ID

36969

Beskrivning

A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02349295

Länk

https://clinicaltrials.gov/show/NCT02349295

Nyckelord

Versioner (1)
  1. 2019-06-24 2019-06-24 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

24 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Psoriatic Arthritis NCT02349295

Engelsk

Eligibility Psoriatic Arthritis NCT02349295

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
presents with established diagnosis of active psoriatic arthritis (psa) for at least 6 months, and currently meets classification for psoriatic arthritis (caspar) criteria
Beskrivning

Psoriatic Arthritis Disease length | Classification Criteria Psoriatic Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0008902
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C0003872
active psa defined as the presence of at least 3 tender and at least 3 swollen joints
Beskrivning

Tender joint count | Swollen joint count

Datatyp

boolean

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2]
C0451521
presence of active psoriatic skin lesion or a history of plaque psoriasis (ps)
Beskrivning

Psoriasis Skin lesion | Psoriatic plaque

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0037284
UMLS CUI [2]
C0920235
men must agree to use a reliable method of birth control or remain abstinent during the study
Beskrivning

Gender Contraceptive methods | Gender Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Beskrivning

Gender Contraceptive methods | Gender Sexual Abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cdmards)
Beskrivning

DMARDs conventional Quantity In the past

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0439858
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1444637
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current use of biologic agents for treatment of ps or psa
Beskrivning

Biological agents Psoriatic plaque | Biological agents Psoriatic Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C0920235
UMLS CUI [2,1]
C0005515
UMLS CUI [2,2]
C0003872
inadequate response to greater than 2 biologic dmards
Beskrivning

Biologic DMARDs Quantity | Disease Response Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4055380
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
current use of more than one cdmards
Beskrivning

DMARDs conventional Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0439858
UMLS CUI [1,3]
C1265611
diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than psa
Beskrivning

Arthritis | Spondylarthropathy | Exception Psoriatic Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003864
UMLS CUI [2]
C0949691
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003872
have received treatment with interleukin (il) -17 or il12/23 targeted monoclonal antibody (mab) therapy
Beskrivning

Monoclonal Antibody Therapy Targeting Interleukin-17 | Monoclonal Antibody Therapy Targeting Interleukin-12 | Monoclonal Antibody Therapy Targeting interleukin-23

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279694
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0384648
UMLS CUI [2,1]
C0279694
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C0123759
UMLS CUI [3,1]
C0279694
UMLS CUI [3,2]
C1521840
UMLS CUI [3,3]
C0963088
serious disorder or illness other than psoriatic arthritis
Beskrivning

Illness Serious | Illness Except Psoriatic Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0003872
serious infection within the last 3 months
Beskrivning

Communicable Disease Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
breastfeeding or nursing (lactating) women
Beskrivning

Breast Feeding | Lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0022925
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Similar models

Eligibility Psoriatic Arthritis NCT02349295

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Psoriatic Arthritis Disease length | Classification Criteria Psoriatic Arthritis
Item
presents with established diagnosis of active psoriatic arthritis (psa) for at least 6 months, and currently meets classification for psoriatic arthritis (caspar) criteria
boolean
C0003872 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0008902 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C0003872 (UMLS CUI [2,3])
Tender joint count | Swollen joint count
Item
active psa defined as the presence of at least 3 tender and at least 3 swollen joints
boolean
C0451530 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
Psoriasis Skin lesion | Psoriatic plaque
Item
presence of active psoriatic skin lesion or a history of plaque psoriasis (ps)
boolean
C0033860 (UMLS CUI [1,1])
C0037284 (UMLS CUI [1,2])
C0920235 (UMLS CUI [2])
Gender Contraceptive methods | Gender Sexual Abstinence
Item
men must agree to use a reliable method of birth control or remain abstinent during the study
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
Gender Contraceptive methods | Gender Sexual Abstinence
Item
women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
DMARDs conventional Quantity In the past
Item
have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cdmards)
boolean
C0242708 (UMLS CUI [1,1])
C0439858 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Biological agents Psoriatic plaque | Biological agents Psoriatic Arthritis
Item
current use of biologic agents for treatment of ps or psa
boolean
C0005515 (UMLS CUI [1,1])
C0920235 (UMLS CUI [1,2])
C0005515 (UMLS CUI [2,1])
C0003872 (UMLS CUI [2,2])
Biologic DMARDs Quantity | Disease Response Inadequate
Item
inadequate response to greater than 2 biologic dmards
boolean
C4055380 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
DMARDs conventional Quantity
Item
current use of more than one cdmards
boolean
C0242708 (UMLS CUI [1,1])
C0439858 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Arthritis | Spondylarthropathy | Exception Psoriatic Arthritis
Item
diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than psa
boolean
C0003864 (UMLS CUI [1])
C0949691 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003872 (UMLS CUI [3,2])
Monoclonal Antibody Therapy Targeting Interleukin-17 | Monoclonal Antibody Therapy Targeting Interleukin-12 | Monoclonal Antibody Therapy Targeting interleukin-23
Item
have received treatment with interleukin (il) -17 or il12/23 targeted monoclonal antibody (mab) therapy
boolean
C0279694 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0384648 (UMLS CUI [1,3])
C0279694 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C0123759 (UMLS CUI [2,3])
C0279694 (UMLS CUI [3,1])
C1521840 (UMLS CUI [3,2])
C0963088 (UMLS CUI [3,3])
Illness Serious | Illness Except Psoriatic Arthritis
Item
serious disorder or illness other than psoriatic arthritis
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0003872 (UMLS CUI [2,3])
Communicable Disease Serious
Item
serious infection within the last 3 months
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Breast Feeding | Lactation
Item
breastfeeding or nursing (lactating) women
boolean
C0006147 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
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