ID

3739

Description

ODM derived from http://clinicaltrials.gov/show/NCT01294774

Link

http://clinicaltrials.gov/show/NCT01294774

Keywords

Versions (2)
  1. 2/28/13 2/28/13 - Martin Dugas
  2. 9/20/21 9/20/21 -
Uploaded on

February 28, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01294774 Subacute Cutaneous Lupus Erythematosus

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 18 Years to 65 Years
Description

age 18 Years to 65 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
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)
Description

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)

Data type

boolean

Alias
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024140
SNOMED CT 2011_0131
239891002
MedDRA 14.1
10057903
ICD-10-CM Version 2010
L93.1
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Exclusion Criteria
Description

Exclusion Criteria

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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C2347662
UMLS CUI 2011AA
C0027697
SNOMED CT 2011_0131
52845002
MedDRA 14.1
10029117
ICD-10-CM Version 2010
N08
UMLS CUI 2011AA
C0449389
SNOMED CT 2011_0131
260766009
UMLS CUI 2011AA
C2709248
SNOMED CT 2011_0131
264164005
LOINC Version 232
MTHU031874
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0332675
SNOMED CT 2011_0131
105612003
MedDRA 14.1
10061245
UMLS CUI 2011AA
C0699792
SNOMED CT 2011_0131
263498003
UMLS CUI 2011AA
CL414700
UMLS CUI 2011AA
C0409974
SNOMED CT 2011_0131
200936003
MedDRA 14.1
10025134
ICD-10-CM Version 2010
L93
ICD-9-CM Version 2011
695.4
Treated by
Description

Patients who have been treated with:

Data type

boolean

Alias
UMLS CUI 2011AA
C0332293
SNOMED CT 2011_0131
28995006
immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.
Description

immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021027
SNOMED CT 2011_0131
399771004
HL7 V3 2006_05
14
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.
Description

rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0732355
SNOMED CT 2011_0131
386919002
UMLS CUI 2011AA
C0010583
SNOMED CT 2011_0131
387420009
LOINC Version 232
MTHU029970
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0021079
SNOMED CT 2011_0131
86553008
a medium or high dose (>= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.
Description

a medium or high dose (>= 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439536
SNOMED CT 2011_0131
255508009
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0032952
SNOMED CT 2011_0131
116602009
LOINC Version 232
MTHU003245
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C0149783
SNOMED CT 2011_0131
297279009
MedDRA 14.1
10062117
antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.
Description

antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0003374
SNOMED CT 2011_0131
80229008
UMLS CUI 2011AA
C0020336
SNOMED CT 2011_0131
373540008
LOINC Version 232
MTHU016851
UMLS CUI 2011AA
C0008269
SNOMED CT 2011_0131
373468005
LOINC Version 232
MTHU014870
UMLS CUI 2011AA
C0034403
SNOMED CT 2011_0131
350225009
LOINC Version 232
MTHU007608
biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.
Description

biologic therapies, such as etanercept, within the last 4 weeks prior to randomization.

Data type

boolean

Alias
UMLS CUI 2011AA
C0005527
UMLS CUI 2011AA
C0717758
SNOMED CT 2011_0131
387045004
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C1963758
SNOMED CT 2011_0131
86553008
MedDRA 14.1
10067473
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0883242
LOINC Version 232
MTHU011568
UMLS CUI 2011AA
C0039736
SNOMED CT 2011_0131
78702007
UMLS CUI 2011AA
C2267033
UMLS CUI 2011AA
C0010980
SNOMED CT 2011_0131
17308007
LOINC Version 232
MTHU024811
total lymphoid irradiation or bone marrow transplantation.
Description

total lymphoid irradiation or bone marrow transplantation.

Data type

boolean

Alias
UMLS CUI 2011AA
C1519560
UMLS CUI 2011AA
C0005961
SNOMED CT 2011_0131
23719005
MedDRA 14.1
10061730
ICD-9-CM Version 2011
41.00
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.
Description

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.

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0015780
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C0024554
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
UMLS CUI 2011AA
C0015671
SNOMED CT 2011_0131
66839005
LOINC Version 232
MTHU035601
HL7 V3 2006_05
FTH
UMLS CUI 2011AA
C0008059
SNOMED CT 2011_0131
67822003
HL7 V3 2006_05
CHILD
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
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)
Item Group
Exclusion Criteria
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)
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