ID

15580

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

  1. 6/3/16 6/3/16 -
Uploaded on

June 3, 2016

DOI

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License

Creative Commons BY 4.0

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ToFingo Screening V1 Adverse Event NCT02325440

ToFingo Screening V1 Adverse Event NCT02325440

Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Adverse Event
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
AE Start date
Description

AE Start date

Data type

date

Alias
UMLS CUI [1]
C2697888
AE meets definition of SAE
Description

AE meets definition of SAE

Data type

boolean

Alias
UMLS CUI [1]
C1519255
SAE-ID
Description

SAE-ID

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1300638

Similar models

ToFingo Screening V1 Adverse Event NCT02325440

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
AE Start date
Item
AE Start date
date
C2697888 (UMLS CUI [1])
AE meets definition of SAE
Item
AE meets definition of SAE
boolean
C1519255 (UMLS CUI [1])
SAE-ID
Item
SAE-ID
integer
C1519255 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])

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