ID
15336
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 (6)
- 27-05-16 27-05-16 -
- 27-05-16 27-05-16 -
- 27-05-16 27-05-16 -
- 27-05-16 27-05-16 -
- 30-05-16 30-05-16 - Julian Varghese
- 31-05-16 31-05-16 -
Geüploaded op
27 mei 2016
DOI
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Licentie
Creative Commons BY-NC 3.0
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ToFingo Screening V1 Patient Information Background Information NCT02325440
ToFingo Screening V1 Patient Information Background Information NCT02325440
Beschrijving
Patient information
Alias
- UMLS CUI-1
- C1955348
Beschrijving
Last name
Datatype
text
Alias
- UMLS CUI [1]
- C0421448
Beschrijving
First name
Datatype
text
Alias
- UMLS CUI [1]
- C1443235
Beschrijving
Sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Screening failure
Datatype
boolean
Alias
- UMLS CUI [1]
- C1512714
Beschrijving
Specify reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C1512714
- UMLS CUI [1,2]
- C0566251
Beschrijving
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
Informed consent (Study)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Date of Informed consent (Study)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beschrijving
Informed consent lumbal puncture (optional)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
Beschrijving
Date of Informed Consent lumbar puncture
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0037943
- UMLS CUI [1,3]
- C0001108
Beschrijving
Relevant medical history/current medical conditions
Alias
- UMLS CUI-1
- C0262926
Beschrijving
Diagnosis/Surgery
Datatype
text
Alias
- UMLS CUI [1]
- C0011900|C0543467
Beschrijving
Date of Diagnosis/Surgery
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011900|C0543467
- UMLS CUI [1,2]
- C0011008
Beschrijving
Active at start of study
Datatype
boolean
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
MS history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0026769
Beschrijving
Date of confirmed MS diagnosis
Datatype
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C0011900
- UMLS CUI [1,3]
- C0011008
Beschrijving
Date of first MS symptoms
Datatype
date
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011008
Beschrijving
Previous MS therapies received
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0026769
- UMLS CUI [1,2]
- C3539076
Beschrijving
if yes, please specify
Datatype
text
Alias
- UMLS CUI [1]
- C4020596
Beschrijving
if other, please specify
Datatype
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])