ID

36549

Description

Open-Label, Multicenter Study in Subjects With Relapsing-Remitting Multiple Sclerosis to Evaluate the Safety of 240 mg BG00012 (dimethyl fumarate) TID Administered as Add-On Therapy to Beta Interferons (IFNβ) or Glatiramer Acetate (GA); ODM derived from: https://clinicaltrials.gov/show/NCT01156311

Link

https://clinicaltrials.gov/show/NCT01156311

Keywords

Versions (2)
  1. 1/19/19 1/19/19 -
  2. 5/21/19 5/21/19 -
Copyright Holder

Biogen

Uploaded on

May 21, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Combination Study of Dimethyl Fumarate in Relapsing-Remitting Multiple Sclerosis NCT01156311

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Key Inclusion Criteria
Description

Key Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patient age between 18 and 55 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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

Diagnosis of RRMS according to McDonald criteria and brain MRI lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0679228
UMLS CUI [1,2]
C0751967
UMLS CUI [2,1]
C0412675
UMLS CUI [2,2]
C0221198
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C0026769
must have an expanded disability status scale (EDSS) between 0.0 and 5.0, inclusive.
Description

EDSS

Data type

boolean

Alias
UMLS CUI [1]
C0451246
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
Description

Participants receiving Rebif must be prescribed 44 μg by subcutaneous injection three times per week.

Data type

boolean

Alias
UMLS CUI [1,1]
C0289884
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0332185
UMLS CUI [2,1]
C0289884
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [2,4]
C0489652
UMLS CUI [3,1]
C0015980
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0332185
UMLS CUI [4,1]
C0015980
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C0489652
Key Exclusion Criteria
Description

Key Exclusion Criteria

Alias
UMLS CUI-1
C0680251
primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005)
Description

Primary progressive, secondary progressive, or progressive relapsing MS

Data type

boolean

Alias
UMLS CUI [1]
C0751964
UMLS CUI [2]
C0751965
UMLS CUI [3]
C0393666
other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0008679
UMLS CUI [1,3]
C0021053
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C0001314
UMLS CUI [3,2]
C0042075
UMLS CUI [4,1]
C0001314
UMLS CUI [4,2]
C0024115
pregnant or nursing women
Description

Pregnant or nursing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation within 6 months prior to study enrollment in any other drug, biologic, or device study.
Description

Other drug, biologic, or device study participation within 6 months prior

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0005527
UMLS CUI [3,1]
C0332185
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0699733
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Key Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Patient age between 18 and 55 years
boolean
C0001779 (UMLS CUI [1])
Diagnosis of RRMS according to McDonald criteria and brain MRI lesion
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
C0679228 (UMLS CUI [1,1])
C0751967 (UMLS CUI [1,2])
C0412675 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C0026769 (UMLS CUI [2,4])
EDSS
Item
must have an expanded disability status scale (EDSS) between 0.0 and 5.0, inclusive.
boolean
C0451246 (UMLS CUI [1])
Same dose of IFNβ or GA prior to and during study
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
boolean
C0289884 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
C0289884 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0489652 (UMLS CUI [2,4])
C0015980 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0332185 (UMLS CUI [3,4])
C0015980 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0489652 (UMLS CUI [4,4])
Item Group
Key Exclusion Criteria
C0680251 (UMLS CUI-1)
Primary progressive, secondary progressive, or progressive relapsing MS
Item
primary progressive, secondary progressive, or progressive relapsing MS (as defined by Polman et al. 2005)
boolean
C0751964 (UMLS CUI [1])
C0751965 (UMLS CUI [2])
C0393666 (UMLS CUI [3])
other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease
Item
other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease.
boolean
C0205394 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
C0021053 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
C0001314 (UMLS CUI [3,1])
C0042075 (UMLS CUI [3,2])
C0001314 (UMLS CUI [4,1])
C0024115 (UMLS CUI [4,2])
Pregnant or nursing
Item
pregnant or nursing women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Other drug, biologic, or device study participation within 6 months prior
Item
participation within 6 months prior to study enrollment in any other drug, biologic, or device study.
boolean
C0332185 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0005527 (UMLS CUI [2,3])
C0332185 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0699733 (UMLS CUI [3,3])
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