ID

41606

Description

An Observational Quality of Life Study in Participants With Rheumatoid Arthritis Treated With Rituximab; ODM derived from: https://clinicaltrials.gov/show/NCT02507752

Link

https://clinicaltrials.gov/show/NCT02507752

Keywords

Versions (1)
  1. 11/24/20 11/24/20 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

November 24, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02507752

English

Eligibility Rheumatoid Arthritis NCT02507752

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult participants of both genders who are 18 years or older
Description

gender, age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
diagnosis of ra for at least 6 months according to the criteria of the american college of rheumatology (acr) of 1987 for the ra classification
Description

ra for min. 6 months according to criteria of the american college of rheumatology (acr) for the ra classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0003873
UMLS CUI [1,3]
C0008902
UMLS CUI [1,4]
C3273740
participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
Description

recent medically prescribed or infusion of rituximab

Data type

boolean

Alias
UMLS CUI [1,1]
C0278329
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0393022
UMLS CUI [2,1]
C0574032
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C0393022
ability to meet the program's requirements and to voluntarily sign the informed consent term.
Description

fulfill program's requirements and informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1550543
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0008976
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
Description

recent investigational medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0304229
participants with an active infection
Description

active infection

Data type

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0205177
participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
Description

conditions interfering with ability to understand requests of data collection and with protocol compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1273101
UMLS CUI [1,4]
C1272683
UMLS CUI [1,5]
C0010995
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
functional class iv defined based on the acr functionality criteria for ra
Description

acr functionality criteria for ra: functional class IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C3273747
UMLS CUI [1,3]
C0598463
UMLS CUI [1,4]
C0456387
participants who can not or who do not want, for any reason, to answer the questionnaires.
Description

unwilling or unable to answer questionaires

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0034394
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Similar models

Eligibility Rheumatoid Arthritis NCT02507752

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
gender, age
Item
adult participants of both genders who are 18 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ra for min. 6 months according to criteria of the american college of rheumatology (acr) for the ra classification
Item
diagnosis of ra for at least 6 months according to the criteria of the american college of rheumatology (acr) of 1987 for the ra classification
boolean
C0332185 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0008902 (UMLS CUI [1,3])
C3273740 (UMLS CUI [1,4])
recent medically prescribed or infusion of rituximab
Item
participants with medically prescribed or being administered with unique rituximab infusion in the least 3 days, according to the approved label
boolean
C0278329 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0393022 (UMLS CUI [1,3])
C0574032 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0393022 (UMLS CUI [2,3])
fulfill program's requirements and informed consent
Item
ability to meet the program's requirements and to voluntarily sign the informed consent term.
boolean
C1550543 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
recent investigational medication
Item
participants who have received any investigational medication within less than or equal to (<=) 1 year before the first dose of the currently indicated treatment
boolean
C0332185 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
active infection
Item
participants with an active infection
boolean
C3714514 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
conditions interfering with ability to understand requests of data collection and with protocol compliance
Item
participants with conditions that may interfere in the ability to understand the requests of data collection and to obey to the study's requirements
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1273101 (UMLS CUI [1,3])
C1272683 (UMLS CUI [1,4])
C0010995 (UMLS CUI [1,5])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
acr functionality criteria for ra: functional class IV
Item
functional class iv defined based on the acr functionality criteria for ra
boolean
C0003873 (UMLS CUI [1,1])
C3273747 (UMLS CUI [1,2])
C0598463 (UMLS CUI [1,3])
C0456387 (UMLS CUI [1,4])
unwilling or unable to answer questionaires
Item
participants who can not or who do not want, for any reason, to answer the questionnaires.
boolean
C1299582 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0558080 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
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