ID

30109

Descripción

Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00690573

Link

https://clinicaltrials.gov/show/NCT00690573

Palabras clave

Versiones (1)
  1. 11/5/18 11/5/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

11 de mayo de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Juvenile Rheumatoid Arthritis NCT00690573

Inglés

Eligibility Juvenile Rheumatoid Arthritis NCT00690573

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of polyarticular juvenile rheumatoid arthritis (jra) according to the criteria of the american college on rheumatology (acr)
Descripción

Polyarticular juvenile rheumatoid arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0311221
disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (nsaids) or methotrexate (mtx)
Descripción

Disease Poorly controlled | Anti-Inflammatory Agents, Non-Steroidal | Methotrexate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3853134
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0025677
presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
Descripción

Swollen joint count | Deformity Absent | Joints Quantity Limitation of joint movement | Pain with range of motion | Pain pressure | Tenderness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2,1]
C0302142
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0022417
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0231589
UMLS CUI [4]
C3842100
UMLS CUI [5]
C3647129
UMLS CUI [6]
C0234233
stable dosage of mtx for at least 12 weeks prior to the screening visit or discontinuation of mtx at least 14 days prior to baseline visit (day 1)
Descripción

Methotrexate Dosage Stable | Methotrexate Discontinued

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C1444662
discontinuation of disease-modifying antirheumatic drugs (dmards) other than mtx at least 28 days before screening visit
Descripción

DMARDs Discontinuation | Exception Methotrexate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of inflammatory joint disease other than jra
Descripción

Inflammatory joint disease | Exception Polyarticular juvenile rheumatoid arthritis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0311221
functional class iv jra by acr criteria
Descripción

Polyarticular juvenile rheumatoid arthritis ACR Classification Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0311221
UMLS CUI [1,2]
C4055474
clinically significant cardiac disease or laboratory abnormalities
Descripción

Heart Disease | LABORATORY ABNORMALITIES

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1853129
any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Descripción

Study Subject Participation Status Unsuitable for other reasons

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3844399
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Similar models

Eligibility Juvenile Rheumatoid Arthritis NCT00690573

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Polyarticular juvenile rheumatoid arthritis
Item
diagnosis of polyarticular juvenile rheumatoid arthritis (jra) according to the criteria of the american college on rheumatology (acr)
boolean
C0311221 (UMLS CUI [1])
Disease Poorly controlled | Anti-Inflammatory Agents, Non-Steroidal | Methotrexate
Item
disease activity inadequately controlled by nonsteroidal anti-inflammatory drugs (nsaids) or methotrexate (mtx)
boolean
C0012634 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
Swollen joint count | Deformity Absent | Joints Quantity Limitation of joint movement | Pain with range of motion | Pain pressure | Tenderness
Item
presence at screening of at least 5 swollen joints (not due to deformity) and at least 3 joints with limitation of passive motion with pain by passive motion or/and pain by pressure (tenderness)
boolean
C0451521 (UMLS CUI [1])
C0302142 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0022417 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0231589 (UMLS CUI [3,3])
C3842100 (UMLS CUI [4])
C3647129 (UMLS CUI [5])
C0234233 (UMLS CUI [6])
Methotrexate Dosage Stable | Methotrexate Discontinued
Item
stable dosage of mtx for at least 12 weeks prior to the screening visit or discontinuation of mtx at least 14 days prior to baseline visit (day 1)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
DMARDs Discontinuation | Exception Methotrexate
Item
discontinuation of disease-modifying antirheumatic drugs (dmards) other than mtx at least 28 days before screening visit
boolean
C0242708 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Inflammatory joint disease | Exception Polyarticular juvenile rheumatoid arthritis
Item
history of inflammatory joint disease other than jra
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0311221 (UMLS CUI [2,2])
Polyarticular juvenile rheumatoid arthritis ACR Classification Criteria
Item
functional class iv jra by acr criteria
boolean
C0311221 (UMLS CUI [1,1])
C4055474 (UMLS CUI [1,2])
Heart Disease | LABORATORY ABNORMALITIES
Item
clinically significant cardiac disease or laboratory abnormalities
boolean
C0018799 (UMLS CUI [1])
C1853129 (UMLS CUI [2])
Study Subject Participation Status Unsuitable for other reasons
Item
any subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
boolean
C2348568 (UMLS CUI [1,1])
C3844399 (UMLS CUI [1,2])
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