Informações:
Falhas:
ID
23008
Descrição
Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis (RA) Despite Methotrexate (MTX) Therapy in Japan; ODM derived from: https://clinicaltrials.gov/show/NCT00688103
Link
https://clinicaltrials.gov/show/NCT00688103
Palavras-chave
Versões (1)
- 19/06/2017 19/06/2017 -
Transferido a
19 de junho de 2017
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00688103
Eligibility Rheumatoid Arthritis NCT00688103
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00688103
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
patients had to be at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis
Item
fulfilled the 1987 revised classification criteria for ra by in american college of rheumatology (acr)
boolean
C0003873 (UMLS CUI [1])
Etanercept | Tender joint count | Swollen joint count
Item
met the guidelines for the proper use of etn in japan (having at least 6 tender joints and 6 swollen joints
boolean
C0717758 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
C0451530 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
serum C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
either serum c-reactive protein more than 2 mg/dl or esr no less than 28 mm at 1 hour, with adequate safety profiles)
boolean
C2229674 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
C1176468 (UMLS CUI [2])
Rheumatoid Arthritis Class Functional
Item
be acr functional class i-iii
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Methotrexate U/week Dose Stable
Item
have been receiving mtx 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment
boolean
C0025677 (UMLS CUI [1,1])
C0560588 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
C0560588 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
Prednisone U/day | prednisolone U/day | prednisolone equivalent
Item
patients who required concurrent use of prednisone (psl) >10 mg/day, or its equivalent, were excluded from study entry
boolean
C0032952 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
C0456683 (UMLS CUI [1,2])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
Prednisolone equivalent Dose Increment
Item
the start of dose increment of psl equivalents within 3 months of the study enrollment
boolean
C0032950 (UMLS CUI [1,1])
C3242703 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1705117 (UMLS CUI [1,4])
C3242703 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1705117 (UMLS CUI [1,4])
Antirheumatic Agents | Methotrexate Excluded | Prednisolone equivalent Excluded
Item
experience of antirheumatic therapy except for mtx and psl equivalents
boolean
C0003191 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
C0025677 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0032950 (UMLS CUI [3,1])
C3242703 (UMLS CUI [3,2])
C2828389 (UMLS CUI [3,3])
Etanercept | Biological treatment
Item
previous treatment with etn or any other biological treatment
boolean
C0717758 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C1531518 (UMLS CUI [2])