ID

19935

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 week 24 and week 48.

Keywords

  1. 1/30/17 1/30/17 -
  2. 1/31/17 1/31/17 -
  3. 1/31/17 1/31/17 -
Uploaded on

January 31, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


No comments

In order to download data models you must be logged in. Please log in or register for free.

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
Description

Serum Antibody Testing

Alias
UMLS CUI-1
C3833453
Serum antibody testing
Description

Serum antibody testing

Data type

integer

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

PK (Pre-Dose)

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

Blood draw (pre-dose) for pharmacokinetics

Data type

integer

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

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
Description

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

Data type

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
Type
Description | Question | Decode (Coded Value)
Data type
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)

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial