ID
15786
Description
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
Lien
https://clinicaltrials.gov/ct2/show/NCT02325440
Mots-clés
Versions (3)
- 01/06/2016 01/06/2016 -
- 03/06/2016 03/06/2016 -
- 13/06/2016 13/06/2016 -
Téléchargé le
13 juin 2016
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
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ToFingo Screening V1 Physical examination NCT02325440
ToFingo Screening V1 Physical examination NCT02325440
- StudyEvent: ODM
Description
Physical examination
Alias
- UMLS CUI-1
- C0031809
Description
Head and neck: Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0460004
Description
Head and neck: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0460004
- UMLS CUI [1,2]
- C0947611
Description
Lung: Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0024109
Description
Lung: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0024109
- UMLS CUI [1,2]
- C0947611
Description
Skin: Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1123023
Description
Skin: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C1123023
- UMLS CUI [1,2]
- C0947611
Description
Heart: Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0018787
Description
Heart: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0018787
- UMLS CUI [1,2]
- C0947611
Description
Abdomen: Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0000726
Description
Abdomen: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0000726
- UMLS CUI [1,2]
- C0947611
Description
General appearance: Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C1148438
Description
General appearance: Comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C1148438
- UMLS CUI [1,2]
- C0947611
Description
Vitalzeichen
Alias
- UMLS CUI-1
- C0518766
Description
Body Height
Type de données
integer
Unités de mesure
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Sitting pulse rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0277814
Description
Oral temperature
Type de données
float
Unités de mesure
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0442027
Description
systolic blood pressure
Type de données
integer
Unités de mesure
- /minute
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Type de données
integer
Unités de mesure
- /minute
Alias
- UMLS CUI [1]
- C0428883
Description
Neurological examination
Alias
- UMLS CUI-1
- C0027853
Description
Neurological abnormality other than MS
Type de données
text
Alias
- UMLS CUI [1]
- C0027765
Description
Neurological examination result
Type de données
text
Alias
- UMLS CUI [1]
- C0027853
Description
Neurological examination comment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0947611
Description
EDSS Score
Type de données
float
Alias
- UMLS CUI [1]
- C0451246
Description
MS relapses
Alias
- UMLS CUI-1
- C0856120
Description
MS exacerbations since last visit
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0581392
- UMLS CUI [1,2]
- C2047944
Description
Steroid therapy used for recent MS relapses
Type de données
text
Alias
- UMLS CUI [1,1]
- C0149783
- UMLS CUI [1,2]
- C0856120
Description
Laboratory (Blood chemistry/Heamatology)
Alias
- UMLS CUI-1
- C0022877
Description
ALT-level (GPT)
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
AST-level (GOT)
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
HbA1C
Type de données
float
Unités de mesure
- mmol/mol
Alias
- UMLS CUI [1]
- C0019018
Description
Alkaline phosphatase
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
GGT
Type de données
float
Unités de mesure
- U/L
Alias
- UMLS CUI [1]
- C0202035
Description
Total Bilirubin
Type de données
float
Unités de mesure
- mg/dL
Alias
- UMLS CUI [1]
- C0201913
Description
WBC
Type de données
float
Unités de mesure
- Tsd./uL
Alias
- UMLS CUI [1]
- C0023508
Description
Lymphocytes
Type de données
float
Unités de mesure
- Tsd./uL
Alias
- UMLS CUI [1]
- C0200635
Similar models
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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