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)
  1. 01-06-16 01-06-16 -
  2. 03-06-16 03-06-16 -
  3. 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

Duits Engels

ToFingo Screening V1 Physical examination NCT02325440

1 Formulieren  
Study administration
Beschrijving

Study administration

Data entry for this CRF completed
Beschrijving

Data entry for this CRF completed

Datatype

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Beschrijving

Assessment Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Current patient (ID)
Beschrijving

Current patient (ID)

Datatype

text

Alias
UMLS CUI [1]
C2348585
Physical examination
Beschrijving

Physical examination

Alias
UMLS CUI-1
C0031809
Head and neck: Result
Beschrijving

Head and neck: Result

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0460004
Head and neck: Comment
Beschrijving

Head and neck: Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0460004
UMLS CUI [1,2]
C0947611
Lung: Result
Beschrijving

Lung: Result

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0024109
Lung: Comment
Beschrijving

Lung: Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0947611
Skin: Result
Beschrijving

Skin: Result

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1123023
Skin: Comment
Beschrijving

Skin: Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1123023
UMLS CUI [1,2]
C0947611
Heart: Result
Beschrijving

Heart: Result

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0018787
Heart: Comment
Beschrijving

Heart: Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0018787
UMLS CUI [1,2]
C0947611
Abdomen: Result
Beschrijving

Abdomen: Result

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0000726
Abdomen: Comment
Beschrijving

Abdomen: Comment

Datatype

text

Alias
UMLS CUI [1,1]
C0000726
UMLS CUI [1,2]
C0947611
General appearance: Result
Beschrijving

General appearance: Result

Datatype

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1148438
General appearance: Comment
Beschrijving

General appearance: Comment

Datatype

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C0947611
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Body Height
Beschrijving

Body Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Beschrijving

Body weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting pulse rate
Beschrijving

Sitting pulse rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
bpm
Oral temperature
Beschrijving

Oral temperature

Datatype

float

Maateenheden
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
systolic blood pressure
Beschrijving

systolic blood pressure

Datatype

integer

Maateenheden
  • /minute
Alias
UMLS CUI [1]
C0871470
/minute
Diastolic blood pressure
Beschrijving

Diastolic blood pressure

Datatype

integer

Maateenheden
  • /minute
Alias
UMLS CUI [1]
C0428883
/minute
Neurological examination
Beschrijving

Neurological examination

Alias
UMLS CUI-1
C0027853
Neurological abnormality other than MS
Beschrijving

Neurological abnormality other than MS

Datatype

text

Alias
UMLS CUI [1]
C0027765
Neurological examination result
Beschrijving

Neurological examination result

Datatype

text

Alias
UMLS CUI [1]
C0027853
Neurological examination comment
Beschrijving

Neurological examination comment

Datatype

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0947611
EDSS Score
Beschrijving

Expanded Disability Status Scale (Kurtzke Score)

Datatype

float

Alias
UMLS CUI [1]
C0451246
MS relapses
Beschrijving

MS relapses

Alias
UMLS CUI-1
C0856120
MS exacerbations since last visit
Beschrijving

MS exacerbations since last visit

Datatype

integer

Alias
UMLS CUI [1,1]
C0581392
UMLS CUI [1,2]
C2047944
Steroid therapy used for recent MS relapses
Beschrijving

Steroid therapy used for recent MS relapses

Datatype

text

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0856120
Laboratory (Blood chemistry/Heamatology)
Beschrijving

Laboratory (Blood chemistry/Heamatology)

Alias
UMLS CUI-1
C0022877
ALT-level (GPT)
Beschrijving

ALT-level (GPT)

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
AST-level (GOT)
Beschrijving

AST-level (GOT)

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
HbA1C
Beschrijving

HbA1C

Datatype

float

Maateenheden
  • mmol/mol
Alias
UMLS CUI [1]
C0019018
mmol/mol
Alkaline phosphatase
Beschrijving

Alkaline phosphatase

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
GGT
Beschrijving

GGT

Datatype

float

Maateenheden
  • U/L
Alias
UMLS CUI [1]
C0202035
U/L
Total Bilirubin
Beschrijving

Total Bilirubin

Datatype

float

Maateenheden
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
WBC
Beschrijving

WBC

Datatype

float

Maateenheden
  • Tsd./uL
Alias
UMLS CUI [1]
C0023508
Tsd./uL
Lymphocytes
Beschrijving

Lymphocytes

Datatype

float

Maateenheden
  • Tsd./uL
Alias
UMLS CUI [1]
C0200635
Tsd./uL
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Similar models

ToFingo Screening V1 Physical examination NCT02325440

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Study administration
Data entry for this CRF completed
Item
Data entry for this CRF completed
boolean
C3899518 (UMLS CUI [1])
Assessment Date
Item
Assessment date
date
C0011008 (UMLS CUI [1])
Current patient (ID)
Item
Current patient (ID)
text
C2348585 (UMLS CUI [1])
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Head and neck: Result
Item
Head and neck: Result
text
C0031809 (UMLS CUI [1,1])
C0460004 (UMLS CUI [1,2])
Head and neck: Comment
Item
Head and neck: Comment
text
C0460004 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Lung: Result
Item
Lung: Result
text
C0031809 (UMLS CUI [1,1])
C0024109 (UMLS CUI [1,2])
Lung: Comment
Item
Lung: Comment
text
C0024109 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Skin: Result
Item
Skin: Result
text
C0031809 (UMLS CUI [1,1])
C1123023 (UMLS CUI [1,2])
Skin: Comment
Item
Skin: Comment
text
C1123023 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Heart: Result
Item
Heart: Result
text
C0031809 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Heart: Comment
Item
Heart: Comment
text
C0018787 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Abdomen: Result
Item
Abdomen: Result
text
C0031809 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Abdomen: Comment
Item
Abdomen: Comment
text
C0000726 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
General appearance: Result
Item
General appearance: Result
text
C0031809 (UMLS CUI [1,1])
C1148438 (UMLS CUI [1,2])
General appearance: Comment
Item
General appearance: Comment
text
C1148438 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Body Height
Item
Body Height
integer
C0005890 (UMLS CUI [1])
Body weight
Item
Body weight
float
C0005910 (UMLS CUI [1])
Sitting pulse rate
Item
Sitting pulse rate
integer
C0018810 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Oral temperature
Item
Oral temperature
float
C0005903 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
systolic blood pressure
Item
systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Item Group
Neurological examination
C0027853 (UMLS CUI-1)
Neurological abnormality other than MS
Item
Neurological abnormality other than MS
text
C0027765 (UMLS CUI [1])
Neurological examination result
Item
Neurological examination result
text
C0027853 (UMLS CUI [1])
Neurological examination comment
Item
Neurological examination comment
text
C0027853 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
EDSS Score
Item
EDSS Score
float
C0451246 (UMLS CUI [1])
Item Group
MS relapses
C0856120 (UMLS CUI-1)
MS exacerbations since last visit
Item
MS exacerbations since last visit
integer
C0581392 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
Steroid therapy used for recent MS relapses
Item
Steroid therapy used for recent MS relapses
text
C0149783 (UMLS CUI [1,1])
C0856120 (UMLS CUI [1,2])
Item Group
Laboratory (Blood chemistry/Heamatology)
C0022877 (UMLS CUI-1)
ALT-level (GPT)
Item
ALT-level (GPT)
float
C0201836 (UMLS CUI [1])
AST-level (GOT)
Item
AST-level (GOT)
float
C0201899 (UMLS CUI [1])
HbA1C
Item
HbA1C
float
C0019018 (UMLS CUI [1])
Alkaline phosphatase
Item
Alkaline phosphatase
float
C0201850 (UMLS CUI [1])
GGT
Item
GGT
float
C0202035 (UMLS CUI [1])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
WBC
Item
WBC
float
C0023508 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0200635 (UMLS CUI [1])
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