ID

19899

Description

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS.

Keywords

Versions (1)
  1. 1/30/17 1/30/17 -
Uploaded on

January 30, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Relapse Assessment CRFs Multiple Sklerosis Tysabri NCT00027300

English

Relapse Assessment CRFs Multiple Sklerosis Tysabri NCT00027300

1 forms  
Relapse Assessment
Description

Relapse Assessment

Alias
UMLS CUI-1
C0035020
UMLS CUI-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 subject evaluated by treating neurologist
Description

Date subject evaluated by neurologist

Data type

date

Alias
UMLS CUI [1,1]
C0583578
UMLS CUI [1,2]
C0011008
Does the treating neurologist suspect that the subject has experienced a relapse?
Description

Suspected relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C0522483
UMLS CUI [1,2]
C0035020
If "Yes", examining neurologist to perform EDSS
Description

Reason for EDSS performance

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0451246
EDSS
Description

EDSS

Alias
UMLS CUI-1
C0451246
Evalutation date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0011008
EDSS visual
Description

EDSS visual

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C1321512
EDSS brainstem
Description

EDSS brainstem

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0006121
EDSS pyramidal
Description

EDSS pyramidal

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0228060
EDSS cerebellar
Description

EDSS cerebellar

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0007765
EDSS sensory
Description

EDSS sonsory

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0445254
EDSS bowel or bladder
Description

EDSS bowel or bladder

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0021853
UMLS CUI [2,1]
C0451246
UMLS CUI [2,2]
C0005682
EDSS cerebral
Description

EDSS cerebral

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C3829397
Check the box that indicates the furthest distance the subject is able to walk without aid or rest:
Description

actual distance walked

Data type

integer

Alias
UMLS CUI [1]
C0429888
EDSS score: __ * _
Description

EDSS Score

Data type

float

Alias
UMLS CUI [1]
C0451246
UMLS CUI [2]
C0429888
Treating neurologist evaluation
Description

Treating neurologist evaluation

Alias
UMLS CUI-1
C0237426
UMLS CUI-2
C0220825
Has the subject experienced a relapse (i.e. having new or recurrent symptoms, lasting more than 48 hours with corresponding objective findings documented on the examining neurologist's exam)?
Description

Relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
Onset date of MS relapse (Record relapse on Adverse Event page)
Description

Onset date of MS relapse

Data type

date

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0011008
Was the subject treated with IV methylprednisolone per protocol? (Record on Concomitant Medication form)
Description

Treatment with iv methylprednisolone

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0025815
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Similar models

Relapse Assessment CRFs Multiple Sklerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Relapse Assessment
C0035020 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Date neurologist contacted
Item
Date treating neurologist contacted by subject
date
C3251708 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Date subject evaluated by neurologist
Item
Date subject evaluated by treating neurologist
date
C0583578 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Suspected relapse
Item
Does the treating neurologist suspect that the subject has experienced a relapse?
boolean
C0522483 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
Reason for EDSS performance
Item
If "Yes", examining neurologist to perform EDSS
text
C0392360 (UMLS CUI [1,1])
C0451246 (UMLS CUI [1,2])
Item Group
EDSS
C0451246 (UMLS CUI-1)
Date
Item
Evalutation date
date
C0451246 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
EDSS visual
Item
EDSS visual
float
C0451246 (UMLS CUI [1,1])
C1321512 (UMLS CUI [1,2])
EDSS brainstem
Item
EDSS brainstem
float
C0451246 (UMLS CUI [1,1])
C0006121 (UMLS CUI [1,2])
EDSS pyramidal
Item
EDSS pyramidal
float
C0451246 (UMLS CUI [1,1])
C0228060 (UMLS CUI [1,2])
EDSS cerebellar
Item
EDSS cerebellar
float
C0451246 (UMLS CUI [1,1])
C0007765 (UMLS CUI [1,2])
EDSS sonsory
Item
EDSS sensory
float
C0451246 (UMLS CUI [1,1])
C0445254 (UMLS CUI [1,2])
EDSS bowel or bladder
Item
EDSS bowel or bladder
float
C0451246 (UMLS CUI [1,1])
C0021853 (UMLS CUI [1,2])
C0451246 (UMLS CUI [2,1])
C0005682 (UMLS CUI [2,2])
EDSS cerebral
Item
EDSS cerebral
float
C0451246 (UMLS CUI [1,1])
C3829397 (UMLS CUI [1,2])
Item
Check the box that indicates the furthest distance the subject is able to walk without aid or rest:
integer
C0429888 (UMLS CUI [1])
actual distance walked
Code List
Check the box that indicates the furthest distance the subject is able to walk without aid or rest:
CL Item
< 100 metres (1)
CL Item
≥ 100 metres and < 200 metres (2)
CL Item
≥ 200 metres and < 300 metres (3)
CL Item
≥ 300 metres and < 500 metres (4)
CL Item
≥ 500 metres (5)
EDSS Score
Item
EDSS score: __ * _
float
C0451246 (UMLS CUI [1])
C0429888 (UMLS CUI [2])
Item Group
Treating neurologist evaluation
C0237426 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
Relapse
Item
Has the subject experienced a relapse (i.e. having new or recurrent symptoms, lasting more than 48 hours with corresponding objective findings documented on the examining neurologist's exam)?
boolean
C0856120 (UMLS CUI [1])
Onset date of MS relapse
Item
Onset date of MS relapse (Record relapse on Adverse Event page)
date
C0856120 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Treatment with iv methylprednisolone
Item
Was the subject treated with IV methylprednisolone per protocol? (Record on Concomitant Medication form)
boolean
C0013216 (UMLS CUI [1,1])
C0025815 (UMLS CUI [1,2])
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