ID

39928

Beschreibung

A Study in Participants With Psoriatic Arthritis Attending Dermatology Clinics; ODM derived from: https://clinicaltrials.gov/show/NCT02470481

Link

https://clinicaltrials.gov/show/NCT02470481

Stichworte

Versionen (3)
  1. 19.01.19 19.01.19 -
  2. 11.02.20 11.02.20 - Christian Arras
  3. 04.03.20 04.03.20 - Christian Arras
Rechteinhaber

Janssen Research & Development, LLC

Hochgeladen am

4. März 2020

DOI

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Lizenz

Creative Commons BY-NC 4.0
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Eligibility Psoriatic Arthritis NCT02470481

Englisch

Eligibility Psoriatic Arthritis NCT02470481

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must be a man or woman aged 18 to 65 years of age, inclusive
Beschreibung

Gender, Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
the patient must have an established diagnosis of psoriasis (based upon clinical evidence, and documented medical history [19])
Beschreibung

Diagnosis of psoriasis, clinical evidence, medical history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0033860
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0205210
the patient must be able to read and write in the target language (english, mandarin or korean; or other relevant target languages)
Beschreibung

Able to read, able to write, English, Mandarin, Korean, target language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0586740
UMLS CUI [3,2]
C0682398
UMLS CUI [4,1]
C0584993
UMLS CUI [4,2]
C0682398
UMLS CUI [5,1]
C0586740
UMLS CUI [5,2]
C0022774
UMLS CUI [6,1]
C0584993
UMLS CUI [6,2]
C0022774
UMLS CUI [7,1]
C0586740
UMLS CUI [7,2]
C0023008
UMLS CUI [7,3]
C1521840
UMLS CUI [8,1]
C0584993
UMLS CUI [8,2]
C0023008
UMLS CUI [8,3]
C1521840
each patient must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
Beschreibung

Informed consent form

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
an established diagnosis of psoriatic arthritis
Beschreibung

diagnosis of psoriatic arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003872
ever have received systemic treatment with a disease modifying antirheumatic drug (dmard) for arthritis or spondylitis (inflammatory back pain)
Beschreibung

medical history, Systemic treatment, DMARD, Arthritis, Spondylitis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C4055380
UMLS CUI [1,4]
C0003864
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C4055380
UMLS CUI [2,4]
C0038012
ever have received systemic treatment with a biologic therapy for psoriasis (including infliximab, golimumab, ustekinumab, adalimumab or etanercept)
Beschreibung

Psoriasis, Medical history, Systemic therapy including Infliximab, Golimumab, Ustekinumab, Adalimumab and Etanercept

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1515119
UMLS CUI [1,3]
C0033860
UMLS CUI [2]
C0666743
UMLS CUI [3]
C2353893
UMLS CUI [4]
C1122087
UMLS CUI [5]
C1608841
UMLS CUI [6]
C0717758
a history of employment in or are currently employed in the healthcare industry
Beschreibung

Healthcare facility, employment history, current employment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1286384
UMLS CUI [1,2]
C0018704
UMLS CUI [2,1]
C0552390
UMLS CUI [2,2]
C0018704
participated in the translation and linguistic validation of the EARP questionnaire
Beschreibung

Translation and linguistic validation, Screening questionnaire

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040712
UMLS CUI [1,2]
C1134635
UMLS CUI [2,1]
C0681291
UMLS CUI [2,2]
C1519941
UMLS CUI [2,3]
C1134635
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Ähnliche Modelle

Eligibility Psoriatic Arthritis NCT02470481

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender, Age
Item
patient must be a man or woman aged 18 to 65 years of age, inclusive
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Diagnosis of psoriasis, clinical evidence, medical history
Item
the patient must have an established diagnosis of psoriasis (based upon clinical evidence, and documented medical history [19])
boolean
C0033860 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0033860 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
Able to read, able to write, English, Mandarin, Korean, target language
Item
the patient must be able to read and write in the target language (english, mandarin or korean; or other relevant target languages)
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0586740 (UMLS CUI [3,1])
C0682398 (UMLS CUI [3,2])
C0584993 (UMLS CUI [4,1])
C0682398 (UMLS CUI [4,2])
C0586740 (UMLS CUI [5,1])
C0022774 (UMLS CUI [5,2])
C0584993 (UMLS CUI [6,1])
C0022774 (UMLS CUI [6,2])
C0586740 (UMLS CUI [7,1])
C0023008 (UMLS CUI [7,2])
C1521840 (UMLS CUI [7,3])
C0584993 (UMLS CUI [8,1])
C0023008 (UMLS CUI [8,2])
C1521840 (UMLS CUI [8,3])
Informed consent form
Item
each patient must sign an informed consent form (icf) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
diagnosis of psoriatic arthritis
Item
an established diagnosis of psoriatic arthritis
boolean
C0003872 (UMLS CUI [1])
medical history, Systemic treatment, DMARD, Arthritis, Spondylitis
Item
ever have received systemic treatment with a disease modifying antirheumatic drug (dmard) for arthritis or spondylitis (inflammatory back pain)
boolean
C0262926 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C4055380 (UMLS CUI [1,3])
C0003864 (UMLS CUI [1,4])
C0262926 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C4055380 (UMLS CUI [2,3])
C0038012 (UMLS CUI [2,4])
Psoriasis, Medical history, Systemic therapy including Infliximab, Golimumab, Ustekinumab, Adalimumab and Etanercept
Item
ever have received systemic treatment with a biologic therapy for psoriasis (including infliximab, golimumab, ustekinumab, adalimumab or etanercept)
boolean
C0262926 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
C0033860 (UMLS CUI [1,3])
C0666743 (UMLS CUI [2])
C2353893 (UMLS CUI [3])
C1122087 (UMLS CUI [4])
C1608841 (UMLS CUI [5])
C0717758 (UMLS CUI [6])
Healthcare facility, employment history, current employment
Item
a history of employment in or are currently employed in the healthcare industry
boolean
C1286384 (UMLS CUI [1,1])
C0018704 (UMLS CUI [1,2])
C0552390 (UMLS CUI [2,1])
C0018704 (UMLS CUI [2,2])
Translation and linguistic validation, Screening questionnaire
Item
participated in the translation and linguistic validation of the EARP questionnaire
boolean
C0040712 (UMLS CUI [1,1])
C1134635 (UMLS CUI [1,2])
C0681291 (UMLS CUI [2,1])
C1519941 (UMLS CUI [2,2])
C1134635 (UMLS CUI [2,3])
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