ID

15423

Beschreibung

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

Stichworte

Versionen (1)
  1. 31.05.16 31.05.16 -
Hochgeladen am

31. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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ToFingo V5 Study relevant assessments NCT02325440

Englisch

ToFingo Screening V5 Study relevant assessments NCT02325440

1 Formulare  
Study administration
Beschreibung

Study administration

Data entry for this CRF completed
Beschreibung

Data entry for this CRF completed

Datentyp

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Beschreibung

Assessment Date

Datentyp

date

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

Current patient (ID)

Datentyp

text

Alias
UMLS CUI [1]
C2348585
MRI
Beschreibung

MRI

Alias
UMLS CUI-1
C0024485
MRI performed
Beschreibung

MRT performed

Datentyp

boolean

Alias
UMLS CUI [1]
C0024485
GD+
Beschreibung

Gadolinium enhancement marker for bloodbarrier breakdown

Datentyp

boolean

Alias
UMLS CUI [1]
C0855566
T2w
Beschreibung

T2w

Datentyp

text

Number of GD+ lesions
Beschreibung

Number of GD+ lesions

Datentyp

integer

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

Number of enlarging GD+ lesions

Datentyp

integer

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

Number of new T2w lesions

Datentyp

integer

Number of enlarging T2w lesions
Beschreibung

Number of enlarging T2w lesions

Datentyp

integer

Blood
Beschreibung

Blood

Alias
UMLS CUI-1
C0005767
Peripheral blood taken
Beschreibung

Peripheral blood taken

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date of collection
Beschreibung

Date of collection

Datentyp

date

Alias
UMLS CUI [1]
C2584899
PBMCs isolated
Beschreibung

PBMCs isolated

Datentyp

boolean

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

Date of isolation

Datentyp

date

Alias
UMLS CUI [1]
C2584899
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Ähnliche Modelle

ToFingo Screening V5 Study relevant assessments NCT02325440

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