ID

11914

Descripción

BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients https://clinicaltrials.gov/ct2/show/NCT00099502 The purpose of this study is to determine - whether treatment with Betaferon / Betaseron (interferon beta-1b) 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms - whether treatment with Betaferon / Betaseron (interferon beta-1b) tolerable and more efficacious than treatment with Copaxone (Glatiramer Acetate) 20 mg

Link

https://clinicaltrials.gov/ct2/show/NCT00099502

Palabras clave

Versiones (2)
  1. 11/12/13 11/12/13 - Martin Dugas
  2. 21/8/15 21/8/15 - Martin Dugas
Subido en

21 de agosto de 2015

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

Alemán Inglés

Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

1 formularios  
Inclusion criteria
Descripción

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Female and male patients
Descripción

Female and male patients

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
Aged 18-55 years
Descripción

Aged 18-55 years

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)
Descripción

Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0751967
EDSS score of 0 to 5.0
Descripción

EDSS score of 0 to 5.0

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0451246
Treatment-naive to IFNB or Copaxone
Descripción

Treatment

Tipo de datos

boolean

Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Neurological progression at disease onset or between relapses
Descripción

Neurological progression at disease onset or between relapses

Tipo de datos

boolean

Serious or acute heart diseases
Descripción

Serious or acute heart diseases

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018799
History of severe depression or suicide attempt
Descripción

History of severe depression or suicide attempt

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0588008
Serious or acute liver, renal or bone marrow dysfunction
Descripción

dysfunctions

Tipo de datos

boolean

Monoclonal gammopathy
Descripción

Monoclonal gammopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1136085
Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
Descripción

Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
Pregnancy or lactation
Descripción

Pregnancy or lactation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Medical Concepts
Descripción

Medical Concepts

Betaferon
Descripción

Betaferon

Tipo de datos

string

Alias
UMLS CUI
C0244714
Copaxone
Descripción

Copaxone

Tipo de datos

string

Alias
UMLS CUI
C0528175
Depression
Descripción

Depression

Tipo de datos

string

Alias
UMLS CUI
C0011581
SNOMEDCT
35489007
MDR
10012399
ICD10CM
F34.1
Suicide attempt
Descripción

Suicide attempt

Tipo de datos

string

Alias
UMLS CUI
C0038663
SNOMEDCT
82313006
MDR
10042464
ICD10CM
T14.91
CTCAE
E12969
Red blood cell count
Descripción

RBC

Tipo de datos

string

Alias
UMLS CUI
C0362910
LNC
789-8
White blood cell count
Descripción

WBC

Tipo de datos

string

Alias
UMLS CUI
C0023508
SNOMEDCT
767002
MDR
10047939
LNC
6690-2
Platelet count - finding
Descripción

Platelet count - finding

Tipo de datos

string

Alias
UMLS CUI
C1287267
SNOMEDCT
365632008
LNC
777-3
Creatinine
Descripción

Creatinine

Tipo de datos

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Liver Dysfunction
Descripción

Liver Dysfunction

Tipo de datos

string

Alias
UMLS CUI
C0086565
SNOMEDCT
75183008
MDR
10019670
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
Descripción

AST

Tipo de datos

string

Alias
UMLS CUI
C0004002
SNOMEDCT
26091008
LNC
MTHU004883
Aspartate aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Descripción

AST Measurement in Serum/Plasma

Tipo de datos

string

Alias
UMLS CUI
C0364055
LNC
1920-8
Glutamate Pyruvate Transaminase (GPT) = Alanine Transaminase (ALT)
Descripción

ALT

Tipo de datos

string

Alias
UMLS CUI
C0001899
SNOMEDCT
56935002
LNC
MTHU006766
Alanine aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Descripción

ALT Measurement in Serum/Plasma

Tipo de datos

string

Alias
UMLS CUI
C0363876
LNC
1742-6
Gamma-glutamyl transferase
Descripción

Gamma GT

Tipo de datos

string

Alias
UMLS CUI
C0017040
SNOMEDCT
60153001
LNC
MTHU001941
Gamma glutamyl transferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Descripción

Gamma GT Measurement

Tipo de datos

string

Alias
UMLS CUI
C0364459
LNC
2324-2
Glutamate Dehydrogenase
Descripción

GLDH

Tipo de datos

string

Alias
UMLS CUI
C0017786
SNOMEDCT
75284005
LNC
MTHU011411
Glutamate dehydrogenase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
Descripción

GLDH Measurement

Tipo de datos

string

Alias
UMLS CUI
C0364507
LNC
2367-1
Monoclonal Gammapathies
Descripción

Monoclonal Gammapathy

Tipo de datos

string

Alias
UMLS CUI
C1136085
SNOMEDCT
109983007
MDR
10060880
ICD10CM
D47.2
Hypersensitivity
Descripción

Allergy

Tipo de datos

string

Alias
UMLS CUI
C0020517
SNOMEDCT
418634005
ICD10CM
T78.40
Magnetic resonance imaging contrast media allergy
Descripción

Magnetic resonance imaging contrast media allergy

Tipo de datos

string

Alias
UMLS CUI
C0570564
SNOMEDCT
293639009
Interferons allergy
Descripción

Interferons allergy

Tipo de datos

string

Alias
UMLS CUI
C0571288
SNOMEDCT
294375008
Drug Allergy
Descripción

Drug Allergy

Tipo de datos

string

Alias
UMLS CUI
C0013182
SNOMEDCT
416098002
MDR
10013700
ICD10CM
T88.7
HL7V3.0
DALG
Albumin solution allergy
Descripción

Albumin solution allergy

Tipo de datos

string

Alias
UMLS CUI
C0571759
SNOMEDCT
294854007
Mannitol (substance)
Descripción

Mannitol (substance)

Tipo de datos

string

Alias
UMLS CUI
C0024730
SNOMEDCT
387168006
LNC
MTHU015736
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Similar models

Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Gender
Item
Female and male patients
boolean
C0079399 (UMLS CUI [1])
Age
Item
Aged 18-55 years
boolean
C0001779 (UMLS CUI [1])
RRMS
Item
Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)
boolean
C0751967 (UMLS CUI [1])
EDSS score
Item
EDSS score of 0 to 5.0
boolean
C0451246 (UMLS CUI [1])
Treatment
Item
Treatment-naive to IFNB or Copaxone
boolean
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Neurological progression
Item
Neurological progression at disease onset or between relapses
boolean
heart diseases
Item
Serious or acute heart diseases
boolean
C0018799 (UMLS CUI [1])
Severe depression
Item
History of severe depression or suicide attempt
boolean
C0588008 (UMLS CUI [1])
dysfunctions
Item
Serious or acute liver, renal or bone marrow dysfunction
boolean
Monoclonal gammopathy
Item
Monoclonal gammopathy
boolean
C1136085 (UMLS CUI [1])
Allergies
Item
Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
boolean
C0020517 (UMLS CUI [1])
Pregnancy or lactation
Item
Pregnancy or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Item Group
Medical Concepts
Betaferon
Item
Betaferon
string
C0244714 (UMLS CUI)
Copaxone
Item
Copaxone
string
C0528175 (UMLS CUI)
Depression
Item
Depression
string
C0011581 (UMLS CUI)
35489007 (SNOMEDCT)
10012399 (MDR)
F34.1 (ICD10CM)
Suicide attempt
Item
Suicide attempt
string
C0038663 (UMLS CUI)
82313006 (SNOMEDCT)
10042464 (MDR)
T14.91 (ICD10CM)
E12969 (CTCAE)
RBC
Item
Red blood cell count
string
C0362910 (UMLS CUI)
789-8 (LNC)
WBC
Item
White blood cell count
string
C0023508 (UMLS CUI)
767002 (SNOMEDCT)
10047939 (MDR)
6690-2 (LNC)
Platelet count - finding
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMEDCT)
777-3 (LNC)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
75183008 (SNOMEDCT)
10019670 (MDR)
AST
Item
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
string
C0004002 (UMLS CUI)
26091008 (SNOMEDCT)
MTHU004883 (LNC)
AST Measurement in Serum/Plasma
Item
Aspartate aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0364055 (UMLS CUI)
1920-8 (LNC)
ALT
Item
Glutamate Pyruvate Transaminase (GPT) = Alanine Transaminase (ALT)
string
C0001899 (UMLS CUI)
56935002 (SNOMEDCT)
MTHU006766 (LNC)
ALT Measurement in Serum/Plasma
Item
Alanine aminotransferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0363876 (UMLS CUI)
1742-6 (LNC)
Gamma GT
Item
Gamma-glutamyl transferase
string
C0017040 (UMLS CUI)
60153001 (SNOMEDCT)
MTHU001941 (LNC)
Gamma GT Measurement
Item
Gamma glutamyl transferase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0364459 (UMLS CUI)
2324-2 (LNC)
GLDH
Item
Glutamate Dehydrogenase
string
C0017786 (UMLS CUI)
75284005 (SNOMEDCT)
MTHU011411 (LNC)
GLDH Measurement
Item
Glutamate dehydrogenase:Catalytic Concentration:Point in time:Serum/Plasma:Quantitative
string
C0364507 (UMLS CUI)
2367-1 (LNC)
Monoclonal Gammapathy
Item
Monoclonal Gammapathies
string
C1136085 (UMLS CUI)
109983007 (SNOMEDCT)
10060880 (MDR)
D47.2 (ICD10CM)
Allergy
Item
Hypersensitivity
string
C0020517 (UMLS CUI)
418634005 (SNOMEDCT)
T78.40 (ICD10CM)
Magnetic resonance imaging contrast media allergy
Item
Magnetic resonance imaging contrast media allergy
string
C0570564 (UMLS CUI)
293639009 (SNOMEDCT)
Interferons allergy
Item
Interferons allergy
string
C0571288 (UMLS CUI)
294375008 (SNOMEDCT)
Drug Allergy
Item
Drug Allergy
string
C0013182 (UMLS CUI)
416098002 (SNOMEDCT)
10013700 (MDR)
T88.7 (ICD10CM)
DALG (HL7V3.0)
Albumin solution allergy
Item
Albumin solution allergy
string
C0571759 (UMLS CUI)
294854007 (SNOMEDCT)
Mannitol (substance)
Item
Mannitol (substance)
string
C0024730 (UMLS CUI)
387168006 (SNOMEDCT)
MTHU015736 (LNC)
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