ID

15423

Beskrivning

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

Länk

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

Nyckelord

Versioner (1)
  1. 2016-05-31 2016-05-31 -
Uppladdad den

31 maj 2016

DOI

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Licens

Creative Commons BY 4.0
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ToFingo V5 Study relevant assessments NCT02325440

Engelsk

ToFingo Screening V5 Study relevant assessments NCT02325440

1 Formulär  
Study administration
Beskrivning

Study administration

Data entry for this CRF completed
Beskrivning

Data entry for this CRF completed

Datatyp

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Beskrivning

Assessment Date

Datatyp

date

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

Current patient (ID)

Datatyp

text

Alias
UMLS CUI [1]
C2348585
MRI
Beskrivning

MRI

Alias
UMLS CUI-1
C0024485
MRI performed
Beskrivning

MRT performed

Datatyp

boolean

Alias
UMLS CUI [1]
C0024485
GD+
Beskrivning

Gadolinium enhancement marker for bloodbarrier breakdown

Datatyp

boolean

Alias
UMLS CUI [1]
C0855566
T2w
Beskrivning

T2w

Datatyp

text

Number of GD+ lesions
Beskrivning

Number of GD+ lesions

Datatyp

integer

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

Number of enlarging GD+ lesions

Datatyp

integer

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

Number of new T2w lesions

Datatyp

integer

Number of enlarging T2w lesions
Beskrivning

Number of enlarging T2w lesions

Datatyp

integer

Blood
Beskrivning

Blood

Alias
UMLS CUI-1
C0005767
Peripheral blood taken
Beskrivning

Peripheral blood taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date of collection
Beskrivning

Date of collection

Datatyp

date

Alias
UMLS CUI [1]
C2584899
PBMCs isolated
Beskrivning

PBMCs isolated

Datatyp

boolean

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

Date of isolation

Datatyp

date

Alias
UMLS CUI [1]
C2584899
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Similar models

ToFingo Screening V5 Study relevant assessments NCT02325440

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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