ID

18300

Beschrijving

Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00493077

Link

https://clinicaltrials.gov/show/NCT00493077

Trefwoorden

Versies (1)
  1. 28-10-16 28-10-16 -
Geüploaded op

28 oktober 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00493077

Engels

Eligibility Multiple Sclerosis NCT00493077

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing-remitting ms according to poser criteria(cdms or lsdms)30 or ms according to mcdonald criteria
Beschrijving

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis

Datatype

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0026769
disability equivalent to an edss of 6.0 or less at screening
Beschrijving

EDSS

Datatype

boolean

Alias
UMLS CUI [1]
C0451246
neutralizing antibody titre > 20 and <500 in two consecutive nab tests. one must be from before screening
Beschrijving

Neutralizing Antibodies Titer | Neutralizing Antibodies Tests Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C0475208
UMLS CUI [2,1]
C0475463
UMLS CUI [2,2]
C0392366
UMLS CUI [2,3]
C1265611
previous treatment with either subcutaneous administered interferon-b-1b (betaferon®) or interferon-b-1a (rebif tm) prior to enrolment
Beschrijving

interferon beta-1b Subcutaneous | Betaferon | Interferon beta-1a Subcutaneous | Rebif

Datatype

boolean

Alias
UMLS CUI [1,1]
C0244713
UMLS CUI [1,2]
C1522438
UMLS CUI [2]
C0592527
UMLS CUI [3,1]
C0254119
UMLS CUI [3,2]
C1522438
UMLS CUI [4]
C0752980
a priori has been decided to be treated with avonex
Beschrijving

Avonex

Datatype

boolean

Alias
UMLS CUI [1]
C0594372
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
is nab positive on avonex
Beschrijving

Neutralizing Antibodies Positive Avonex

Datatype

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0594372
history of major depression
Beschrijving

Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv), or significant hypertension (bp > 180/110 mmhg)
Beschrijving

Heart failure | Cardiomyopathies | Cardiac Arrhythmia Significant | Myocardial Ischemia Unstable | Myocardial Ischemia Advanced | New York Heart Association Classification | Hypertensive disease Significant | Blood Pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0750502
UMLS CUI [4,1]
C0151744
UMLS CUI [4,2]
C0443343
UMLS CUI [5,1]
C0151744
UMLS CUI [5,2]
C0205179
UMLS CUI [6]
C1275491
UMLS CUI [7,1]
C0020538
UMLS CUI [7,2]
C0750502
UMLS CUI [8]
C0005823
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
Beschrijving

Renal Insufficiency | Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
Beschrijving

Systemic disease Affecting patient safety | Systemic disease Compliance behavior Limited | Systemic disease Affecting Disability Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0231170
UMLS CUI [3,4]
C1261322
women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. to avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
Beschrijving

Pregnancy | Breast Feeding | Postmenopausal state | Female Sterilization | Sexual Abstinence | Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0036899
UMLS CUI [6]
C0700589
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Similar models

Eligibility Multiple Sclerosis NCT00493077

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis
Item
relapsing-remitting ms according to poser criteria(cdms or lsdms)30 or ms according to mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
EDSS
Item
disability equivalent to an edss of 6.0 or less at screening
boolean
C0451246 (UMLS CUI [1])
Neutralizing Antibodies Titer | Neutralizing Antibodies Tests Quantity
Item
neutralizing antibody titre > 20 and <500 in two consecutive nab tests. one must be from before screening
boolean
C0475463 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C0475463 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
interferon beta-1b Subcutaneous | Betaferon | Interferon beta-1a Subcutaneous | Rebif
Item
previous treatment with either subcutaneous administered interferon-b-1b (betaferon®) or interferon-b-1a (rebif tm) prior to enrolment
boolean
C0244713 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0592527 (UMLS CUI [2])
C0254119 (UMLS CUI [3,1])
C1522438 (UMLS CUI [3,2])
C0752980 (UMLS CUI [4])
Avonex
Item
a priori has been decided to be treated with avonex
boolean
C0594372 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neutralizing Antibodies Positive Avonex
Item
is nab positive on avonex
boolean
C0475463 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0594372 (UMLS CUI [1,3])
Major Depressive Disorder
Item
history of major depression
boolean
C1269683 (UMLS CUI [1])
Heart failure | Cardiomyopathies | Cardiac Arrhythmia Significant | Myocardial Ischemia Unstable | Myocardial Ischemia Advanced | New York Heart Association Classification | Hypertensive disease Significant | Blood Pressure
Item
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv), or significant hypertension (bp > 180/110 mmhg)
boolean
C0018801 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0750502 (UMLS CUI [3,2])
C0151744 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0151744 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1275491 (UMLS CUI [6])
C0020538 (UMLS CUI [7,1])
C0750502 (UMLS CUI [7,2])
C0005823 (UMLS CUI [8])
Renal Insufficiency | Creatinine measurement, serum
Item
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Systemic disease Affecting patient safety | Systemic disease Compliance behavior Limited | Systemic disease Affecting Disability Evaluation
Item
any systemic disease that can influence the patient's safety and compliance, or the evaluation of the disability
boolean
C0442893 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0442893 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0231170 (UMLS CUI [3,3])
C1261322 (UMLS CUI [3,4])
Pregnancy | Breast Feeding | Postmenopausal state | Female Sterilization | Sexual Abstinence | Contraceptive methods
Item
women who are pregnant, breast-feeding or have the possibility for pregnancy during the trial. to avoid pregnancy, women have to be postmenopausal, surgical sterile, sexually inactive or practice reliable contraceptives
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
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