ID

11914

Description

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

Keywords

Versions (2)
  1. 12/11/13 12/11/13 - Martin Dugas
  2. 8/21/15 8/21/15 - Martin Dugas
Uploaded on

August 21, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

German English

Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

1 forms  
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Female and male patients
Description

Female and male patients

Data type

boolean

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

Aged 18-55 years

Data type

boolean

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

Diagnosis of RRMS (Relapsing-Remitting Multiple Sclerosis)

Data type

boolean

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

EDSS score of 0 to 5.0

Data type

boolean

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

Treatment

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

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

Neurological progression at disease onset or between relapses

Data type

boolean

Serious or acute heart diseases
Description

Serious or acute heart diseases

Data type

boolean

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

History of severe depression or suicide attempt

Data type

boolean

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

dysfunctions

Data type

boolean

Monoclonal gammopathy
Description

Monoclonal gammopathy

Data type

boolean

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

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

Data type

boolean

Alias
UMLS CUI [1]
C0020517
Pregnancy or lactation
Description

Pregnancy or lactation

Data type

boolean

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

Medical Concepts

Betaferon
Description

Betaferon

Data type

string

Alias
UMLS CUI
C0244714
Copaxone
Description

Copaxone

Data type

string

Alias
UMLS CUI
C0528175
Depression
Description

Depression

Data type

string

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

Suicide attempt

Data type

string

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

RBC

Data type

string

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

WBC

Data type

string

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

Platelet count - finding

Data type

string

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

Creatinine

Data type

string

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

Liver Dysfunction

Data type

string

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

AST

Data type

string

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

AST Measurement in Serum/Plasma

Data type

string

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

ALT

Data type

string

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

ALT Measurement in Serum/Plasma

Data type

string

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

Gamma GT

Data type

string

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

Gamma GT Measurement

Data type

string

Alias
UMLS CUI
C0364459
LNC
2324-2
Glutamate Dehydrogenase
Description

GLDH

Data type

string

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

GLDH Measurement

Data type

string

Alias
UMLS CUI
C0364507
LNC
2367-1
Monoclonal Gammapathies
Description

Monoclonal Gammapathy

Data type

string

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

Allergy

Data type

string

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

Magnetic resonance imaging contrast media allergy

Data type

string

Alias
UMLS CUI
C0570564
SNOMEDCT
293639009
Interferons allergy
Description

Interferons allergy

Data type

string

Alias
UMLS CUI
C0571288
SNOMEDCT
294375008
Drug Allergy
Description

Drug Allergy

Data type

string

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

Albumin solution allergy

Data type

string

Alias
UMLS CUI
C0571759
SNOMEDCT
294854007
Mannitol (substance)
Description

Mannitol (substance)

Data type

string

Alias
UMLS CUI
C0024730
SNOMEDCT
387168006
LNC
MTHU015736
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Similar models

Eligibility Multiple Sclerosis Betaferon/Betaseron NCT00099502

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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