ID

39677

Description

An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab); ODM derived from: https://clinicaltrials.gov/show/NCT01667458

Link

https://clinicaltrials.gov/show/NCT01667458

Keywords

Versions (2)
  1. 19/01/19 19/01/19 -
  2. 09/02/20 09/02/20 - Christian Arras
Copyright Holder

Hoffmann-La Roche

Uploaded on

9 febbraio 2020

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Rheumatoid Arthritis NCT01667458

English

Eligibility Rheumatoid Arthritis NCT01667458

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
Description

moderate to severe active rheumatoid arthritis, disease activity, DAS28

Data type

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C4481729
inadequate clinical response to current treatment with >/= 2 non-biologic dmards, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-tnf therapy
Description

Clinical response to DMARD + Methotrexate or Anti-TNF therapy, inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0025677
UMLS CUI [1,4]
C1704632
UMLS CUI [1,5]
C0205412
UMLS CUI [2,1]
C0281481
UMLS CUI [2,2]
C1704632
UMLS CUI [2,3]
C0205412
eligible for roactemra/actemra treatment in daily clinical practice
Description

Eligible Roactemra, Eligible Actemra

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C3272237
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C2740854
absence of evolutive tuberculosis (tb)
Description

Tuberculosis, Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to tocilizumab or any of the excipients
Description

Hypersensitivity, Tocilicumab or other excipients

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1609165
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0015237
active, severe infections
Description

Active Infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205082
pregnant or lactating women
Description

Pregnant, lactating

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in any other interventional study
Description

Study Participation, Interventional Study

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3274035
patients with major depression
Description

Depression

Data type

boolean

Alias
UMLS CUI [1]
C1269683
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Similar models

Eligibility Rheumatoid Arthritis NCT01667458

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
adult patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
moderate to severe active rheumatoid arthritis, disease activity, DAS28
Item
moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C4481729 (UMLS CUI [3])
Clinical response to DMARD + Methotrexate or Anti-TNF therapy, inadequate
Item
inadequate clinical response to current treatment with >/= 2 non-biologic dmards, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-tnf therapy
boolean
C0242708 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
C1704632 (UMLS CUI [1,4])
C0205412 (UMLS CUI [1,5])
C0281481 (UMLS CUI [2,1])
C1704632 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
Eligible Roactemra, Eligible Actemra
Item
eligible for roactemra/actemra treatment in daily clinical practice
boolean
C1548635 (UMLS CUI [1,1])
C3272237 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C2740854 (UMLS CUI [2,2])
Tuberculosis, Absent
Item
absence of evolutive tuberculosis (tb)
boolean
C0041296 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity, Tocilicumab or other excipients
Item
hypersensitivity to tocilizumab or any of the excipients
boolean
C0020517 (UMLS CUI [1,1])
C1609165 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
Active Infections
Item
active, severe infections
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Pregnant, lactating
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Participation, Interventional Study
Item
participation in any other interventional study
boolean
C2348568 (UMLS CUI [1,1])
C3274035 (UMLS CUI [1,2])
Depression
Item
patients with major depression
boolean
C1269683 (UMLS CUI [1])
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