ID

23012

Description

Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA; ODM derived from: https://clinicaltrials.gov/show/NCT01117480

Link

https://clinicaltrials.gov/show/NCT01117480

Keywords

Versions (1)
  1. 6/19/17 6/19/17 -
Uploaded on

June 19, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01117480

English

Eligibility Rheumatoid Arthritis NCT01117480

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is eligible to take part in the registry as per the product monograph.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patients that are naïve to adalimumab therapy / or patients that have been receiving adalimumab therapy for less than 4 months.
Description

Adalimumab Therapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C1122087
UMLS CUI [1,2]
C0919936
patient has moderately to severely active ra.
Description

Rheumatoid arthritis, moderate | Rheumatoid Arthritis Severe

Data type

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
patient who has had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards).
Description

Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
patient received provincial or private (insurance companies) approval for adalimumab.
Description

Approval Insurance company Adalimumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0205540
UMLS CUI [1,2]
C1549448
UMLS CUI [1,3]
C1122087
patient is able to give written informed consent and to understand the survey requirements.
Description

Informed Consent | Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C2348563
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient to whom a traditional dmard had never been tried.
Description

Disease-Modifying Antirheumatic Drugs Therapy Attempt Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1516084
UMLS CUI [1,4]
C0332268
patient with a known hypersensitivity to adalimumab, or any of its components.
Description

Hypersensitivity Adalimumab | Hypersensitivity Adalimumab Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1122087
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1122087
UMLS CUI [2,3]
C1705248
patient is receiving free adalimumab as part of a compassionate program or an early access drug distribution program.
Description

Adalimumab Free

Data type

boolean

Alias
UMLS CUI [1,1]
C1122087
UMLS CUI [1,2]
C1996904
patient with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes.
Description

Comorbidity Affecting Research results | Mental disorders Affecting Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683954
patient with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the patient will not be available for a period of time (> 12 months) while being enrolled in the survey.
Description

Condition Study Subject Participation Status Exclusion | Condition Clinical Trial Completion Excluded | Language comprehension Limited | Patient Unavailable Time Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C2828389
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0439801
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C0686905
UMLS CUI [4,3]
C1948053
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Similar models

Eligibility Rheumatoid Arthritis NCT01117480

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status
Item
patient is eligible to take part in the registry as per the product monograph.
boolean
C2348568 (UMLS CUI [1])
Adalimumab Therapy naive
Item
patients that are naïve to adalimumab therapy / or patients that have been receiving adalimumab therapy for less than 4 months.
boolean
C1122087 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Rheumatoid arthritis, moderate | Rheumatoid Arthritis Severe
Item
patient has moderately to severely active ra.
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate
Item
patient who has had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards).
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Approval Insurance company Adalimumab
Item
patient received provincial or private (insurance companies) approval for adalimumab.
boolean
C0205540 (UMLS CUI [1,1])
C1549448 (UMLS CUI [1,2])
C1122087 (UMLS CUI [1,3])
Informed Consent | Comprehension Study Protocol
Item
patient is able to give written informed consent and to understand the survey requirements.
boolean
C0021430 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Disease-Modifying Antirheumatic Drugs Therapy Attempt Lacking
Item
patient to whom a traditional dmard had never been tried.
boolean
C0242708 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1516084 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
Hypersensitivity Adalimumab | Hypersensitivity Adalimumab Component
Item
patient with a known hypersensitivity to adalimumab, or any of its components.
boolean
C0020517 (UMLS CUI [1,1])
C1122087 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1122087 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Adalimumab Free
Item
patient is receiving free adalimumab as part of a compassionate program or an early access drug distribution program.
boolean
C1122087 (UMLS CUI [1,1])
C1996904 (UMLS CUI [1,2])
Comorbidity Affecting Research results | Mental disorders Affecting Research results
Item
patient with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Condition Study Subject Participation Status Exclusion | Condition Clinical Trial Completion Excluded | Language comprehension Limited | Patient Unavailable Time Period
Item
patient with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the patient will not be available for a period of time (> 12 months) while being enrolled in the survey.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C2828389 (UMLS CUI [2,4])
C0233733 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C1948053 (UMLS CUI [4,3])
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