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)
- 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
ToFingo Screening V5 Study relevant assessments NCT02325440
- StudyEvent: ODM
Beskrivning
MRI
Alias
- UMLS CUI-1
- C0024485
Beskrivning
MRT performed
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0024485
Beskrivning
Gadolinium enhancement marker for bloodbarrier breakdown
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0855566
Beskrivning
T2w
Datatyp
text
Beskrivning
Number of GD+ lesions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1333400
- UMLS CUI [1,2]
- C0449788
Beskrivning
Number of enlarging GD+ lesions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1333400
- UMLS CUI [1,2]
- C0442800
- UMLS CUI [1,3]
- C0449788
Beskrivning
Number of new T2w lesions
Datatyp
integer
Beskrivning
Number of enlarging T2w lesions
Datatyp
integer
Beskrivning
Blood
Alias
- UMLS CUI-1
- C0005767
Beskrivning
Peripheral blood taken
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beskrivning
Date of collection
Datatyp
date
Alias
- UMLS CUI [1]
- C2584899
Beskrivning
PBMCs isolated
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1321301
- UMLS CUI [1,2]
- C0185115
Beskrivning
Date of isolation
Datatyp
date
Alias
- UMLS CUI [1]
- C2584899
Similar models
ToFingo Screening V5 Study relevant assessments NCT02325440
- StudyEvent: ODM
C0449788 (UMLS CUI [1,2])
C0442800 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
C0185115 (UMLS CUI [1,2])