ID

21479

Beschreibung

A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00441103

Link

https://clinicaltrials.gov/show/NCT00441103

Stichworte

Versionen (1)
  1. 24.04.17 24.04.17 -
Hochgeladen am

24. April 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00441103

Englisch

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00441103

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females between 18 and 60 years of age
Beschreibung

Gender and age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study
Beschreibung

Gynaecological Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
have relapsing remitting multiple sclerosis (rrms) according to the revised mcdonald criteria 2005
Beschreibung

Relapsing remitting multiple sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
have brain and/or spinal mri with findings typical of multiple sclerosis (ms)
Beschreibung

Brain and/or spinal MRI

Datentyp

boolean

Alias
UMLS CUI [1]
C0412675
UMLS CUI [2]
C2454646
have disease duration for more than 12 months
Beschreibung

Disease duration

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
have disease activity characterized by at least one clinical event and one or more gadolinium-enhancing mri lesions within the 6 months prior to randomization
Beschreibung

Clinical event or gadolinium enhancing MRI lesion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0441471
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C0016911
have score of <=5.5 on the expanded disability status scale (edss)
Beschreibung

EDSS

Datentyp

boolean

Alias
UMLS CUI [1]
C0451246
be willing and able to comply with the protocol for the duration of the study
Beschreibung

Compliance behaviour

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
have given written informed consent prior to any study-related procedure not part of the normal medical practice
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any disease other than ms that could better explain his/her signs and symptoms
Beschreibung

Differential Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0011906
have complete transverse myelitis or bilateral optic neuritis
Beschreibung

Transverse myelitis or bilateral optic neuritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026976
UMLS CUI [2]
C0861152
have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [acth]), or total lymphoid irradiation
Beschreibung

Monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy or total lymphoid irradiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0003250
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021079
UMLS CUI [5]
C1519560
have received within 3 months prior to baseline any approved disease-modifying therapy for ms, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure
Beschreibung

Pharmacotherapy for MS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0026769
have received within 30 days prior to baseline oral or systemic corticosteroids or acth
Beschreibung

Steroid therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0149783
other protocol defined exclusion criteria could apply
Beschreibung

Exclusion Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C0680251
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Ähnliche Modelle

Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00441103

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender and age
Item
males and females between 18 and 60 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gynaecological Status
Item
female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either: post-menopausal or surgically sterile or use an effective method of contraception for the duration of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Relapsing remitting multiple sclerosis
Item
have relapsing remitting multiple sclerosis (rrms) according to the revised mcdonald criteria 2005
boolean
C0751967 (UMLS CUI [1])
Brain and/or spinal MRI
Item
have brain and/or spinal mri with findings typical of multiple sclerosis (ms)
boolean
C0412675 (UMLS CUI [1])
C2454646 (UMLS CUI [2])
Disease duration
Item
have disease duration for more than 12 months
boolean
C0872146 (UMLS CUI [1])
Clinical event or gadolinium enhancing MRI lesion
Item
have disease activity characterized by at least one clinical event and one or more gadolinium-enhancing mri lesions within the 6 months prior to randomization
boolean
C0026769 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0024485 (UMLS CUI [2,1])
C0016911 (UMLS CUI [2,2])
EDSS
Item
have score of <=5.5 on the expanded disability status scale (edss)
boolean
C0451246 (UMLS CUI [1])
Compliance behaviour
Item
be willing and able to comply with the protocol for the duration of the study
boolean
C1321605 (UMLS CUI [1])
Informed consent
Item
have given written informed consent prior to any study-related procedure not part of the normal medical practice
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Differential Diagnosis
Item
have any disease other than ms that could better explain his/her signs and symptoms
boolean
C0011906 (UMLS CUI [1])
Transverse myelitis or bilateral optic neuritis
Item
have complete transverse myelitis or bilateral optic neuritis
boolean
C0026976 (UMLS CUI [1])
C0861152 (UMLS CUI [2])
Monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy or total lymphoid irradiation
Item
have received or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [acth]), or total lymphoid irradiation
boolean
C0003250 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021079 (UMLS CUI [4])
C1519560 (UMLS CUI [5])
Pharmacotherapy for MS
Item
have received within 3 months prior to baseline any approved disease-modifying therapy for ms, cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, any investigational drug, or experimental procedure
boolean
C0013216 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
Steroid therapy
Item
have received within 30 days prior to baseline oral or systemic corticosteroids or acth
boolean
C0149783 (UMLS CUI [1])
Exclusion Criteria
Item
other protocol defined exclusion criteria could apply
boolean
C0680251 (UMLS CUI [1])
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