ID
43389
Description
ODM derived from http://clinicaltrials.gov/show/NCT00606450
Link
http://clinicaltrials.gov/show/NCT00606450
Keywords
Versions (3)
- 12/10/13 12/10/13 - Martin Dugas
- 4/15/14 4/15/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00606450 Psoriasis
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
Must not have clinically significant underlying disease processes
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C1522240
- SNOMED CT 2011_0131
- 415178003
Description
Must not be pregnant or lactating females
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
- C2828358
Description
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
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0332257
- SNOMED CT 2011_0131
- 55919000
- UMLS CUI 2011AA
- C0022877
- SNOMED CT 2011_0131
- 261904005
- LOINC Version 232
- MTHU029808
- UMLS CUI 2011AA
- C1704258
- UMLS CUI 2011AA
- C1883420
- UMLS CUI 2011AA
- C0035647
- SNOMED CT 2011_0131
- 30207005
- HL7 V3 2006_05
- RSK
- UMLS CUI 2011AA
- C2348568
- UMLS CUI 2011AA
- C0441723
- SNOMED CT 2011_0131
- 257553007
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0459471
- SNOMED CT 2011_0131
- 280452008
- LOINC Version 232
- MTHU003869
- UMLS CUI 2011AA
- C0681873
Description
Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0026926
- SNOMED CT 2011_0131
- 36354002
- MedDRA 14.1
- 10028461
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
Description
Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205257
- SNOMED CT 2011_0131
- 255599008
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0205275
- SNOMED CT 2011_0131
- 44104002
- UMLS CUI 2011AA
- C0026926
- SNOMED CT 2011_0131
- 36354002
- MedDRA 14.1
- 10028461
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
Description
Must not have a known history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0332157
- SNOMED CT 2011_0131
- 24932003
- UMLS CUI 2011AA
- C0026926
- SNOMED CT 2011_0131
- 36354002
- MedDRA 14.1
- 10028461
- UMLS CUI 2011AA
- C0009450
- SNOMED CT 2011_0131
- 257551009
- MedDRA 14.1
- 10021789
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
Description
Must not be an immigrant from a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0282163
- SNOMED CT 2011_0131
- 161158003
- UMLS CUI 2011AA
- C0205250
- SNOMED CT 2011_0131
- 75540009
- UMLS CUI 2011AA
- C0021149
- UMLS CUI 2011AA
- C0454664
- SNOMED CT 2011_0131
- 223369002
- UMLS CUI 2011AA
- C0026926
- SNOMED CT 2011_0131
- 36354002
- MedDRA 14.1
- 10028461
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
Description
Must not have current erythrodermic, guttate, or pustular psoriasis
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0521116
- SNOMED CT 2011_0131
- 15240007
- UMLS CUI 2011AA
- C0748052
- SNOMED CT 2011_0131
- 200977004
- MedDRA 14.1
- 10015278
- UMLS CUI 2011AA
- C0343052
- SNOMED CT 2011_0131
- 37042000
- ICD-10-CM Version 2010
- L40.4
- UMLS CUI 2011AA
- C0152081
- SNOMED CT 2011_0131
- 200973000
- MedDRA 14.1
- 10037159
Description
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
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1320680
- SNOMED CT 2011_0131
- 405786003
- UMLS CUI 2011AA
- C0022423
- SNOMED CT 2011_0131
- 61254005
- UMLS CUI 2011AA
- CL102947
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0750729
- SNOMED CT 2011_0131
- 288524001
- UMLS CUI 2011AA
- C0010592
- SNOMED CT 2011_0131
- 387467008
- LOINC Version 232
- MTHU005140
- UMLS CUI 2011AA
- C0005527
- UMLS CUI 2011AA
- C0962603
- SNOMED CT 2011_0131
- 398691006
- UMLS CUI 2011AA
- C0717758
- SNOMED CT 2011_0131
- 387045004
- UMLS CUI 2011AA
- C1320125
- SNOMED CT 2011_0131
- 407005009
- UMLS CUI 2011AA
- C0666743
- SNOMED CT 2011_0131
- 386891004
- LOINC Version 232
- MTHU018219
- UMLS CUI 2011AA
- C1122087
- SNOMED CT 2011_0131
- 407317001
Description
Must not use topical therapy within 14 days of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0150349
- SNOMED CT 2011_0131
- 386439008
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C2825407
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0034656
Description
Must not use systemic therapy for psoriasis within 28 days of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1515119
- UMLS CUI 2011AA
- C0033860
- SNOMED CT 2011_0131
- 9014002
- MedDRA 14.1
- 10037153
- ICD-10-CM Version 2010
- L40
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0034656
Description
Must not use phototherapy within 28 days of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0031765
- SNOMED CT 2011_0131
- 31394004
- MedDRA 14.1
- 10063925
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0439231
- SNOMED CT 2011_0131
- 258706009
- HL7 V3 2006_05
- MO
- UMLS CUI 2011AA
- C0034656
Description
Must not use adalimumab or infliximab within 3 months of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1122087
- SNOMED CT 2011_0131
- 407317001
- UMLS CUI 2011AA
- C0666743
- SNOMED CT 2011_0131
- 386891004
- LOINC Version 232
- MTHU018219
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C2825406
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0034656
Description
Must not use etanercept or efalizumab within 56 days of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0717758
- SNOMED CT 2011_0131
- 387045004
- UMLS CUI 2011AA
- C1320125
- SNOMED CT 2011_0131
- 407005009
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0439228
- SNOMED CT 2011_0131
- 258703001
- HL7 V3 2006_05
- D
- UMLS CUI 2011AA
- C0034656
Description
Must not use alefacept within 6 months of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0962603
- SNOMED CT 2011_0131
- 398691006
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C2825407
- UMLS CUI 2011AA
- C0439234
- SNOMED CT 2011_0131
- 258707000
- HL7 V3 2006_05
- Y
- UMLS CUI 2011AA
- C0034656
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288556008 (SNOMED CT 2011_0131)
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371881003 (SNOMED CT 2011_0131)
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C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (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)
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)
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)
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258707000 (SNOMED CT 2011_0131)
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C0034656 (UMLS CUI 2011AA)
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407005009 (SNOMED CT 2011_0131)
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C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
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C0034656 (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)
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