ID

36953

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01877668

Trefwoorden

Versies (1)
  1. 23-06-19 23-06-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 juni 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Psoriatic Arthritis NCT01877668

Engels

Eligibility Psoriatic Arthritis NCT01877668

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Arthritis, Psoriatic

Datatype

boolean

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

Psoriatic Arthritis Classification Criteria

Datatype

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).
Beschrijving

Requirement Absent Non-Biologic DMARD

Datatype

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
Beschrijving

Methotrexate | leflunomide | Sulfasalazine

Datatype

boolean

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

Requirement Absent TNF inhibitors biologic

Datatype

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
Beschrijving

Swollen joint count | Tender joint count

Datatype

boolean

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

Psoriasis Skin lesion

Datatype

boolean

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

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
Beschrijving

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

Datatype

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
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatype

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
Beschrijving

Congestive heart failure New York Heart Association Classification

Datatype

boolean

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

Hypersensitivity Biological agents | Infusion related reaction Biological agents

Datatype

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
Beschrijving

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

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0151317
Terug naar het begin van de pagina

Similar models

Eligibility Psoriatic Arthritis NCT01877668

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial