ID

19908

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 s to be obtained in (Dose 1) week 0 and (Dose 6) week 20.

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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Intensive PK and PD CRFs Multiple Sclerosis Tysabri NCT00027300

English

Intensive PK and PD CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
Pharmacokinetics
Description

Pharmacokinetics

Alias
UMLS CUI-1
C0031327
1. Pre-infusion
Description

1. Pre-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C0585032
2. Immediately post-infusion
Description

2. Immediately post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
3. 2 hours +/- 15 minutes post-infusion
Description

3. 2 hours +/- 15 minutes post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C4035164
4. 24 hours +/- 1 hour post-infusion
Description

4. 24 hours +/- 1 hour post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C1442770
5. 1 week +/- 4 hours post-infusion
Description

5. 1 week +/- 4 hours post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C1547085
6. 2 weeks +/- 4 hours post-infusion
Description

6. 2 weeks +/- 4 hours post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
7. 3 weeks +/- 4 hours post-infusion
Description

7. 3 weeks +/- 4 hours post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
8. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)
Description

8. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
Pharmacodynamics (alpha4 Integrin Saturation)
Description

Pharmacodynamics (alpha4 Integrin Saturation)

Alias
UMLS CUI-1
C0851347
1. Pre-infusion
Description

1. Pre-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C0585032
2. 2 hours +/- 15 minutes post-infusion
Description

2. 2 hours +/- 15 minutes post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C4035164
3. 1 week +/- 4 hours post-infusion
Description

3. 1 week +/- 4 hours post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C1547085
4. 2 weeks +/- 4 hours post-infusion
Description

4. 2 weeks +/- 4 hours post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
5. 3 weeks +/- 4 hours post-infusion
Description

5. 3 weeks +/- 4 hours post-infusion

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
6. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)
Description

6. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)

Data type

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
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Similar models

Intensive PK and PD CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Pharmacokinetics
C0031327 (UMLS CUI-1)
Item
1. Pre-infusion
integer
C0021440 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
Line number
Code List
1. Pre-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
2. Immediately post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
Line number
Code List
2. Immediately post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
3. 2 hours +/- 15 minutes post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C4035164 (UMLS CUI [1,3])
Line number
Code List
3. 2 hours +/- 15 minutes post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
4. 24 hours +/- 1 hour post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C1442770 (UMLS CUI [1,3])
Line number
Code List
4. 24 hours +/- 1 hour post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
5. 1 week +/- 4 hours post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C1547085 (UMLS CUI [1,3])
Line number
Code List
5. 1 week +/- 4 hours post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
6. 2 weeks +/- 4 hours post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
Line number
Code List
6. 2 weeks +/- 4 hours post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
7. 3 weeks +/- 4 hours post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
Line number
Code List
7. 3 weeks +/- 4 hours post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
8. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
Line number
Code List
8. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item Group
Pharmacodynamics (alpha4 Integrin Saturation)
C0851347 (UMLS CUI-1)
Item
1. Pre-infusion
integer
C0021440 (UMLS CUI [1,1])
C0585032 (UMLS CUI [1,2])
Line number
Code List
1. Pre-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
2. 2 hours +/- 15 minutes post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C4035164 (UMLS CUI [1,3])
Line number
Code List
2. 2 hours +/- 15 minutes post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
3. 1 week +/- 4 hours post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C1547085 (UMLS CUI [1,3])
Line number
Code List
3. 1 week +/- 4 hours post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
4. 2 weeks +/- 4 hours post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
Line number
Code List
4. 2 weeks +/- 4 hours post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
5. 3 weeks +/- 4 hours post-infusion
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
Line number
Code List
5. 3 weeks +/- 4 hours post-infusion
CL Item
Sample Collected (1)
CL Item
No Sample (2)
Item
6. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)
integer
C0021440 (UMLS CUI [1,1])
C3272301 (UMLS CUI [1,2])
C0439230 (UMLS CUI [1,3])
Line number
Code List
6. 4 weeks +/- 1 day post-infusion (prior to infusion dose #7)
CL Item
Sample Collected (1)
CL Item
No Sample (2)
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