ID

15343

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 (3)
  1. 27.05.16 27.05.16 -
  2. 31.05.16 31.05.16 -
  3. 31.05.16 31.05.16 -
Hochgeladen am

27. Mai 2016

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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ToFingo Screening V1 Pre-examination NCT02325440

Englisch

ToFingo Screening V1 Pre-examination NCT02325440

1 Formulare  
Other
Beschreibung

Other

Alias
UMLS CUI-1
C0205394
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
MSFC (Multiple Sclerosis Functional Composite Measure)
Beschreibung

MSFC (Multiple Sclerosis Functional Composite Measure)

Alias
UMLS CUI-1
C0026769
UMLS CUI-2
C0449820
Endscore
Beschreibung

Endscore

Datentyp

integer

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0449820
Last natalizumab dose
Beschreibung

Last natalizumab dose

Alias
UMLS CUI-1
C1762893
UMLS CUI-2
C1172734
Last natalizumab dose taken (300mg)
Beschreibung

Last natalizumab dose taken (300mg)

Datentyp

date

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1172734
Ophthalmologic examination
Beschreibung

Ophthalmologic examination

Alias
UMLS CUI-1
C0200149
Opthalmologic examination: Result
Beschreibung

Opthalmologic examination: Result

Datentyp

text

Alias
UMLS CUI [1]
C0200149
Opthalmologic examination: Comment
Beschreibung

Opthalmologic examination: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0200149
UMLS CUI [1,2]
C0947611
History of uveitis or diabetes mellitus: Result
Beschreibung

History of uveitis or diabetes melitus: Result

Datentyp

text

Alias
UMLS CUI [1]
C0042164|C0011849
History of uveitis or diabetes mellitus: Comment
Beschreibung

History of uveitis or diabetes mellitus: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C0042164|C0011849
UMLS CUI [1,2]
C0947611
Abnormalities: Result
Beschreibung

Abnormalities: Result

Datentyp

text

Alias
UMLS CUI [1]
C1704258
Abnormalities: Comment
Beschreibung

Abnormalities: Comment

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0947611
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Ähnliche Modelle

ToFingo Screening V1 Pre-examination NCT02325440

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Other
C0205394 (UMLS CUI-1)
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
MSFC (Multiple Sclerosis Functional Composite Measure)
C0026769 (UMLS CUI-1)
C0449820 (UMLS CUI-2)
Endscore
Item
Endscore
integer
C0026769 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Last natalizumab dose
C1762893 (UMLS CUI-1)
C1172734 (UMLS CUI-2)
Last natalizumab dose taken (300mg)
Item
Last natalizumab dose taken (300mg)
date
C1762893 (UMLS CUI [1,1])
C1172734 (UMLS CUI [1,2])
Item Group
Ophthalmologic examination
C0200149 (UMLS CUI-1)
Opthalmologic examination: Result
Item
Opthalmologic examination: Result
text
C0200149 (UMLS CUI [1])
Opthalmologic examination: Comment
Item
Opthalmologic examination: Comment
text
C0200149 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
History of uveitis or diabetes melitus: Result
Item
History of uveitis or diabetes mellitus: Result
text
C0042164|C0011849 (UMLS CUI [1])
History of uveitis or diabetes mellitus: Comment
Item
History of uveitis or diabetes mellitus: Comment
text
C0042164|C0011849 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Abnormalities: Result
Item
Abnormalities: Result
text
C1704258 (UMLS CUI [1])
Abnormalities: Comment
Item
Abnormalities: Comment
text
C1704258 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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