ID

39677

Beschrijving

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

Trefwoorden

  1. 19-01-19 19-01-19 -
  2. 09-02-20 09-02-20 - Christian Arras
Houder van rechten

Hoffmann-La Roche

Geüploaded op

9 februari 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Rheumatoid Arthritis NCT01667458

Eligibility Rheumatoid Arthritis NCT01667458

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

moderate to severe active rheumatoid arthritis, disease activity, DAS28

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Eligible Roactemra, Eligible Actemra

Datatype

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)
Beschrijving

Tuberculosis, Absent

Datatype

boolean

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

Exclusion Criteria

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

Hypersensitivity, Tocilicumab or other excipients

Datatype

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
Beschrijving

Active Infections

Datatype

boolean

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

Pregnant, lactating

Datatype

boolean

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

Study Participation, Interventional Study

Datatype

boolean

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

Depression

Datatype

boolean

Alias
UMLS CUI [1]
C1269683

Similar models

Eligibility Rheumatoid Arthritis NCT01667458

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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