ID

15787

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. 6/1/16 6/1/16 -
  2. 6/13/16 6/13/16 -
Uploaded on

June 13, 2016

DOI

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License

Creative Commons BY 4.0

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ToFingo Screening V1 Previous and concomitant medication non drug therapies NCT02325440

ToFingo Screening V1 Previous and concomitant medication non drug therapies NCT02325440

Study administration
Description

Study administration

Data entry for this CRF completed
Description

Data entry for this CRF completed

Data type

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Description

Assessment Date

Data type

date

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

Current patient (ID)

Data type

text

Alias
UMLS CUI [1]
C2348585
Previous and concomitant medication
Description

Previous and concomitant medication

Alias
UMLS CUI-1
C0033045
Medication/non-drug therapy
Description

Medication/non-drug therapy

Data type

integer

Alias
UMLS CUI [1]
C0013227
Start date of therapy
Description

Start date of therapy

Data type

date

Alias
UMLS CUI [1]
C1707481
End date of therapy
Description

End date of therapy

Data type

date

Alias
UMLS CUI [1]
C1707480
Single dose/Unit
Description

Single dose/Unit

Data type

float

Measurement units
  • mg
Alias
UMLS CUI [1]
C1960417
mg
Amount/Unit
Description

Amount/Unit

Data type

integer

Frequency/Unit
Description

Frequency/Unit

Data type

integer

Alias
UMLS CUI [1]
C3476109

Similar models

ToFingo Screening V1 Previous and concomitant medication non drug therapies NCT02325440

Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Previous and concomitant medication
C0033045 (UMLS CUI-1)
Medication/non-drug therapy
Item
Medication/non-drug therapy
integer
C0013227 (UMLS CUI [1])
Start date of therapy
Item
Start date of therapy
date
C1707481 (UMLS CUI [1])
End date of therapy
Item
End date of therapy
date
C1707480 (UMLS CUI [1])
Single dose/Unit
Item
Single dose/Unit
float
C1960417 (UMLS CUI [1])
Amount/Unit
Item
Amount/Unit
integer
Frequency/Unit
Item
Frequency/Unit
integer
C3476109 (UMLS CUI [1])

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