ID
43063
Description
ODM derived from http://clinicaltrials.gov/show/NCT01194219
Link
http://clinicaltrials.gov/show/NCT01194219
Keywords
Versions (3)
- 3/19/13 3/19/13 - Martin Dugas
- 4/19/14 4/19/14 - 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 NCT01194219 Plaque Psoriasis
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL411789
- UMLS CUI 2011AA
- C0033860
- SNOMED CT 2011_0131
- 9014002
- MedDRA 14.1
- 10037153
- ICD-10-CM Version 2010
- L40
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0205164
- SNOMED CT 2011_0131
- 255603008
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0012634
- SNOMED CT 2011_0131
- 64572001
Description
Pregnant or breast feeding
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Description
History of allergy to any component of the study drug
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0489531
- LOINC Version 232
- MTHU001065
- UMLS CUI 2011AA
- C1705248
- UMLS CUI 2011AA
- C0304229
- SNOMED CT 2011_0131
- 902003
Description
Hepatitis B surface antigen positive at Screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0149709
- SNOMED CT 2011_0131
- 165806002
- MedDRA 14.1
- 10019742
- UMLS CUI 2011AA
- C1409616
Description
Anti-hepatitis C antibody positive at Screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0003250
- SNOMED CT 2011_0131
- 49616005
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
- UMLS CUI 2011AA
- C0019196
- SNOMED CT 2011_0131
- 50711007
- MedDRA 14.1
- 10019744
- ICD-10-CM Version 2010
- B19.20
- ICD-9-CM Version 2011
- 070.7
- UMLS CUI 2011AA
- CL415097
- UMLS CUI 2011AA
- C1409616
Description
Active tuberculosis (TB) or a history of incompletely treated TB
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0151332
- SNOMED CT 2011_0131
- 427099000
- MedDRA 14.1
- 10071157
- 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
- C0041296
- SNOMED CT 2011_0131
- 56717001
- MedDRA 14.1
- 10044755
- LOINC Version 232
- MTHU020835
- ICD-10-CM Version 2010
- A15-A19
- ICD-9-CM Version 2011
- 010-018.99
Description
Clinically significant abnormality on 12-Lead ECG at Screening
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
- C0522055
- SNOMED CT 2011_0131
- 102594003
- MedDRA 14.1
- 10014363
- UMLS CUI 2011AA
- C1409616
Description
Clinically significant abnormal chest x-ray
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
- C0436503
- SNOMED CT 2011_0131
- 168734001
- MedDRA 14.1
- 10008499
Description
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0019699
- SNOMED CT 2011_0131
- 165816005
- MedDRA 14.1
- 10020188
- ICD-10-CM Version 2010
- Z21
- UMLS CUI 2011AA
- C0853602
- MedDRA 14.1
- 10021450
- UMLS CUI 2011AA
- C0596032
Description
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0740858
- SNOMED CT 2011_0131
- 66214007
- MedDRA 14.1
- 10066169
- LOINC Version 232
- MTHU019364
- UMLS CUI 2011AA
- C1299544
- SNOMED CT 2011_0131
- 371435006
Description
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0004623
- SNOMED CT 2011_0131
- 87628006
- MedDRA 14.1
- 10060945
- ICD-10-CM Version 2010
- A49.9
- UMLS CUI 2011AA
- C1514873
- UMLS CUI 2011AA
- C0559681
- SNOMED CT 2011_0131
- 281791007
- UMLS CUI 2011AA
- C1533685
- SNOMED CT 2011_0131
- 59108006
- MedDRA 14.1
- 10052995
- UMLS CUI 2011AA
- C0003232
- SNOMED CT 2011_0131
- 255631004
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0042769
- SNOMED CT 2011_0131
- 34014006
- MedDRA 14.1
- 10047461
- ICD-10-CM Version 2010
- B34.9
- UMLS CUI 2011AA
- C0026946
- SNOMED CT 2011_0131
- 3218000
- MedDRA 14.1
- 10017533
- ICD-10-CM Version 2010
- B35-B49
- ICD-9-CM Version 2011
- 110-118.99
Description
Malignancy or history of malignancy (except for treated [ie, cured] basal cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0006826
- SNOMED CT 2011_0131
- 363346000
- MedDRA 14.1
- 10028997
- LOINC Version 232
- MTHU010328
- ICD-10-CM Version 2010
- C00-C96
- UMLS CUI 2011AA
- C2735088
- LOINC Version 232
- MTHU034770
- UMLS CUI 2011AA
- C1554961
- HL7 V3 2006_05
- E
- UMLS CUI 2011AA
- CL415147
- UMLS CUI 2011AA
- C1880198
- UMLS CUI 2011AA
- C0007117
- SNOMED CT 2011_0131
- 1338007, 254701007
- MedDRA 14.1
- 10004146
- UMLS CUI 2011AA
- C0334245
- SNOMED CT 2011_0131
- 59529006
- MedDRA 14.1
- 10022782
- UMLS CUI 2011AA
- C0206708
- SNOMED CT 2011_0131
- 285636001
- MedDRA 14.1
- 10056576
- UMLS CUI 2011AA
- C0851140
- SNOMED CT 2011_0131
- 92564006
- MedDRA 14.1
- 10061809
- ICD-10-CM Version 2010
- D06.9
- ICD-9-CM Version 2011
- 233.1
Description
Psoriasis flare or rebound within 4 weeks prior to Screening
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0235763
- MedDRA 14.1
- 10037156
- UMLS CUI 2011AA
- C0033860
- SNOMED CT 2011_0131
- 9014002
- MedDRA 14.1
- 10037153
- ICD-10-CM Version 2010
- L40
- UMLS CUI 2011AA
- C0277556
- SNOMED CT 2011_0131
- 58184002
Description
Evidence of skin conditions that would interfere with clinical assessments
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1719933
- SNOMED CT 2011_0131
- 422000003
- LOINC Version 232
- MTHU034830
- UMLS CUI 2011AA
- C0521102
- SNOMED CT 2011_0131
- 78235001
- UMLS CUI 2011AA
- C0205210
- SNOMED CT 2011_0131
- 58147004
- UMLS CUI 2011AA
- C1516048
Description
Topical therapy within 2 weeks of randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0150349
- SNOMED CT 2011_0131
- 386439008
- UMLS CUI 2011AA
- C0332285
- SNOMED CT 2011_0131
- 18720000
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- UMLS CUI 2011AA
- C0439230
- SNOMED CT 2011_0131
- 258705008
- HL7 V3 2006_05
- WK
- UMLS CUI 2011AA
- C0034656
Description
Systemic therapy for psoriasis within 4 weeks prior to 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
Description
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0031765
Description
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1122087
- SNOMED CT 2011_0131
- 407317001
- UMLS CUI 2011AA
- C0717758
- SNOMED CT 2011_0131
- 387045004
- UMLS CUI 2011AA
- C0666743
- SNOMED CT 2011_0131
- 386891004
- LOINC Version 232
- MTHU018219
- UMLS CUI 2011AA
- C1172157
- SNOMED CT 2011_0131
- 430307008
Description
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0962603
- SNOMED CT 2011_0131
- 398691006
- UMLS CUI 2011AA
- C2744325
- UMLS CUI 2011AA
- C1608841
- SNOMED CT 2011_0131
- 443644001
Description
Use of any investigational drug within 4 weeks prior to randomization
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- CL407060
- UMLS CUI 2011AA
- C0013230
Description
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0439590
- SNOMED CT 2011_0131
- 255224006
- UMLS CUI 2011AA
- C1456711
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0183827
- UMLS CUI 2011AA
- C0205394
- SNOMED CT 2011_0131
- 74964007
- UMLS CUI 2011AA
- C0041625
- SNOMED CT 2011_0131
- 41355003
- UMLS CUI 2011AA
- C0449416
- SNOMED CT 2011_0131
- 260753009
Description
Prior treatment with apremilast
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C1678805
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Eligibility
- StudyEvent: Eligibility
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255603008 (SNOMED CT 2011_0131)
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19032002 (SNOMED CT 2011_0131)
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56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
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010-018.99 (ICD-9-CM Version 2011)
58147004 (SNOMED CT 2011_0131)
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386134007 (SNOMED CT 2011_0131)
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102594003 (SNOMED CT 2011_0131)
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281791007 (SNOMED CT 2011_0131)
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59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
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386891004 (SNOMED CT 2011_0131)
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C1172157 (UMLS CUI 2011AA)
430307008 (SNOMED CT 2011_0131)
398691006 (SNOMED CT 2011_0131)
C2744325 (UMLS CUI 2011AA)
C1608841 (UMLS CUI 2011AA)
443644001 (SNOMED CT 2011_0131)
260676000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
255224006 (SNOMED CT 2011_0131)
C1456711 (UMLS CUI 2011AA)
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260676000 (SNOMED CT 2011_0131)
C0183827 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0041625 (UMLS CUI 2011AA)
41355003 (SNOMED CT 2011_0131)
C0449416 (UMLS CUI 2011AA)
260753009 (SNOMED CT 2011_0131)
C1678805 (UMLS CUI 2011AA)