Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00441103

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StudyEvent: Eligibility
1. Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00441103

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

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])

Exclusion Criteria

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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Eligibility Multiple Sclerosis, Relapsing-Remitting NCT00441103