ID

36984

Beschreibung

Study of Efficacy, Safety and Effect on Radiographic Progession of Brodalumab in Subjects With Psoriatic Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02029495

Link

https://clinicaltrials.gov/show/NCT02029495

Stichworte

Versionen (1)
  1. 26.06.19 26.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

26. Juni 2019

DOI

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Eligibility Psoriatic Arthritis NCT02029495

Englisch

Eligibility Psoriatic Arthritis NCT02029495

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject has a diagnosis of psoriatic arthritis (by the classification of psoriatic arthritis criteria (caspar), with ≥ 3 tender and ≥ 3 swollen joints (excluding the distal interphalangeal joints)).
Beschreibung

Arthritis, Psoriatic | Classification Criteria Psoriatic Arthritis | Tender joint count | Swollen joint count | Exception Interphalangeal joints Distal

Datentyp

boolean

Alias
UMLS CUI [1]
C0003872
UMLS CUI [2,1]
C0008902
UMLS CUI [2,2]
C0243161
UMLS CUI [2,3]
C0003872
UMLS CUI [3]
C0451530
UMLS CUI [4]
C0451521
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1563055
UMLS CUI [5,3]
C0205108
subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated crp.
Beschreibung

Psoriasis Skin lesion Quantity | Erosion Quantity Radiography | Elevated C-reactive protein

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033860
UMLS CUI [1,2]
C0037284
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C3887524
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0034571
UMLS CUI [3]
C0742906
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has known history of active tuberculosis.
Beschreibung

Tuberculosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0041296
subject has a planned surgical intervention between baseline and the week 52 evaluation.
Beschreibung

Surgical intervention Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549433
UMLS CUI [1,2]
C1301732
subject has an active infection or history of infections.
Beschreibung

Communicable Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
Beschreibung

Systemic disease Uncontrolled | Kidney Failure | Heart failure | Hypertensive disease | Liver disease | Diabetes Mellitus | Anemia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0020538
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0011849
UMLS CUI [7]
C0002871
subject has any concurrent medical condition or electrocardiogram (ecg) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
Beschreibung

Comorbidity At risk Study Subject | Electrocardiogram abnormal At risk Study Subject

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0681850
UMLS CUI [2,1]
C0522055
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0681850
subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
Beschreibung

Severe depression Patient Health Questionnaire - 9 Item | Feeling suicidal Columbia suicide severity rating scale | Suicidal behavior Columbia suicide severity rating scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0588008
UMLS CUI [1,2]
C4083201
UMLS CUI [2,1]
C0424000
UMLS CUI [2,2]
C3888485
UMLS CUI [3,1]
C1760428
UMLS CUI [3,2]
C3888485
subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
Beschreibung

Mental disorders At risk Patient safety | Substance Use Disorders At risk Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0038586
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
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Ähnliche Modelle

Eligibility Psoriatic Arthritis NCT02029495

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Arthritis, Psoriatic | Classification Criteria Psoriatic Arthritis | Tender joint count | Swollen joint count | Exception Interphalangeal joints Distal
Item
subject has a diagnosis of psoriatic arthritis (by the classification of psoriatic arthritis criteria (caspar), with ≥ 3 tender and ≥ 3 swollen joints (excluding the distal interphalangeal joints)).
boolean
C0003872 (UMLS CUI [1])
C0008902 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
C0003872 (UMLS CUI [2,3])
C0451530 (UMLS CUI [3])
C0451521 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1563055 (UMLS CUI [5,2])
C0205108 (UMLS CUI [5,3])
Psoriasis Skin lesion Quantity | Erosion Quantity Radiography | Elevated C-reactive protein
Item
subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on a centrally read radiograph or an elevated crp.
boolean
C0033860 (UMLS CUI [1,1])
C0037284 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3887524 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0034571 (UMLS CUI [2,3])
C0742906 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Tuberculosis
Item
subject has known history of active tuberculosis.
boolean
C0041296 (UMLS CUI [1])
Surgical intervention Planned
Item
subject has a planned surgical intervention between baseline and the week 52 evaluation.
boolean
C0549433 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Communicable Diseases
Item
subject has an active infection or history of infections.
boolean
C0009450 (UMLS CUI [1])
Systemic disease Uncontrolled | Kidney Failure | Heart failure | Hypertensive disease | Liver disease | Diabetes Mellitus | Anemia
Item
subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
boolean
C0442893 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0035078 (UMLS CUI [2])
C0018801 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
C0002871 (UMLS CUI [7])
Comorbidity At risk Study Subject | Electrocardiogram abnormal At risk Study Subject
Item
subject has any concurrent medical condition or electrocardiogram (ecg) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
boolean
C0009488 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,3])
C0522055 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0681850 (UMLS CUI [2,3])
Severe depression Patient Health Questionnaire - 9 Item | Feeling suicidal Columbia suicide severity rating scale | Suicidal behavior Columbia suicide severity rating scale
Item
subject has severe depression measured by personal health questionnaire depression scale (phq-8) or suicidal ideation/behavior as measured by and columbia suicide severity rating scale (e-cssrs)
boolean
C0588008 (UMLS CUI [1,1])
C4083201 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2,1])
C3888485 (UMLS CUI [2,2])
C1760428 (UMLS CUI [3,1])
C3888485 (UMLS CUI [3,2])
Mental disorders At risk Patient safety | Substance Use Disorders At risk Patient safety
Item
subject has a history or evidence of psychiatric disorder or substance abuse considered by the investigator to pose a risk to subject safety
boolean
C0004936 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0038586 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
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