Eligibility NCT01194219 Plaque Psoriasis

ODM derived from http://clinicaltrials.gov/show/NCT01194219

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males or females, ≥ 18 years of age at the time of signing the informed consent document
Item
Males or females, ≥ 18 years of age at the time of signing the informed consent document
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C2348583 (UMLS CUI 2011AA)
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
Item
Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
Have moderate to severe plaque psoriasis at Screening and Baseline
Item
Have moderate to severe plaque psoriasis at Screening and Baseline
boolean
C1299393 (UMLS CUI 2011AA)
371924009 (SNOMED CT 2011_0131)
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
C1409616 (UMLS CUI 2011AA)
C1442488 (UMLS CUI 2011AA)
Must meet all laboratory criteria
Item
Must meet all laboratory criteria
boolean
C1550543 (UMLS CUI 2011AA)
FLFS (HL7 V3 2006_05)
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL414621 (UMLS CUI 2011AA)
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
Item
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use 2 forms of contraception as described by the Study Doctor while on study medication and for at least 28 days after taking the last dose of study medication
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0348078 (UMLS CUI 2011AA)
246176004 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.
Item
Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (latex condom or any nonlatex condom NOT made out of natural [animal] membrane [eg, polyurethane]) while on study medication and for a least 28 days after the last dose of study medication.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0042387 (UMLS CUI 2011AA)
22523008 (SNOMED CT 2011_0131)
10047133 (MedDRA 14.1)
63.73 (ICD-9-CM Version 2011)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0023115 (UMLS CUI 2011AA)
400664008 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0032616 (UMLS CUI 2011AA)
255781002 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
Item
Other than psoriasis, history of any clinically significant (as determined by the Investigator) or other major uncontrolled disease.
boolean
CL411789 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Pregnant or breast feeding
Item
Pregnant or breast feeding
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
History of allergy to any component of the study drug
Item
History of allergy to any component of the study drug
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C1705248 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Hepatitis B surface antigen positive at Screening
Item
Hepatitis B surface antigen positive at Screening
boolean
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Anti-hepatitis C antibody positive at Screening
Item
Anti-hepatitis C antibody positive at Screening
boolean
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0019196 (UMLS CUI 2011AA)
50711007 (SNOMED CT 2011_0131)
10019744 (MedDRA 14.1)
B19.20 (ICD-10-CM Version 2010)
070.7 (ICD-9-CM Version 2011)
CL415097 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
Active tuberculosis (TB) or a history of incompletely treated TB
Item
Active tuberculosis (TB) or a history of incompletely treated TB
boolean
C0151332 (UMLS CUI 2011AA)
427099000 (SNOMED CT 2011_0131)
10071157 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0041296 (UMLS CUI 2011AA)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.1)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
Clinically significant abnormality on 12-Lead ECG at Screening
Item
Clinically significant abnormality on 12-Lead ECG at Screening
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0522055 (UMLS CUI 2011AA)
102594003 (SNOMED CT 2011_0131)
10014363 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Clinically significant abnormal chest x-ray
Item
Clinically significant abnormal chest x-ray
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0436503 (UMLS CUI 2011AA)
168734001 (SNOMED CT 2011_0131)
10008499 (MedDRA 14.1)
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
Item
History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019699 (UMLS CUI 2011AA)
165816005 (SNOMED CT 2011_0131)
10020188 (MedDRA 14.1)
Z21 (ICD-10-CM Version 2010)
C0853602 (UMLS CUI 2011AA)
10021450 (MedDRA 14.1)
C0596032 (UMLS CUI 2011AA)
Active substance abuse or a history of substance abuse within 6 months prior to Screening
Item
Active substance abuse or a history of substance abuse within 6 months prior to Screening
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0740858 (UMLS CUI 2011AA)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
Item
Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening
boolean
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
C1514873 (UMLS CUI 2011AA)
C0559681 (UMLS CUI 2011AA)
281791007 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0042769 (UMLS CUI 2011AA)
34014006 (SNOMED CT 2011_0131)
10047461 (MedDRA 14.1)
B34.9 (ICD-10-CM Version 2010)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
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)
Item
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)
boolean
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL415147 (UMLS CUI 2011AA)
C1880198 (UMLS CUI 2011AA)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0334245 (UMLS CUI 2011AA)
59529006 (SNOMED CT 2011_0131)
10022782 (MedDRA 14.1)
C0206708 (UMLS CUI 2011AA)
285636001 (SNOMED CT 2011_0131)
10056576 (MedDRA 14.1)
C0851140 (UMLS CUI 2011AA)
92564006 (SNOMED CT 2011_0131)
10061809 (MedDRA 14.1)
D06.9 (ICD-10-CM Version 2010)
233.1 (ICD-9-CM Version 2011)
Psoriasis flare or rebound within 4 weeks prior to Screening
Item
Psoriasis flare or rebound within 4 weeks prior to Screening
boolean
C0235763 (UMLS CUI 2011AA)
10037156 (MedDRA 14.1)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0277556 (UMLS CUI 2011AA)
58184002 (SNOMED CT 2011_0131)
Evidence of skin conditions that would interfere with clinical assessments
Item
Evidence of skin conditions that would interfere with clinical assessments
boolean
C1719933 (UMLS CUI 2011AA)
422000003 (SNOMED CT 2011_0131)
MTHU034830 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
Topical therapy within 2 weeks of randomization
Item
Topical therapy within 2 weeks of randomization
boolean
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Systemic therapy for psoriasis within 4 weeks prior to randomization
Item
Systemic therapy for psoriasis within 4 weeks prior to 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)
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
Item
Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
boolean
C0031765 (UMLS CUI 2011AA)
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
Item
Adalimumab, etanercept, infliximab, or certolizumab pegol within 12 weeks prior to randomization
boolean
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
C0717758 (UMLS CUI 2011AA)
387045004 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C1172157 (UMLS CUI 2011AA)
430307008 (SNOMED CT 2011_0131)
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
Item
Alefacept, briakinumab, or ustekinumab within 24 weeks prior to randomization
boolean
C0962603 (UMLS CUI 2011AA)
398691006 (SNOMED CT 2011_0131)
C2744325 (UMLS CUI 2011AA)
C1608841 (UMLS CUI 2011AA)
443644001 (SNOMED CT 2011_0131)
Use of any investigational drug within 4 weeks prior to randomization
Item
Use of any investigational drug within 4 weeks prior to randomization
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
Item
Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
boolean
C0439590 (UMLS CUI 2011AA)
255224006 (SNOMED CT 2011_0131)
C1456711 (UMLS CUI 2011AA)
C1524063 (UMLS CUI 2011AA)
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)
Prior treatment with apremilast
Item
Prior treatment with apremilast
boolean
C1514463 (UMLS CUI 2011AA)
C1678805 (UMLS CUI 2011AA)

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