ID

19908

Beschreibung

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.

Stichworte

Versionen (1)
  1. 30.01.17 30.01.17 -
Hochgeladen am

30. Januar 2017

DOI

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Intensive PK and PD CRFs Multiple Sclerosis Tysabri NCT00027300

Englisch

Intensive PK and PD CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare  
Pharmacokinetics
Beschreibung

Pharmacokinetics

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

1. Pre-infusion

Datentyp

integer

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

2. Immediately post-infusion

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

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)
Beschreibung

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

Datentyp

integer

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

Pharmacodynamics (alpha4 Integrin Saturation)

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

1. Pre-infusion

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

integer

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

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

Datentyp

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)
Beschreibung

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021440
UMLS CUI [1,2]
C3272301
UMLS CUI [1,3]
C0439230
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Ähnliche Modelle

Intensive PK and PD CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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