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

Link

https://clinicaltrials.gov/ct2/show/NCT02325440

Keywords

Versions (3)
  1. 6/1/16 6/1/16 -
  2. 6/3/16 6/3/16 -
  3. 6/13/16 6/13/16 -
Uploaded on

June 13, 2016

DOI

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License

Creative Commons BY 4.0
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ToFingo Screening V1 Physical examination NCT02325440

German English

ToFingo Screening V1 Physical examination NCT02325440

1 forms  
Study administration
Description

Study administration

Data entry for this CRF completed
Description

Data entry for this CRF completed

Data type

boolean

Alias
UMLS CUI [1]
C3899518
Assessment date
Description

Assessment Date

Data type

date

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

Current patient (ID)

Data type

text

Alias
UMLS CUI [1]
C2348585
Physical examination
Description

Physical examination

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

Head and neck: Result

Data type

text

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

Head and neck: Comment

Data type

text

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

Lung: Result

Data type

text

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

Lung: Comment

Data type

text

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

Skin: Result

Data type

text

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

Skin: Comment

Data type

text

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

Heart: Result

Data type

text

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

Heart: Comment

Data type

text

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

Abdomen: Result

Data type

text

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

Abdomen: Comment

Data type

text

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

General appearance: Result

Data type

text

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

General appearance: Comment

Data type

text

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

Vital signs

Alias
UMLS CUI-1
C0518766
Body Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Body weight
Description

Body weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Sitting pulse rate
Description

Sitting pulse rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0277814
bpm
Oral temperature
Description

Oral temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0442027
°C
systolic blood pressure
Description

systolic blood pressure

Data type

integer

Measurement units
  • /minute
Alias
UMLS CUI [1]
C0871470
/minute
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • /minute
Alias
UMLS CUI [1]
C0428883
/minute
Neurological examination
Description

Neurological examination

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

Neurological abnormality other than MS

Data type

text

Alias
UMLS CUI [1]
C0027765
Neurological examination result
Description

Neurological examination result

Data type

text

Alias
UMLS CUI [1]
C0027853
Neurological examination comment
Description

Neurological examination comment

Data type

text

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

Expanded Disability Status Scale (Kurtzke Score)

Data type

float

Alias
UMLS CUI [1]
C0451246
MS relapses
Description

MS relapses

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

MS exacerbations since last visit

Data type

integer

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

Steroid therapy used for recent MS relapses

Data type

text

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

Laboratory (Blood chemistry/Heamatology)

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

ALT-level (GPT)

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
AST-level (GOT)
Description

AST-level (GOT)

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
HbA1C
Description

HbA1C

Data type

float

Measurement units
  • mmol/mol
Alias
UMLS CUI [1]
C0019018
mmol/mol
Alkaline phosphatase
Description

Alkaline phosphatase

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
GGT
Description

GGT

Data type

float

Measurement units
  • U/L
Alias
UMLS CUI [1]
C0202035
U/L
Total Bilirubin
Description

Total Bilirubin

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201913
mg/dL
WBC
Description

WBC

Data type

float

Measurement units
  • Tsd./uL
Alias
UMLS CUI [1]
C0023508
Tsd./uL
Lymphocytes
Description

Lymphocytes

Data type

float

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

ToFingo Screening V1 Physical examination NCT02325440

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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