ID
15336
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 (6)
- 2016-05-27 2016-05-27 -
- 2016-05-27 2016-05-27 -
- 2016-05-27 2016-05-27 -
- 2016-05-27 2016-05-27 -
- 2016-05-30 2016-05-30 - Julian Varghese
- 2016-05-31 2016-05-31 -
Uppladdad den
27 maj 2016
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
ToFingo Screening V1 Patient Information Background Information NCT02325440
ToFingo Screening V1 Patient Information Background Information NCT02325440
Beskrivning
Patient information
Alias
- UMLS CUI-1
- C1955348
Beskrivning
Last name
Datatyp
text
Alias
- UMLS CUI [1]
- C0421448
Beskrivning
First name
Datatyp
text
Alias
- UMLS CUI [1]
- C1443235
Beskrivning
Sex
Datatyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Date of birth
Datatyp
date
Alias
- UMLS CUI [1]
- C0421451
Beskrivning
Screening failure
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1512714
Beskrivning
Specify reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1512714
- UMLS CUI [1,2]
- C0566251
Beskrivning
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beskrivning
Informed consent (Study)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
Date of Informed consent (Study)
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beskrivning
Informed consent lumbal puncture (optional)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
Beskrivning
Date of Informed Consent lumbar puncture
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
- UMLS CUI [1,3]
- C0001108
Beskrivning
Relevant medical history/current medical conditions
Alias
- UMLS CUI-1
- C0262926
Beskrivning
Diagnosis/Surgery
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900|C0543467
Beskrivning
Date of Diagnosis/Surgery
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011900|C0543467
- UMLS CUI [1,2]
- C0011008
Beskrivning
Active at start of study
Datatyp
boolean
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
MS history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026769
Beskrivning
Date of confirmed MS diagnosis
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0011008
Beskrivning
Date of first MS symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Beskrivning
Previous MS therapies received
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C3539076
Beskrivning
if yes, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C4020596
Beskrivning
if other, please specify
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
ToFingo Screening V1 Patient Information Background Information NCT02325440
C0566251 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0037943 (UMLS CUI [1,2])
C0037943 (UMLS CUI [1,2])
C0001108 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C3539076 (UMLS CUI [1,2])