ID

4875

Description

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

Link

http://clinicaltrials.gov/show/NCT00333411

Keywords

Versions (2)
  1. 2/16/12 2/16/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
Uploaded on

April 13, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00333411 Psoriasis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

18 Years to 75 Years
Description

Age

Data type

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
Description

plaque-type psoriasis

Data type

boolean

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

duration >= 6months

Data type

boolean

Patients must be candidates for systemic psoriasis treatment or phototherapy
Description

Patients must be candidates for systemic psoriasis treatment or phototherapy

Data type

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)
Description

informed consent

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Patients with primary guttatae, erythrodermic, or pustular psoriasis
Description

Patients with primary guttatae, erythrodermic, or pustular psoriasis

Data type

boolean

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

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

Data type

boolean

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

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

Data type

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).
Description

excluded medications

Data type

boolean

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

liver disease

Data type

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
Description

significant illness

Data type

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)
Description

serum creatinine and WBC

Data type

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)
Description

ALT, AST, Bilirubin

Data type

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)
Description

abnormal lab

Data type

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
Description

HIV, Hepatitis

Data type

boolean

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

Cancer

Data type

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
Description

cardiac repolarisation

Data type

boolean

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

drug or alcohol abuse

Data type

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]
Description

pregnant or nursing

Data type

boolean

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

sun exposure

Data type

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]
Description

other trial

Data type

boolean

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

allergy

Data type

boolean

Body mass index > 34 kg/m2 at screening
Description

BMI

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

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

Psoriasis

Data type

string

Alias
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
Systemic Therapy
Description

Systemic Therapy

Data type

string

Alias
UMLS CUI 2011AA
C1515119
Phototherapy
Description

Light therapy

Data type

string

Alias
UMLS CUI 2011AA
C0031765
SNOMED CT 2011_0131
31394004
MedDRA 14.1
10063925
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI 2011AA
C0021430
Psoriasis guttata
Description

guttate psoriasis

Data type

string

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

erythrodermic psoriasis

Data type

string

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

pustular psoriasis

Data type

string

Alias
UMLS CUI 2011AA
C0152081
SNOMED CT 2011_0131
200973000
MedDRA 14.1
10037159
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI 2011AA
C0013227
Liver diseases
Description

Liver disorder

Data type

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
Creatinine
Description

Creatinine

Data type

string

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
15373003
MedDRA 14.1
10011358
LOINC Version 232
38483-4
White Blood Cell Count procedure (WBC)
Description

Leukocyte Count

Data type

string

Alias
UMLS CUI 2011AA
C0023508
SNOMED CT 2011_0131
767002
MedDRA 14.1
10047939
GPT (Serum)
Description

ALT

Data type

string

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
MedDRA 14.1
10001844
GOT (Serum)
Description

AST

Data type

string

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

Bilirubin

Data type

string

Alias
UMLS CUI 2011AA
C1278039
SNOMED CT 2011_0131
79706000
LOINC Version 232
1975-2
Human immunodeficiency virus infection
Description

HIV Infection

Data type

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
Description

Hepatitis B,C

Data type

string

Alias
UMLS CUI 1
C0019196
UMLS CUI 2
C0019163
SNOMED CT 2011_0131
29001004
MedDRA 14.1
10019717
Systemic infection
Description

Sepsis

Data type

string

Alias
UMLS CUI 2011AA
C0243026
SNOMED CT 2011_0131
91302008
MedDRA 14.1
10040047
ICD-9-CM Version 2011
995.91
Malignant Neoplasms
Description

Cancer

Data type

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
Electrocardiogram
Description

ECG

Data type

string

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

Drug abuse

Data type

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
Alcohol abuse
Description

Alcohol abuse

Data type

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
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI 2011AA
C0549206
MedDRA 14.1
10036586
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
Contraception
Description

Contraception

Data type

string

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

Serum pregnancy test

Data type

string

Alias
UMLS CUI 2011AA
C0430060
SNOMED CT 2011_0131
166434005
Sun Exposure
Description

Sun Exposure

Data type

string

Alias
UMLS CUI 2011AA
C1456711
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI 2011AA
C2348568
Hypersensitivity
Description

Allergy

Data type

string

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
257550005
ICD-10-CM Version 2010
T78.40
Body mass index
Description

BMI

Data type

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 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
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
Exclusion Criteria
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
Medical Concepts
Age
Item
Age
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
Systemic Therapy
string
C1515119 (UMLS CUI 2011AA)
Light therapy
Item
Phototherapy
string
C0031765 (UMLS CUI 2011AA)
31394004 (SNOMED CT 2011_0131)
10063925 (MedDRA 14.1)
Informed Consent
Item
Informed Consent
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
Medication
string
C0013227 (UMLS CUI 2011AA)
Liver disorder
Item
Liver diseases
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
Creatinine
string
C0201976 (UMLS CUI 2011AA)
15373003 (SNOMED CT 2011_0131)
10011358 (MedDRA 14.1)
38483-4 (LOINC Version 232)
Leukocyte Count
Item
White Blood Cell Count procedure (WBC)
string
C0023508 (UMLS CUI 2011AA)
767002 (SNOMED CT 2011_0131)
10047939 (MedDRA 14.1)
ALT
Item
GPT (Serum)
string
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
10001844 (MedDRA 14.1)
AST
Item
GOT (Serum)
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
Human immunodeficiency virus infection
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
Systemic infection
string
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
Cancer
Item
Malignant Neoplasms
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
Electrocardiogram
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
Alcohol abuse
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
pregnant
string
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Contraception
Item
Contraception
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
Sun Exposure
string
C1456711 (UMLS CUI 2011AA)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI 2011AA)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
BMI
Item
Body mass index
string
C1305855 (UMLS CUI 2011AA)
140075008 (SNOMED CT 2011_0131)
10005894 (MedDRA 14.1)
LP35925-4 (LOINC Version 232)
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