ID

39259

Descrição

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT01290887

Link

https://clinicaltrials.gov/show/NCT01290887

Palavras-chave

Versões (1)
  1. 13/12/2019 13/12/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

13 de dezembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Eosinophilic Asthma NCT01290887

Inglês

Eligibility Eosinophilic Asthma NCT01290887

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent is obtained.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
patient must have completed treatment in a previous cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
Descrição

Treatment completed | Exacerbation of asthma Clinical Trial | Investigational New Drugs Dose Quantity | Pulmonary function Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0580352
UMLS CUI [2,1]
C0349790
UMLS CUI [2,2]
C0008976
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0024119
UMLS CUI [4,2]
C0008976
the patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
Descrição

Protocol Compliance | Patient Available Clinical Study Follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
other criteria may apply; please contact the investigator for more information.
Descrição

Inclusion criteria Additional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1524062
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
Descrição

Comorbidity Interferes with Study Protocol | Comorbidity Interferes with Protocol Compliance | Comorbidity compromises Patient safety

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C1113679
the patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
Descrição

Interference Lung disease | Chronic Obstructive Airway Disease | Pulmonary Fibrosis | Carcinoma of lung

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0521102
UMLS CUI [1,2]
C0024115
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0034069
UMLS CUI [4]
C0684249
the patient is a current smoker.
Descrição

Tobacco use

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543414
the patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
Descrição

Protocol Compliance Poor Expected

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C1517001
the patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [gerd]).
Descrição

Aggravating factors Poorly controlled | Gastroesophageal reflux disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0436331
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0017168
female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [iud], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Vaginal Spermicides | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Transdermal contraception | Contraceptive implant | Injectable contraception | Contraception, Barrier

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
UMLS CUI [4]
C0087145
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0021900
UMLS CUI [7]
C0009905
UMLS CUI [8]
C1168146
UMLS CUI [9]
C1657106
UMLS CUI [10]
C1262153
UMLS CUI [11]
C0004764
the patient has a current infection or disease that may preclude assessment of asthma.
Descrição

Communicable Disease Excludes Assessment Asthma | Disease Excludes Assessment Asthma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0004096
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1516048
UMLS CUI [2,4]
C0004096
other criteria may apply; please contact the investigator for more information.
Descrição

Exclusion Criteria Additional

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Eosinophilic Asthma NCT01290887

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent is obtained.
boolean
C0021430 (UMLS CUI [1])
Treatment completed | Exacerbation of asthma Clinical Trial | Investigational New Drugs Dose Quantity | Pulmonary function Clinical Trial
Item
patient must have completed treatment in a previous cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
boolean
C0580352 (UMLS CUI [1])
C0349790 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0013230 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0024119 (UMLS CUI [4,1])
C0008976 (UMLS CUI [4,2])
Protocol Compliance | Patient Available Clinical Study Follow-up
Item
the patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
boolean
C0525058 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Inclusion criteria Additional
Item
other criteria may apply; please contact the investigator for more information.
boolean
C1512693 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Comorbidity Interferes with Study Protocol | Comorbidity Interferes with Protocol Compliance | Comorbidity compromises Patient safety
Item
the patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
boolean
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
Interference Lung disease | Chronic Obstructive Airway Disease | Pulmonary Fibrosis | Carcinoma of lung
Item
the patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
boolean
C0521102 (UMLS CUI [1,1])
C0024115 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0684249 (UMLS CUI [4])
Tobacco use
Item
the patient is a current smoker.
boolean
C0543414 (UMLS CUI [1])
Protocol Compliance Poor Expected
Item
the patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
boolean
C0525058 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Aggravating factors Poorly controlled | Gastroesophageal reflux disease
Item
the patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [gerd]).
boolean
C0436331 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0017168 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent | Vaginal Spermicides | Sexual Abstinence | Intrauterine Devices | Contraceptives, Oral | Transdermal contraception | Contraceptive implant | Injectable contraception | Contraception, Barrier
Item
female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [iud], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0087145 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0021900 (UMLS CUI [6])
C0009905 (UMLS CUI [7])
C1168146 (UMLS CUI [8])
C1657106 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C0004764 (UMLS CUI [11])
Communicable Disease Excludes Assessment Asthma | Disease Excludes Assessment Asthma
Item
the patient has a current infection or disease that may preclude assessment of asthma.
boolean
C0009450 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0004096 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
C0004096 (UMLS CUI [2,4])
Exclusion Criteria Additional
Item
other criteria may apply; please contact the investigator for more information.
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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