ID
15786
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)
- 01.06.16 01.06.16 -
- 03.06.16 03.06.16 -
- 13.06.16 13.06.16 -
Hochgeladen am
13. Juni 2016
DOI
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Lizenz
Creative Commons BY 4.0
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ToFingo Screening V1 Physical examination NCT02325440
ToFingo Screening V1 Physical examination NCT02325440
- StudyEvent: ODM
Beschreibung
Physical examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Head and neck: Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0460004
Beschreibung
Head and neck: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0947611
Beschreibung
Lung: Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Beschreibung
Lung: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0024109
- UMLS CUI [1,2]
- C0947611
Beschreibung
Skin: Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1123023
Beschreibung
Skin: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0947611
Beschreibung
Heart: Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Beschreibung
Heart: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0018787
- UMLS CUI [1,2]
- C0947611
Beschreibung
Abdomen: Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Beschreibung
Abdomen: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0000726
- UMLS CUI [1,2]
- C0947611
Beschreibung
General appearance: Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1148438
Beschreibung
General appearance: Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C0947611
Beschreibung
Vitalzeichen
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Body weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Sitting pulse rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Beschreibung
Oral temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Beschreibung
systolic blood pressure
Datentyp
integer
Maßeinheiten
- /minute
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- /minute
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Neurological examination
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Neurological abnormality other than MS
Datentyp
text
Alias
- UMLS CUI [1]
- C0027765
Beschreibung
Neurological examination result
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Neurological examination comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0947611
Beschreibung
EDSS Score
Datentyp
float
Alias
- UMLS CUI [1]
- C0451246
Beschreibung
MS relapses
Alias
- UMLS CUI-1
- C0856120
Beschreibung
MS exacerbations since last visit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0581392
- UMLS CUI [1,2]
- C2047944
Beschreibung
Steroid therapy used for recent MS relapses
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0149783
- UMLS CUI [1,2]
- C0856120
Beschreibung
Laboratory (Blood chemistry/Heamatology)
Alias
- UMLS CUI-1
- C0022877
Beschreibung
ALT-level (GPT)
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
AST-level (GOT)
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
HbA1C
Datentyp
float
Maßeinheiten
- mmol/mol
Alias
- UMLS CUI [1]
- C0019018
Beschreibung
Alkaline phosphatase
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0201850
Beschreibung
GGT
Datentyp
float
Maßeinheiten
- U/L
Alias
- UMLS CUI [1]
- C0202035
Beschreibung
Total Bilirubin
Datentyp
float
Maßeinheiten
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
WBC
Datentyp
float
Maßeinheiten
- Tsd./uL
Alias
- UMLS CUI [1]
- C0023508
Beschreibung
Lymphocytes
Datentyp
float
Maßeinheiten
- Tsd./uL
Alias
- UMLS CUI [1]
- C0200635
Ähnliche Modelle
ToFingo Screening V1 Physical examination NCT02325440
- StudyEvent: ODM
C0460004 (UMLS CUI [1,2])
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])
C0947611 (UMLS CUI [1,2])
C2047944 (UMLS CUI [1,2])
C0856120 (UMLS CUI [1,2])
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