ID

39677

Descripción

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

Palabras clave

Versiones (2)
  1. 19/1/19 19/1/19 -
  2. 9/2/20 9/2/20 - Christian Arras
Titular de derechos de autor

Hoffmann-La Roche

Subido en

9 de febrero de 2020

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Rheumatoid Arthritis NCT01667458

Inglés

Eligibility Rheumatoid Arthritis NCT01667458

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

moderate to severe active rheumatoid arthritis, disease activity, DAS28

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Eligible Roactemra, Eligible Actemra

Tipo de datos

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)
Descripción

Tuberculosis, Absent

Tipo de datos

boolean

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

Exclusion Criteria

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

Hypersensitivity, Tocilicumab or other excipients

Tipo de datos

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
Descripción

Active Infections

Tipo de datos

boolean

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

Pregnant, lactating

Tipo de datos

boolean

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

Study Participation, Interventional Study

Tipo de datos

boolean

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

Depression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
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Similar models

Eligibility Rheumatoid Arthritis NCT01667458

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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