ID

4578

Beschreibung

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

Stichworte

Versionen (2)
  1. 11.12.13 11.12.13 - Martin Dugas
  2. 21.08.15 21.08.15 - Martin Dugas
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11. Dezember 2013

DOI

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Eligibility NCT00099502 Multiple Sclerosis

Deutsch Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Beschreibung

Inclusion criteria

Female and male patients
Beschreibung

Gender

Datentyp

boolean

Aged 18-55 years
Beschreibung

Age

Datentyp

boolean

Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)
Beschreibung

RRMS

Datentyp

boolean

EDSS score of 0 to 5.0
Beschreibung

EDSS score

Datentyp

boolean

Treatment-naive to IFNB or Copaxone
Beschreibung

Treatment

Datentyp

boolean

Exclusion criteria
Beschreibung

Exclusion criteria

Neurological progression at disease onset or between relapses
Beschreibung

Neurological progression

Datentyp

boolean

Serious or acute heart diseases
Beschreibung

heart diseases

Datentyp

boolean

History of severe depression or suicide attempt
Beschreibung

depression or suicide

Datentyp

boolean

Serious or acute liver, renal or bone marrow dysfunction
Beschreibung

dysfunctions

Datentyp

boolean

Monoclonal gammopathy
Beschreibung

Monoclonal gammopathy

Datentyp

boolean

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

Allergies

Datentyp

boolean

Pregnancy or lactation
Beschreibung

Pregnancy or lactation

Datentyp

boolean

Medical Concepts
Beschreibung

Medical Concepts

Multiple Sclerosis
Beschreibung

Multiple Sclerosis

Datentyp

string

Alias
UMLS CUI
C0026769
SNOMEDCT
24700007
MDR
10028245
LNC
MTHU020805
ICD10CM
G35
ICD9CM
340
Multiple Sclerosis, Relapsing-Remitting
Beschreibung

Multiple Sclerosis, Relapsing-Remitting

Datentyp

string

Alias
UMLS CUI
C0751967
SNOMEDCT
426373005
MDR
10063399
Betaferon
Beschreibung

Betaferon

Datentyp

string

Alias
UMLS CUI
C0244714
Copaxone
Beschreibung

Copaxone

Datentyp

string

Alias
UMLS CUI
C0528175
Gender
Beschreibung

Gender

Datentyp

string

Alias
UMLS CUI
C0079399
SNOMEDCT
263495000
LNC
MTHU002975
Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMEDCT
424144002
LNC
MTHU010047
EDSS - Expanded disability status scale
Beschreibung

EDSS

Datentyp

string

Alias
UMLS CUI
C0451246
SNOMEDCT
273554001
Heart Diseases
Beschreibung

Heart Diseases

Datentyp

string

Alias
UMLS CUI
C0018799
SNOMEDCT
56265001
MDR
10061024
ICD10CM
I51.9
ICD9CM
429.9
Depression
Beschreibung

Depression

Datentyp

string

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

Suicide attempt

Datentyp

string

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

RBC

Datentyp

string

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

WBC

Datentyp

string

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

Platelet count - finding

Datentyp

string

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

Creatinine

Datentyp

string

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

Liver Dysfunction

Datentyp

string

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

AST

Datentyp

string

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

AST Measurement in Serum/Plasma

Datentyp

string

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

ALT

Datentyp

string

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

ALT Measurement in Serum/Plasma

Datentyp

string

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

Gamma GT

Datentyp

string

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

Gamma GT Measurement

Datentyp

string

Alias
UMLS CUI
C0364459
LNC
2324-2
Glutamate Dehydrogenase
Beschreibung

GLDH

Datentyp

string

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

GLDH Measurement

Datentyp

string

Alias
UMLS CUI
C0364507
LNC
2367-1
Monoclonal Gammapathies
Beschreibung

Monoclonal Gammapathy

Datentyp

string

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

Allergy

Datentyp

string

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

Magnetic resonance imaging contrast media allergy

Datentyp

string

Alias
UMLS CUI
C0570564
SNOMEDCT
293639009
Interferons allergy
Beschreibung

Interferons allergy

Datentyp

string

Alias
UMLS CUI
C0571288
SNOMEDCT
294375008
Drug Allergy
Beschreibung

Drug Allergy

Datentyp

string

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

Albumin solution allergy

Datentyp

string

Alias
UMLS CUI
C0571759
SNOMEDCT
294854007
Mannitol (substance)
Beschreibung

Mannitol (substance)

Datentyp

string

Alias
UMLS CUI
C0024730
SNOMEDCT
387168006
LNC
MTHU015736
Patient currently pregnant
Beschreibung

Patient currently pregnant

Datentyp

string

Alias
UMLS CUI
C0549206
MDR
10036586
SNOMEDCT
77386006
Breast Feeding
Beschreibung

Breast Feeding

Datentyp

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMEDCT
169741004
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion criteria
Gender
Item
Female and male patients
boolean
Age
Item
Aged 18-55 years
boolean
RRMS
Item
Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)
boolean
EDSS score
Item
EDSS score of 0 to 5.0
boolean
Treatment
Item
Treatment-naive to IFNB or Copaxone
boolean
Item Group
Exclusion criteria
Neurological progression
Item
Neurological progression at disease onset or between relapses
boolean
heart diseases
Item
Serious or acute heart diseases
boolean
depression or suicide
Item
History of severe depression or suicide attempt
boolean
dysfunctions
Item
Serious or acute liver, renal or bone marrow dysfunction
boolean
Monoclonal gammopathy
Item
Monoclonal gammopathy
boolean
Allergies
Item
Known allergy to Gadolinium-DTPA, to IFNs (Interferons), to glatiramer acetate, to human albumin or to mannitol
boolean
Pregnancy or lactation
Item
Pregnancy or lactation
boolean
Item Group
Medical Concepts
Multiple Sclerosis
Item
Multiple Sclerosis
string
C0026769 (UMLS CUI)
24700007 (SNOMEDCT)
10028245 (MDR)
MTHU020805 (LNC)
G35 (ICD10CM)
340 (ICD9CM)
Multiple Sclerosis, Relapsing-Remitting
Item
Multiple Sclerosis, Relapsing-Remitting
string
C0751967 (UMLS CUI)
426373005 (SNOMEDCT)
10063399 (MDR)
Betaferon
Item
Betaferon
string
C0244714 (UMLS CUI)
Copaxone
Item
Copaxone
string
C0528175 (UMLS CUI)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMEDCT)
MTHU002975 (LNC)
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMEDCT)
MTHU010047 (LNC)
EDSS
Item
EDSS - Expanded disability status scale
string
C0451246 (UMLS CUI)
273554001 (SNOMEDCT)
Heart Diseases
Item
Heart Diseases
string
C0018799 (UMLS CUI)
56265001 (SNOMEDCT)
10061024 (MDR)
I51.9 (ICD10CM)
429.9 (ICD9CM)
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)
Patient currently pregnant
Item
Patient currently pregnant
string
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMEDCT)
Breast Feeding
Item
Breast Feeding
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMEDCT)
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