ID
15423
Beschrijving
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
Trefwoorden
Versies (1)
- 31-05-16 31-05-16 -
Geüploaded op
31 mei 2016
DOI
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Licentie
Creative Commons BY 4.0
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ToFingo V5 Study relevant assessments NCT02325440
ToFingo Screening V5 Study relevant assessments NCT02325440
- StudyEvent: ODM
Beschrijving
MRI
Alias
- UMLS CUI-1
- C0024485
Beschrijving
MRT performed
Datatype
boolean
Alias
- UMLS CUI [1]
- C0024485
Beschrijving
Gadolinium enhancement marker for bloodbarrier breakdown
Datatype
boolean
Alias
- UMLS CUI [1]
- C0855566
Beschrijving
T2w
Datatype
text
Beschrijving
Number of GD+ lesions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1333400
- UMLS CUI [1,2]
- C0449788
Beschrijving
Number of enlarging GD+ lesions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1333400
- UMLS CUI [1,2]
- C0442800
- UMLS CUI [1,3]
- C0449788
Beschrijving
Number of new T2w lesions
Datatype
integer
Beschrijving
Number of enlarging T2w lesions
Datatype
integer
Beschrijving
Blood
Alias
- UMLS CUI-1
- C0005767
Beschrijving
Peripheral blood taken
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Date of collection
Datatype
date
Alias
- UMLS CUI [1]
- C2584899
Beschrijving
PBMCs isolated
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321301
- UMLS CUI [1,2]
- C0185115
Beschrijving
Date of isolation
Datatype
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])