ID

4875

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00333411

Länk

http://clinicaltrials.gov/show/NCT00333411

Nyckelord

Versioner (2)
  1. 2012-02-16 2012-02-16 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility NCT00333411 Psoriasis

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

18 Years to 75 Years
Beskrivning

Age

Datatyp

boolean

Patients with stable moderate to severe plaque-type psoriasis involving >10% body surface area, with minimum disease severity PASI >10 and with static PGA of at least moderate (score of at least 3) at screening visit
Beskrivning

plaque-type psoriasis

Datatyp

boolean

Psoriasis disease duration of at least 6 months prior to screening
Beskrivning

duration >= 6months

Datatyp

boolean

Patients must be candidates for systemic psoriasis treatment or phototherapy
Beskrivning

Patients must be candidates for systemic psoriasis treatment or phototherapy

Datatyp

boolean

Patient must give informed consent and sign an approved consent form prior to any study procedures, including wash out of prohibited medications (Patients participating in the PK sub-study will sign an additional consent form. Refusal to participate in the sub-study will not exclude from participation in the main trial)
Beskrivning

informed consent

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Patients with primary guttatae, erythrodermic, or pustular psoriasis
Beskrivning

Patients with primary guttatae, erythrodermic, or pustular psoriasis

Datatyp

boolean

Patients who have previously discontinued efalizumab treatment due to lack of efficacy
Beskrivning

Patients who have previously discontinued efalizumab treatment due to lack of efficacy

Datatyp

boolean

Patients using treatments that could interfere with the primary endpoint of the study (cf. protocol section 4.2.2.1)
Beskrivning

Patients using treatments that could interfere with the primary endpoint of the study

Datatyp

boolean

Patients on treatment with warfarin, paracetamol (acetaminophen), some NSAIDs, some antidepressants, medications known to induce or inhibit CYP3A4, or any other concomitant medication where potential drug-drug interactions with BIRT 2584 XX could either result in decreased efficacy or an unacceptable benefit-risk assessment, and where replacement of that concomitant medication with a safe equivalent drug is not possible (cf. protocol section 4.2.2.2 and the Investigator Site File).
Beskrivning

excluded medications

Datatyp

boolean

Patients with active liver disease or history of any significant liver disease
Beskrivning

liver disease

Datatyp

boolean

Any clinically significant illness or unstable disease which according to investigator judgement may either put the patient at risk because of participation in the study or may influence the results of the study or the patients ability to participate
Beskrivning

significant illness

Datatyp

boolean

Patient with serum creatinine and/or white blood cell count >1.5 x ULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
Beskrivning

serum creatinine and WBC

Datatyp

boolean

Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
Beskrivning

ALT, AST, Bilirubin

Datatyp

boolean

Abnormal values of other laboratory parameters at screening that would define a clinically significant disease as described above (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
Beskrivning

abnormal lab

Datatyp

boolean

Positive testing at screening, or history of HIV or hepatitis B or hepatitis C, or any serious infection (requiring hospitalisation or parenteral antibiotic therapy) in the past 3 months prior to screening
Beskrivning

HIV, Hepatitis

Datatyp

boolean

History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
Beskrivning

Cancer

Datatyp

boolean

Patients with the following findings at the screening visit that could interfere with cardiac repolarisation: marked baseline prolongation of QT/QTc interval as measured on ECG (e.g. QTc interval >450ms), history of additional risk factors for Torsade de pointe (e.g. heart failure, - hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT/QTc interval
Beskrivning

cardiac repolarisation

Datatyp

boolean

History of drug or alcohol abuse within the past two years
Beskrivning

drug or alcohol abuse

Datatyp

boolean

Pre-menopausal (last menstruation 1 year prior to screening) sexually active woman who: is pregnant or nursing, is of child bearing potential and not practicing acceptable methods of birth control, or does not plan to continue practising an acceptable method throughout the study (acceptable methods of birth control include surgical sterilisation, intrauterine devices, double barrier, male partner sterilisation, but not hormonal contraceptives) [A negative serum pregnancy test at screening (Visit 1) and a negative urine test prior to randomisation (Visit 2) are required]
Beskrivning

pregnant or nursing

Datatyp

boolean

Patient not willing to avoid excess sun exposure during the trial duration
Beskrivning

sun exposure

Datatyp

boolean

Patients who have taken an investigational drug, within the last 4 weeks or 5 half lives (which ever is greater) prior to randomisation [Patients who have been treated with any investigational antibody or fusion protein within the past 12 weeks before randomisation are excluded]
Beskrivning

other trial

Datatyp

boolean

Known allergy to BIRT 2584 XX or to the excipients used for tablet formulation
Beskrivning

allergy

Datatyp

boolean

Body mass index > 34 kg/m2 at screening
Beskrivning

BMI

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Alter
Beskrivning

Age

Datatyp

string

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
102518004
Psoriasis
Beskrivning

Psoriasis

Datatyp

string

Alias
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
Systemische Therapie
Beskrivning

Systemic Therapy

Datatyp

string

Alias
UMLS CUI 2011AA
C1515119
Phototherapie
Beskrivning

Light therapy

Datatyp

string

Alias
UMLS CUI 2011AA
C0031765
SNOMED CT 2011_0131
31394004
MedDRA 14.1
10063925
Einverständniserklärung
Beskrivning

Informed Consent

Datatyp

string

Alias
UMLS CUI 2011AA
C0021430
Psoriasis guttata
Beskrivning

guttate psoriasis

Datatyp

string

Alias
UMLS CUI 2011AA
C0343052
SNOMED CT 2011_0131
37042000
ICD-10-CM Version 2010
L40.4
exfoliative psoriasis
Beskrivning

erythrodermic psoriasis

Datatyp

string

Alias
UMLS CUI 2011AA
C0748052
SNOMED CT 2011_0131
200977004
MedDRA 14.1
10015278
pustular psoriasis
Beskrivning

pustular psoriasis

Datatyp

string

Alias
UMLS CUI 2011AA
C0152081
SNOMED CT 2011_0131
200973000
MedDRA 14.1
10037159
Medikation
Beskrivning

Pharmaceutical Preparations

Datatyp

string

Alias
UMLS CUI 2011AA
C0013227
Lebererkrankung
Beskrivning

Liver disorder

Datatyp

string

Alias
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Kreatinin
Beskrivning

Creatinine

Datatyp

string

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
Leukozyten-Anzahl
Beskrivning

Leukocyte Count

Datatyp

string

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
ALT
Beskrivning

ALT

Datatyp

string

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
MedDRA 14.1
10001844
AST
Beskrivning

AST

Datatyp

string

Alias
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
MedDRA 14.1
10003543
Bilirubin
Beskrivning

Bilirubin

Datatyp

string

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
HIV Infektion
Beskrivning

HIV Infection

Datatyp

string

Alias
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Hepatitis
Beskrivning

Hepatitis B,C

Datatyp

string

Alias
UMLS CUI 1
C0019196
UMLS CUI 2
C0019163
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
Sepsis
Beskrivning

Sepsis

Datatyp

string

Alias
UMLS CUI 2011AA
C0243026
SNOMED CT 2011_0131
91302008
MedDRA 14.1
10040047
ICD-9-CM Version 2011
995.91
Krebs
Beskrivning

Cancer

Datatyp

string

Alias
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Elektrokardiogramm (EKG)
Beskrivning

ECG

Datatyp

string

Alias
UMLS CUI 2011AA
C1623258
SNOMED CT 2011_0131
46825001
MedDRA 14.1
10014084
Drug abuse
Beskrivning

Drug abuse

Datatyp

string

Alias
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Alkohol-Abusus
Beskrivning

Alcohol abuse

Datatyp

string

Alias
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
schwanger
Beskrivning

pregnant

Datatyp

string

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
Stillzeit
Beskrivning

Lactation

Datatyp

string

Alias
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Kontrazeption
Beskrivning

Contraception

Datatyp

string

Alias
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Serum pregnancy test (B-HCG)
Beskrivning

Serum pregnancy test

Datatyp

string

Alias
UMLS CUI 2011AA
C0430060
SNOMED CT 2011_0131
166434005
Sonnenexposition
Beskrivning

Sun Exposure

Datatyp

string

Alias
UMLS CUI 2011AA
C1456711
Registrierung
Beskrivning

Enrollment

Datatyp

string

Alias
UMLS CUI 2011AA
C2348568
Allergie
Beskrivning

Allergy

Datatyp

string

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
BMI
Beskrivning

BMI

Datatyp

string

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
Age
Item
18 Years to 75 Years
boolean
plaque-type psoriasis
Item
Patients with stable moderate to severe plaque-type psoriasis involving >10% body surface area, with minimum disease severity PASI >10 and with static PGA of at least moderate (score of at least 3) at screening visit
boolean
duration >= 6months
Item
Psoriasis disease duration of at least 6 months prior to screening
boolean
Patients must be candidates for systemic psoriasis treatment or phototherapy
Item
Patients must be candidates for systemic psoriasis treatment or phototherapy
boolean
informed consent
Item
Patient must give informed consent and sign an approved consent form prior to any study procedures, including wash out of prohibited medications (Patients participating in the PK sub-study will sign an additional consent form. Refusal to participate in the sub-study will not exclude from participation in the main trial)
boolean
Item Group
Ausschlusskriterien
Patients with primary guttatae, erythrodermic, or pustular psoriasis
Item
Patients with primary guttatae, erythrodermic, or pustular psoriasis
boolean
Patients who have previously discontinued efalizumab treatment due to lack of efficacy
Item
Patients who have previously discontinued efalizumab treatment due to lack of efficacy
boolean
Patients using treatments that could interfere with the primary endpoint of the study
Item
Patients using treatments that could interfere with the primary endpoint of the study (cf. protocol section 4.2.2.1)
boolean
excluded medications
Item
Patients on treatment with warfarin, paracetamol (acetaminophen), some NSAIDs, some antidepressants, medications known to induce or inhibit CYP3A4, or any other concomitant medication where potential drug-drug interactions with BIRT 2584 XX could either result in decreased efficacy or an unacceptable benefit-risk assessment, and where replacement of that concomitant medication with a safe equivalent drug is not possible (cf. protocol section 4.2.2.2 and the Investigator Site File).
boolean
liver disease
Item
Patients with active liver disease or history of any significant liver disease
boolean
significant illness
Item
Any clinically significant illness or unstable disease which according to investigator judgement may either put the patient at risk because of participation in the study or may influence the results of the study or the patients ability to participate
boolean
serum creatinine and WBC
Item
Patient with serum creatinine and/or white blood cell count >1.5 x ULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
boolean
ALT, AST, Bilirubin
Item
Patients with ALT, AST and/or total bilirubin > 1.5xULN at screening (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
boolean
abnormal lab
Item
Abnormal values of other laboratory parameters at screening that would define a clinically significant disease as described above (Repeat laboratory is allowed once between screening and randomisation prior to excluding the patient)
boolean
HIV, Hepatitis
Item
Positive testing at screening, or history of HIV or hepatitis B or hepatitis C, or any serious infection (requiring hospitalisation or parenteral antibiotic therapy) in the past 3 months prior to screening
boolean
Cancer
Item
History of malignancy in the past 5 years or suspicion of active malignant disease except treated cutaneous squamous cell or basal cell carcinoma
boolean
cardiac repolarisation
Item
Patients with the following findings at the screening visit that could interfere with cardiac repolarisation: marked baseline prolongation of QT/QTc interval as measured on ECG (e.g. QTc interval >450ms), history of additional risk factors for Torsade de pointe (e.g. heart failure, - hypokalemia, family history of long QT syndrome), use of concomitant medications that prolong the QT/QTc interval
boolean
drug or alcohol abuse
Item
History of drug or alcohol abuse within the past two years
boolean
pregnant or nursing
Item
Pre-menopausal (last menstruation 1 year prior to screening) sexually active woman who: is pregnant or nursing, is of child bearing potential and not practicing acceptable methods of birth control, or does not plan to continue practising an acceptable method throughout the study (acceptable methods of birth control include surgical sterilisation, intrauterine devices, double barrier, male partner sterilisation, but not hormonal contraceptives) [A negative serum pregnancy test at screening (Visit 1) and a negative urine test prior to randomisation (Visit 2) are required]
boolean
sun exposure
Item
Patient not willing to avoid excess sun exposure during the trial duration
boolean
other trial
Item
Patients who have taken an investigational drug, within the last 4 weeks or 5 half lives (which ever is greater) prior to randomisation [Patients who have been treated with any investigational antibody or fusion protein within the past 12 weeks before randomisation are excluded]
boolean
allergy
Item
Known allergy to BIRT 2584 XX or to the excipients used for tablet formulation
boolean
BMI
Item
Body mass index > 34 kg/m2 at screening
boolean
Item Group
Medizinische Konzepte
Age
Item
Alter
string
C0001779 (UMLS CUI 2011AA)
102518004 (SNOMED CT 2011_0131)
Psoriasis
Item
Psoriasis
string
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
Systemic Therapy
Item
Systemische Therapie
string
C1515119 (UMLS CUI 2011AA)
Light therapy
Item
Phototherapie
string
C0031765 (UMLS CUI 2011AA)
31394004 (SNOMED CT 2011_0131)
10063925 (MedDRA 14.1)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI 2011AA)
guttate psoriasis
Item
Psoriasis guttata
string
C0343052 (UMLS CUI 2011AA)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
erythrodermic psoriasis
Item
exfoliative psoriasis
string
C0748052 (UMLS CUI 2011AA)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.1)
pustular psoriasis
Item
pustular psoriasis
string
C0152081 (UMLS CUI 2011AA)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.1)
Pharmaceutical Preparations
Item
Medikation
string
C0013227 (UMLS CUI 2011AA)
Liver disorder
Item
Lebererkrankung
string
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Creatinine
Item
Kreatinin
string
C0201976 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
Leukocyte Count
Item
Leukozyten-Anzahl
string
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
ALT
Item
ALT
string
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
10001844 (MedDRA 14.1)
AST
Item
AST
string
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
10003543 (MedDRA 14.1)
Bilirubin
Item
Bilirubin
string
C1278039 (UMLS CUI 2011AA)
79706000 (SNOMED CT 2011_0131)
1975-2 (LOINC Version 232)
HIV Infection
Item
HIV Infektion
string
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Hepatitis B,C
Item
Hepatitis
string
C0019196 (UMLS CUI 1)
C0019163 (UMLS CUI 2)
29001004 (SNOMED CT 2011_0131)
10019717 (MedDRA 14.1)
Sepsis
Item
Sepsis
string
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
Cancer
Item
Krebs
string
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
ECG
Item
Elektrokardiogramm (EKG)
string
C1623258 (UMLS CUI 2011AA)
46825001 (SNOMED CT 2011_0131)
10014084 (MedDRA 14.1)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Alcohol abuse
Item
Alkohol-Abusus
string
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Contraception
Item
Kontrazeption
string
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Serum pregnancy test
Item
Serum pregnancy test (B-HCG)
string
C0430060 (UMLS CUI 2011AA)
166434005 (SNOMED CT 2011_0131)
Sun Exposure
Item
Sonnenexposition
string
C1456711 (UMLS CUI 2011AA)
Enrollment
Item
Registrierung
string
C2348568 (UMLS CUI 2011AA)
Allergy
Item
Allergie
string
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
BMI
Item
BMI
string
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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