ID

23012

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01117480

Nyckelord

Versioner (1)
  1. 2017-06-19 2017-06-19 -
Uppladdad den

19 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01117480

Engelsk

Eligibility Rheumatoid Arthritis NCT01117480

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Study Subject Participation Status

Datatyp

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.
Beskrivning

Adalimumab Therapy naive

Datatyp

boolean

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

Rheumatoid arthritis, moderate | Rheumatoid Arthritis Severe

Datatyp

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).
Beskrivning

Disease-Modifying Antirheumatic Drugs Quantity | Response Inadequate

Datatyp

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.
Beskrivning

Approval Insurance company Adalimumab

Datatyp

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.
Beskrivning

Informed Consent | Comprehension Study Protocol

Datatyp

boolean

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

Exclusion Criteria

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

Disease-Modifying Antirheumatic Drugs Therapy Attempt Lacking

Datatyp

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.
Beskrivning

Hypersensitivity Adalimumab | Hypersensitivity Adalimumab Component

Datatyp

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.
Beskrivning

Adalimumab Free

Datatyp

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.
Beskrivning

Comorbidity Affecting Research results | Mental disorders Affecting Research results

Datatyp

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.
Beskrivning

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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