ID

31680

Beschrijving

TIght COntrol of Psoriatic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01106079

Link

https://clinicaltrials.gov/show/NCT01106079

Trefwoorden

Versies (1)
  1. 20-09-18 20-09-18 -
Houder van rechten

See clinicaltrials.gov

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20 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Psoriatic Arthritis NCT01106079

Engels

Eligibility Psoriatic Arthritis NCT01106079

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with a diagnosis of psoriatic arthritis by a consultant rheumatologist with less than 24 months disease duration.
Beschrijving

Psoriatic Arthritis Disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003872
UMLS CUI [1,2]
C0872146
active disease defined by at least one tender or swollen joint or active enthesitis.
Beschrijving

Disease Tender joint count | Disease Swollen joint count | Enthesitis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0451530
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0451521
UMLS CUI [3]
C1282952
age ≥18 years at the time of signing the informed consent form and either male or female patients.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patient understands the objectives of the study and is able and willing to sign the informed consent form.
Beschrijving

Comprehension Study Protocol | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
men and women of child bearing potential (wcbp) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
Beschrijving

Gender Contraceptive methods Quantity | Childbearing Potential Contraceptive methods Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1265611
adequate full blood count within 28 days before randomisation:
Beschrijving

Complete Blood Count

Datatype

boolean

Alias
UMLS CUI [1]
C0009555
haemoglobin count > 8.5 g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
white blood count (wbc) > 3.5 x 10*9/l
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) > 1.5 x 10*9/l
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100 x 10*9/l
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
adequate hepatobiliary function within 28 days before randomisation:
Beschrijving

Hepatobiliary System function

Datatype

boolean

Alias
UMLS CUI [1,1]
C1711359
UMLS CUI [1,2]
C0031843
*alt and/or ast levels must be within 3 times the upper limit of normal range (uln) for the laboratory conducting the test.
Beschrijving

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
the patient must be able to adhere to the study visit schedule and other protocol requirements.
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment for articular disease with disease modifying drugs (dmards) including, but not limited to, methotrexate, sulfasalazine, leflunomide,
Beschrijving

Prior Therapy Arthropathy | Antirheumatic Drugs, Disease-Modifying | Methotrexate | Sulfasalazine | leflunomide

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0022408
UMLS CUI [2]
C0242708
UMLS CUI [3]
C0025677
UMLS CUI [4]
C0036078
UMLS CUI [5]
C0063041
women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
Beschrijving

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Psoriatic Arthritis NCT01106079

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Psoriatic Arthritis Disease length
Item
patients with a diagnosis of psoriatic arthritis by a consultant rheumatologist with less than 24 months disease duration.
boolean
C0003872 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Disease Tender joint count | Disease Swollen joint count | Enthesitis
Item
active disease defined by at least one tender or swollen joint or active enthesitis.
boolean
C0012634 (UMLS CUI [1,1])
C0451530 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0451521 (UMLS CUI [2,2])
C1282952 (UMLS CUI [3])
Age
Item
age ≥18 years at the time of signing the informed consent form and either male or female patients.
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent
Item
patient understands the objectives of the study and is able and willing to sign the informed consent form.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Gender Contraceptive methods Quantity | Childbearing Potential Contraceptive methods Quantity
Item
men and women of child bearing potential (wcbp) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Complete Blood Count
Item
adequate full blood count within 28 days before randomisation:
boolean
C0009555 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin count > 8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood count (wbc) > 3.5 x 10*9/l
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) > 1.5 x 10*9/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100 x 10*9/l
boolean
C0032181 (UMLS CUI [1])
Hepatobiliary System function
Item
adequate hepatobiliary function within 28 days before randomisation:
boolean
C1711359 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
*alt and/or ast levels must be within 3 times the upper limit of normal range (uln) for the laboratory conducting the test.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Protocol Compliance
Item
the patient must be able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Arthropathy | Antirheumatic Drugs, Disease-Modifying | Methotrexate | Sulfasalazine | leflunomide
Item
previous treatment for articular disease with disease modifying drugs (dmards) including, but not limited to, methotrexate, sulfasalazine, leflunomide,
boolean
C1514463 (UMLS CUI [1,1])
C0022408 (UMLS CUI [1,2])
C0242708 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0036078 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Investigational New Drugs
Item
use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.
boolean
C0013230 (UMLS CUI [1])
Terug naar het begin van de pagina 

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