ID

42771

Description

ODM derived from http://clinicaltrials.gov/show/NCT00574249

Link

http://clinicaltrials.gov/show/NCT00574249

Keywords

Versions (2)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00574249 Chronic Plaque Psoriasis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
Description

Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis

Data type

boolean

Alias
UMLS CUI 2011AA
C0332140
SNOMED CT 2011_0131
39154008
UMLS CUI 2011AA
C1304119
SNOMED CT 2011_0131
402310007
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0406317
SNOMED CT 2011_0131
200965009
ICD-10-CM Version 2010
L40.0
Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
Description

Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA

Data type

boolean

Alias
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0438286
SNOMED CT 2011_0131
266721009
MedDRA 14.1
10063670
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
CL415164
HL7 V3 2006_05
OINT
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0443202
SNOMED CT 2011_0131
263740005
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C0853073
MedDRA 14.1
10037580
Subject is judged to be in generally good health as determined by the principal investigator
Description

Subject is judged to be in generally good health as determined by the principal investigator

Data type

boolean

Alias
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C0018759
SNOMED CT 2011_0131
406221003
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
C1521895
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Subject has previous exposure to adalimumab
Description

Subject has previous exposure to adalimumab

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C1122087
SNOMED CT 2011_0131
407317001
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
Description

Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0457454
SNOMED CT 2011_0131
278308006
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0332237
SNOMED CT 2011_0131
359540000
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0870186
UMLS CUI 2011AA
C0564461
SNOMED CT 2011_0131
286632006
UMLS CUI 2011AA
CL414606
Subject is taking or requires oral or injectible corticosteroids
Description

Subject is taking or requires oral or injectible corticosteroids

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
Description

Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0748052
SNOMED CT 2011_0131
200977004
MedDRA 14.1
10015278
UMLS CUI 2011AA
C0152081
SNOMED CT 2011_0131
200973000
MedDRA 14.1
10037159
UMLS CUI 2011AA
C1304130
SNOMED CT 2011_0131
402325007
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
C0332162
SNOMED CT 2011_0131
77374008
UMLS CUI 2011AA
C0343052
SNOMED CT 2011_0131
37042000
ICD-10-CM Version 2010
L40.4
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Description

Subject considered by the investigator, for any reason, to be an unsuitable candidate

Data type

boolean

Alias
UMLS CUI 2011AA
C1548788
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Description

Female subject who is pregnant or breast-feeding or considering becoming pregnant

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C1517001
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Calcium Metabolism Disorders
Description

Subject has a calcium metabolism disorder

Data type

boolean

Alias
UMLS CUI 2011AA
C0006705
SNOMED CT 2011_0131
71638002
MedDRA 14.1
10006974
ICD-10-CM Version 2010
E83.5
ICD-9-CM Version 2011
275.4
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
Item
Subject had a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and has moderate to severe plaque psoriasis
boolean
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C1304119 (UMLS CUI 2011AA)
402310007 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1881878 (UMLS CUI 2011AA)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
Item
Subject must have been treated and failed to respond to, or has a contraindication to, or is intolerant to at least two different systemic therapies, one of which must be cyclosporine, or methotrexate or oral PUVA
boolean
CL415147 (UMLS CUI 2011AA)
C0438286 (UMLS CUI 2011AA)
266721009 (SNOMED CT 2011_0131)
10063670 (MedDRA 14.1)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
CL415164 (UMLS CUI 2011AA)
OINT (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0443202 (UMLS CUI 2011AA)
263740005 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C0853073 (UMLS CUI 2011AA)
10037580 (MedDRA 14.1)
Subject is judged to be in generally good health as determined by the principal investigator
Item
Subject is judged to be in generally good health as determined by the principal investigator
boolean
C0681850 (UMLS CUI 2011AA)
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0018759 (UMLS CUI 2011AA)
406221003 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
C1521895 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Subject has previous exposure to adalimumab
Item
Subject has previous exposure to adalimumab
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
Item
Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0457454 (UMLS CUI 2011AA)
278308006 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0332237 (UMLS CUI 2011AA)
359540000 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0870186 (UMLS CUI 2011AA)
C0564461 (UMLS CUI 2011AA)
286632006 (SNOMED CT 2011_0131)
CL414606 (UMLS CUI 2011AA)
Subject is taking or requires oral or injectible corticosteroids
Item
Subject is taking or requires oral or injectible corticosteroids
boolean
C1512806 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
Item
Subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0748052 (UMLS CUI 2011AA)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.1)
C0152081 (UMLS CUI 2011AA)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.1)
C1304130 (UMLS CUI 2011AA)
402325007 (SNOMED CT 2011_0131)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C0332162 (UMLS CUI 2011AA)
77374008 (SNOMED CT 2011_0131)
C0343052 (UMLS CUI 2011AA)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Item
Subject considered by the investigator, for any reason, to be an unsuitable candidate
boolean
C1548788 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Item
Female subject who is pregnant or breast-feeding or considering becoming pregnant
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C1517001 (UMLS CUI 2011AA)
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Subject has a calcium metabolism disorder
Item
Calcium Metabolism Disorders
boolean
C0006705 (UMLS CUI 2011AA)
71638002 (SNOMED CT 2011_0131)
10006974 (MedDRA 14.1)
E83.5 (ICD-10-CM Version 2010)
275.4 (ICD-9-CM Version 2011)
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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