ID
15786
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 (3)
- 01-06-16 01-06-16 -
- 03-06-16 03-06-16 -
- 13-06-16 13-06-16 -
Geüploaded op
13 juni 2016
DOI
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Licentie
Creative Commons BY 4.0
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ToFingo Screening V1 Physical examination NCT02325440
ToFingo Screening V1 Physical examination NCT02325440
- StudyEvent: ODM
Beschrijving
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Head and neck: Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0460004
Beschrijving
Head and neck: Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0947611
Beschrijving
Lung: Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Beschrijving
Lung: Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0024109
- UMLS CUI [1,2]
- C0947611
Beschrijving
Skin: Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1123023
Beschrijving
Skin: Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0947611
Beschrijving
Heart: Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Beschrijving
Heart: Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0018787
- UMLS CUI [1,2]
- C0947611
Beschrijving
Abdomen: Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschrijving
Abdomen: Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0000726
- UMLS CUI [1,2]
- C0947611
Beschrijving
General appearance: Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1148438
Beschrijving
General appearance: Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C0947611
Beschrijving
Vitalzeichen
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Sitting pulse rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Beschrijving
Oral temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Beschrijving
systolic blood pressure
Datatype
integer
Maateenheden
- /minute
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- /minute
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Neurological examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Neurological abnormality other than MS
Datatype
text
Alias
- UMLS CUI [1]
- C0027765
Beschrijving
Neurological examination result
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Neurological examination comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0947611
Beschrijving
EDSS Score
Datatype
float
Alias
- UMLS CUI [1]
- C0451246
Beschrijving
MS relapses
Alias
- UMLS CUI-1
- C0856120
Beschrijving
MS exacerbations since last visit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0581392
- UMLS CUI [1,2]
- C2047944
Beschrijving
Steroid therapy used for recent MS relapses
Datatype
text
Alias
- UMLS CUI [1,1]
- C0149783
- UMLS CUI [1,2]
- C0856120
Beschrijving
Laboratory (Blood chemistry/Heamatology)
Alias
- UMLS CUI-1
- C0022877
Beschrijving
ALT-level (GPT)
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
AST-level (GOT)
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
HbA1C
Datatype
float
Maateenheden
- mmol/mol
Alias
- UMLS CUI [1]
- C0019018
Beschrijving
Alkaline phosphatase
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
GGT
Datatype
float
Maateenheden
- U/L
Alias
- UMLS CUI [1]
- C0202035
Beschrijving
Total Bilirubin
Datatype
float
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
WBC
Datatype
float
Maateenheden
- Tsd./uL
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Lymphocytes
Datatype
float
Maateenheden
- Tsd./uL
Alias
- UMLS CUI [1]
- C0200635
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ToFingo Screening V1 Physical examination NCT02325440
- StudyEvent: ODM
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C0947611 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1123023 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0018787 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0000726 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1148438 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0442027 (UMLS CUI [1,2])
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C2047944 (UMLS CUI [1,2])
C0856120 (UMLS CUI [1,2])
Geen commentaren