ID

15343

Description

Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

Link

https://clinicaltrials.gov/ct2/show/NCT02325440

Keywords

Versions (3)
  1. 5/27/16 5/27/16 -
  2. 5/31/16 5/31/16 -
  3. 5/31/16 5/31/16 -
Uploaded on

May 27, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0 Legacy
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.

Back to model comments
Itemgroup comments for :

Item comments for :

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

ToFingo Screening V1 Pre-examination NCT02325440

English

ToFingo Screening V1 Pre-examination NCT02325440

1 forms  
Other
Description

Other

Alias
UMLS CUI-1
C0205394
Data entry for this CRF completed
Description

Data entry for this CRF completed

Data type

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Current patient (ID)
Description

Current patient (ID)

Data type

text

Alias
UMLS CUI [1]
C2348585
MSFC (Multiple Sclerosis Functional Composite Measure)
Description

MSFC (Multiple Sclerosis Functional Composite Measure)

Alias
UMLS CUI-1
C0026769
UMLS CUI-2
C0449820
Endscore
Description

Endscore

Data type

integer

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0449820
Last natalizumab dose
Description

Last natalizumab dose

Alias
UMLS CUI-1
C1762893
UMLS CUI-2
C1172734
Last natalizumab dose taken (300mg)
Description

Last natalizumab dose taken (300mg)

Data type

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1172734
Ophthalmologic examination
Description

Ophthalmologic examination

Alias
UMLS CUI-1
C0200149
Opthalmologic examination: Result
Description

Opthalmologic examination: Result

Data type

text

Alias
UMLS CUI [1]
C0200149
Opthalmologic examination: Comment
Description

Opthalmologic examination: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0947611
History of uveitis or diabetes mellitus: Result
Description

History of uveitis or diabetes melitus: Result

Data type

text

Alias
UMLS CUI [1]
C0042164|C0011849
History of uveitis or diabetes mellitus: Comment
Description

History of uveitis or diabetes mellitus: Comment

Data type

text

Alias
UMLS CUI [1,1]
C0042164|C0011849
UMLS CUI [1,2]
C0947611
Abnormalities: Result
Description

Abnormalities: Result

Data type

text

Alias
UMLS CUI [1]
C1704258
Abnormalities: Comment
Description

Abnormalities: Comment

Data type

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0947611
Back to the top of the page

Similar models

ToFingo Screening V1 Pre-examination NCT02325440

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Other
C0205394 (UMLS CUI-1)
Data entry for this CRF completed
Item
Data entry for this CRF completed
boolean
C3899518 (UMLS CUI [1])
Assessment Date
Item
Assessment date
date
C0011008 (UMLS CUI [1])
Current patient (ID)
Item
Current patient (ID)
text
C2348585 (UMLS CUI [1])
Item Group
MSFC (Multiple Sclerosis Functional Composite Measure)
C0026769 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
Endscore
Item
Endscore
integer
C0026769 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Last natalizumab dose
C1762893 (UMLS CUI-1)
C1172734 (UMLS CUI-2)
Last natalizumab dose taken (300mg)
Item
Last natalizumab dose taken (300mg)
date
C1762893 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Item Group
Ophthalmologic examination
C0200149 (UMLS CUI-1)
Opthalmologic examination: Result
Item
Opthalmologic examination: Result
text
C0200149 (UMLS CUI [1])
Opthalmologic examination: Comment
Item
Opthalmologic examination: Comment
text
C0200149 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
History of uveitis or diabetes melitus: Result
Item
History of uveitis or diabetes mellitus: Result
text
C0042164|C0011849 (UMLS CUI [1])
History of uveitis or diabetes mellitus: Comment
Item
History of uveitis or diabetes mellitus: Comment
text
C0042164|C0011849 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Abnormalities: Result
Item
Abnormalities: Result
text
C1704258 (UMLS CUI [1])
Abnormalities: Comment
Item
Abnormalities: Comment
text
C1704258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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