ID

4874

Description

ODM derived from http://clinicaltrials.gov/show/NCT00233662

Link

http://clinicaltrials.gov/show/NCT00233662

Keywords

Versions (2)
  1. 2/14/12 2/14/12 -
  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 NCT00233662 Chronic Plaque Psoriasis

German English

Eligibility

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

Inclusion Criteria

16 Years and older
Description

Age

Data type

boolean

Written informed consent
Description

consent

Data type

boolean

Diagnosed with chronic plaque psoriasis and require systemic therapy
Description

Chronic Plaque Psoriasis

Data type

boolean

CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
Description

CD4+

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Unstable erthrodermic or pustular psoriasis
Description

Unstable erthrodermic or pustular psoriasis

Data type

boolean

Diagnosis of guttate psoriasis
Description

guttate psoriasis

Data type

boolean

Serious local infection or systemic infection within 3 months prior to first dose of alefacept
Description

Serious infection

Data type

boolean

Positive for HIV antibody
Description

HIV

Data type

boolean

Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded
Description

Cancer

Data type

boolean

Evidence of active tuberculosis, Current treatment for active tuberculosis or tuberculosis prophylaxis
Description

tuberculosis

Data type

boolean

Female patients unwilling to practice effective contraception as defined by the investigator
Description

contraception

Data type

boolean

Female patients who are pregnant or breast-feeding
Description

pregnant or breast-feeding

Data type

boolean

Current enrollment in any other investigational drug study
Description

other study

Data type

boolean

Previous participation in this study or previous alefacept studies
Description

Previous alefacept

Data type

boolean

Medical Concepts
Description

Medical Concepts

Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2011_0131
102518004
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Psoriasis
Description

Psoriasis

Data type

string

Alias
UMLS CUI
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.0
10037153
ICD-10-CM Version 2010
L40
Systemic Therapy
Description

Systemic Therapy

Data type

string

Alias
UMLS CUI
C1515119
Absolute CD4 count procedure
Description

CD4+ lymphocyte count

Data type

string

Alias
UMLS CUI
C1277776
SNOMED CT 2011_0131
313660005
exfoliative psoriasis
Description

erythrodermic psoriasis

Data type

string

Alias
UMLS CUI
C0748052
SNOMED CT 2011_0131
200977004
MedDRA 14.0
10015278
Psoriasis guttata
Description

guttate psoriasis

Data type

string

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

pustular psoriasis

Data type

string

Alias
UMLS CUI
C0152081
SNOMED CT 2011_0131
200973000
MedDRA 14.0
10037159
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.0
10021789
Human immunodeficiency virus infection
Description

HIV Infection

Data type

string

Alias
UMLS CUI
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.0
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.0
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
TBC
Description

Tuberculosis

Data type

string

Alias
UMLS CUI
C0041296
SNOMED CT 2011_0131
56717001
MedDRA 14.0
10044755
LOINC Version 232
MTHU020835
ICD-10-CM Version 2010
A15-A19
ICD-9-CM Version 2011
010-018.99
Contraception
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.0
10010808
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 14.0
10036586
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 14.0
10006247
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C2348568
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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
16 Years and older
boolean
consent
Item
Written informed consent
boolean
Chronic Plaque Psoriasis
Item
Diagnosed with chronic plaque psoriasis and require systemic therapy
boolean
CD4+
Item
CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
boolean
Item Group
Exclusion Criteria
Unstable erthrodermic or pustular psoriasis
Item
Unstable erthrodermic or pustular psoriasis
boolean
guttate psoriasis
Item
Diagnosis of guttate psoriasis
boolean
Serious infection
Item
Serious local infection or systemic infection within 3 months prior to first dose of alefacept
boolean
HIV
Item
Positive for HIV antibody
boolean
Cancer
Item
Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded
boolean
tuberculosis
Item
Evidence of active tuberculosis, Current treatment for active tuberculosis or tuberculosis prophylaxis
boolean
contraception
Item
Female patients unwilling to practice effective contraception as defined by the investigator
boolean
pregnant or breast-feeding
Item
Female patients who are pregnant or breast-feeding
boolean
other study
Item
Current enrollment in any other investigational drug study
boolean
Previous alefacept
Item
Previous participation in this study or previous alefacept studies
boolean
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2011_0131)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Psoriasis
Item
Psoriasis
string
C0033860 (UMLS CUI)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.0)
L40 (ICD-10-CM Version 2010)
Systemic Therapy
Item
Systemic Therapy
string
C1515119 (UMLS CUI)
CD4+ lymphocyte count
Item
Absolute CD4 count procedure
string
C1277776 (UMLS CUI)
313660005 (SNOMED CT 2011_0131)
erythrodermic psoriasis
Item
exfoliative psoriasis
string
C0748052 (UMLS CUI)
200977004 (SNOMED CT 2011_0131)
10015278 (MedDRA 14.0)
guttate psoriasis
Item
Psoriasis guttata
string
C0343052 (UMLS CUI)
37042000 (SNOMED CT 2011_0131)
L40.4 (ICD-10-CM Version 2010)
pustular psoriasis
Item
pustular psoriasis
string
C0152081 (UMLS CUI)
200973000 (SNOMED CT 2011_0131)
10037159 (MedDRA 14.0)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.0)
HIV Infection
Item
Human immunodeficiency virus infection
string
C0019693 (UMLS CUI)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.0)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.0)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Tuberculosis
Item
TBC
string
C0041296 (UMLS CUI)
56717001 (SNOMED CT 2011_0131)
10044755 (MedDRA 14.0)
MTHU020835 (LOINC Version 232)
A15-A19 (ICD-10-CM Version 2010)
010-018.99 (ICD-9-CM Version 2011)
Contraception
Item
Contraception
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.0)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 14.0)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 14.0)
Enrollment
Item
Enrollment
string
C2348568 (UMLS CUI)
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