ID

19762

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 ist to be obtained in Screening

Keywords

Versions (1)
  1. 1/27/17 1/27/17 -
Uploaded on

January 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Treatment History CRFs Multiple Sclerosis Tysabri NCT00027300

English

Treatment History CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms  
MS Treatment History
Description

MS Treatment History

Alias
UMLS CUI-1
C0814462
UMLS CUI-2
C0026769
Has subject received any of the therapies listed below for treatment of MS since the subject was diagnosed with MS?
Description

further received therapies

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0026769
If "YES" provide details.
Description

If "YES" provide details.

Data type

text

Therapy
Description

Therapy

Data type

integer

Alias
UMLS CUI [1]
C0087111
previously received?
Description

previously received

Data type

boolean

Alias
UMLS CUI [1]
C1514463
Duration of Most Recent Treatment (specify number of days, weeks, or month)*
Description

*Do NOT include steroids taken for non-MS conditions. Do NOT include IV steroids taken for relapse. Only include chronic steroid treatment taken for MS (e.g. booster therapy).

Data type

float

Alias
UMLS CUI [1]
C0449238
UMLS CUI [2]
C0439228
UMLS CUI [3]
C0439230
UMLS CUI [4]
C0439231
Date of last dose
Description

Last Dose

Data type

date

Alias
UMLS CUI [1]
C1762893
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Similar models

Treatment History CRFs Multiple Sclerosis Tysabri NCT00027300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
MS Treatment History
C0814462 (UMLS CUI-1)
C0026769 (UMLS CUI-2)
further received therapies
Item
Has subject received any of the therapies listed below for treatment of MS since the subject was diagnosed with MS?
boolean
C1514463 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
If "YES" provide details.
Item
If "YES" provide details.
text
Item
Therapy
integer
C0087111 (UMLS CUI [1])
Theraphy
Code List
Therapy
CL Item
4-Aminopyridine fapridine (4-AP) (1)
CL Item
Azathioprine (2)
CL Item
Cyclophosphamide (3)
CL Item
Cyclosporine (4)
CL Item
Glatiramer acetate (5)
CL Item
Intraveneous immunoglobin (IVIG) (6)
CL Item
Linomide (7)
CL Item
Methotrexate (8)
CL Item
Mitoxantrone (9)
CL Item
Plasmapheresis or cytapheresis (10)
CL Item
Steroids (Do NOT record in shaded areas.)** (11)
CL Item
Interferon beta-1a (specify trade name) (12)
CL Item
Interferon beta-1b (specify trade name) (13)
CL Item
Other (14)
CL Item
Other (15)
previously received
Item
previously received?
boolean
C1514463 (UMLS CUI [1])
Duration
Item
Duration of Most Recent Treatment (specify number of days, weeks, or month)*
float
C0449238 (UMLS CUI [1])
C0439228 (UMLS CUI [2])
C0439230 (UMLS CUI [3])
C0439231 (UMLS CUI [4])
Last Dose
Item
Date of last dose
date
C1762893 (UMLS CUI [1])
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