Eligibility

  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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