ID

19881

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. Documentation process: This form is to be obtained in Screening, Baseline week 0, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96, week 108, week 120, week 128 and in Premature Study Withdrawl.

Keywords

  1. 1/30/17 1/30/17 -
Uploaded on

January 30, 2017

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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EDSS CRFs Multiple Sclerosis Tysabri NCT00027300

EDSS CRFs Multiple Sclerosis Tysabri NCT00027300

EDSS Evaluation
Description

EDSS Evaluation

Alias
UMLS CUI-1
C0451246
UMLS CUI-2
C1321512
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 sensory

Data type

float

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0682648
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

Similar models

EDSS CRFs Multiple Sclerosis Tysabri NCT00027300

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
EDSS Evaluation
C0451246 (UMLS CUI-1)
C1321512 (UMLS CUI-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 sensory
Item
EDSS sensory
float
C0451246 (UMLS CUI [1,1])
C0682648 (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])
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])

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