ID

31874

Beschrijving

A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT00810199

Link

https://clinicaltrials.gov/show/NCT00810199

Trefwoorden

  1. 05-10-18 05-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00810199

Eligibility Rheumatoid Arthritis NCT00810199

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, ≥ 18 years of age;
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
moderate to severe active rheumatoid arthritis (disease activity score (das28) > 4.4);
Beschrijving

Rheumatoid arthritis moderate Disease activity score das28 | Rheumatoid Arthritis Severe Disease activity score das28

Datatype

boolean

Alias
UMLS CUI [1,1]
C2368567
UMLS CUI [1,2]
C4481729
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C4481729
inadequate response to methotrexate;
Beschrijving

Methotrexate Response Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.
Beschrijving

Methotrexate Dose Stable U/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with a biologic;
Beschrijving

Biological agent

Datatype

boolean

Alias
UMLS CUI [1]
C0005515
rheumatoid arthritis (ra) functional class iv;
Beschrijving

Rheumatoid Arthritis Functional Status Class

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
Beschrijving

Bacterial Infections | Virus Diseases | Mycoses | Mycobacterial Infections | Communicable Diseases | Recurrent bacterial infection | Recurrent viral infection | Recurrent fungal infections | Recurrent mycobacterial infections | Recurrent infections

Datatype

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0042769
UMLS CUI [3]
C0026946
UMLS CUI [4]
C0026918
UMLS CUI [5]
C0009450
UMLS CUI [6]
C1844383
UMLS CUI [7]
C1837066
UMLS CUI [8]
C1844384
UMLS CUI [9]
C4023438
UMLS CUI [10]
C0239998
evidence of active malignant disease.
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826

Similar models

Eligibility Rheumatoid Arthritis NCT00810199

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, ≥ 18 years of age;
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid arthritis moderate Disease activity score das28 | Rheumatoid Arthritis Severe Disease activity score das28
Item
moderate to severe active rheumatoid arthritis (disease activity score (das28) > 4.4);
boolean
C2368567 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4481729 (UMLS CUI [2,3])
Methotrexate Response Inadequate
Item
inadequate response to methotrexate;
boolean
C0025677 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
Methotrexate Dose Stable U/week
Item
on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Biological agent
Item
prior treatment with a biologic;
boolean
C0005515 (UMLS CUI [1])
Rheumatoid Arthritis Functional Status Class
Item
rheumatoid arthritis (ra) functional class iv;
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Bacterial Infections | Virus Diseases | Mycoses | Mycobacterial Infections | Communicable Diseases | Recurrent bacterial infection | Recurrent viral infection | Recurrent fungal infections | Recurrent mycobacterial infections | Recurrent infections
Item
known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections;
boolean
C0004623 (UMLS CUI [1])
C0042769 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0026918 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C1844383 (UMLS CUI [6])
C1837066 (UMLS CUI [7])
C1844384 (UMLS CUI [8])
C4023438 (UMLS CUI [9])
C0239998 (UMLS CUI [10])
Malignant Neoplasms
Item
evidence of active malignant disease.
boolean
C0006826 (UMLS CUI [1])

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