age 18 Years to 65 Years
Item
age 18 Years to 65 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Male and female patients,18 to 65 years of age inclusive, who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al. at least three months before study entry (screening)
Item
Male and female patients,18 to 65 years of age inclusive, who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al. at least three months before study entry (screening)
boolean
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024140 (UMLS CUI 2011AA)
239891002 (SNOMED CT 2011_0131)
10057903 (MedDRA 14.1)
L93.1 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren`s syndrome are allowed to enter the study at the Investigator`s discretion.
Item
Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren`s syndrome are allowed to enter the study at the Investigator`s discretion.
boolean
C2347662 (UMLS CUI 2011AA)
C0027697 (UMLS CUI 2011AA)
52845002 (SNOMED CT 2011_0131)
10029117 (MedDRA 14.1)
N08 (ICD-10-CM Version 2010)
C0449389 (UMLS CUI 2011AA)
260766009 (SNOMED CT 2011_0131)
C2709248 (UMLS CUI 2011AA)
264164005 (SNOMED CT 2011_0131)
MTHU031874 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0332675 (UMLS CUI 2011AA)
105612003 (SNOMED CT 2011_0131)
10061245 (MedDRA 14.1)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
CL414700 (UMLS CUI 2011AA)
C0409974 (UMLS CUI 2011AA)
200936003 (SNOMED CT 2011_0131)
10025134 (MedDRA 14.1)
L93 (ICD-10-CM Version 2010)
695.4 (ICD-9-CM Version 2011)
Patients who have been treated with:
Item
Treated by
boolean
C0332293 (UMLS CUI 2011AA)
28995006 (SNOMED CT 2011_0131)
immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
Item
immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
boolean
C0021027 (UMLS CUI 2011AA)
399771004 (SNOMED CT 2011_0131)
14 (HL7 V3 2006_05)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
Item
rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
boolean
C0732355 (UMLS CUI 2011AA)
386919002 (SNOMED CT 2011_0131)
C0010583 (UMLS CUI 2011AA)
387420009 (SNOMED CT 2011_0131)
MTHU029970 (LOINC Version 232)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021079 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
a medium or high dose (>= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
Item
a medium or high dose (>= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
boolean
C0439536 (UMLS CUI 2011AA)
255508009 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0032952 (UMLS CUI 2011AA)
116602009 (SNOMED CT 2011_0131)
MTHU003245 (LOINC Version 232)
CL415123 (UMLS CUI 2011AA)
C0149783 (UMLS CUI 2011AA)
297279009 (SNOMED CT 2011_0131)
10062117 (MedDRA 14.1)
antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
Item
antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
boolean
C0003374 (UMLS CUI 2011AA)
80229008 (SNOMED CT 2011_0131)
C0020336 (UMLS CUI 2011AA)
373540008 (SNOMED CT 2011_0131)
MTHU016851 (LOINC Version 232)
C0008269 (UMLS CUI 2011AA)
373468005 (SNOMED CT 2011_0131)
MTHU014870 (LOINC Version 232)
C0034403 (UMLS CUI 2011AA)
350225009 (SNOMED CT 2011_0131)
MTHU007608 (LOINC Version 232)
biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
Item
biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
boolean
C0005527 (UMLS CUI 2011AA)
C0717758 (UMLS CUI 2011AA)
387045004 (SNOMED CT 2011_0131)
any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization.
Item
any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization.
boolean
C1963758 (UMLS CUI 2011AA)
86553008 (SNOMED CT 2011_0131)
10067473 (MedDRA 14.1)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0883242 (UMLS CUI 2011AA)
MTHU011568 (LOINC Version 232)
C0039736 (UMLS CUI 2011AA)
78702007 (SNOMED CT 2011_0131)
C2267033 (UMLS CUI 2011AA)
C0010980 (UMLS CUI 2011AA)
17308007 (SNOMED CT 2011_0131)
MTHU024811 (LOINC Version 232)
total lymphoid irradiation or bone marrow transplantation.
Item
total lymphoid irradiation or bone marrow transplantation.
boolean
C1519560 (UMLS CUI 2011AA)
C0005961 (UMLS CUI 2011AA)
23719005 (SNOMED CT 2011_0131)
10061730 (MedDRA 14.1)
41.00 (ICD-9-CM Version 2011)
Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
Item
Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C2828358 (UMLS CUI 2011AA)
C0015780 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0024554 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
C0015671 (UMLS CUI 2011AA)
66839005 (SNOMED CT 2011_0131)
MTHU035601 (LOINC Version 232)
FTH (HL7 V3 2006_05)
C0008059 (UMLS CUI 2011AA)
67822003 (SNOMED CT 2011_0131)
CHILD (HL7 V3 2006_05)