ID

19138

Descrição

Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies; ODM derived from: https://clinicaltrials.gov/show/NCT00492466

Link

https://clinicaltrials.gov/show/NCT00492466

Palavras-chave

Versões (1)
  1. 07/12/2016 07/12/2016 -
Transferido a

7 de dezembro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT00492466

Inglês

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00492466

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing remitting multiple sclerosis according to poser criteria (cdms or ldms) or multiple sclerosis according to mcdonald criteria
Descrição

Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2]
C0026769
disability equivalent to edss of 6.0 or less
Descrição

EDSS

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451246
clinical activity defined as at least one relapse rate within the last 12 months
Descrição

Relapse Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C1265611
nab titre >20 (measured at least 48 hours after last interferon-beta injection
Descrição

Neutralizing Antibody titer measurement | Interferon-beta Injection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0475463
UMLS CUI [1,2]
C0474643
UMLS CUI [2,1]
C0015980
UMLS CUI [2,2]
C1828121
has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (rebif) for at least 24 hours before enrollment
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0244713
UMLS CUI [1,2]
C1522438
UMLS CUI [2,1]
C0254119
UMLS CUI [2,2]
C1522438
UMLS CUI [3,1]
C0752980
UMLS CUI [3,2]
C1522438
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any condition that might give rise to similar symptoms as ms
Descrição

Condition Causing Symptoms Multiple Sclerosis Similar

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0026769
UMLS CUI [1,5]
C2348205
immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
Descrição

Immunomodulation | Interferon beta-1a | interferon beta-1b | Therapeutic immunosuppression

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1963758
UMLS CUI [2]
C0254119
UMLS CUI [3]
C0244713
UMLS CUI [4]
C0021079
treatment with glucocorticoids or acth less than one month prior to inclusion into the trial
Descrição

Glucocorticoids | Corticotropin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2]
C0001655
history of major depression
Descrição

Major Depressive Disorder

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1269683
alcohol or drug dependency
Descrição

Substance Dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038580
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv)
Descrição

Heart failure | Cardiomyopathy | Cardiac Arrhythmia Significant | Myocardial Ischemia Unstable New York Heart Association Classification | Myocardial Ischemia Advanced New York Heart Association Classification

Tipo de dados

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 [4,3]
C1275491
UMLS CUI [5,1]
C0151744
UMLS CUI [5,2]
C0205179
UMLS CUI [5,3]
C1275491
hypertension (bp > 180/110 mmhg)
Descrição

Hypertensive disease | Blood Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005823
renal insufficiency defined as serum creatinine > 1.5 times the upper normal reference limit
Descrição

Renal Insufficiency | Creatinine measurement, serum

Tipo de dados

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
Descrição

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

Tipo de dados

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]
C0439801
UMLS CUI [2,3]
C1321605
UMLS CUI [3,1]
C0442893
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C0231170
gastro-intestinal ulcers, gastritis, or dyspepsia
Descrição

Gastrointestinal ulcer | Gastritis | Dyspepsia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0237938
UMLS CUI [2]
C0017152
UMLS CUI [3]
C0013395
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
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C0332149
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0015787
UMLS CUI [6]
C0036899
UMLS CUI [7]
C0700589
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Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT00492466

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis
Item
relapsing remitting multiple sclerosis according to poser criteria (cdms or ldms) or multiple sclerosis according to mcdonald criteria
boolean
C0751967 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
EDSS
Item
disability equivalent to edss of 6.0 or less
boolean
C0451246 (UMLS CUI [1])
Relapse Quantity
Item
clinical activity defined as at least one relapse rate within the last 12 months
boolean
C0277556 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Neutralizing Antibody titer measurement | Interferon-beta Injection
Item
nab titre >20 (measured at least 48 hours after last interferon-beta injection
boolean
C0475463 (UMLS CUI [1,1])
C0474643 (UMLS CUI [1,2])
C0015980 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
interferon beta-1b Subcutaneous | Interferon beta-1a Subcutaneous | Rebif Subcutaneous
Item
has been treated with subcutaneously administered interferon-beta-1b or interferon-beta-1a (rebif) for at least 24 hours before enrollment
boolean
C0244713 (UMLS CUI [1,1])
C1522438 (UMLS CUI [1,2])
C0254119 (UMLS CUI [2,1])
C1522438 (UMLS CUI [2,2])
C0752980 (UMLS CUI [3,1])
C1522438 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Condition Causing Symptoms Multiple Sclerosis Similar
Item
any condition that might give rise to similar symptoms as ms
boolean
C0348080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0026769 (UMLS CUI [1,4])
C2348205 (UMLS CUI [1,5])
Immunomodulation | Interferon beta-1a | interferon beta-1b | Therapeutic immunosuppression
Item
immunomodulatory therapy other than interferon-beta-1a or interferon-beta-1b or any immunosuppressive treatment six months prior to inclusion into the trial
boolean
C1963758 (UMLS CUI [1])
C0254119 (UMLS CUI [2])
C0244713 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
Glucocorticoids | Corticotropin
Item
treatment with glucocorticoids or acth less than one month prior to inclusion into the trial
boolean
C0017710 (UMLS CUI [1])
C0001655 (UMLS CUI [2])
Major Depressive Disorder
Item
history of major depression
boolean
C1269683 (UMLS CUI [1])
Substance Dependence
Item
alcohol or drug dependency
boolean
C0038580 (UMLS CUI [1])
Heart failure | Cardiomyopathy | Cardiac Arrhythmia Significant | Myocardial Ischemia Unstable New York Heart Association Classification | Myocardial Ischemia Advanced New York Heart Association Classification
Item
cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (nyha iii or iv)
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])
C1275491 (UMLS CUI [4,3])
C0151744 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1275491 (UMLS CUI [5,3])
Hypertensive disease | Blood Pressure
Item
hypertension (bp > 180/110 mmhg)
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
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 Limiting Compliance behavior | Systemic disease Affecting Evaluation Disability
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])
C0439801 (UMLS CUI [2,2])
C1321605 (UMLS CUI [2,3])
C0442893 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0231170 (UMLS CUI [3,4])
Gastrointestinal ulcer | Gastritis | Dyspepsia
Item
gastro-intestinal ulcers, gastritis, or dyspepsia
boolean
C0237938 (UMLS CUI [1])
C0017152 (UMLS CUI [2])
C0013395 (UMLS CUI [3])
Pregnancy | Breast Feeding | Pregnancy Possible | 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])
C0032961 (UMLS CUI [3,1])
C0332149 (UMLS CUI [3,2])
C0232970 (UMLS CUI [4])
C0015787 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0700589 (UMLS CUI [7])
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