ID

36549

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01156311

Nyckelord

Versioner (2)
  1. 2019-01-19 2019-01-19 -
  2. 2019-05-21 2019-05-21 -
Rättsinnehavare

Biogen

Uppladdad den

21 maj 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Combination Study of Dimethyl Fumarate in Relapsing-Remitting Multiple Sclerosis NCT01156311

Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Key Inclusion Criteria
Beskrivning

Key Inclusion Criteria

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

Age

Datatyp

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.
Beskrivning

Diagnosis of RRMS according to McDonald criteria and brain MRI lesion

Datatyp

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.
Beskrivning

EDSS

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Key Exclusion Criteria

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

Primary progressive, secondary progressive, or progressive relapsing MS

Datatyp

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.
Beskrivning

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

Datatyp

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
Beskrivning

Pregnant or nursing

Datatyp

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.
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial