Information:
Fel:
ID
30109
Beskrivning
Safety, Efficacy, and Pharmacokinetics of Adalimumab in Japanese Children With Juvenile Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00690573
Länk
https://clinicaltrials.gov/show/NCT00690573
Nyckelord
Versioner (1)
- 2018-05-11 2018-05-11 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
11 maj 2018
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Juvenile Rheumatoid Arthritis NCT00690573
Eligibility Juvenile Rheumatoid Arthritis NCT00690573
- StudyEvent: Eligibility
Similar models
Eligibility Juvenile Rheumatoid Arthritis NCT00690573
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
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])
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])
C1444662 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
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])
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])
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])
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])
C3844399 (UMLS CUI [1,2])