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ID
34550
Description
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01156311
Link
https://clinicaltrials.gov/show/NCT01156311
Keywords
Versions (2)
- 1/19/19 1/19/19 -
- 5/21/19 5/21/19 -
Copyright Holder
see on clinicaltrials.gov
Uploaded on
January 19, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Eligibility Relapsing-Remitting Multiple Sclerosis NCT01156311
Eligibility Relapsing-Remitting Multiple Sclerosis NCT01156311
- StudyEvent: Eligibility
Similar models
Eligibility Relapsing-Remitting Multiple Sclerosis NCT01156311
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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