ID

36953

Beskrivning

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study; ODM derived from: https://clinicaltrials.gov/show/NCT01877668

Länk

https://clinicaltrials.gov/show/NCT01877668

Nyckelord

Versioner (1)
  1. 2019-06-23 2019-06-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 juni 2019

DOI

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Creative Commons BY 4.0
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Eligibility Psoriatic Arthritis NCT01877668

Engelsk

Eligibility Psoriatic Arthritis NCT01877668

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
males or females, aged >= 18 years at time of consent.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have a diagnosis of psoriatic arthritis (psa) of >= 6 months
Beskrivning

Arthritis, Psoriatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0003872
meet the classification criteria of psa (caspar) at time of screening
Beskrivning

Psoriatic Arthritis Classification Criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C0243161
must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (dmard).
Beskrivning

Requirement Absent Non-Biologic DMARD

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4054347
concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
Beskrivning

Methotrexate | leflunomide | Sulfasalazine

Datatyp

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0063041
UMLS CUI [3]
C0036078
must not have taken a biologic tumour necrosis factor inhibitor
Beskrivning

Requirement Absent TNF inhibitors biologic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C3653350
UMLS CUI [1,4]
C0205460
must have 3 or more swollen joints and 3 or more tender joints
Beskrivning

Swollen joint count | Tender joint count

Datatyp

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
must have active psoriasis skin lesions
Beskrivning

Psoriasis Skin lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0037284
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
Beskrivning

Psoriasis Without Plaque | Erythrodermic psoriasis | Guttate psoriasis | Pustular psoriasis | Exception Psoriasis of nail

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0920235
UMLS CUI [2]
C0748052
UMLS CUI [3]
C0343052
UMLS CUI [4]
C0152081
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0406322
pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
new york heart association class iii and iv congestive heart failure
Beskrivning

Congestive heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
history of hypersensitivity or infusion reaction to biologic agents
Beskrivning

Hypersensitivity Biological agents | Infusion related reaction Biological agents

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0005515
UMLS CUI [2,1]
C0948715
UMLS CUI [2,2]
C0005515
infection with hiv, hepatitis b virus, hepatitis c virus, or other chronic infection
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C | Chronic infectious disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0151317
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Similar models

Eligibility Psoriatic Arthritis NCT01877668

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
males or females, aged >= 18 years at time of consent.
boolean
C0001779 (UMLS CUI [1])
Arthritis, Psoriatic
Item
have a diagnosis of psoriatic arthritis (psa) of >= 6 months
boolean
C0003872 (UMLS CUI [1])
Psoriatic Arthritis Classification Criteria
Item
meet the classification criteria of psa (caspar) at time of screening
boolean
C0003872 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Requirement Absent Non-Biologic DMARD
Item
must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (dmard).
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4054347 (UMLS CUI [1,3])
Methotrexate | leflunomide | Sulfasalazine
Item
concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
boolean
C0025677 (UMLS CUI [1])
C0063041 (UMLS CUI [2])
C0036078 (UMLS CUI [3])
Requirement Absent TNF inhibitors biologic
Item
must not have taken a biologic tumour necrosis factor inhibitor
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3653350 (UMLS CUI [1,3])
C0205460 (UMLS CUI [1,4])
Swollen joint count | Tender joint count
Item
must have 3 or more swollen joints and 3 or more tender joints
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Psoriasis Skin lesion
Item
must have active psoriasis skin lesions
boolean
C0033860 (UMLS CUI [1,1])
C0037284 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Psoriasis Without Plaque | Erythrodermic psoriasis | Guttate psoriasis | Pustular psoriasis | Exception Psoriasis of nail
Item
have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
boolean
C0033860 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0920235 (UMLS CUI [1,3])
C0748052 (UMLS CUI [2])
C0343052 (UMLS CUI [3])
C0152081 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0406322 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Congestive heart failure New York Heart Association Classification
Item
new york heart association class iii and iv congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Hypersensitivity Biological agents | Infusion related reaction Biological agents
Item
history of hypersensitivity or infusion reaction to biologic agents
boolean
C0020517 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
C0948715 (UMLS CUI [2,1])
C0005515 (UMLS CUI [2,2])
HIV Infection | Hepatitis B | Hepatitis C | Chronic infectious disease
Item
infection with hiv, hepatitis b virus, hepatitis c virus, or other chronic infection
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0151317 (UMLS CUI [4])
Tillbaka till toppen 

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