ID

44865

Description

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Unsceduled relapse assessment visit

Keywords

  1. 6/14/16 6/14/16 -
  2. 6/18/16 6/18/16 -
  3. 6/18/16 6/18/16 -
  4. 2/18/22 2/18/22 - Martin Dugas
Copyright Holder

Biogen

Uploaded on

February 18, 2022

DOI

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License

Creative Commons BY-NC 4.0

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Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

Alias
UMLS CUI [1]
C2826711
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Vital Signs
Description

Vital Signs

Date of examination
Description

Date of examination

Data type

date

Alias
UMLS CUI [1]
C2826643
Blood Pressure
Description

Blood Pressure

Data type

text

Alias
UMLS CUI [1]
C0005823
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0039476
°C
Physical examination
Description

Physical examination

Body System
Description

Body System

Data type

integer

Alias
UMLS CUI [1]
C0460002
Examination Status
Description

Examination Status

Data type

integer

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0449438
Abnormal examination findings
Description

physical examination findings

Data type

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0243095
EDSS Evaluation
Description

EDSS Evaluation

Date of Evaluation
Description

EDSS Date

Data type

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
Functional System Scores
Description

Functional System Scores

Visual
Description

Visual System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0042789
UMLS CUI [1,2]
C0451246
Brinstem
Description

Brainstem System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
Pyramidal
Description

Pyramidal System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0228060
UMLS CUI [1,2]
C0451246
Cerebellar
Description

Cerebellar System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0007765
UMLS CUI [1,2]
C0451246
Sensory
Description

Sensory System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0682648
UMLS CUI [1,2]
C0451246
Bowel or Bladder
Description

Bowel or Bladder System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C2707247
Cerebral
Description

Cerebral System EDSS

Data type

text

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C0451246
Relapse assessment
Description

Relapse assessment

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1516048
Date treating neurologist contacted by subject
Description

Date neurologist contacted

Data type

date

Alias
UMLS CUI [1,1]
C3251708
UMLS CUI [1,2]
C0011008
Date treating neurologist performed neurological examination and collected vitals
Description

***treating neurologist to perform neurological exam including EDSS.***

Data type

date

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0518766
UMLS CUI [2,2]
C0011008
Has the subject experienced a protocol-defined relapse ( having new or recurrent symptoms more than 24 hours not associated with fever or stress ans with new objective findings)?
Description

After the Treating Neurologist has reviewed the results of the relapse assessments: No: Record the event on the Adverse Event CRF If the treating Neurologist still considers the event to be an MS relapse, record the event as "MS relaplse: non-protocol defined" and provide responses to questions 1 and 2. If Yes: Record the event on the Adverse Event CRF as "MS relapse" and provide responses to questions 1 and 2.

Data type

boolean

Alias
UMLS CUI [1]
C0277556
Onset date of MS relapse symptoms?
Description

MS relapse symptoms onset date

Data type

date

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0011008
Was the subject treated with IV Methylprednisolon per protocol?
Description

If so, please record on concommitant medication form

Data type

boolean

Alias
UMLS CUI [1]
C0747791
Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visual Function Test
Description

Visual Function Test

Date of Evaluation
Description

Visual Function test date

Data type

date

Alias
UMLS CUI [1,1]
C0234621
UMLS CUI [1,2]
C0392366
UMLS CUI [1,3]
C0011008
Contrast Sensitivity Evaluation Binocular
Description

Contrast Sensitivity Evaluation Binocular

100% Chart, Total # Correct
Description

Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct

Data type

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
2,5% Chart, Total # Correct
Description

Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct

Data type

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
1,25% Chart, Total # Correct
Description

Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct

Data type

float

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Snellen visual acuity equivalent
Description

Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent

Data type

text

Alias
UMLS CUI [1,1]
C0009928
UMLS CUI [1,2]
C0042794
Additional Surveys
Description

Additional Surveys

EQ5D Questionnaire
Description

EQ5D

Data type

text

Alias
UMLS CUI [1]
C2733251
SF-36 Questionaire
Description

SF-36

Data type

text

Alias
UMLS CUI [1]
C1519136
SF 36: vitality
Description

SF 36: vitality

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0424589
SF-36: physical functioning
Description

SF-36: physical functioning

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0516981
SF-36: bodily pain
Description

SF-36: bodily pain

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C3890602
SF-36: general health perceptions
Description

SF-36: general health perceptions

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C2936631
SF-36 physical function
Description

SF-36: physical function

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0516981
SF-36: emotional role functioning
Description

SF-36: emotional role functioning

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C2370883
SF-36: social role functioning
Description

SF-36: social role functioning

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0035820
SF-36: Mental health
Description

SF-36: Mental health

Data type

integer

Alias
UMLS CUI [1,1]
C0518214
UMLS CUI [1,2]
C0025353

Similar models

Unsceduled relapse assessment visit BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C2826711 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Vital Signs
Date of examination
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Blood Pressure
Item
Blood Pressure
text
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Item Group
Physical examination
Item
Body System
integer
C0460002 (UMLS CUI [1])
Code List
Body System
CL Item
Skin (1)
CL Item
HEENT  (2)
CL Item
Lymph nodes (3)
CL Item
Neck and Thyroid  (4)
CL Item
Breasts (5)
CL Item
Chest/Lungs (6)
CL Item
Heart  (7)
CL Item
Vascular (8)
CL Item
Abdomen (9)
CL Item
Rectal  (10)
CL Item
Neurological  (11)
CL Item
Extremities/Joints (12)
Item
Examination Status
integer
C0031809 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Examination Status
CL Item
Not done (1)
CL Item
Normal (2)
CL Item
Abnormal (please specify) (3)
physical examination findings
Item
Abnormal examination findings
text
C0031809 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
Item Group
EDSS Evaluation
EDSS Date
Item
Date of Evaluation
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Functional System Scores
Visual System EDSS
Item
Visual
text
C0042789 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Brainstem System EDSS
Item
Brinstem
text
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
Pyramidal System EDSS
Item
Pyramidal
text
C0228060 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Cerebellar System EDSS
Item
Cerebellar
text
C0007765 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Sensory System EDSS
Item
Sensory
text
C0682648 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Bowel or Bladder System EDSS
Item
Bowel or Bladder
text
C0451246 (UMLS CUI [1,1])
C2707247 (UMLS CUI [1,2])
Cerebral System EDSS
Item
Cerebral
text
C0006104 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Item Group
Relapse assessment
C0035020 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Date neurologist contacted
Item
Date treating neurologist contacted by subject
date
C3251708 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
neurological examination date, vital signs date
Item
Date treating neurologist performed neurological examination and collected vitals
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
protocol defined relapse
Item
Has the subject experienced a protocol-defined relapse ( having new or recurrent symptoms more than 24 hours not associated with fever or stress ans with new objective findings)?
boolean
C0277556 (UMLS CUI [1])
MS relapse symptoms onset date
Item
Onset date of MS relapse symptoms?
date
C0856120 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
prednisolone treatment
Item
Was the subject treated with IV Methylprednisolon per protocol?
boolean
C0747791 (UMLS CUI [1])
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Visual Function Test
Visual Function test date
Item
Date of Evaluation
date
C0234621 (UMLS CUI [1,1])
C0392366 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Contrast Sensitivity Evaluation Binocular
Contrast Sensitivity Evaluation Binocular: 100% Chart, Total # Correct
Item
100% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 2,5% Chart, Total # Correct
Item
2,5% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: 1,25% Chart, Total # Correct
Item
1,25% Chart, Total # Correct
float
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Contrast Sensitivity Evaluation Binocular: Snellen visual acuity equivalent
Item
Snellen visual acuity equivalent
text
C0009928 (UMLS CUI [1,1])
C0042794 (UMLS CUI [1,2])
Item Group
Additional Surveys
EQ5D
Item
EQ5D Questionnaire
text
C2733251 (UMLS CUI [1])
SF-36
Item
SF-36 Questionaire
text
C1519136 (UMLS CUI [1])
SF 36: vitality
Item
SF 36: vitality
integer
C0518214 (UMLS CUI [1,1])
C0424589 (UMLS CUI [1,2])
SF-36: physical functioning
Item
SF-36: physical functioning
integer
C0518214 (UMLS CUI [1,1])
C0516981 (UMLS CUI [1,2])
SF-36: bodily pain
Item
SF-36: bodily pain
integer
C0518214 (UMLS CUI [1,1])
C3890602 (UMLS CUI [1,2])
SF-36: general health perceptions
Item
SF-36: general health perceptions
integer
C0518214 (UMLS CUI [1,1])
C2936631 (UMLS CUI [1,2])
SF-36: physical function
Item
SF-36 physical function
integer
C0518214 (UMLS CUI [1,1])
C0516981 (UMLS CUI [1,2])
SF-36: emotional role functioning
Item
SF-36: emotional role functioning
integer
C0518214 (UMLS CUI [1,1])
C2370883 (UMLS CUI [1,2])
SF-36: social role functioning
Item
SF-36: social role functioning
integer
C0518214 (UMLS CUI [1,1])
C0035820 (UMLS CUI [1,2])
SF-36: Mental health
Item
SF-36: Mental health
integer
C0518214 (UMLS CUI [1,1])
C0025353 (UMLS CUI [1,2])

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