ID

15423

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 (1)
  1. 5/31/16 5/31/16 -
Uploaded on

May 31, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
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.

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 V5 Study relevant assessments NCT02325440

English

ToFingo Screening V5 Study relevant assessments NCT02325440

1 forms  
Study administration
Description

Study administration

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
MRI
Description

MRI

Alias
UMLS CUI-1
C0024485
MRI performed
Description

MRT performed

Data type

boolean

Alias
UMLS CUI [1]
C0024485
GD+
Description

Gadolinium enhancement marker for bloodbarrier breakdown

Data type

boolean

Alias
UMLS CUI [1]
C0855566
T2w
Description

T2w

Data type

text

Number of GD+ lesions
Description

Number of GD+ lesions

Data type

integer

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C0449788
Number of enlarging GD+ lesions
Description

Number of enlarging GD+ lesions

Data type

integer

Alias
UMLS CUI [1,1]
C1333400
UMLS CUI [1,2]
C0442800
UMLS CUI [1,3]
C0449788
Number of new T2w lesions
Description

Number of new T2w lesions

Data type

integer

Number of enlarging T2w lesions
Description

Number of enlarging T2w lesions

Data type

integer

Blood
Description

Blood

Alias
UMLS CUI-1
C0005767
Peripheral blood taken
Description

Peripheral blood taken

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date of collection
Description

Date of collection

Data type

date

Alias
UMLS CUI [1]
C2584899
PBMCs isolated
Description

PBMCs isolated

Data type

boolean

Alias
UMLS CUI [1,1]
C1321301
UMLS CUI [1,2]
C0185115
Date of isolation
Description

Date of isolation

Data type

date

Alias
UMLS CUI [1]
C2584899
Back to the top of the page

Similar models

ToFingo Screening V5 Study relevant assessments NCT02325440

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Study administration
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
MRI
C0024485 (UMLS CUI-1)
MRT performed
Item
MRI performed
boolean
C0024485 (UMLS CUI [1])
GD+
Item
GD+
boolean
C0855566 (UMLS CUI [1])
T2w
Item
T2w
text
Number of GD+ lesions
Item
Number of GD+ lesions
integer
C1333400 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of enlarging GD+ lesions
Item
Number of enlarging GD+ lesions
integer
C1333400 (UMLS CUI [1,1])
C0442800 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Number of new T2w lesions
Item
Number of new T2w lesions
integer
Number of enlarging T2w lesions
Item
Number of enlarging T2w lesions
integer
Item Group
Blood
C0005767 (UMLS CUI-1)
Peripheral blood taken
Item
Peripheral blood taken
boolean
C0005834 (UMLS CUI [1])
Date of collection
Item
Date of collection
date
C2584899 (UMLS CUI [1])
PBMCs isolated
Item
PBMCs isolated
boolean
C1321301 (UMLS CUI [1,1])
C0185115 (UMLS CUI [1,2])
Date of isolation
Item
Date of isolation
date
C2584899 (UMLS CUI [1])
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