age at least 18 Years
Item
Alter mindestens 18 Jahre
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that has been present for at least 3 years before the screening visit
Item
Chronic AD diagnosed by the Eichenfield revised criteria of Hannifin and Rajka that has been present for at least 3 years before the screening visit
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Eczema Area and Severity Index (EASI) score >/= 12 at the screening and baseline visits
Item
Eczema Area and Severity Index (EASI) score >/= 12 at the screening and baseline visits
boolean
C0013595 (UMLS CUI 2011AA)
43116000 (SNOMED CT 2011_0131)
10014184 (MedDRA 14.1)
L30.9 (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)
Investigator's Global Assessment (IGA) score >/= 3 at the screening and baseline visits
Item
Investigator's Global Assessment (IGA) score >/= 3 at the screening and baseline visits
boolean
CL102947 (UMLS CUI 2011AA)
C0281858 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
>/= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
Item
>/= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
boolean
C0005902 (UMLS CUI 2011AA)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
History of inadequate response to a stable (>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit
Item
History of inadequate response to a stable (>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1320680 (UMLS CUI 2011AA)
405786003 (SNOMED CT 2011_0131)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C1562036 (UMLS CUI 2011AA)
416798007 (SNOMED CT 2011_0131)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit
Item
Positive Hepatitis B surface antigen, and/or positive Hepatitis C antibody at the screening visit
boolean
C0149709 (UMLS CUI 2011AA)
165806002 (SNOMED CT 2011_0131)
10019742 (MedDRA 14.1)
C0281863 (UMLS CUI 2011AA)
10019747 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit
Item
Treatment with an investigational drug within 8 weeks or within 5 half-lives, if known, whichever is longer, before the baseline visit
boolean
C0039798 (UMLS CUI 2011AA)
C0013230 (UMLS CUI 2011AA)
Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
Item
Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
boolean
C0039798 (UMLS CUI 2011AA)
C0595726 (UMLS CUI 2011AA)
372517002 (SNOMED CT 2011_0131)
Treatment with systemic corticosteroids within 4 weeks before the baseline visit
Item
Treatment with systemic corticosteroids within 4 weeks before the baseline visit
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
Item
Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
boolean
C0039798 (UMLS CUI 2011AA)
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C1099414 (UMLS CUI 2011AA)
385580005 (SNOMED CT 2011_0131)
Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
Item
Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
boolean
C1515119 (UMLS CUI 2011AA)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0005525 (UMLS CUI 2011AA)
Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit
Item
Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, or antifungals within 4 weeks before the screening visit or superficial skin infections within 1 week before the screening visit
boolean
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C1514873 (UMLS CUI 2011AA)
C0559681 (UMLS CUI 2011AA)
281791007 (SNOMED CT 2011_0131)
C0559680 (UMLS CUI 2011AA)
281790008 (SNOMED CT 2011_0131)
C0003451 (UMLS CUI 2011AA)
372701006 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C0205124 (UMLS CUI 2011AA)
26283006 (SNOMED CT 2011_0131)
C0037278 (UMLS CUI 2011AA)
108365000 (SNOMED CT 2011_0131)
10040872 (MedDRA 14.1)
E11568 (CTCAE 1105E)
Known history of human immunodeficiency virus (HIV) infection
Item
Known history of human immunodeficiency virus (HIV) infection
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
History of clinical parasite infection, other than treated trichomoniasis
Item
History of clinical parasite infection, other than treated trichomoniasis
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0747256 (UMLS CUI 2011AA)
17322007 (SNOMED CT 2011_0131)
10021857 (MedDRA 14.1)
CL411789 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0040921 (UMLS CUI 2011AA)
56335008 (SNOMED CT 2011_0131)
10044620 (MedDRA 14.1)
A59 (ICD-10-CM Version 2010)
131 (ICD-9-CM Version 2011)
History of malignancy within 5 years before the baseline visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed
Item
History of malignancy within 5 years before the baseline visit, with the following exceptions: patients with a history of completely treated carcinoma in situ of cervix, and non-metastatic squamous or basal cell carcinoma of the skin are allowed
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0580352 (UMLS CUI 2011AA)
182992009 (SNOMED CT 2011_0131)
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)
C1518422 (UMLS CUI 2011AA)
C0036525 (UMLS CUI 2011AA)
77879006 (SNOMED CT 2011_0131)
10027474 (MedDRA 14.1)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007, 254701007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
Item
Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C0278060 (UMLS CUI 2011AA)
36456004 (SNOMED CT 2011_0131)
MTHU001424 (LOINC Version 232)
MTHU117157 (CTCAE 1105E)
C1882509 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0683954 (UMLS CUI 2011AA)
Pregnant or breast-feeding women
Item
Pregnant or breast-feeding women
boolean
C0549206 (UMLS CUI 1)
10036586 (MedDRA 1)
C0006147 (UMLS CUI 2)
10006247 (MedDRA 2)
Unwilling to use adequate birth control, if of reproductive potential and sexually active
Item
Unwilling to use adequate birth control, if of reproductive potential and sexually active
boolean
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0750557 (UMLS CUI 2011AA)
C0035150 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)