Informações:
Falhas:
ID
31907
Descrição
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01007435
Link
https://clinicaltrials.gov/show/NCT01007435
Palavras-chave
Versões (1)
- 08/10/2018 08/10/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
8 de outubro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01007435
Eligibility Rheumatoid Arthritis NCT01007435
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT01007435
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Adult | Age
Item
adult patients ≥ 18 years of age.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
Rheumatoid Arthritis Duration
Item
rheumatoid arthritis of ≤ 2 years duration.
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
Disease activity score das28
Item
disease activity score 28 (das28) > 3.2.
boolean
C4481729 (UMLS CUI [1])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc) ≥ 4 of 66 joints, tender joint count (tjc) ≥ 6 of 68 joints.
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
C0451530 (UMLS CUI [2])
Rheumatoid factor positive | Anti-cyclic citrullinated peptide Positive
Item
rheumatoid factor (rf) and/or anti−cyclic citrullinated peptide (anti-ccp) positive (if rf and anti-ccp negative > 1 erosion required at screening).
boolean
C0151379 (UMLS CUI [1])
C1320283 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1320283 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
erythrocyte sedimentation rate (esr) ≥ 28 mm/h or c-reactive protein (crp) ≥ 10 mg/l at screening.
boolean
C1176468 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
C0201657 (UMLS CUI [2])
tocilizumab
Item
previous treatment with tocilizumab.
boolean
C1609165 (UMLS CUI [1])
Methotrexate | Biological agent
Item
previous treatment with methotrexate or biologic agent.
boolean
C0025677 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C0005515 (UMLS CUI [2])
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than rheumatoid arthritis (ra).
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of or current inflammatory joint disease other than ra.
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in ra.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])