ID

4875

Descrição

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

Link

http://clinicaltrials.gov/show/NCT00333411

Palavras-chave

Versões (2)
  1. 16/02/2012 16/02/2012 -
  2. 13/04/2014 13/04/2014 - Julian Varghese
Transferido a

13 de abril de 2014

DOI

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Licença

Creative Commons BY 4.0
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Eligibility NCT00333411 Psoriasis

Alemão Inglês

Eligibility

1 Formulários  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Descrição

Einschlusskriterien

18 Years to 75 Years
Descrição

Age

Tipo de dados

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
Descrição

plaque-type psoriasis

Tipo de dados

boolean

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

duration >= 6months

Tipo de dados

boolean

Patients must be candidates for systemic psoriasis treatment or phototherapy
Descrição

Patients must be candidates for systemic psoriasis treatment or phototherapy

Tipo de dados

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)
Descrição

informed consent

Tipo de dados

boolean

Ausschlusskriterien
Descrição

Ausschlusskriterien

Patients with primary guttatae, erythrodermic, or pustular psoriasis
Descrição

Patients with primary guttatae, erythrodermic, or pustular psoriasis

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

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).
Descrição

excluded medications

Tipo de dados

boolean

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

liver disease

Tipo de dados

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
Descrição

significant illness

Tipo de dados

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)
Descrição

serum creatinine and WBC

Tipo de dados

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)
Descrição

ALT, AST, Bilirubin

Tipo de dados

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)
Descrição

abnormal lab

Tipo de dados

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
Descrição

HIV, Hepatitis

Tipo de dados

boolean

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

Cancer

Tipo de dados

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
Descrição

cardiac repolarisation

Tipo de dados

boolean

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

drug or alcohol abuse

Tipo de dados

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]
Descrição

pregnant or nursing

Tipo de dados

boolean

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

sun exposure

Tipo de dados

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]
Descrição

other trial

Tipo de dados

boolean

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

allergy

Tipo de dados

boolean

Body mass index > 34 kg/m2 at screening
Descrição

BMI

Tipo de dados

boolean

Medizinische Konzepte
Descrição

Medizinische Konzepte

Alter
Descrição

Age

Tipo de dados

string

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

Psoriasis

Tipo de dados

string

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

Systemic Therapy

Tipo de dados

string

Alias
UMLS CUI 2011AA
C1515119
Phototherapie
Descrição

Light therapy

Tipo de dados

string

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

Informed Consent

Tipo de dados

string

Alias
UMLS CUI 2011AA
C0021430
Psoriasis guttata
Descrição

guttate psoriasis

Tipo de dados

string

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

erythrodermic psoriasis

Tipo de dados

string

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

pustular psoriasis

Tipo de dados

string

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

Pharmaceutical Preparations

Tipo de dados

string

Alias
UMLS CUI 2011AA
C0013227
Lebererkrankung
Descrição

Liver disorder

Tipo de dados

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
Descrição

Creatinine

Tipo de dados

string

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

Leukocyte Count

Tipo de dados

string

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

ALT

Tipo de dados

string

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

AST

Tipo de dados

string

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

Bilirubin

Tipo de dados

string

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

HIV Infection

Tipo de dados

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
Descrição

Hepatitis B,C

Tipo de dados

string

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

Sepsis

Tipo de dados

string

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

Cancer

Tipo de dados

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)
Descrição

ECG

Tipo de dados

string

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

Drug abuse

Tipo de dados

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
Descrição

Alcohol abuse

Tipo de dados

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
Descrição

pregnant

Tipo de dados

string

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
Stillzeit
Descrição

Lactation

Tipo de dados

string

Alias
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Kontrazeption
Descrição

Contraception

Tipo de dados

string

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

Serum pregnancy test

Tipo de dados

string

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

Sun Exposure

Tipo de dados

string

Alias
UMLS CUI 2011AA
C1456711
Registrierung
Descrição

Enrollment

Tipo de dados

string

Alias
UMLS CUI 2011AA
C2348568
Allergie
Descrição

Allergy

Tipo de dados

string

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

BMI

Tipo de dados

string

Alias
UMLS CUI 2011AA
C1305855
SNOMED CT 2011_0131
140075008
MedDRA 14.1
10005894
LOINC Version 232
LP35925-4
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Similar models

Eligibility

1 Formulários
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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)
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