ID

34533

Description

Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01443364

Link

https://clinicaltrials.gov/show/NCT01443364

Keywords

  1. 1/19/19 1/19/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Rheumatoid Arthritis NCT01443364

Eligibility Rheumatoid Arthritis NCT01443364

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of adult-onset rheumatoid arthritis (ra) for a duration of at least 6 months but not longer than 5 years
Description

Adult onset Rheumatoid Arthritis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1853562
UMLS CUI [1,2]
C0003873
UMLS CUI [1,3]
C0449238
positive rheumatoid factor (rf) and/or positive anti cyclic citrullinated peptide (anti-ccp)
Description

Rheumatoid factor positive | Anti-cyclic citrullinated peptide Positive

Data type

boolean

Alias
UMLS CUI [1]
C0151379
UMLS CUI [2,1]
C1320283
UMLS CUI [2,2]
C1514241
active ra disease
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
subjects must have failed at least one traditional disease modifying anti-rheumatic drug (dmard).
Description

DMARD Quantity failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0231175
subject is naïve to ra related biologics
Description

Therapy naive Biological agents Rheumatoid Arthritis Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0005515
UMLS CUI [1,3]
C0003873
UMLS CUI [1,4]
C0439849
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a diagnosis of any other inflammatory arthritis
Description

Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003864
history of infected joint prosthesis, or other significant infection
Description

Prosthetic joint infection | Communicable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0410808
UMLS CUI [2]
C0009450
known tuberculosis (tb) disease or high risk of acquiring tb infection
Description

Tuberculosis | High risk of Tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0041296

Similar models

Eligibility Rheumatoid Arthritis NCT01443364

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult onset Rheumatoid Arthritis Duration
Item
diagnosis of adult-onset rheumatoid arthritis (ra) for a duration of at least 6 months but not longer than 5 years
boolean
C1853562 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Rheumatoid factor positive | Anti-cyclic citrullinated peptide Positive
Item
positive rheumatoid factor (rf) and/or positive anti cyclic citrullinated peptide (anti-ccp)
boolean
C0151379 (UMLS CUI [1])
C1320283 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Rheumatoid Arthritis
Item
active ra disease
boolean
C0003873 (UMLS CUI [1])
DMARD Quantity failed
Item
subjects must have failed at least one traditional disease modifying anti-rheumatic drug (dmard).
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Therapy naive Biological agents Rheumatoid Arthritis Related
Item
subject is naïve to ra related biologics
boolean
C0919936 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Arthritis
Item
a diagnosis of any other inflammatory arthritis
boolean
C0003864 (UMLS CUI [1])
Prosthetic joint infection | Communicable Disease
Item
history of infected joint prosthesis, or other significant infection
boolean
C0410808 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
Tuberculosis | High risk of Tuberculosis
Item
known tuberculosis (tb) disease or high risk of acquiring tb infection
boolean
C0041296 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0041296 (UMLS CUI [2,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial