ID

19223

Description

Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children; ODM derived from: https://clinicaltrials.gov/show/NCT00484809

Lien

https://clinicaltrials.gov/show/NCT00484809

Mots-clés

  1. 13/12/2016 13/12/2016 -
Téléchargé le

13 décembre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00484809

Eligibility Rheumatoid Arthritis NCT00484809

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion in this study will be as per the approved indications in the package insert.
Description

Indication Disease | Package Insert

Type de données

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0030174
patients with moderately to severely active ra.
Description

Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe

Type de données

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
children with jra who have had an inadequate response to one or more dmards.
Description

Children | Juvenile rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate

Type de données

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C3714757
UMLS CUI [3,1]
C0242708
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0205412
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hypersensitivity to etanercept or any of its components.
Description

Hypersensitivity Etanercept | Hypersensitivity Etanercept Component

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0717758
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0717758
UMLS CUI [2,3]
C1705248
known significant concurrent medical disease, including:
Description

Comorbidity Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
Description

Congestive heart failure | Angina Pectoris Uncontrolled | Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0027051
cancer or history of cancer
Description

Malignant Neoplasms

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
active infection
Description

Communicable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0009450
sepsis or risk of sepsis
Description

Sepsis | At risk for sepsis

Type de données

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2]
C4047386
active tuberculosis or a past history of tuberculosis
Description

Tuberculosis

Type de données

boolean

Alias
UMLS CUI [1]
C0041296
pancytopenia
Description

Pancytopenia

Type de données

boolean

Alias
UMLS CUI [1]
C0030312
females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
Description

Pregnancy | Breast Feeding | Risk of Pregnancy | Gender Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C4048193
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
patients who are planning to undergo elective surgery during the study period.
Description

Elective Surgical Procedure Planned

Type de données

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732

Similar models

Eligibility Rheumatoid Arthritis NCT00484809

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Indication Disease | Package Insert
Item
inclusion in this study will be as per the approved indications in the package insert.
boolean
C3146298 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0030174 (UMLS CUI [2])
Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
patients with moderately to severely active ra.
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Children | Juvenile rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate
Item
children with jra who have had an inadequate response to one or more dmards.
boolean
C0008059 (UMLS CUI [1])
C3714757 (UMLS CUI [2])
C0242708 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1704632 (UMLS CUI [4,1])
C0205412 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Etanercept | Hypersensitivity Etanercept Component
Item
known hypersensitivity to etanercept or any of its components.
boolean
C0020517 (UMLS CUI [1,1])
C0717758 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0717758 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Comorbidity Significant
Item
known significant concurrent medical disease, including:
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Congestive heart failure | Angina Pectoris Uncontrolled | Myocardial Infarction
Item
congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
Malignant Neoplasms
Item
cancer or history of cancer
boolean
C0006826 (UMLS CUI [1])
Communicable Disease
Item
active infection
boolean
C0009450 (UMLS CUI [1])
Sepsis | At risk for sepsis
Item
sepsis or risk of sepsis
boolean
C0243026 (UMLS CUI [1])
C4047386 (UMLS CUI [2])
Tuberculosis
Item
active tuberculosis or a past history of tuberculosis
boolean
C0041296 (UMLS CUI [1])
Pancytopenia
Item
pancytopenia
boolean
C0030312 (UMLS CUI [1])
Pregnancy | Breast Feeding | Risk of Pregnancy | Gender Contraceptive methods
Item
females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4048193 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Elective Surgical Procedure Planned
Item
patients who are planning to undergo elective surgery during the study period.
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])

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