Eligibility NCT00606450 Psoriasis
ODM derived from http://clinicaltrials.gov/show/NCT00606450

Eligibility

  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)
Must understand and voluntarily sign an informed consent form
Item
Must understand and voluntarily sign an informed consent form
boolean
C0021430 (UMLS CUI 2011AA)
Must be in good health as judged by the investigator
Item
Must be in good health as judged by the investigator
boolean
C0031206 (UMLS CUI 2011AA)
405153007 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Must be able to adhere to the study visit schedule and other protocol requirements
Item
Must be able to adhere to the study visit schedule and other protocol requirements
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0086960 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Must have a >= 6 month history of moderate-to-severe plaque-type psoriasis
Item
Must have a >= 6 month history of moderate-to-severe plaque-type psoriasis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Must have a PASI score >=10 and BSA >=10%
Item
Must have a PASI score >=10 and BSA >=10%
boolean
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0439793 (UMLS CUI 2011AA)
246112005 (SNOMED CT 2011_0131)
C0918012 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C0005902 (UMLS CUI 2011AA)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
Must meet specific laboratory criteria
Item
Must meet specific laboratory criteria
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C1552740 (UMLS CUI 2011AA)
INSTANCE (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL414621 (UMLS CUI 2011AA)
Must be a candidate for photo/systemic therapy
Item
Must be a candidate for photo/systemic therapy
boolean
C1548635 (UMLS CUI 2011AA)
ELG (HL7 V3 2006_05)
C0031765 (UMLS CUI 2011AA)
31394004 (SNOMED CT 2011_0131)
10063925 (MedDRA 14.1)
C1515119 (UMLS CUI 2011AA)
Women of childbearing potential must have a negative pregnancy test
Item
Women of childbearing potential must have a negative pregnancy test
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Must not have clinically significant underlying disease processes
Item
Must not have clinically significant underlying disease processes
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1522240 (UMLS CUI 2011AA)
415178003 (SNOMED CT 2011_0131)
Must not be pregnant or lactating females
Item
Must not be pregnant or lactating females
boolean
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
Item
Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
C1704258 (UMLS CUI 2011AA)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C2348568 (UMLS CUI 2011AA)
C0441723 (UMLS CUI 2011AA)
257553007 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0681873 (UMLS CUI 2011AA)
Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
Item
Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0026926 (UMLS CUI 2011AA)
36354002 (SNOMED CT 2011_0131)
10028461 (MedDRA 14.1)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
Item
Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0205275 (UMLS CUI 2011AA)
44104002 (SNOMED CT 2011_0131)
C0026926 (UMLS CUI 2011AA)
36354002 (SNOMED CT 2011_0131)
10028461 (MedDRA 14.1)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
Must not have a known history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
Item
Must not have a known history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0026926 (UMLS CUI 2011AA)
36354002 (SNOMED CT 2011_0131)
10028461 (MedDRA 14.1)
C0021311 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Must not be an immigrant from a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
Item
Must not be an immigrant from a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
boolean
C0282163 (UMLS CUI 2011AA)
161158003 (SNOMED CT 2011_0131)
C0205250 (UMLS CUI 2011AA)
75540009 (SNOMED CT 2011_0131)
C0021149 (UMLS CUI 2011AA)
C0454664 (UMLS CUI 2011AA)
223369002 (SNOMED CT 2011_0131)
C0026926 (UMLS CUI 2011AA)
36354002 (SNOMED CT 2011_0131)
10028461 (MedDRA 14.1)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1554196 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Must not have current erythrodermic, guttate, or pustular psoriasis
Item
Must not have current erythrodermic, guttate, or pustular psoriasis
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0748052 (UMLS CUI 2011AA)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.1)
C0343052 (UMLS CUI 2011AA)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
C0152081 (UMLS CUI 2011AA)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.1)
Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
Item
Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1320680 (UMLS CUI 2011AA)
405786003 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0750729 (UMLS CUI 2011AA)
288524001 (SNOMED CT 2011_0131)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0005527 (UMLS CUI 2011AA)
C0962603 (UMLS CUI 2011AA)
398691006 (SNOMED CT 2011_0131)
C0717758 (UMLS CUI 2011AA)
387045004 (SNOMED CT 2011_0131)
C1320125 (UMLS CUI 2011AA)
407005009 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
Must not use topical therapy within 14 days of randomization
Item
Must not use topical therapy within 14 days of randomization
boolean
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Must not use systemic therapy for psoriasis within 28 days of randomization
Item
Must not use systemic therapy for psoriasis within 28 days of randomization
boolean
C1515119 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Must not use phototherapy within 28 days of randomization
Item
Must not use phototherapy within 28 days of randomization
boolean
C0031765 (UMLS CUI 2011AA)
31394004 (SNOMED CT 2011_0131)
10063925 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Must not use adalimumab or infliximab within 3 months of randomization
Item
Must not use adalimumab or infliximab within 3 months of randomization
boolean
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Must not use etanercept or efalizumab within 56 days of randomization
Item
Must not use etanercept or efalizumab within 56 days of randomization
boolean
C0717758 (UMLS CUI 2011AA)
387045004 (SNOMED CT 2011_0131)
C1320125 (UMLS CUI 2011AA)
407005009 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Must not use alefacept within 6 months of randomization
Item
Must not use alefacept within 6 months of randomization
boolean
C0962603 (UMLS CUI 2011AA)
398691006 (SNOMED CT 2011_0131)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C2825407 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)