ID

4578

Description

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

Mots-clés

  1. 11/12/2013 11/12/2013 - Martin Dugas
  2. 21/08/2015 21/08/2015 - Martin Dugas
Téléchargé le

11 décembre 2013

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00099502 Multiple Sclerosis

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

Gender
Description

Gender

Type de données

boolean

Age
Description

Age

Type de données

boolean

RRMS
Description

RRMS

Type de données

boolean

EDSS score
Description

EDSS score

Type de données

boolean

Treatment
Description

Treatment

Type de données

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

Neurological progression
Description

Neurological progression

Type de données

boolean

heart diseases
Description

heart diseases

Type de données

boolean

depression or suicide
Description

depression or suicide

Type de données

boolean

dysfunctions
Description

dysfunctions

Type de données

boolean

Monoclonal gammopathy
Description

Monoclonal gammopathy

Type de données

boolean

Allergies
Description

Allergies

Type de données

boolean

Pregnancy or lactation
Description

Pregnancy or lactation

Type de données

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Multiple Sclerosis
Description

Multiple Sclerosis

Type de données

string

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

Multiple Sclerosis, Relapsing-Remitting

Type de données

string

Alias
UMLS CUI
C0751967
SNOMEDCT
426373005
MDR
10063399
Betaferon
Description

Betaferon

Type de données

string

Alias
UMLS CUI
C0244714
Copaxone
Description

Copaxone

Type de données

string

Alias
UMLS CUI
C0528175
Gender
Description

Gender

Type de données

string

Alias
UMLS CUI
C0079399
SNOMEDCT
263495000
LNC
MTHU002975
Age
Description

Age

Type de données

string

Alias
UMLS CUI
C0001779
SNOMEDCT
424144002
LNC
MTHU010047
EDSS
Description

EDSS

Type de données

string

Alias
UMLS CUI
C0451246
SNOMEDCT
273554001
Heart Diseases
Description

Heart Diseases

Type de données

string

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

Depression

Type de données

string

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

Suicide attempt

Type de données

string

Alias
UMLS CUI
C0038663
SNOMEDCT
82313006
MDR
10042464
ICD10CM
T14.91
CTCAE
E12969
RBC
Description

RBC

Type de données

string

Alias
UMLS CUI
C0362910
LNC
789-8
WBC
Description

WBC

Type de données

string

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

Platelet count - finding

Type de données

string

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

Creatinine

Type de données

string

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

Liver Dysfunction

Type de données

string

Alias
UMLS CUI
C0086565
SNOMEDCT
75183008
MDR
10019670
AST
Description

AST

Type de données

string

Alias
UMLS CUI
C0004002
SNOMEDCT
26091008
LNC
MTHU004883
AST Measurement in Serum/Plasma
Description

AST Measurement in Serum/Plasma

Type de données

string

Alias
UMLS CUI
C0364055
LNC
1920-8
ALT
Description

ALT

Type de données

string

Alias
UMLS CUI
C0001899
SNOMEDCT
56935002
LNC
MTHU006766
ALT Measurement in Serum/Plasma
Description

ALT Measurement in Serum/Plasma

Type de données

string

Alias
UMLS CUI
C0363876
LNC
1742-6
Gamma GT
Description

Gamma GT

Type de données

string

Alias
UMLS CUI
C0017040
SNOMEDCT
60153001
LNC
MTHU001941
Gamma GT Measurement
Description

Gamma GT Measurement

Type de données

string

Alias
UMLS CUI
C0364459
LNC
2324-2
GLDH
Description

GLDH

Type de données

string

Alias
UMLS CUI
C0017786
SNOMEDCT
75284005
LNC
MTHU011411
GLDH Measurement
Description

GLDH Measurement

Type de données

string

Alias
UMLS CUI
C0364507
LNC
2367-1
Monoclonal Gammapathy
Description

Monoclonal Gammapathy

Type de données

string

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

Allergy

Type de données

string

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

Magnetic resonance imaging contrast media allergy

Type de données

string

Alias
UMLS CUI
C0570564
SNOMEDCT
293639009
Interferons allergy
Description

Interferons allergy

Type de données

string

Alias
UMLS CUI
C0571288
SNOMEDCT
294375008
Drug Allergy
Description

Drug Allergy

Type de données

string

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

Albumin solution allergy

Type de données

string

Alias
UMLS CUI
C0571759
SNOMEDCT
294854007
Mannitol (substance)
Description

Mannitol (substance)

Type de données

string

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

Patient currently pregnant

Type de données

string

Alias
UMLS CUI
C0549206
MDR
10036586
SNOMEDCT
77386006
Breast Feeding
Description

Breast Feeding

Type de données

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMEDCT
169741004

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Einschlusskriterien
Gender
Item
boolean
Age
Item
boolean
RRMS
Item
boolean
EDSS score
Item
boolean
Treatment
Item
boolean
Item Group
Ausschlusskriterien
Neurological progression
Item
boolean
heart diseases
Item
boolean
depression or suicide
Item
boolean
dysfunctions
Item
boolean
Monoclonal gammopathy
Item
boolean
Allergies
Item
boolean
Pregnancy or lactation
Item
boolean
Item Group
Medizinische Konzepte
Multiple Sclerosis
Item
string
C0026769 (UMLS CUI)
24700007 (SNOMEDCT)
10028245 (MDR)
MTHU020805 (LNC)
G35 (ICD10CM)
340 (ICD9CM)
Multiple Sclerosis, Relapsing-Remitting
Item
string
C0751967 (UMLS CUI)
426373005 (SNOMEDCT)
10063399 (MDR)
Betaferon
Item
string
C0244714 (UMLS CUI)
Copaxone
Item
string
C0528175 (UMLS CUI)
Gender
Item
string
C0079399 (UMLS CUI)
263495000 (SNOMEDCT)
MTHU002975 (LNC)
Age
Item
string
C0001779 (UMLS CUI)
424144002 (SNOMEDCT)
MTHU010047 (LNC)
EDSS
Item
string
C0451246 (UMLS CUI)
273554001 (SNOMEDCT)
Heart Diseases
Item
string
C0018799 (UMLS CUI)
56265001 (SNOMEDCT)
10061024 (MDR)
I51.9 (ICD10CM)
429.9 (ICD9CM)
Depression
Item
string
C0011581 (UMLS CUI)
35489007 (SNOMEDCT)
10012399 (MDR)
F34.1 (ICD10CM)
Suicide attempt
Item
string
C0038663 (UMLS CUI)
82313006 (SNOMEDCT)
10042464 (MDR)
T14.91 (ICD10CM)
E12969 (CTCAE)
RBC
Item
string
C0362910 (UMLS CUI)
789-8 (LNC)
WBC
Item
string
C0023508 (UMLS CUI)
767002 (SNOMEDCT)
10047939 (MDR)
6690-2 (LNC)
Platelet count - finding
Item
string
C1287267 (UMLS CUI)
365632008 (SNOMEDCT)
777-3 (LNC)
Creatinine
Item
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Liver Dysfunction
Item
string
C0086565 (UMLS CUI)
75183008 (SNOMEDCT)
10019670 (MDR)
AST
Item
string
C0004002 (UMLS CUI)
26091008 (SNOMEDCT)
MTHU004883 (LNC)
AST Measurement in Serum/Plasma
Item
string
C0364055 (UMLS CUI)
1920-8 (LNC)
ALT
Item
string
C0001899 (UMLS CUI)
56935002 (SNOMEDCT)
MTHU006766 (LNC)
ALT Measurement in Serum/Plasma
Item
string
C0363876 (UMLS CUI)
1742-6 (LNC)
Gamma GT
Item
string
C0017040 (UMLS CUI)
60153001 (SNOMEDCT)
MTHU001941 (LNC)
Gamma GT Measurement
Item
string
C0364459 (UMLS CUI)
2324-2 (LNC)
GLDH
Item
string
C0017786 (UMLS CUI)
75284005 (SNOMEDCT)
MTHU011411 (LNC)
GLDH Measurement
Item
string
C0364507 (UMLS CUI)
2367-1 (LNC)
Monoclonal Gammapathy
Item
string
C1136085 (UMLS CUI)
109983007 (SNOMEDCT)
10060880 (MDR)
D47.2 (ICD10CM)
Allergy
Item
string
C0020517 (UMLS CUI)
418634005 (SNOMEDCT)
T78.40 (ICD10CM)
Magnetic resonance imaging contrast media allergy
Item
string
C0570564 (UMLS CUI)
293639009 (SNOMEDCT)
Interferons allergy
Item
string
C0571288 (UMLS CUI)
294375008 (SNOMEDCT)
Drug Allergy
Item
string
C0013182 (UMLS CUI)
416098002 (SNOMEDCT)
10013700 (MDR)
T88.7 (ICD10CM)
DALG (HL7V3.0)
Albumin solution allergy
Item
string
C0571759 (UMLS CUI)
294854007 (SNOMEDCT)
Mannitol (substance)
Item
string
C0024730 (UMLS CUI)
387168006 (SNOMEDCT)
MTHU015736 (LNC)
Patient currently pregnant
Item
string
C0549206 (UMLS CUI)
10036586 (MDR)
77386006 (SNOMEDCT)
Breast Feeding
Item
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMEDCT)

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