Eligibility Relapsing-Remitting Multiple Sclerosis NCT01156311

Criteria
Description

Criteria

must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (rrms) according to mcdonald criteria #1-4 (polman et al, 2005 [appendix i]), and have a prior brain magnetic resonance imaging (mri) demonstrating lesion (s) consistent with multiple sclerosis (ms) from any point in time.
Description

ID.1

Type de données

boolean

must have an expanded disability status scale (edss) between 0.0 and 5.0, inclusive.
Description

ID.2

Type de données

boolean

must be taking the same dose of a prescribed ifnβ (either avonex, betaseron, rebif) or ga for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. participants receiving rebif must be prescribed 44 μg by subcutaneous injection three times per week.
Description

ID.3

Type de données

boolean

key exclusion criteria:
Description

ID.4

Type de données

boolean

primary progressive, secondary progressive, or progressive relapsing ms (as defined by polman et al. 2005).
Description

ID.5

Type de données

boolean

other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
Description

ID.6

Type de données

boolean

pregnant or nursing women.
Description

ID.7

Type de données

boolean

participation within 6 months prior to study enrollment in any other drug, biologic, or device study.
Description

ID.8

Type de données

boolean

note: other protocol-defined inclusion/exclusion criteria may apply.
Description

ID.9

Type de données

boolean

Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01156311

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
ID.1
Item
must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (rrms) according to mcdonald criteria #1-4 (polman et al, 2005 [appendix i]), and have a prior brain magnetic resonance imaging (mri) demonstrating lesion (s) consistent with multiple sclerosis (ms) from any point in time.
boolean
ID.2
Item
must have an expanded disability status scale (edss) between 0.0 and 5.0, inclusive.
boolean
ID.3
Item
must be taking the same dose of a prescribed ifnβ (either avonex, betaseron, rebif) or ga for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. participants receiving rebif must be prescribed 44 μg by subcutaneous injection three times per week.
boolean
ID.4
Item
key exclusion criteria:
boolean
ID.5
Item
primary progressive, secondary progressive, or progressive relapsing ms (as defined by polman et al. 2005).
boolean
ID.6
Item
other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
boolean
ID.7
Item
pregnant or nursing women.
boolean
ID.8
Item
participation within 6 months prior to study enrollment in any other drug, biologic, or device study.
boolean
ID.9
Item
note: other protocol-defined inclusion/exclusion criteria may apply.
boolean