ID

43407

Description

ODM derived from http://clinicaltrials.gov/show/NCT00456092

Link

http://clinicaltrials.gov/show/NCT00456092

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 NCT00456092 Psoriatic Arthritis

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
diagnosis of psoriatic arthritis (Moll and Wright criteria) including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
Description

diagnosis of psoriatic arthritis (Moll and Wright criteria) including symmetrical or asymmetrical peripheral joint involvement for at least 6 months

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0003872
SNOMED CT 2011_0131
33339001
MedDRA 14.1
10037162
ICD-10-CM Version 2010
L40.50
ICD-9-CM Version 2011
696.0
UMLS CUI 2011AA
C0679228
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0205100
SNOMED CT 2011_0131
14414005
UMLS CUI 2011AA
C0427306
SNOMED CT 2011_0131
250126000
UMLS CUI 2011AA
C0427307
SNOMED CT 2011_0131
250127009
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
active psoriatic arthritis defined as at least 3 tender and at least 3 swollen joints
Description

active psoriatic arthritis defined as at least 3 tender and at least 3 swollen joints

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0003872
SNOMED CT 2011_0131
33339001
MedDRA 14.1
10037162
ICD-10-CM Version 2010
L40.50
ICD-9-CM Version 2011
696.0
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0439091
SNOMED CT 2011_0131
276138003
HL7 V3 2006_05
GE
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0240094
SNOMED CT 2011_0131
110288007
MedDRA 14.1
10048913
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0152031
SNOMED CT 2011_0131
271771009
MedDRA 14.1
10023232
Rheumatoid factor negative
Description

negative RF

Data type

boolean

Alias
UMLS CUI 2011AA
C0427391
SNOMED CT 2011_0131
165840002
MedDRA 14.1
10048574
if on MTX, must be on for at least 24 weeks and on stable dose at least 56 days before screening
Description

if on MTX, must be on for at least 24 weeks and on stable dose at least 56 days before screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0025677
SNOMED CT 2011_0131
387381009
LOINC Version 232
MTHU005020
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
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
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
if on oral steroids, must be on stable dose of prednisone <=10mg/day or equivalent for 28 days
Description

if on oral steroids, must be on stable dose of prednisone <=10mg/day or equivalent for 28 days

Data type

boolean

Alias
UMLS CUI 2011AA
C0574135
if on NSAID, must be on a stable dose at least 14 days prior to screening
Description

if on NSAID, must be on a stable dose at least 14 days prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0750557
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005
UMLS CUI 2011AA
C0205360
SNOMED CT 2011_0131
58158008
LOINC Version 232
MTHU015276
UMLS CUI 2011AA
C0178602
SNOMED CT 2011_0131
260911001
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
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
Lab criteria: Hb >9g/dL, HCT >27%, WBC >3000/uL and <20000/uL, neut >1500/uL, platelets >100,000/uL, creatinine <1.5mg/dL, total bilirubin <2.0mg/dL, AST and ALT < 1.5 ULN
Description

Lab criteria: Hb >9g/dL, HCT >27%, WBC >3000/uL and <20000/uL, neut >1500/uL, platelets >100,000/uL, creatinine <1.5mg/dL, total bilirubin <2.0mg/dL, AST and ALT < 1.5 ULN

Data type

boolean

Alias
UMLS CUI 2011AA
C0022877
SNOMED CT 2011_0131
261904005
LOINC Version 232
MTHU029808
UMLS CUI 2011AA
CL414621
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C0018935
SNOMED CT 2011_0131
28317006
MedDRA 14.1
10018837
LOINC Version 232
MTHU002446
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
UMLS CUI 2011AA
C0200633
SNOMED CT 2011_0131
30630007
MedDRA 14.1
10029363
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C0010294
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
UMLS CUI 2011AA
C0201913
SNOMED CT 2011_0131
359986008
MedDRA 14.1
10004696
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C1519815
FCBP must have negative pregnancy tests and be on two forms of contraception throughout the study
Description

FCBP must have negative pregnancy tests and be on two forms of contraception throughout the study

Data type

boolean

Alias
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0427780
SNOMED CT 2011_0131
250425007
MedDRA 14.1
10036574
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
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
Males must use barrier contraception with FCBP partner
Description

Males must use barrier contraception with FCBP partner

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0004764
SNOMED CT 2011_0131
225370004
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
clinically significant diseases
Description

clinically significant diseases

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
any condition placing subject at risk
Description

any condition placing subject at risk

Data type

boolean

Alias
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0030705
SNOMED CT 2011_0131
116154003
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
pregnant or lactating females
Description

pregnant or lactating females

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
UMLS CUI 2011AA
C2828358
UMLS CUI 2011AA
C0086287
SNOMED CT 2011_0131
248152002
HL7 V3 2006_05
F
history of TB infection within 3 years
Description

history of TB infection within 3 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0375796
ICD-10-CM Version 2010
Z86.11
ICD-9-CM Version 2011
V12.01
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
history of incompletely treated latent TB
Description

history of incompletely treated latent TB

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205257
SNOMED CT 2011_0131
255599008
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C1609538
MedDRA 14.1
10065048
clinically significant abnormality on CXR at screening
Description

clinically significant abnormality on CXR at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0436503
SNOMED CT 2011_0131
168734001
MedDRA 14.1
10008499
UMLS CUI 2011AA
C1409616
current erythrodermic, guttate or pustular psoriasis
Description

current erythrodermic, guttate or pustular psoriasis

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
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
C0152081
SNOMED CT 2011_0131
200973000
MedDRA 14.1
10037159
history of infected joint prosthesis within 5 years
Description

history of infected joint prosthesis within 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0410808
SNOMED CT 2011_0131
213121005
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
systemic therapy including sulphasalazine, leflunomide, chloroquine, hydroxychloroquine, gold, parenteral steroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine and fumaric acid esters within 28 days of randomization
Description

systemic therapy including sulphasalazine, leflunomide, chloroquine, hydroxychloroquine, gold, parenteral steroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine and fumaric acid esters within 28 days of randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0036078
SNOMED CT 2011_0131
387248006
LOINC Version 232
MTHU003000
UMLS CUI 2011AA
C0718644
SNOMED CT 2011_0131
386981009
LOINC Version 232
MTHU017708
UMLS CUI 2011AA
C0008269
SNOMED CT 2011_0131
373468005
LOINC Version 232
MTHU014870
UMLS CUI 2011AA
C0020336
SNOMED CT 2011_0131
373540008
LOINC Version 232
MTHU016851
UMLS CUI 2011AA
C0018026
SNOMED CT 2011_0131
2309006
LOINC Version 232
MTHU005003
UMLS CUI 2011AA
CL383595
UMLS CUI 2011AA
C0030817
SNOMED CT 2011_0131
387235007
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C1527415
SNOMED CT 2011_0131
26643006
HL7 V3 2006_05
_OralRoute
UMLS CUI 2011AA
C2267033
UMLS CUI 2011AA
C0209368
SNOMED CT 2011_0131
386976000
UMLS CUI 2011AA
C0039902
SNOMED CT 2011_0131
387407006
LOINC Version 232
MTHU014979
UMLS CUI 2011AA
C0020402
SNOMED CT 2011_0131
56602009
UMLS CUI 2011AA
C0072980
SNOMED CT 2011_0131
387014003
LOINC Version 232
MTHU013897
UMLS CUI 2011AA
C0085149
SNOMED CT 2011_0131
386975001
LOINC Version 232
MTHU001849
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C1959568
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
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
C0034656
topical therapy for treatment of psoriasis within 14 days of randomization (except mild or moderate steroids and non medicated emollients)
Description

topical therapy for treatment of psoriasis within 14 days of randomization (except mild or moderate steroids and non medicated emollients)

Data type

boolean

Alias
UMLS CUI 2011AA
C0150349
SNOMED CT 2011_0131
386439008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0034656
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C1881878
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0013983
SNOMED CT 2011_0131
373380003
phototherapy within 28 days randomization
Description

phototherapy within 28 days randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0031765
etanercept within 56 days randomization
Description

etanercept within 56 days randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0717758
SNOMED CT 2011_0131
387045004
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205454
SNOMED CT 2011_0131
7319005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0034656
Adalimumab, efalizumab, or infliximab within 84 days randomization
Description

Adalimumab, efalizumab, or infliximab within 84 days randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C1122087
SNOMED CT 2011_0131
407317001
UMLS CUI 2011AA
C1320125
SNOMED CT 2011_0131
407005009
UMLS CUI 2011AA
C0666743
SNOMED CT 2011_0131
386891004
LOINC Version 232
MTHU018219
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205458
SNOMED CT 2011_0131
82809009
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0034656
alefacept within 24 weeks randomization
Description

alefacept within 24 weeks randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0962603
SNOMED CT 2011_0131
398691006
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
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
C0034656
use of any intra-articular steroids within 28 days randomization
Description

use of any intra-articular steroids within 28 days randomization

Data type

boolean

Alias
UMLS CUI 2011AA
C0205528
SNOMED CT 2011_0131
12130007
UMLS CUI 2011AA
C0038317
SNOMED CT 2011_0131
116566001
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
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
C0034656
use of any investigational medication within 28 days randomization or 5 half-lives whichever is longer
Description

use of any investigational medication within 28 days randomization or 5 half-lives whichever is longer

Data type

boolean

Alias
UMLS CUI 2011AA
C1517586
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
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
C0034656
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0018517
clinically significant abnormality on ECG at screening
Description

clinically significant abnormality on ECG at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0522055
SNOMED CT 2011_0131
102594003
MedDRA 14.1
10014363
UMLS CUI 2011AA
C1409616
high risk factors for HIV or hepatitis B or C
Description

high risk factors for HIV or hepatitis B or C

Data type

boolean

Alias
UMLS CUI 2011AA
C1830377
LOINC Version 232
MTHU021331
UMLS CUI 2011AA
C0019682
SNOMED CT 2011_0131
19030005
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
history of malignancy within 5 years (except basal cell skin carcinomas and/or fewer than 3 treated squamous cell skin carcinomas
Description

history of malignancy within 5 years (except basal cell skin carcinomas and/or fewer than 3 treated squamous cell skin carcinomas

Data type

boolean

Alias
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0553723
SNOMED CT 2011_0131
254651007
MedDRA 14.1
10041834
evidence of skin conditions at screening that would interfere with evaluations of psoriasis
Description

evidence of skin conditions at screening that would interfere with evaluations of psoriasis

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C1719933
SNOMED CT 2011_0131
422000003
LOINC Version 232
MTHU034830
UMLS CUI 2011AA
C1409616
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
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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)
diagnosis of psoriatic arthritis (Moll and Wright criteria) including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
Item
diagnosis of psoriatic arthritis (Moll and Wright criteria) including symmetrical or asymmetrical peripheral joint involvement for at least 6 months
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0003872 (UMLS CUI 2011AA)
33339001 (SNOMED CT 2011_0131)
10037162 (MedDRA 14.1)
L40.50 (ICD-10-CM Version 2010)
696.0 (ICD-9-CM Version 2011)
C0679228 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0205100 (UMLS CUI 2011AA)
14414005 (SNOMED CT 2011_0131)
C0427306 (UMLS CUI 2011AA)
250126000 (SNOMED CT 2011_0131)
C0427307 (UMLS CUI 2011AA)
250127009 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
active psoriatic arthritis defined as at least 3 tender and at least 3 swollen joints
Item
active psoriatic arthritis defined as at least 3 tender and at least 3 swollen joints
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0003872 (UMLS CUI 2011AA)
33339001 (SNOMED CT 2011_0131)
10037162 (MedDRA 14.1)
L40.50 (ICD-10-CM Version 2010)
696.0 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0240094 (UMLS CUI 2011AA)
110288007 (SNOMED CT 2011_0131)
10048913 (MedDRA 14.1)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0152031 (UMLS CUI 2011AA)
271771009 (SNOMED CT 2011_0131)
10023232 (MedDRA 14.1)
negative RF
Item
Rheumatoid factor negative
boolean
C0427391 (UMLS CUI 2011AA)
165840002 (SNOMED CT 2011_0131)
10048574 (MedDRA 14.1)
if on MTX, must be on for at least 24 weeks and on stable dose at least 56 days before screening
Item
if on MTX, must be on for at least 24 weeks and on stable dose at least 56 days before screening
boolean
C0750557 (UMLS CUI 2011AA)
C0025677 (UMLS CUI 2011AA)
387381009 (SNOMED CT 2011_0131)
MTHU005020 (LOINC Version 232)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (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)
if on oral steroids, must be on stable dose of prednisone <=10mg/day or equivalent for 28 days
Item
if on oral steroids, must be on stable dose of prednisone <=10mg/day or equivalent for 28 days
boolean
C0574135 (UMLS CUI 2011AA)
if on NSAID, must be on a stable dose at least 14 days prior to screening
Item
if on NSAID, must be on a stable dose at least 14 days prior to screening
boolean
C0750557 (UMLS CUI 2011AA)
C0003211 (UMLS CUI 2011AA)
16403005 (SNOMED CT 2011_0131)
C0205360 (UMLS CUI 2011AA)
58158008 (SNOMED CT 2011_0131)
MTHU015276 (LOINC Version 232)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (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)
Lab criteria: Hb >9g/dL, HCT >27%, WBC >3000/uL and <20000/uL, neut >1500/uL, platelets >100,000/uL, creatinine <1.5mg/dL, total bilirubin <2.0mg/dL, AST and ALT < 1.5 ULN
Item
Lab criteria: Hb >9g/dL, HCT >27%, WBC >3000/uL and <20000/uL, neut >1500/uL, platelets >100,000/uL, creatinine <1.5mg/dL, total bilirubin <2.0mg/dL, AST and ALT < 1.5 ULN
boolean
C0022877 (UMLS CUI 2011AA)
261904005 (SNOMED CT 2011_0131)
MTHU029808 (LOINC Version 232)
CL414621 (UMLS CUI 2011AA)
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C0018935 (UMLS CUI 2011AA)
28317006 (SNOMED CT 2011_0131)
10018837 (MedDRA 14.1)
MTHU002446 (LOINC Version 232)
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
C0200633 (UMLS CUI 2011AA)
30630007 (SNOMED CT 2011_0131)
10029363 (MedDRA 14.1)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C0010294 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
C0201913 (UMLS CUI 2011AA)
359986008 (SNOMED CT 2011_0131)
10004696 (MedDRA 14.1)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
FCBP must have negative pregnancy tests and be on two forms of contraception throughout the study
Item
FCBP must have negative pregnancy tests and be on two forms of contraception throughout the study
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
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)
Males must use barrier contraception with FCBP partner
Item
Males must use barrier contraception with FCBP partner
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0004764 (UMLS CUI 2011AA)
225370004 (SNOMED CT 2011_0131)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
clinically significant diseases
Item
clinically significant diseases
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
any condition placing subject at risk
Item
any condition placing subject at risk
boolean
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
pregnant or lactating females
Item
pregnant or lactating females
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
history of TB infection within 3 years
Item
history of TB infection within 3 years
boolean
C0375796 (UMLS CUI 2011AA)
Z86.11 (ICD-10-CM Version 2010)
V12.01 (ICD-9-CM Version 2011)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
history of incompletely treated latent TB
Item
history of incompletely treated latent TB
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205257 (UMLS CUI 2011AA)
255599008 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C1609538 (UMLS CUI 2011AA)
10065048 (MedDRA 14.1)
clinically significant abnormality on CXR at screening
Item
clinically significant abnormality on CXR at screening
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0436503 (UMLS CUI 2011AA)
168734001 (SNOMED CT 2011_0131)
10008499 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
current erythrodermic, guttate or pustular psoriasis
Item
current erythrodermic, guttate or pustular psoriasis
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (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)
C0152081 (UMLS CUI 2011AA)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.1)
history of infected joint prosthesis within 5 years
Item
history of infected joint prosthesis within 5 years
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0410808 (UMLS CUI 2011AA)
213121005 (SNOMED CT 2011_0131)
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)
systemic therapy including sulphasalazine, leflunomide, chloroquine, hydroxychloroquine, gold, parenteral steroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine and fumaric acid esters within 28 days of randomization
Item
systemic therapy including sulphasalazine, leflunomide, chloroquine, hydroxychloroquine, gold, parenteral steroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine and fumaric acid esters within 28 days of randomization
boolean
C1515119 (UMLS CUI 2011AA)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0036078 (UMLS CUI 2011AA)
387248006 (SNOMED CT 2011_0131)
MTHU003000 (LOINC Version 232)
C0718644 (UMLS CUI 2011AA)
386981009 (SNOMED CT 2011_0131)
MTHU017708 (LOINC Version 232)
C0008269 (UMLS CUI 2011AA)
373468005 (SNOMED CT 2011_0131)
MTHU014870 (LOINC Version 232)
C0020336 (UMLS CUI 2011AA)
373540008 (SNOMED CT 2011_0131)
MTHU016851 (LOINC Version 232)
C0018026 (UMLS CUI 2011AA)
2309006 (SNOMED CT 2011_0131)
MTHU005003 (LOINC Version 232)
CL383595 (UMLS CUI 2011AA)
C0030817 (UMLS CUI 2011AA)
387235007 (SNOMED CT 2011_0131)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C1527415 (UMLS CUI 2011AA)
26643006 (SNOMED CT 2011_0131)
_OralRoute (HL7 V3 2006_05)
C2267033 (UMLS CUI 2011AA)
C0209368 (UMLS CUI 2011AA)
386976000 (SNOMED CT 2011_0131)
C0039902 (UMLS CUI 2011AA)
387407006 (SNOMED CT 2011_0131)
MTHU014979 (LOINC Version 232)
C0020402 (UMLS CUI 2011AA)
56602009 (SNOMED CT 2011_0131)
C0072980 (UMLS CUI 2011AA)
387014003 (SNOMED CT 2011_0131)
MTHU013897 (LOINC Version 232)
C0085149 (UMLS CUI 2011AA)
386975001 (SNOMED CT 2011_0131)
MTHU001849 (LOINC Version 232)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C1959568 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (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)
C0034656 (UMLS CUI 2011AA)
topical therapy for treatment of psoriasis within 14 days of randomization (except mild or moderate steroids and non medicated emollients)
Item
topical therapy for treatment of psoriasis within 14 days of randomization (except mild or moderate steroids and non medicated emollients)
boolean
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C1881878 (UMLS CUI 2011AA)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0013983 (UMLS CUI 2011AA)
373380003 (SNOMED CT 2011_0131)
phototherapy within 28 days randomization
Item
phototherapy within 28 days randomization
boolean
C0031765 (UMLS CUI 2011AA)
etanercept within 56 days randomization
Item
etanercept within 56 days randomization
boolean
C0717758 (UMLS CUI 2011AA)
387045004 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205454 (UMLS CUI 2011AA)
7319005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
Adalimumab, efalizumab, or infliximab within 84 days randomization
Item
Adalimumab, efalizumab, or infliximab within 84 days randomization
boolean
C1122087 (UMLS CUI 2011AA)
407317001 (SNOMED CT 2011_0131)
C1320125 (UMLS CUI 2011AA)
407005009 (SNOMED CT 2011_0131)
C0666743 (UMLS CUI 2011AA)
386891004 (SNOMED CT 2011_0131)
MTHU018219 (LOINC Version 232)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205458 (UMLS CUI 2011AA)
82809009 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
alefacept within 24 weeks randomization
Item
alefacept within 24 weeks randomization
boolean
C0962603 (UMLS CUI 2011AA)
398691006 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0034656 (UMLS CUI 2011AA)
use of any intra-articular steroids within 28 days randomization
Item
use of any intra-articular steroids within 28 days randomization
boolean
C0205528 (UMLS CUI 2011AA)
12130007 (SNOMED CT 2011_0131)
C0038317 (UMLS CUI 2011AA)
116566001 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (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)
C0034656 (UMLS CUI 2011AA)
use of any investigational medication within 28 days randomization or 5 half-lives whichever is longer
Item
use of any investigational medication within 28 days randomization or 5 half-lives whichever is longer
boolean
C1517586 (UMLS CUI 2011AA)
C0013227 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (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)
C0034656 (UMLS CUI 2011AA)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0018517 (UMLS CUI 2011AA)
clinically significant abnormality on ECG at screening
Item
clinically significant abnormality on ECG at screening
boolean
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0522055 (UMLS CUI 2011AA)
102594003 (SNOMED CT 2011_0131)
10014363 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
high risk factors for HIV or hepatitis B or C
Item
high risk factors for HIV or hepatitis B or C
boolean
C1830377 (UMLS CUI 2011AA)
MTHU021331 (LOINC Version 232)
C0019682 (UMLS CUI 2011AA)
19030005 (SNOMED CT 2011_0131)
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)
history of malignancy within 5 years (except basal cell skin carcinomas and/or fewer than 3 treated squamous cell skin carcinomas
Item
history of malignancy within 5 years (except basal cell skin carcinomas and/or fewer than 3 treated squamous cell skin carcinomas
boolean
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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
CL415147 (UMLS CUI 2011AA)
C0553723 (UMLS CUI 2011AA)
254651007 (SNOMED CT 2011_0131)
10041834 (MedDRA 14.1)
evidence of skin conditions at screening that would interfere with evaluations of psoriasis
Item
evidence of skin conditions at screening that would interfere with evaluations of psoriasis
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C1719933 (UMLS CUI 2011AA)
422000003 (SNOMED CT 2011_0131)
MTHU034830 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
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)
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