ID

15786

Descripción

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

Palabras clave

Versiones (3)
  1. 1/6/16 1/6/16 -
  2. 3/6/16 3/6/16 -
  3. 13/6/16 13/6/16 -
Subido en

13 de junio de 2016

DOI

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Licencia

Creative Commons BY 4.0
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ToFingo Screening V1 Physical examination NCT02325440

Alemán Inglés

ToFingo Screening V1 Physical examination NCT02325440

1 formularios  
Study administration
Descripción

Study administration

Data entry for this CRF completed
Descripción

Data entry for this CRF completed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3899518
Assessment Date
Descripción

Assessment Date

Tipo de datos

date

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

Current patient (ID)

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Physical examination
Descripción

Physical examination

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

Head and neck: Result

Tipo de datos

text

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

Head and neck: Comment

Tipo de datos

text

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

Lung: Result

Tipo de datos

text

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

Lung: Comment

Tipo de datos

text

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

Skin: Result

Tipo de datos

text

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

Skin: Comment

Tipo de datos

text

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

Heart: Result

Tipo de datos

text

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

Heart: Comment

Tipo de datos

text

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

Abdomen: Result

Tipo de datos

text

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

Abdomen: Comment

Tipo de datos

text

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

General appearance: Result

Tipo de datos

text

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

General appearance: Comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1148438
UMLS CUI [1,2]
C0947611
Vitalzeichen
Descripción

Vitalzeichen

Alias
UMLS CUI-1
C0518766
Body Height
Descripción

Body Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Descripción

Body weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting pulse rate
Descripción

Sitting pulse rate

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
bpm
Oral temperature
Descripción

Oral temperature

Tipo de datos

float

Unidades de medida
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
Blutdruck syst.
Descripción

systolic blood pressure

Tipo de datos

integer

Unidades de medida
  • /minute
Alias
UMLS CUI [1]
C0871470
/minute
Diastolic blood pressure
Descripción

Diastolic blood pressure

Tipo de datos

integer

Unidades de medida
  • /minute
Alias
UMLS CUI [1]
C0428883
/minute
Neurological examination
Descripción

Neurological examination

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

Neurological abnormality other than MS

Tipo de datos

text

Alias
UMLS CUI [1]
C0027765
Neurological examination result
Descripción

Neurological examination result

Tipo de datos

text

Alias
UMLS CUI [1]
C0027853
Neurological examination comment
Descripción

Neurological examination comment

Tipo de datos

text

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

EDSS Score

Tipo de datos

float

Alias
UMLS CUI [1]
C0451246
MS relapses
Descripción

MS relapses

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

MS exacerbations since last visit

Tipo de datos

integer

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

Steroid therapy used for recent MS relapses

Tipo de datos

text

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

Laboratory (Blood chemistry/Heamatology)

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

ALT-level (GPT)

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
AST-level (GOT)
Descripción

AST-level (GOT)

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
HbA1C
Descripción

HbA1C

Tipo de datos

float

Unidades de medida
  • mmol/mol
Alias
UMLS CUI [1]
C0019018
mmol/mol
Alkaline phosphatase
Descripción

Alkaline phosphatase

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
GGT
Descripción

GGT

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0202035
U/L
Total Bilirubin
Descripción

Total Bilirubin

Tipo de datos

float

Unidades de medida
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
WBC
Descripción

WBC

Tipo de datos

float

Unidades de medida
  • Tsd./uL
Alias
UMLS CUI [1]
C0023508
Tsd./uL
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

float

Unidades de medida
  • Tsd./uL
Alias
UMLS CUI [1]
C0200635
Tsd./uL
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Similar models

ToFingo Screening V1 Physical examination NCT02325440

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