ID

19910

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.

Keywords

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

January 30, 2017

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License

Creative Commons BY-NC 3.0
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MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

English

MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
MS Diagnostic Criteria
Description

MS Diagnostic Criteria

Alias
UMLS CUI-1
C0026769
UMLS CUI-2
C0679228
2 or more clinical attacks; 2 or more objective Lesions; none additional Requirements to Make Diagnosis: clinical evidence will suffice (additional evidence desirable but must be consistent with MS.)
Description

1. 2 or more clinical attacks, 2 or more objective Lesions and none additional Requirements

Data type

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
2 or more clinical attacks; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination is SPACE by MRI OR positive CSF and 2 more MRI lesions constant wit MS OR further clinical attack involving different site
Description

2.. 2 or more clinical attacks, 1 objective Lesion and Dissemination in space

Data type

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
1 clinical attack; 2 or more objective Lesions; Additional Requirements to Make Diagnosis: Dissemination in TIME by MRI OR second clinical attack
Description

3. 1 clinical attack, 2 or more objective Lesions and Dissemination in time

Data type

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
1 (monosymptomatic) clinical attack; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination in SPACE by MRI OR positive CSF and 2 or more MRI lesions consitent with MS AND Dissemination in TIME by MRI OR second clinical attack
Description

4. 1 clinical attack, 1 objective Lesion and Dissemination in space AND time

Data type

integer

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0221198
UMLS CUI [3,1]
C3887511
UMLS CUI [3,2]
C0205210
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Similar models

MS Diagnostic Criteria CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
MS Diagnostic Criteria
C0026769 (UMLS CUI-1)
C0679228 (UMLS CUI-2)
1. 2 or more clinical attacks, 2 or more objective Lesions and none additional Requirements
Item
2 or more clinical attacks; 2 or more objective Lesions; none additional Requirements to Make Diagnosis: clinical evidence will suffice (additional evidence desirable but must be consistent with MS.)
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
2.. 2 or more clinical attacks, 1 objective Lesion and Dissemination in space
Item
2 or more clinical attacks; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination is SPACE by MRI OR positive CSF and 2 more MRI lesions constant wit MS OR further clinical attack involving different site
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
3. 1 clinical attack, 2 or more objective Lesions and Dissemination in time
Item
1 clinical attack; 2 or more objective Lesions; Additional Requirements to Make Diagnosis: Dissemination in TIME by MRI OR second clinical attack
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
4. 1 clinical attack, 1 objective Lesion and Dissemination in space AND time
Item
1 (monosymptomatic) clinical attack; 1 objective Lesion; Additional Requirements to Make Diagnosis: Dissemination in SPACE by MRI OR positive CSF and 2 or more MRI lesions consitent with MS AND Dissemination in TIME by MRI OR second clinical attack
integer
C0026769 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C3887511 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
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