotrexate [mtx], cyclosporine, gold salts, troleandomycin, immune globulin intravenous [igiv], mycophenolate mofetil)
boolean
C0004096 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2])
cancer history
Item
history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma −
boolean
C1512706 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
cervix carcinoma
Item
in-situ of the cervix.
boolean
C0302592 (UMLS CUI [1,1])
C0851135 (UMLS CUI [1,2])
listeria, hiv, hepatitis b, immunodeficiency syndrome, cns demyelinating disease or active tb
Item
history of listeria, human immunodeficiency virus (hiv), chronic or active hepatitis b, an immunodeficiency syndrome, central nervous system (cns) demyelinating disease or active tb
boolean
C0023859 (UMLS CUI [1])
C0019682 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019163 (UMLS CUI [4])
C0011303 (UMLS CUI [5])
C0041296 (UMLS CUI [6])
pregnancy or lactation
Item
females who are pregnant or will not discontinue breast-feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
drug or alcohol abuse
Item
subject with a history of clinically significant drug or alcohol abuse in the last year
boolean
C0038586 (UMLS CUI [1])
poorly controlled medical condition
Item
subjects with a poorly controlled medical condition.
boolean
C0009488 (UMLS CUI [1])
abnormal laboratory values
Item
abnormal, clinically significant screening laboratory and other analyses (including ecg).
boolean
C1254595 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
exposure to tysabri
Item
subjects with any prior exposure to tysabri® (natalizumab)
boolean
C0332157 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
prior treatment with any tnf antagonist, including adalimumab
Item
prior treatment with any tnf antagonist, including adalimumab
boolean
C1514463 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
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