ID

19935

Beskrivning

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 week 24 and week 48.

Nyckelord

  1. 2017-01-30 2017-01-30 -
  2. 2017-01-31 2017-01-31 -
  3. 2017-01-31 2017-01-31 -
Uppladdad den

31 januari 2017

DOI

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Licens

Creative Commons BY-NC 3.0

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Antibody and Pharmacokinetics Pre- and Post-Dose CRFs Multiple Sclerosis Tysabri NCT00027300

Antibody and Pharmacokinetics Pre- and Post-Dose CRFs Multiple Sclerosis Tysabri NCT00027300

Serum Antibody Testing
Beskrivning

Serum Antibody Testing

Alias
UMLS CUI-1
C3833453
Serum antibody testing
Beskrivning

Serum antibody testing

Datatyp

integer

Alias
UMLS CUI [1,1]
C3833453
UMLS CUI [1,2]
C1516698
PK (Pre-Dose)
Beskrivning

PK (Pre-Dose)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0439565
Blood draw (pre-dose) for pharmacokinetics
Beskrivning

Blood draw (pre-dose) for pharmacokinetics

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C0439565
PK (1 to 3 hours post-dose)
Beskrivning

PK (1 to 3 hours post-dose)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0439568
Blood draw (1 to 3 hours post-dose) for pharmacokinetics
Beskrivning

Blood draw (1 to 3 hours post-dose) for pharmacokinetics

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031327
UMLS CUI [1,3]
C0439568

Similar models

Antibody and Pharmacokinetics Pre- and Post-Dose CRFs Multiple Sclerosis Tysabri NCT00027300

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Serum Antibody Testing
C3833453 (UMLS CUI-1)
Item
Serum antibody testing
integer
C3833453 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
Code List
Serum antibody testing
CL Item
sample collected (1)
CL Item
no sample (2)
Item Group
PK (Pre-Dose)
C0031327 (UMLS CUI-1)
C0439565 (UMLS CUI-2)
Item
Blood draw (pre-dose) for pharmacokinetics
integer
C0005834 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0439565 (UMLS CUI [1,3])
Code List
Blood draw (pre-dose) for pharmacokinetics
CL Item
sample collected (1)
CL Item
no sample (2)
Item Group
PK (1 to 3 hours post-dose)
C0031327 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
Item
Blood draw (1 to 3 hours post-dose) for pharmacokinetics
integer
C0005834 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Code List
Blood draw (1 to 3 hours post-dose) for pharmacokinetics
CL Item
sample collected (1)
CL Item
no sample (2)

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