ID

12591

Descripción

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01356602

Link

https://clinicaltrials.gov/show/NCT01356602

Palabras clave

Versiones (1)
  1. 3/12/15 3/12/15 -
Subido en

3 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Acute Gouty Arthritis NCT01356602

Inglés

Eligibility Acute Gouty Arthritis NCT01356602

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
3 or more gout flares within last year
Descripción

3 or more gout flares within last year

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1619733
contraindication, intolerance or lack of efficacy for nsaids and/or colchicine
Descripción

contraindication, intolerance or lack of efficacy for nsaids and/or colchicine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C1744706
UMLS CUI [3]
C0235828
body mass index of less than or equal to 45 kg/m2
Descripción

body mass index of less than or equal to 45 kg/m2

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, nsaids (such as aspirin), colchicine.
Descripción

use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, nsaids (such as aspirin), colchicine.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
hemodialysis
Descripción

hemodialysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019004
live vaccine within 3 months before first dose
Descripción

live vaccine within 3 months before first dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042211
donation or loss of 400 ml or more within 3 months before first dose
Descripción

donation or loss of 400 ml or more within 3 months before first dose

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C0553700
gout brought on by other factors such as chemotherapy, lead, transplant, etc.
Descripción

gout brought on by other factors such as chemotherapy, lead, transplant, etc.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3665472
UMLS CUI [2]
C0023175
UMLS CUI [3]
C0040732
presence of other acute inflammatory arthritis such as rheumatoid arthritis
Descripción

presence of other acute inflammatory arthritis such as rheumatoid arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as hiv, hepatitis, tuberculosis and other infections/conditions
Descripción

any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as hiv, hepatitis, tuberculosis and other infections/conditions

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0439801
UMLS CUI [3]
C0009488
significant cardiovascular conditions such as uncontrolled hypertension
Descripción

significant cardiovascular conditions such as uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
significant medical diseases such as uncontrolled diabetes, thyroid disease
Descripción

significant medical diseases such as uncontrolled diabetes, thyroid disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
history of malignancy of any organ system within the past 5 years
Descripción

history of malignancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
women who are pregnant or nursing
Descripción

pregnant or breastfeeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other protocol-defined inclusion/exclusion criteria may apply
Descripción

other protocol-defined inclusion/exclusion criteria may apply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205394
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Similar models

Eligibility Acute Gouty Arthritis NCT01356602

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
3 or more gout flares within last year
Item
3 or more gout flares within last year
boolean
C1619733 (UMLS CUI [1])
contraindication, intolerance or lack of efficacy for nsaids and/or colchicine
Item
contraindication, intolerance or lack of efficacy for nsaids and/or colchicine
boolean
C1301624 (UMLS CUI [1])
C1744706 (UMLS CUI [2])
C0235828 (UMLS CUI [3])
body mass index of less than or equal to 45 kg/m2
Item
body mass index of less than or equal to 45 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, nsaids (such as aspirin), colchicine.
Item
use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, nsaids (such as aspirin), colchicine.
boolean
C2347852 (UMLS CUI [1])
hemodialysis
Item
hemodialysis
boolean
C0019004 (UMLS CUI [1])
live vaccine within 3 months before first dose
Item
live vaccine within 3 months before first dose
boolean
C0042211 (UMLS CUI [1])
donation or loss of 400 ml or more within 3 months before first dose
Item
donation or loss of 400 ml or more within 3 months before first dose
boolean
C0005794 (UMLS CUI [1])
C0553700 (UMLS CUI [2])
gout brought on by other factors such as chemotherapy, lead, transplant, etc.
Item
gout brought on by other factors such as chemotherapy, lead, transplant, etc.
boolean
C3665472 (UMLS CUI [1])
C0023175 (UMLS CUI [2])
C0040732 (UMLS CUI [3])
presence of other acute inflammatory arthritis such as rheumatoid arthritis
Item
presence of other acute inflammatory arthritis such as rheumatoid arthritis
boolean
C0009488 (UMLS CUI [1])
any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as hiv, hepatitis, tuberculosis and other infections/conditions
Item
any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as hiv, hepatitis, tuberculosis and other infections/conditions
boolean
C0525058 (UMLS CUI [1])
C0439801 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
significant cardiovascular conditions such as uncontrolled hypertension
Item
significant cardiovascular conditions such as uncontrolled hypertension
boolean
C0009488 (UMLS CUI [1])
significant medical diseases such as uncontrolled diabetes, thyroid disease
Item
significant medical diseases such as uncontrolled diabetes, thyroid disease
boolean
C0009488 (UMLS CUI [1])
history of malignancy
Item
history of malignancy of any organ system within the past 5 years
boolean
C0006826 (UMLS CUI [1])
pregnant or breastfeeding
Item
women who are pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
other protocol-defined inclusion/exclusion criteria may apply
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C0205394 (UMLS CUI [1])
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