Informações:
Falhas:
ID
40510
Descrição
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS); ODM derived from: https://clinicaltrials.gov/show/NCT01230827
Link
https://clinicaltrials.gov/show/NCT01230827
Palavras-chave
Versões (1)
- 28/04/2020 28/04/2020 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
28 de abril de 2020
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Juvenile Idiopathic Arthritis NCT01230827
Eligibility Juvenile Idiopathic Arthritis NCT01230827
- StudyEvent: Eligibility
Similar models
Eligibility Juvenile Idiopathic Arthritis NCT01230827
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Diagnosis | Age
Item
diagnosis must have been before the patient's 16th birthday
boolean
C0011900 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Disease length
Item
disease duration of at least 6 months before study entry
boolean
C0872146 (UMLS CUI [1])
Arthritis Joints Count
Item
must have 5 or more joints with active arthritis
boolean
C0003864 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0022417 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
Methotrexate Dose Stable | Body Surface Area
Item
must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [bsa] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate)
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0005902 (UMLS CUI [2])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0005902 (UMLS CUI [2])
Prednisone Dose Stable U/day | NSAIDs Dose Stable
Item
may take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of nsaids (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry
boolean
C0032952 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0003211 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Laboratory Results Qualifying
Item
must have qualifying laboratory values at the first visit.
boolean
C1254595 (UMLS CUI [1,1])
C1514624 (UMLS CUI [1,2])
C1514624 (UMLS CUI [1,2])
Hypersensitivity Golimumab | Intolerance to Golimumab | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar
Item
have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics
boolean
C0020517 (UMLS CUI [1,1])
C2353893 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2353893 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C2353893 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C2353893 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Pregnancy, Planned | Reproduction Planned
Item
are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0035150 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C0035150 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Initiation DMARDs | Initiation Therapeutic immunosuppression
Item
have initiated dmards and/or immunosuppressive therapy within 4 weeks prior to study initiation
boolean
C1704686 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0021079 (UMLS CUI [2,2])
C0242708 (UMLS CUI [1,2])
C1704686 (UMLS CUI [2,1])
C0021079 (UMLS CUI [2,2])