ID

43416

Description

ODM derived from http://clinicaltrials.gov/show/NCT00408187

Link

http://clinicaltrials.gov/show/NCT00408187

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/15/14 4/15/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00408187 Psoriasis

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Aged >= 18 years of age inclusive at time of screening.
Description

Aged >= 18 years of age inclusive at time of screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0439547
SNOMED CT 2011_0131
272105005
UMLS CUI 2011AA
C1409616
Diagnosed with plaque psoriasis >= 6 months prior to screening.
Description

Diagnosed with plaque psoriasis >= 6 months prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0406317
SNOMED CT 2011_0131
200965009
ICD-10-CM Version 2010
L40.0
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
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
Diagnosis of stable, plaque psoriasis, i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.
Description

Diagnosis of stable, plaque psoriasis, i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0406317
SNOMED CT 2011_0131
200965009
ICD-10-CM Version 2010
L40.0
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0205359
SNOMED CT 2011_0131
5054005
UMLS CUI 2011AA
C1272745
SNOMED CT 2011_0131
385633008
UMLS CUI 2011AA
C0332271
SNOMED CT 2011_0131
230993007
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.
Description

Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.

Data type

boolean

Alias
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0231175
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
CL031856
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C0013220
SNOMED CT 2011_0131
228432001
MedDRA 14.1
10052804
UMLS CUI 2011AA
C0033213
SNOMED CT 2011_0131
55607006
Plaque psoriasis involving >= 10% of the body surface area and a SPGA score >= 3 at screening and prior to randomization at the day 0 visit.
Description

Plaque psoriasis involving >= 10% of the body surface area and a SPGA score >= 3 at screening and prior to randomization at the day 0 visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0406317
SNOMED CT 2011_0131
200965009
ICD-10-CM Version 2010
L40.0
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0005902
SNOMED CT 2011_0131
128178001
MedDRA 14.1
10050311
UMLS CUI 2011AA
C0441463
SNOMED CT 2011_0131
257390007
UMLS CUI 2011AA
C0031831
SNOMED CT 2011_0131
309343006
LOINC Version 232
MTHU010489
HL7 V3 2006_05
PHYS
UMLS CUI 2011AA
C0281858
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0919414
SNOMED CT 2011_0131
258317007
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Not pregnant or nursing.
Description

Not pregnant or nursing.

Data type

boolean

Alias
UMLS CUI 2011AA
C0232973
SNOMED CT 2011_0131
60001007
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Sexually active women of childbearing potential or <1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.
Description

Sexually active women of childbearing potential or <1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.

Data type

boolean

Alias
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0232970
SNOMED CT 2011_0131
76498008
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0025266
SNOMED CT 2011_0131
339947000
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C0021359
SNOMED CT 2011_0131
8619003
MedDRA 14.1
10021926
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0039798
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
C0231290
SNOMED CT 2011_0131
237679004
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0009905
SNOMED CT 2011_0131
59261009
UMLS CUI 2011AA
C0419530
SNOMED CT 2011_0131
268464009
UMLS CUI 2011AA
C0205173
SNOMED CT 2011_0131
1305003
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
Written informed consent prior to washout and screening procedures.
Description

Written informed consent prior to washout and screening procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Able to keep study appointments and cooperate with all study requirements, in the opinion of the Investigator.
Description

Able to keep study appointments and cooperate with all study requirements, in the opinion of the Investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0003629
HL7 V3 2006_05
APT
UMLS CUI 2011AA
C0392337
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Has generalized erythrodermic, guttate, or pustular psoriasis.
Description

Has generalized erythrodermic, guttate, or pustular psoriasis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205246
SNOMED CT 2011_0131
60132005
UMLS CUI 2011AA
C0748052
SNOMED CT 2011_0131
200977004
MedDRA 14.1
10015278
UMLS CUI 2011AA
C0343052
SNOMED CT 2011_0131
37042000
ICD-10-CM Version 2010
L40.4
UMLS CUI 2011AA
C0343055
SNOMED CT 2011_0131
238612002
ICD-10-CM Version 2010
L40.1
Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the Investigator.
Description

Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the Investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
Description

A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C1997820
SNOMED CT 2011_0131
429014004
UMLS CUI 2011AA
C1516879
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007137
SNOMED CT 2011_0131
28899001
MedDRA 14.1
10041823
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0728940
SNOMED CT 2011_0131
65801008
UMLS CUI 2011AA
C0010468
SNOMED CT 2011_0131
68688001
UMLS CUI 2011AA
C0185056
SNOMED CT 2011_0131
8401003
MedDRA 14.1
10065267
Has a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.
Description

Has a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0205318
SNOMED CT 2011_0131
19032002
UMLS CUI 2011AA
C0004623
SNOMED CT 2011_0131
87628006
MedDRA 14.1
10060945
ICD-10-CM Version 2010
A49.9
UMLS CUI 2011AA
C0042769
SNOMED CT 2011_0131
34014006
MedDRA 14.1
10047461
ICD-10-CM Version 2010
B34.9
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0559680
SNOMED CT 2011_0131
281790008
UMLS CUI 2011AA
C0348016
SNOMED CT 2011_0131
255560000
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
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
Personal history of tuberculosis
Description

A known history of tuberculosis.

Data type

boolean

Alias
UMLS CUI 2011AA
C0375796
ICD-10-CM Version 2010
Z86.11
ICD-9-CM Version 2011
V12.01
Serologic evidence or known latent HIV, HBV or HCV virus.
Description

Serologic evidence or known latent HIV, HBV or HCV virus.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205473
SNOMED CT 2011_0131
27377004
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0205275
SNOMED CT 2011_0131
44104002
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
UMLS CUI 2011AA
C0019169
SNOMED CT 2011_0131
81665004
UMLS CUI 2011AA
C0220847
SNOMED CT 2011_0131
62944002
MedDRA 14.1
10019752
Uncontrolled hypertension of systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 90 mmHg.
Description

Uncontrolled hypertension of systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 90 mmHg.

Data type

boolean

Alias
UMLS CUI 2011AA
C1868885
MedDRA 14.1
10066860
UMLS CUI 2011AA
C0871470
SNOMED CT 2011_0131
271649006
UMLS CUI 2011AA
C0428883
SNOMED CT 2011_0131
271650006
MDRD GFR < 60 mL/min.
Description

MDRD GFR < 60 mL/min.

Data type

boolean

Alias
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C0012155
SNOMED CT 2011_0131
41829006
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0017654
SNOMED CT 2011_0131
80274001
MedDRA 14.1
10018355
Variation between the screening and Visit 1 SCr >= 30%.
Description

Variation between the screening and Visit 1 SCr >= 30%.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205419
SNOMED CT 2011_0131
40885006
UMLS CUI 2011AA
CL426201
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
ALT, AST, GGT >= 2x upper limit of normal (ULN).
Description

ALT, AST, GGT >= 2x upper limit of normal (ULN).

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0202035
SNOMED CT 2011_0131
69480007
MedDRA 14.1
10017687
LOINC Version 232
2324-2
UMLS CUI 2011AA
C1519815
White Blood Cell Count procedure (WBC)
Description

White blood cell count <= 2.8 x 10 to the ninth power/L.

Data type

boolean

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs interfering with its pharmacokinetics, drugs considered to contribute to psoriasis flare. Or, systemic and topical psoriasis medication that may interfere with assessment of study drug efficacy.
Description

Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs interfering with its pharmacokinetics, drugs considered to contribute to psoriasis flare. Or, systemic and topical psoriasis medication that may interfere with assessment of study drug efficacy.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0683610
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C1710661
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1948053
UMLS CUI 2011AA
C0086188
UMLS CUI 2011AA
C0599918
MedDRA 14.1
10067571
UMLS CUI 2011AA
C2607219
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C0031328
UMLS CUI 2011AA
C1880177
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C1517205
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1522168
SNOMED CT 2011_0131
6064005
HL7 V3 2006_05
TOPICAL
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C1280519
SNOMED CT 2011_0131
255403003
Has used any investigational drug or device within 30 days or 10 half lives (whichever is longer) prior to the screening visit.
Description

Has used any investigational drug or device within 30 days or 10 half lives (whichever is longer) prior to the screening visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
UMLS CUI 2011AA
C2346570
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0205456
SNOMED CT 2011_0131
3445001
UMLS CUI 2011AA
C0018517
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
Current participation in another clinical trial of any drug or biological agent.
Description

Current participation in another clinical trial of any drug or biological agent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
CL407060
UMLS CUI 2011AA
C1254351
UMLS CUI 2011AA
C0005522
SNOMED CT 2011_0131
418980009
Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of randomization. Biological agents include any virus, live vaccine, therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
Description

Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of randomization. Biological agents include any virus, live vaccine, therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512806
UMLS CUI 2011AA
C0005522
SNOMED CT 2011_0131
418980009
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0770694
UMLS CUI 2011AA
C0039614
SNOMED CT 2011_0131
76902006
MedDRA 14.1
10043376
ICD-10-CM Version 2010
A35
ICD-9-CM Version 2011
037
UMLS CUI 2011AA
C2699298
UMLS CUI 2011AA
C0020975
MedDRA 14.1
10006021
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
C0034656
UMLS CUI 2011AA
C0005522
SNOMED CT 2011_0131
418980009
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0042776
SNOMED CT 2011_0131
49872002
UMLS CUI 2011AA
C0042211
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0229671
SNOMED CT 2011_0131
67922002
LOINC Version 232
MTHU001009
UMLS CUI 2011AA
C0040549
SNOMED CT 2011_0131
80917008
UMLS CUI 2011AA
C0003445
SNOMED CT 2011_0131
71862009
UMLS CUI 2011AA
C0003250
SNOMED CT 2011_0131
49616005
UMLS CUI 2011AA
CL415123
UMLS CUI 2011AA
C1514468
Previous exposure to voclosporin.
Description

Previous exposure to voclosporin.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C2607219
A history of clinically defined allergy to ciclosporin, constituents of Neoral or any of the constituents of the ISA247 formulation.
Description

A history of clinically defined allergy to ciclosporin, constituents of Neoral or any of the constituents of the ISA247 formulation.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C0729650
SNOMED CT 2011_0131
312297002
UMLS CUI 2011AA
C2607219
UMLS CUI 2011AA
C1705957
A history of alcoholism or drug addiction.
Description

A history of alcoholism or drug addiction.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0001973
SNOMED CT 2011_0131
284591009
MedDRA 14.1
10001639
ICD-10-CM Version 2010
F10.2
ICD-9-CM Version 2011
305.01
UMLS CUI 2011AA
C1510472
SNOMED CT 2011_0131
191816009
MedDRA 14.1
10013663
ICD-9-CM Version 2011
304
Body weight (observable entity)
Description

Weighs < 45kg (99 lbs).

Data type

boolean

Alias
UMLS CUI 2011AA
C0005910
SNOMED CT 2011_0131
27113001
LOINC Version 232
MTHU001885
A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, in the evaluation of his/her response or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the Investigator.
Description

A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, in the evaluation of his/her response or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the Investigator.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0233459
MedDRA 14.1
10014551
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C2348568
UMLS CUI 2011AA
C0220825
UMLS CUI 2011AA
C0521982
SNOMED CT 2011_0131
182985004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C2607219
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Aged >= 18 years of age inclusive at time of screening.
Item
Aged >= 18 years of age inclusive at time of screening.
boolean
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0439547 (UMLS CUI 2011AA)
272105005 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Diagnosed with plaque psoriasis >= 6 months prior to screening.
Item
Diagnosed with plaque psoriasis >= 6 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)
C0205452 (UMLS CUI 2011AA)
68244004 (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)
Diagnosis of stable, plaque psoriasis, i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.
Item
Diagnosis of stable, plaque psoriasis, i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
C1518422 (UMLS CUI 2011AA)
C0205359 (UMLS CUI 2011AA)
5054005 (SNOMED CT 2011_0131)
C1272745 (UMLS CUI 2011AA)
385633008 (SNOMED CT 2011_0131)
C0332271 (UMLS CUI 2011AA)
230993007 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.
Item
Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.
boolean
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0231175 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL031856 (UMLS CUI 2011AA)
C1515119 (UMLS CUI 2011AA)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0013220 (UMLS CUI 2011AA)
228432001 (SNOMED CT 2011_0131)
10052804 (MedDRA 14.1)
C0033213 (UMLS CUI 2011AA)
55607006 (SNOMED CT 2011_0131)
Plaque psoriasis involving >= 10% of the body surface area and a SPGA score >= 3 at screening and prior to randomization at the day 0 visit.
Item
Plaque psoriasis involving >= 10% of the body surface area and a SPGA score >= 3 at screening and prior to randomization at the day 0 visit.
boolean
C0406317 (UMLS CUI 2011AA)
200965009 (SNOMED CT 2011_0131)
L40.0 (ICD-10-CM Version 2010)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0005902 (UMLS CUI 2011AA)
128178001 (SNOMED CT 2011_0131)
10050311 (MedDRA 14.1)
C0441463 (UMLS CUI 2011AA)
257390007 (SNOMED CT 2011_0131)
C0031831 (UMLS CUI 2011AA)
309343006 (SNOMED CT 2011_0131)
MTHU010489 (LOINC Version 232)
PHYS (HL7 V3 2006_05)
C0281858 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0919414 (UMLS CUI 2011AA)
258317007 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Not pregnant or nursing.
Item
Not pregnant or nursing.
boolean
C0232973 (UMLS CUI 2011AA)
60001007 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Sexually active women of childbearing potential or <1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.
Item
Sexually active women of childbearing potential or <1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.
boolean
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0232970 (UMLS CUI 2011AA)
76498008 (SNOMED CT 2011_0131)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0025266 (UMLS CUI 2011AA)
339947000 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C0021359 (UMLS CUI 2011AA)
8619003 (SNOMED CT 2011_0131)
10021926 (MedDRA 14.1)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0231290 (UMLS CUI 2011AA)
237679004 (SNOMED CT 2011_0131)
C1517741 (UMLS CUI 2011AA)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0009905 (UMLS CUI 2011AA)
59261009 (SNOMED CT 2011_0131)
C0419530 (UMLS CUI 2011AA)
268464009 (SNOMED CT 2011_0131)
C0205173 (UMLS CUI 2011AA)
1305003 (SNOMED CT 2011_0131)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
Written informed consent prior to washout and screening procedures.
Item
Written informed consent prior to washout and screening procedures.
boolean
C0021430 (UMLS CUI 2011AA)
Able to keep study appointments and cooperate with all study requirements, in the opinion of the Investigator.
Item
Able to keep study appointments and cooperate with all study requirements, in the opinion of the Investigator.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0003629 (UMLS CUI 2011AA)
APT (HL7 V3 2006_05)
C0392337 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Has generalized erythrodermic, guttate, or pustular psoriasis.
Item
Has generalized erythrodermic, guttate, or pustular psoriasis.
boolean
C0205246 (UMLS CUI 2011AA)
60132005 (SNOMED CT 2011_0131)
C0748052 (UMLS CUI 2011AA)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.1)
C0343052 (UMLS CUI 2011AA)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
C0343055 (UMLS CUI 2011AA)
238612002 (SNOMED CT 2011_0131)
L40.1 (ICD-10-CM Version 2010)
Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the Investigator.
Item
Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the Investigator.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0220825 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
Item
A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
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)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C1997820 (UMLS CUI 2011AA)
429014004 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C0010468 (UMLS CUI 2011AA)
68688001 (SNOMED CT 2011_0131)
C0185056 (UMLS CUI 2011AA)
8401003 (SNOMED CT 2011_0131)
10065267 (MedDRA 14.1)
Has a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.
Item
Has a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0004623 (UMLS CUI 2011AA)
87628006 (SNOMED CT 2011_0131)
10060945 (MedDRA 14.1)
A49.9 (ICD-10-CM Version 2010)
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)
C1514873 (UMLS CUI 2011AA)
C0559680 (UMLS CUI 2011AA)
281790008 (SNOMED CT 2011_0131)
C0348016 (UMLS CUI 2011AA)
255560000 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (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)
A known history of tuberculosis.
Item
Personal history of tuberculosis
boolean
C0375796 (UMLS CUI 2011AA)
Z86.11 (ICD-10-CM Version 2010)
V12.01 (ICD-9-CM Version 2011)
Serologic evidence or known latent HIV, HBV or HCV virus.
Item
Serologic evidence or known latent HIV, HBV or HCV virus.
boolean
C0205473 (UMLS CUI 2011AA)
27377004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0205275 (UMLS CUI 2011AA)
44104002 (SNOMED CT 2011_0131)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
C0019169 (UMLS CUI 2011AA)
81665004 (SNOMED CT 2011_0131)
C0220847 (UMLS CUI 2011AA)
62944002 (SNOMED CT 2011_0131)
10019752 (MedDRA 14.1)
Uncontrolled hypertension of systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 90 mmHg.
Item
Uncontrolled hypertension of systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 90 mmHg.
boolean
C1868885 (UMLS CUI 2011AA)
10066860 (MedDRA 14.1)
C0871470 (UMLS CUI 2011AA)
271649006 (SNOMED CT 2011_0131)
C0428883 (UMLS CUI 2011AA)
271650006 (SNOMED CT 2011_0131)
MDRD GFR < 60 mL/min.
Item
MDRD GFR < 60 mL/min.
boolean
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C0012155 (UMLS CUI 2011AA)
41829006 (SNOMED CT 2011_0131)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0017654 (UMLS CUI 2011AA)
80274001 (SNOMED CT 2011_0131)
10018355 (MedDRA 14.1)
Variation between the screening and Visit 1 SCr >= 30%.
Item
Variation between the screening and Visit 1 SCr >= 30%.
boolean
C0205419 (UMLS CUI 2011AA)
40885006 (SNOMED CT 2011_0131)
CL426201 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
ALT, AST, GGT >= 2x upper limit of normal (ULN).
Item
ALT, AST, GGT >= 2x upper limit of normal (ULN).
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0202035 (UMLS CUI 2011AA)
69480007 (SNOMED CT 2011_0131)
10017687 (MedDRA 14.1)
2324-2 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
White blood cell count <= 2.8 x 10 to the ninth power/L.
Item
White Blood Cell Count procedure (WBC)
boolean
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs interfering with its pharmacokinetics, drugs considered to contribute to psoriasis flare. Or, systemic and topical psoriasis medication that may interfere with assessment of study drug efficacy.
Item
Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs interfering with its pharmacokinetics, drugs considered to contribute to psoriasis flare. Or, systemic and topical psoriasis medication that may interfere with assessment of study drug efficacy.
boolean
C1514873 (UMLS CUI 2011AA)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0683610 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C1710661 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C1948053 (UMLS CUI 2011AA)
C0086188 (UMLS CUI 2011AA)
C0599918 (UMLS CUI 2011AA)
10067571 (MedDRA 14.1)
C2607219 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0031328 (UMLS CUI 2011AA)
C1880177 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C1517205 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0013227 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1280519 (UMLS CUI 2011AA)
255403003 (SNOMED CT 2011_0131)
Has used any investigational drug or device within 30 days or 10 half lives (whichever is longer) prior to the screening visit.
Item
Has used any investigational drug or device within 30 days or 10 half lives (whichever is longer) prior to the screening visit.
boolean
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C2346570 (UMLS CUI 2011AA)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0205456 (UMLS CUI 2011AA)
3445001 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
Current participation in another clinical trial of any drug or biological agent.
Item
Current participation in another clinical trial of any drug or biological agent.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
CL407060 (UMLS CUI 2011AA)
C1254351 (UMLS CUI 2011AA)
C0005522 (UMLS CUI 2011AA)
418980009 (SNOMED CT 2011_0131)
Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of randomization. Biological agents include any virus, live vaccine, therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
Item
Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of randomization. Biological agents include any virus, live vaccine, therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
boolean
C1512806 (UMLS CUI 2011AA)
C0005522 (UMLS CUI 2011AA)
418980009 (SNOMED CT 2011_0131)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0770694 (UMLS CUI 2011AA)
C0039614 (UMLS CUI 2011AA)
76902006 (SNOMED CT 2011_0131)
10043376 (MedDRA 14.1)
A35 (ICD-10-CM Version 2010)
037 (ICD-9-CM Version 2011)
C2699298 (UMLS CUI 2011AA)
C0020975 (UMLS CUI 2011AA)
10006021 (MedDRA 14.1)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
C0005522 (UMLS CUI 2011AA)
418980009 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0042776 (UMLS CUI 2011AA)
49872002 (SNOMED CT 2011_0131)
C0042211 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0229671 (UMLS CUI 2011AA)
67922002 (SNOMED CT 2011_0131)
MTHU001009 (LOINC Version 232)
C0040549 (UMLS CUI 2011AA)
80917008 (SNOMED CT 2011_0131)
C0003445 (UMLS CUI 2011AA)
71862009 (SNOMED CT 2011_0131)
C0003250 (UMLS CUI 2011AA)
49616005 (SNOMED CT 2011_0131)
CL415123 (UMLS CUI 2011AA)
C1514468 (UMLS CUI 2011AA)
Previous exposure to voclosporin.
Item
Previous exposure to voclosporin.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C2607219 (UMLS CUI 2011AA)
A history of clinically defined allergy to ciclosporin, constituents of Neoral or any of the constituents of the ISA247 formulation.
Item
A history of clinically defined allergy to ciclosporin, constituents of Neoral or any of the constituents of the ISA247 formulation.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C0729650 (UMLS CUI 2011AA)
312297002 (SNOMED CT 2011_0131)
C2607219 (UMLS CUI 2011AA)
C1705957 (UMLS CUI 2011AA)
A history of alcoholism or drug addiction.
Item
A history of alcoholism or drug addiction.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0001973 (UMLS CUI 2011AA)
284591009 (SNOMED CT 2011_0131)
10001639 (MedDRA 14.1)
F10.2 (ICD-10-CM Version 2010)
305.01 (ICD-9-CM Version 2011)
C1510472 (UMLS CUI 2011AA)
191816009 (SNOMED CT 2011_0131)
10013663 (MedDRA 14.1)
304 (ICD-9-CM Version 2011)
Weighs < 45kg (99 lbs).
Item
Body weight (observable entity)
boolean
C0005910 (UMLS CUI 2011AA)
27113001 (SNOMED CT 2011_0131)
MTHU001885 (LOINC Version 232)
A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, in the evaluation of his/her response or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the Investigator.
Item
A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, in the evaluation of his/her response or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the Investigator.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0233459 (UMLS CUI 2011AA)
10014551 (MedDRA 14.1)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
C0220825 (UMLS CUI 2011AA)
C0521982 (UMLS CUI 2011AA)
182985004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C2607219 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
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