ID

31893

Descrição

A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00965653

Link

https://clinicaltrials.gov/show/NCT00965653

Palavras-chave

  1. 07/10/2018 07/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00965653

Eligibility Rheumatoid Arthritis NCT00965653

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adults 18 - 75 years of age
Descrição

Adult | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
active rheumatoid arthritis of >/= 6 months duration
Descrição

Rheumatoid Arthritis Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
Descrição

Methotrexate Response Inadequate | Methotrexate Dose Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
swollen joint count (sjc)>/=4, tender joint count (tjc)>/=6 at screening and baseline
Descrição

Swollen joint count | Tender joint count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
dmards and anti-tnfs, other than methotrexate, withdrawn prior to baseline
Descrição

DMARDs Discontinued | Anti-TNF drug Discontinued | Exception Methotrexate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1562242
UMLS CUI [2,2]
C1444662
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025677
oral corticosteroids (</= 10mg/day prednisone or equivalent) and nsaids on stable dose </= 4 weeks prior to baseline
Descrição

Adrenal Cortex Hormones Oral

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than rheumatoid arthritis
Descrição

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
prior history or current inflammatory joint disease other than rheumatoid arthritis
Descrição

Inflammatory joint disease | Exception Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
Descrição

Major surgery | Operation on joint | Major surgery Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0185132
UMLS CUI [3,1]
C0679637
UMLS CUI [3,2]
C1301732
functional class iv by acr classification
Descrição

Rheumatoid Arthritis Functional Status Class

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387

Similar models

Eligibility Rheumatoid Arthritis NCT00965653

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adults 18 - 75 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid Arthritis Duration
Item
active rheumatoid arthritis of >/= 6 months duration
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Methotrexate Response Inadequate | Methotrexate Dose Stable
Item
inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
boolean
C0025677 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc)>/=4, tender joint count (tjc)>/=6 at screening and baseline
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
DMARDs Discontinued | Anti-TNF drug Discontinued | Exception Methotrexate
Item
dmards and anti-tnfs, other than methotrexate, withdrawn prior to baseline
boolean
C0242708 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1562242 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025677 (UMLS CUI [3,2])
Adrenal Cortex Hormones Oral
Item
oral corticosteroids (</= 10mg/day prednisone or equivalent) and nsaids on stable dose </= 4 weeks prior to baseline
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than rheumatoid arthritis
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
prior history or current inflammatory joint disease other than rheumatoid arthritis
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Major surgery | Operation on joint | Major surgery Planned
Item
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
boolean
C0679637 (UMLS CUI [1])
C0185132 (UMLS CUI [2])
C0679637 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv by acr classification
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])

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