ID

44648

Description

ODM derived from http://clinicaltrials.gov/show/NCT01146444

Link

http://clinicaltrials.gov/show/NCT01146444

Keywords

Versions (3)
  1. 12/6/13 12/6/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01146444 Cutaneous Lupus Erythematosus

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 18 Years to 85 Years
Description

age 18 Years to 85 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
Description

Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.

Data type

boolean

Alias
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
C0024138
SNOMED CT 2011_0131
200938002
MedDRA 14.1
10013072
ICD-10-CM Version 2010
L93.0
UMLS CUI 2011AA
C0406636
SNOMED CT 2011_0131
200941006
UMLS CUI 2011AA
C0205462
SNOMED CT 2011_0131
67151002
UMLS CUI 2011AA
C0750484
Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
Description

Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
UMLS CUI 2011AA
CL424941
UMLS CUI 2011AA
C0014939
SNOMED CT 2011_0131
41598000, 61946003
LOINC Version 232
MTHU003480
UMLS CUI 2011AA
C0033306
SNOMED CT 2011_0131
116614001, 20249007
UMLS CUI 2011AA
C0419530
SNOMED CT 2011_0131
268464009
UMLS CUI 2011AA
C0205195
SNOMED CT 2011_0131
89780004
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0677582
UMLS CUI 2011AA
C0042241
SNOMED CT 2011_0131
20359006
UMLS CUI 2011AA
C0493327
SNOMED CT 2011_0131
368441006
MedDRA 14.1
10007183
UMLS CUI 2011AA
C0037862
SNOMED CT 2011_0131
425484006
Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
Description

Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0020699
SNOMED CT 2011_0131
236886002
MedDRA 14.1
10021151
UMLS CUI 2011AA
C0520483
SNOMED CT 2011_0131
77543007
MedDRA 14.1
10044722
Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
Description

Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.

Data type

boolean

Alias
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0525058
Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
Description

Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.

Data type

boolean

Alias
UMLS CUI 2011AA
C1511795
UMLS CUI 2011AA
C0037284
SNOMED CT 2011_0131
95324001
MedDRA 14.1
10040882
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0024137
SNOMED CT 2011_0131
7119001
MedDRA 14.1
10056509
Signed informed consent form after the nature of the study has been fully explained.
Description

Signed informed consent form after the nature of the study has been fully explained.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Pregnancy or lactation and women with positive pregnancy test.
Description

Pregnancy or lactation and women with positive pregnancy test.

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C0240802
SNOMED CT 2011_0131
250423000
MedDRA 14.1
10036575
Known hypersensitivity or allergic contact reactions to components of the study agents.
Description

Known hypersensitivity or allergic contact reactions to components of the study agents.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0700624
UMLS CUI 2011AA
C0443191
SNOMED CT 2011_0131
263726009
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Treatment with photosensitizing drugs.
Description

Treatment with photosensitizing drugs.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0162713
SNOMED CT 2011_0131
108817007
Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
Description

Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0038817
SNOMED CT 2011_0131
49926000
UMLS CUI 2011AA
C0205296
SNOMED CT 2011_0131
510009
UMLS CUI 2011AA
C2004457
SNOMED CT 2011_0131
71967004
UMLS CUI 2011AA
C0041625
SNOMED CT 2011_0131
41355003
UMLS CUI 2011AA
C0004600
SNOMED CT 2011_0131
123961009
LOINC Version 232
MTHU001427
History of another photodermatosis, except polymorph light eruption (PLE).
Description

History of another photodermatosis, except polymorph light eruption (PLE).

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0920193
MedDRA 14.1
10051246
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0031736
SNOMED CT 2011_0131
238525001
MedDRA 14.1
10036087
ICD-10-CM Version 2010
L56.4
Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
Description

Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.

Data type

boolean

Alias
UMLS CUI 2011AA
C0007114
SNOMED CT 2011_0131
372130007
MedDRA 14.1
10040808
ICD-10-CM Version 2010
C44.9
UMLS CUI 2011AA
C0043346
SNOMED CT 2011_0131
44600005
MedDRA 14.1
10048220
ICD-10-CM Version 2010
Q82.1
Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
Description

Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.

Data type

boolean

Alias
UMLS CUI 2011AA
C1704686
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C2347524
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0024137
SNOMED CT 2011_0131
7119001
MedDRA 14.1
10056509
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0430551
SNOMED CT 2011_0131
87724004
Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
Description

Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient

Data type

boolean

Alias
UMLS CUI 2011AA
C1517925
UMLS CUI 2011AA
C0024137
SNOMED CT 2011_0131
7119001
MedDRA 14.1
10056509
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0430551
SNOMED CT 2011_0131
87724004
UMLS CUI 2011AA
C0004600
SNOMED CT 2011_0131
123961009
LOINC Version 232
MTHU001427
Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
Description

Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C1444749
SNOMED CT 2011_0131
410661009
UMLS CUI 2011AA
C0024137
SNOMED CT 2011_0131
7119001
MedDRA 14.1
10056509
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
Description

Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
CL426143
UMLS CUI 2011AA
C0205164
SNOMED CT 2011_0131
255603008
UMLS CUI 2011AA
C0221423
SNOMED CT 2011_0131
39104002
MedDRA 14.1
10040658
ICD-10-CM Version 2010
R69
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0019993
SNOMED CT 2011_0131
394656005
MedDRA 14.1
10054112
Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
Description

Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:

Data type

boolean

Alias
UMLS CUI 2011AA
C2747927
MedDRA 14.1
10069914
UMLS CUI 2011AA
C0034580
SNOMED CT 2011_0131
4613005
HL7 V3 2006_05
0104
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
CL414621
Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
Description

Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion

Data type

boolean

Alias
UMLS CUI 2011AA
C0036749
SNOMED CT 2011_0131
370469003
MedDRA 14.1
10058556
UMLS CUI 2011AA
C0032231
SNOMED CT 2011_0131
196075003
MedDRA 14.1
10035618
ICD-10-CM Version 2010
R09.1
ICD-9-CM Version 2011
511
UMLS CUI 2011AA
C0031046
SNOMED CT 2011_0131
3238004
MedDRA 14.1
10034484
CTCAE 1105E
E10180
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
UMLS CUI 2011AA
C0232267
SNOMED CT 2011_0131
7036007
MedDRA 14.1
10049759
UMLS CUI 2011AA
C0031039
SNOMED CT 2011_0131
373945007
MedDRA 14.1
10034474
CTCAE 1105E
E10172
Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
Description

Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts

Data type

boolean

Alias
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0033687
SNOMED CT 2011_0131
29738008
MedDRA 14.1
10037032
ICD-10-CM Version 2010
R80
ICD-9-CM Version 2011
791.0
CTCAE 1105E
E13008
UMLS CUI 2011AA
C0427895
SNOMED CT 2011_0131
250445004
Neurologic disorder: seizures or psychosis without other cause.
Description

Neurologic disorder: seizures or psychosis without other cause.

Data type

boolean

Alias
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0033975
SNOMED CT 2011_0131
69322001
MedDRA 14.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE 1105E
E12954
Patients with a documented HIV and/or hepatitis B or C infection.
Description

Patients with a documented HIV and/or hepatitis B or C infection.

Data type

boolean

Alias
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0019163
SNOMED CT 2011_0131
66071002
MedDRA 14.1
10019731
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
Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
Description

Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained

Data type

boolean

Alias
UMLS CUI 2011AA
C1699700
HL7 V3 2006_05
MEDCCAT
UMLS CUI 2011AA
C1883420
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C1522577
UMLS CUI 2011AA
C0242485
SNOMED CT 2011_0131
122869004
LOINC Version 232
MTHU003137
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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
CL425202 (UMLS CUI 2011AA)
age 18 Years to 85 Years
Item
age 18 Years to 85 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
Item
Patients with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE), or lupus erythematosus tumidus (LET) according to the Düsseldorf Classification 2004 (Kuhn and Ruzicka 2004) confirmed by histological analysis.
boolean
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)
C0024138 (UMLS CUI 2011AA)
200938002 (SNOMED CT 2011_0131)
10013072 (MedDRA 14.1)
L93.0 (ICD-10-CM Version 2010)
C0406636 (UMLS CUI 2011AA)
200941006 (SNOMED CT 2011_0131)
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
Item
Women of childbearing potential with a negative pregnancy test at screening (urine test) and using a medically accepted contraceptive regimen (intra-uterine device, partner's vasectomy, >3 months previous hormonal contraception (oestrogen plus gestagen pill, depot injections, or subcutaneous depot) combined with a barrier method (preservative, vaginal diaphragm, cervical cap, spermicide) during the study and for 8 weeks after the last UV exposure.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
CL424941 (UMLS CUI 2011AA)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0033306 (UMLS CUI 2011AA)
116614001, 20249007 (SNOMED CT 2011_0131)
C0419530 (UMLS CUI 2011AA)
268464009 (SNOMED CT 2011_0131)
C0205195 (UMLS CUI 2011AA)
89780004 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0677582 (UMLS CUI 2011AA)
C0042241 (UMLS CUI 2011AA)
20359006 (SNOMED CT 2011_0131)
C0493327 (UMLS CUI 2011AA)
368441006 (SNOMED CT 2011_0131)
10007183 (MedDRA 14.1)
C0037862 (UMLS CUI 2011AA)
425484006 (SNOMED CT 2011_0131)
Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
Item
Women clinically sterile (post-menopausal, undergone hysterectomy or tubal ligation).
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0020699 (UMLS CUI 2011AA)
236886002 (SNOMED CT 2011_0131)
10021151 (MedDRA 14.1)
C0520483 (UMLS CUI 2011AA)
77543007 (SNOMED CT 2011_0131)
10044722 (MedDRA 14.1)
Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
Item
Actively cooperating to participate in the study, to follow the instructions of the investigator and to attend the centre at the agreed times.
boolean
C0392337 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0525058 (UMLS CUI 2011AA)
Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
Item
Development of skin lesions any time under current systemic treatment if patient is receiving systemic medication for the treatment of CLE.
boolean
C1511795 (UMLS CUI 2011AA)
C0037284 (UMLS CUI 2011AA)
95324001 (SNOMED CT 2011_0131)
10040882 (MedDRA 14.1)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
Signed informed consent form after the nature of the study has been fully explained.
Item
Signed informed consent form after the nature of the study has been fully explained.
boolean
C0021430 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Pregnancy or lactation and women with positive pregnancy test.
Item
Pregnancy or lactation and women with positive pregnancy test.
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0240802 (UMLS CUI 2011AA)
250423000 (SNOMED CT 2011_0131)
10036575 (MedDRA 14.1)
Known hypersensitivity or allergic contact reactions to components of the study agents.
Item
Known hypersensitivity or allergic contact reactions to components of the study agents.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0700624 (UMLS CUI 2011AA)
C0443191 (UMLS CUI 2011AA)
263726009 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Treatment with photosensitizing drugs.
Item
Treatment with photosensitizing drugs.
boolean
C0039798 (UMLS CUI 2011AA)
C0162713 (UMLS CUI 2011AA)
108817007 (SNOMED CT 2011_0131)
Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
Item
Exposure to direct natural (sunlight) or artificial UV radiation on the back within 4 weeks prior to entering the study.
boolean
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0038817 (UMLS CUI 2011AA)
49926000 (SNOMED CT 2011_0131)
C0205296 (UMLS CUI 2011AA)
510009 (SNOMED CT 2011_0131)
C2004457 (UMLS CUI 2011AA)
71967004 (SNOMED CT 2011_0131)
C0041625 (UMLS CUI 2011AA)
41355003 (SNOMED CT 2011_0131)
C0004600 (UMLS CUI 2011AA)
123961009 (SNOMED CT 2011_0131)
MTHU001427 (LOINC Version 232)
History of another photodermatosis, except polymorph light eruption (PLE).
Item
History of another photodermatosis, except polymorph light eruption (PLE).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0920193 (UMLS CUI 2011AA)
10051246 (MedDRA 14.1)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0031736 (UMLS CUI 2011AA)
238525001 (SNOMED CT 2011_0131)
10036087 (MedDRA 14.1)
L56.4 (ICD-10-CM Version 2010)
Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
Item
Any current known skin malignancy or any history of skin malignancy within the previous 5 years or Xeroderma pigmentosum.
boolean
C0007114 (UMLS CUI 2011AA)
372130007 (SNOMED CT 2011_0131)
10040808 (MedDRA 14.1)
C44.9 (ICD-10-CM Version 2010)
C0043346 (UMLS CUI 2011AA)
44600005 (SNOMED CT 2011_0131)
10048220 (MedDRA 14.1)
Q82.1 (ICD-10-CM Version 2010)
Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
Item
Initiation or change in the dose of any current systemic medication for the treatment of CLE within 8 weeks prior to standardized photoprovocation.
boolean
C1704686 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C2347524 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0430551 (UMLS CUI 2011AA)
87724004 (SNOMED CT 2011_0131)
Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
Item
Local therapy for the treatment of CLE within two weeks prior to standardized photoprovocation at the back of the patient
boolean
C1517925 (UMLS CUI 2011AA)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0430551 (UMLS CUI 2011AA)
87724004 (SNOMED CT 2011_0131)
C0004600 (UMLS CUI 2011AA)
123961009 (SNOMED CT 2011_0131)
MTHU001427 (LOINC Version 232)
Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
Item
Acute exacerbation of CLE skin disease within 2 weeks prior to entering the study.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0024137 (UMLS CUI 2011AA)
7119001 (SNOMED CT 2011_0131)
10056509 (MedDRA 14.1)
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
Item
Acute illness within 7 days prior to phototesting or major illness including infection or hospitalization within 1 month of study entry.
boolean
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
CL426143 (UMLS CUI 2011AA)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0019993 (UMLS CUI 2011AA)
394656005 (SNOMED CT 2011_0131)
10054112 (MedDRA 14.1)
Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
Item
Anti-dsDNA (RIA) > 7 U/ml and/or at least one of the following criteria:
boolean
C2747927 (UMLS CUI 2011AA)
10069914 (MedDRA 14.1)
C0034580 (UMLS CUI 2011AA)
4613005 (SNOMED CT 2011_0131)
0104 (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
CL414621 (UMLS CUI 2011AA)
Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
Item
Serositis: pleuritis or pericarditis documented by electrocardiogram or rub or evidence of pericardial effusion
boolean
C0036749 (UMLS CUI 2011AA)
370469003 (SNOMED CT 2011_0131)
10058556 (MedDRA 14.1)
C0032231 (UMLS CUI 2011AA)
196075003 (SNOMED CT 2011_0131)
10035618 (MedDRA 14.1)
R09.1 (ICD-10-CM Version 2010)
511 (ICD-9-CM Version 2011)
C0031046 (UMLS CUI 2011AA)
3238004 (SNOMED CT 2011_0131)
10034484 (MedDRA 14.1)
E10180 (CTCAE 1105E)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
C0232267 (UMLS CUI 2011AA)
7036007 (SNOMED CT 2011_0131)
10049759 (MedDRA 14.1)
C0031039 (UMLS CUI 2011AA)
373945007 (SNOMED CT 2011_0131)
10034474 (MedDRA 14.1)
E10172 (CTCAE 1105E)
Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
Item
Renal disorder: proteinuria > 0.5 g/d or > 3+, or cellular casts
boolean
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0033687 (UMLS CUI 2011AA)
29738008 (SNOMED CT 2011_0131)
10037032 (MedDRA 14.1)
R80 (ICD-10-CM Version 2010)
791.0 (ICD-9-CM Version 2011)
E13008 (CTCAE 1105E)
C0427895 (UMLS CUI 2011AA)
250445004 (SNOMED CT 2011_0131)
Neurologic disorder: seizures or psychosis without other cause.
Item
Neurologic disorder: seizures or psychosis without other cause.
boolean
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0033975 (UMLS CUI 2011AA)
69322001 (SNOMED CT 2011_0131)
10061920 (MedDRA 14.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE 1105E)
Patients with a documented HIV and/or hepatitis B or C infection.
Item
Patients with a documented HIV and/or hepatitis B or C infection.
boolean
C1301725 (UMLS CUI 2011AA)
397934002 (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)
C0019163 (UMLS CUI 2011AA)
66071002 (SNOMED CT 2011_0131)
10019731 (MedDRA 14.1)
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)
Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
Item
Any medical condition, which would place the subject at undue risk of, or make it unlikely that follow-up-measurements could be obtained
boolean
C1699700 (UMLS CUI 2011AA)
MEDCCAT (HL7 V3 2006_05)
C1883420 (UMLS CUI 2011AA)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0750558 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C1522577 (UMLS CUI 2011AA)
C0242485 (UMLS CUI 2011AA)
122869004 (SNOMED CT 2011_0131)
MTHU003137 (LOINC Version 232)
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