ID

31680

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01106079

Stichworte

Versionen (1)
  1. 20.09.18 20.09.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Psoriatic Arthritis NCT01106079

Englisch

Eligibility Psoriatic Arthritis NCT01106079

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Psoriatic Arthritis Disease length

Datentyp

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.
Beschreibung

Disease Tender joint count | Disease Swollen joint count | Enthesitis

Datentyp

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.
Beschreibung

Age

Datentyp

boolean

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

Comprehension Study Protocol | Informed Consent

Datentyp

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.
Beschreibung

Gender Contraceptive methods Quantity | Childbearing Potential Contraceptive methods Quantity

Datentyp

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:
Beschreibung

Complete Blood Count

Datentyp

boolean

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

Hemoglobin measurement

Datentyp

boolean

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

White Blood Cell Count procedure

Datentyp

boolean

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

Absolute neutrophil count

Datentyp

boolean

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

Platelet Count measurement

Datentyp

boolean

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

Hepatobiliary System function

Datentyp

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.
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased

Datentyp

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.
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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.
Beschreibung

Pregnancy | Breast Feeding | Pregnancy, Planned

Datentyp

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.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Psoriatic Arthritis NCT01106079

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video